Resources & Links

Byeong: Hello, everyone. Thank you for joining us.

Byeong: Today, we are going to hear a diverse perspective from a multidisciplinary healthcare team members who have operationalized IMDELLTRA^®, tarlatamab-dlle, in their practice.

Byeong: This promotional product program is being presented on behalf of Amgen, the program sponsor. It has been reviewed as consistent with Amgen's internal review policies. The speakers have also been compensated for their time.

Narrator: INDICATION
IMDELLTRA^® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR
CELL-ASSOCIATED NEUROTOXICITY SYNDROME
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Initiate treatment with IMDELLTRA^® using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA^® until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA^® until ICANS resolves or permanently discontinue based on severity.

Byeong: Hi, I’m Byeong Yoon, and I’m privileged to be joined by Dr Martin Dietrich, Dr Wade Iams, Megan May, Sarah Karpen, and Angie Swaim to discuss patient identification and site readiness considerations as it relates to operationalization of IMDELLTRA^® in clinical practice.
To kick us off, Dr Iams, could you please tell us about your first steps in adopting IMDELLTRA^® in your clinic?
Dr Iams: The first step in planning how to adopt IMDELLTRA^® treatment is identifying eligible patients.

Dr Iams: IMDELLTRA^® is indicated for the treatment of adult patients with extensive stage small cell lung cancer who experience disease progression on or after platinum-based chemotherapy.
This means that any patient with extensive-stage small cell lung cancer who has progressed following first-line treatment may be eligible for IMDELLTRA^®.
Byeong: Dr Iams, what do you typically look for in a first-line patient to indicate that progression may have started and when you should start considering a second-line treatment?
Dr Iams: In my experience, I've had patients on first-line maintenance therapy that progress radiographically, meaning the patient has stable clinical symptoms, but the CT scan reveals cancer growth. In this scenario, I typically move to second-line therapy with the identification of progression on the CT scan. Other times, patients on first-line therapy have worsening clinical symptoms such as dyspnea, cough or weight loss. Upon the worsening of these symptoms, I plan second-line therapy, obtain repeat imaging, and if cancer growth is confirmed radiographically, I typically move to second-line therapy.
Different types of doctors on the care team such as a medical oncologist or a thoracic oncologist may be able to help identify treatment-eligible patients.
Tracker systems within the EMR may help identify patients who are potentially eligible for treatments like IMDELLTRA^®. These tracker systems may help flag patients and schedule them for treatment within days.

Angie: Once an eligible patient is prescribed treatment, they should always talk to their doctor to learn more. Other resources include nurses, nurse navigators who can connect with the patient to understand their educational needs, available support system and overall motivation to continue treatment.
Assessing caregiver support available to the patient throughout the treatment process may be a step in knowing how to navigate the care process.
It may be helpful to assign a social worker for a patient follow-up and support.
Because of the need to be within proximity of a healthcare center during treatment with IMDELLTRA^®, some patients may need help finding a place to live after discharge, which is something a social worker may be able to assist with.
Nurses, nurse navigators or advanced practice providers can help educate patients on their treatment regimens, potential adverse reactions and when to contact their provider.
Consider communicating to patients at their health literacy level to empower them and make them feel as comfortable as possible. This may also be an opportunity to introduce them to patient support groups that may be available in the community.
Along with community and patient support, there may be programs available at hospitals for patients who do not have caregiver support. Additionally, Amgen^® SupportPlus and Amgen^® Patient Navigators can help patients and caregivers navigate treatment logistics.
Byeong: Thank you, Angie. That is all such important information. I know we'll have an opportunity to talk about this in a little bit more detail later, but turning back to you, Dr May, can you talk about the multidisciplinary collaboration?

Dr May: So once patients are identified, sites will need to be operationally ready to administer treatment.
Adopting a bispecific antibody program requires engagement across the care team. Consider having an established multidisciplinary team and clinical champions, also referred to as institutional champions, as they may help with an adoption of treatment like IMDELLTRA^®.
These institutional champions may also serve as a constant source of information for the rest of the practice while they're getting familiar with IMDELLTRA^®.
An example that may exemplify the importance of this could be during night shifts. If a non-thoracic or general oncologist is on staff and taking care of an IMDELLTRA^® patient, he or she may be able to reach the thoracic clinical oncologist champion should they have any questions.
Key members of the multidisciplinary team may include clinical or institutional champions, physicians, nurses, pharmacists, nurse navigators, and administrative support staff.
Expanding on the responsibilities of pharmacists, we are involved in shaping medication policies during the Pharmacy and Therapeutics Committee meetings. We verify financial support for patients, create institutional protocols and build treatment plans into EMRs. This can also outline the drug handling and storage of therapies as well as ordering medications.
For IMDELLTRA^®, we may consider meeting with the Pharmacy and Therapeutics Committee early and often in order to expedite decision processes, given how rapidly progressive small cell lung cancer can be.
Byeong: Speaking of ordering medication, Dr May, can you tell us how one can order IMDELLTRA^®?
Dr May: IMDELLTRA^® can be ordered at specific specialty distributors.

Dr Iams: Expanding more on collaboration for adoption of treatment, consider creating co-management strategies between community oncologists and referral medical centers, as well as building strong relationships to help build referral pathways.
Also, there may be opportunities to partner with hematology teams that have experience with bispecific antibodies.
Byeong: Dr Iams, can you briefly share with us your experience about an established team of clinical champions and how that helped operationalize a treatment like IMDELLTRA^® in your clinical practice?
Dr Iams: In my experience, having a clinical champion may be helpful to help the organization move towards being able to administer IMDELLTRA^® safely.
Importantly, having Pharmacy and Therapeutics colleagues involved in the process from the beginning and engaged throughout the execution of IMDELLTRA^® administration can help expedite the process.

Dr Dietrich: In addition to having an established care team, there are several logistical considerations when it comes to adoption of treatments like IMDELLTRA^®.
Considerations of adoption of IMDELLTRA^® include bed availability, training staff, including PI, dosing and administration and safety, access to equipment and medications for adverse reactions, treatment protocols and EMR order sets. Your pharmacist may be able to help build those.

Sarah: As Dr. Dietrich mentioned, it’s important that the whole care team is trained on and understands the IMDELLTRA^® USPI.
Sites should consider comprehensive training programs for staff, as training may help prevent gaps in staff education.
Sites should consider tailoring education for different members of the multidisciplinary team based on their roles and offering regular training to new and/or rotating staff so that they are always prepared.

Dr Iams: Speaking of treatment protocols, they may include patient eligibility criteria, dosing guidelines, administration procedures, strategies for managing potential adverse reactions within the institution.
Consider developing electronic health record order sets as this may reduce the chance of medication errors.
We’ll speak to IMDELLTRA^®-specific strategies for managing potential adverse reactions based on the USPI shortly.

Sarah: I’d like to reiterate that IMDELLTRA^® should only be administered by a qualified healthcare professional with appropriate medical support to manage adverse reactions of special interest.

Angie: As mentioned earlier, given that treatment with bispecific antibodies requires travel to and from an infusion center, consider travel logistics.
Nurse navigators and social workers may help verify that patients have reliable transportation or a caregiver that can drive them to the treatment center.
In my experience, nurse navigators and social workers might also be able to point patients in the direction of local advocacy organizations for additional support.
Byeong: Thank you, Angie, for those comments, and thank you all for joining us and for this illuminating discussion. I found the discussion very helpful, and I'm sure our audience will as well.

Narrator: IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Cytokine Release Syndrome (CRS): IMDELLTRA^® can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA^®, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA^®-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.
Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA^® was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA^® was 15 hours (range: start of infusion to 15 days).
Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).
Administer IMDELLTRA^® following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA^® in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA^®. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA^®. At the first sign of CRS, immediately discontinue IMDELLTRA^® infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA^® based on severity. Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.
Neurologic Toxicity, Including ICANS: IMDELLTRA^® can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA^®, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA^®-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA^®. The median time to onset of ICANS from the first dose of IMDELLTRA^® was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days).
The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.
Patients receiving IMDELLTRA^® are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.
Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA^®. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA^® or permanently discontinue based on severity.
Cytopenias: IMDELLTRA^® can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA^®.
Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA^®, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA^®.
Infections: IMDELLTRA^® can cause serious infections, including life-threatening and fatal infections.
In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA^®, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%).
Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA^® and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA^® based on severity.
Hepatotoxicity: IMDELLTRA^® can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA^®, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS.
Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA^®, and as clinically indicated. Withhold IMDELLTRA^® or permanently discontinue based on severity.
Hypersensitivity: IMDELLTRA^® can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA^® and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA^® based on severity.
Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA^® may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA^® and for 2 months after the last dose.
ADVERSE REACTIONS
The pooled safety population reflects exposure to intravenous IMDELLTRA^®, as a single agent, at the recommended dosage of IMDELLTRA^® 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA^®, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year.
The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%).
The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%).
DOSAGE AND ADMINISTRATION: Important Dosing Information
Administer IMDELLTRA^® as an intravenous infusion over 1 hour.
Administer IMDELLTRA^® according to the step-up dose and schedule in the IMDELLTRA^® PI (Table 1) to reduce the incidence and severity of CRS.
Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA^® up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA^® on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
IMDELLTRA^® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA^® infusion for 22 to 24 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA^® following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
Ensure patients are well hydrated prior to administration of IMDELLTRA^®.
INDICATION
IMDELLTRA^® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Please see IMDELLTRA^® full Prescribing Information, including BOXED WARNINGS.

Byeong: Hello, everyone. Thank you for joining us.

Byeong: Today, we are going to hear a diverse perspective from a multidisciplinary healthcare team members who have operationalized IMDELLTRA^®, tarlatamab-dlle, in their practice.
Byeong: This promotional product program is being presented on behalf of Amgen, the program sponsor. It has been reviewed as consistent with Amgen's internal review policies. The speakers have also been compensated for their time.

Narrator: INDICATION
IMDELLTRA^® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR
CELL-ASSOCIATED NEUROTOXICITY SYNDROME
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Initiate treatment with IMDELLTRA^® using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA^® until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA^® until ICANS resolves or permanently discontinue based on severity.

Byeong: Hi, I’m Byeong Yoon, and I’m privileged to be joined by Dr Martin Dietrich, Megan May, Sarah Karpen, and Angie Swaim to discuss IMDELLTRA^® safety and monitoring requirements, and how sites may prepare to train the care team. Sarah, could you help kick us off?
Sarah: Please remember how it may be important to properly train hospital staff, including the emergency department, ICU staff, and hospitalists, on identifying and managing adverse reactions associated with treatment.

Dr Dietrich: CRS and neurologic toxicity, including ICANS, are adverse reactions of special interest when treating patients with IMDELLTRA^®.
Clinical signs and symptoms of CRS include pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation CRS can be evaluated using the 2019 American Society for Transplantation and Cellular Therapy, or ASTCT, consensus grading criteria.

Dr Dietrich: The grading is based on the presence of fever and the degree of hypotension and hypoxia, as you can see in this table.

Dr Dietrich: Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.

Dr Dietrich: ICANS grading is determined by the most severe events.
Nurses may be able to identify the signs and symptoms of CRS and neurologic toxicity, including ICANS, in clinical practice.

Dr Dietrich: For example, via up-to-date training on the IMDELLTRA^® USPI, AE checklist resources, and institutional protocols.
Also, healthcare teams may communicate within the EMR system on signs and symptoms to monitor for adverse events.

Dr Dietrich: CRS may, depending on grade, be managed with supplemental oxygen and intravenous (IV) fluids, tocilizumab, corticosteroids, vasopressor care, and/or ICU care.

Dr Dietrich: Neurologic toxicity, including ICANS, may, depending on grade, be managed with supportive care, corticosteroids, ICU care, mechanical ventilation, and/or convulsive treatment.
Based on the IMDELLTRA^® full Prescribing Information, IMDELLTRA^® should be withheld or permanently discontinued based on CRS and neurologic toxicity and ICANS severity.

Dr May: Consider having institutional protocols set in place for care teams to refer to when monitoring for and managing adverse reactions such as CRS and neurologic toxicities, including ICANS.
Consider training hospital staff on treating CRS and neurologic toxicities. Hospital staff should refer to the IMDELLTRA^® US Prescribing Information as the main resource and other resources could include institutional protocols, pocket-sized resources and resources available through the EMR.
There are downloadable resources on imdelltrahcp.com to support care teams throughout the administration and monitoring journey.

Angie: Knowing how to treat CRS and ICANS is certainly critical, but patient and caregiver support throughout treatment is also important.
Connecting with a nurse navigator may help address patients’ concerns about treatment and potential adverse reactions, especially when friendly conversations are had up front.
Direct communication may help identify any fears patients may have and may help to educate patients about what to expect with treatment.
Additionally, advanced practice providers may help educate patients about their treatment regimen and how to monitor for symptoms at home. They may also provide educational materials for patients and caregivers to refer to at home.
Patients should also be educated on when to contact their providers.
Consider providing patients with a communication plan with contact information should they have questions throughout the treatment journey.
It may be helpful to also provide patients with community resources, such as information about patient support groups.
Amgen has resources to support the treatment journey, like the IMDELLTRA^® Wallet Card.
From a staff training perspective, consider training nurse navigators who are provided by HCPs to follow up with patients at specific time points throughout the treatment journey. Nurse navigators may be involved at the beginning of care, but also throughout the entire treatment journey.
Byeong: Thanks for sharing those insights, Angie.

Narrator: IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Cytokine Release Syndrome (CRS): IMDELLTRA^® can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA^®, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA^®-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.
Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA^® was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA^® was 15 hours (range: start of infusion to 15 days).
Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).
Administer IMDELLTRA^® following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA^® in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA^®. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA^®. At the first sign of CRS, immediately discontinue IMDELLTRA^® infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA^® based on severity. Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.
Neurologic Toxicity, Including ICANS: IMDELLTRA^® can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA^®, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA^®-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA^®. The median time to onset of ICANS from the first dose of IMDELLTRA^® was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days).
The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.
Patients receiving IMDELLTRA^® are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.
Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA^®. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA^® or permanently discontinue based on severity.
Cytopenias: IMDELLTRA^® can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA^®.
Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA^®, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA^®.
Infections: IMDELLTRA^® can cause serious infections, including life-threatening and fatal infections.
In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA^®, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%).
Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA^® and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA^® based on severity.
Hepatotoxicity: IMDELLTRA^® can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA^®, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS.
Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA^®, and as clinically indicated. Withhold IMDELLTRA^® or permanently discontinue based on severity.
Hypersensitivity: IMDELLTRA^® can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA^® and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA^® based on severity.
Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA^® may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA^® and for 2 months after the last dose.
ADVERSE REACTIONS
The pooled safety population reflects exposure to intravenous IMDELLTRA^®, as a single agent, at the recommended dosage of IMDELLTRA^® 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA^®, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year.
The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%).
The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%).
DOSAGE AND ADMINISTRATION: Important Dosing Information
Administer IMDELLTRA^® as an intravenous infusion over 1 hour.
Administer IMDELLTRA^® according to the step-up dose and schedule in the IMDELLTRA^® PI (Table 1) to reduce the incidence and severity of CRS.
Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA^® up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA^® on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
IMDELLTRA^® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA^® infusion for 22 to 24 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA^® following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
Ensure patients are well hydrated prior to administration of IMDELLTRA^®.
INDICATION
IMDELLTRA^® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Please see IMDELLTRA^® full Prescribing Information, including BOXED WARNINGS.

Byeong: Hello, everyone. Thank you for joining us.

Byeong: Today, we are going to hear a diverse perspective from a multidisciplinary healthcare team members who have operationalized IMDELLTRA^®, tarlatamab-dlle, in their practice.
Byeong: This promotional product program is being presented on behalf of Amgen, the program sponsor. It has been reviewed as consistent with Amgen's internal review policies. The speakers have also been compensated for their time.

Narrator: INDICATION
IMDELLTRA^® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR
CELL-ASSOCIATED NEUROTOXICITY SYNDROME
Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Initiate treatment with IMDELLTRA^® using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA^® until CRS resolves or permanently discontinue based on severity.
Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA^®. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA^® until ICANS resolves or permanently discontinue based on severity.

Byeong: Hi, I’m Byeong Yoon, and I’m privileged to be joined by Dr Martin Dietrich, Dr Wade Iams, Angie Swaim, and Debbie Vizirakis-Savone to discuss considerations for transitions of care as it relates to IMDELLTRA^® treatment.
Dr Dietrich, once an eligible patient is identified for IMDELLTRA^®, what is that next step?
Dr Dietrich: Once we identify a patient and deem them eligible for IMDELLTRA^® treatment, I think the first step is to consider a comprehensive treatment plan.
I think a lot of it is logistics. I think we have to plan where the patient's going to be receiving the initial doses of the therapy and then where the subsequent doses are delivered for the patient, so I think it's very important to think about the entire context of the treatment.
It's helpful to have clear communication between the different moving parts of the care delivery. I think that's a mix between the infusion units and the appropriate healthcare setting where we will deliver the observation part of the care and then the other subsequent doses of therapy in the outpatient setting. So we're trying to utilize the coordination between the different aspects here in a tight coordination.
The use of the EMR is helpful for us. We remind ourselves of the monitoring parameters of the supportive care medication that changes along the treatment step, and at my institution, what we do is we try to update ourselves beyond the electronic medical record by basically providing up-to-date contact information that may be new team members that are in participation of the care delivery in that day, and so making us accessible so that if there are any problems that are occurring that we're able to provide immediate updates and pivot to side effects that may occur.

Dr Iams: Having trained staff and considering critical care and equipment needs across sites of care and the steps of the treatment journey may be important.
Again, institutional champions may help with initiating efforts based on their prior experience with bispecific antibodies.

Angie: As we think about continuation of treatment, it may be important to think about patient access and considerations regarding coverage for treatment across all sites of care.
It may be important to keep in mind that the site of care considerations like inpatient versus outpatient and hospital versus clinic may impact billing and reimbursement for IMDELLTRA^® and that different codes and requirements may be required based on the site of care.

Dr Iams: It may be important to have established transition-of-care plans when needing to transfer patients. Consider creating a transition-of-care plan and checking for admission availability. Give patients clear guidance on how their oncologist will coordinate post-treatment care and monitor for adverse reactions.
It may be helpful to educate the patient's caregiver so that they are clear on the coordination of care process and expectations.
Consider proactively partnering with other institutions. It may be important for partner institutions to also be operationally ready to administer IMDELLTRA^®.
Examples of elements for adoption of IMDELLTRA^® at partner institutions can include available bed space, training of staff on the USPI, for example, on dosing, administration, and monitoring requirements based on the USPI.
Ensuring admission availability to manage adverse reactions of special interest is another consideration. It may be important to maintain communication between care settings and during the treatment process.
The use of EMRs across the continuum of care may be helpful for ensuring providers are informed about patients who are receiving IMDELLTRA^®.
For example, within EMRs, alerts may be tailored to inform healthcare team members that a patient recently received IMDELLTRA^®.

Angie: As mentioned earlier, continuation of care may be challenging to coordinate, especially when patients need to travel far distances for longer time periods for treatment and may not have live-in caregiver support. Giving patients access to programs like Amgen SupportPlus may help.
Proactively consider whether caregivers can provide patients with transportation to and from the hospital or the clinic. And then we mentioned telehealth; this may be appropriate for follow-up care or for patients who live further from care centers.
Another consideration is to give patients and caregivers contact information for providers in the clinic and clear instructions on what to do in the case of an emergency.
Again, we have an IMDELLTRA^® Wallet Card available for patients so that they have a place to keep important contacts and information with them during treatment. In my clinical experience, it is also helpful to provide patients with an information sheet that clearly outlines members of their care team and their roles and responsibilities.

Debbie: As mentioned, patients may also turn to programs like Amgen SupportPlus and specifically the Amgen Patient Navigator Program. An Amgen Patient Navigator is a single point of contact to help answer questions about access and reimbursement, navigating treatment logistics, and to provide supplemental resources as your patients transition from hospital to outpatient care on their Amgen therapy. Amgen Patient Navigators can work with any member of your practice to help with benefits verification and understanding coverage, navigating the prior authorization process, reimbursement and access resources, navigating treatment logistics for the Amgen therapy, education on patient coverage, and on documentation required for sites of care transitioning. They can also answer general questions about the reimbursement process for the Amgen therapy.
Now, please note the Amgen Patient Navigator is not a part of a patient's treatment team and does not provide medical advice or case management services. The Amgen Patient Navigator does not administer Amgen medications. Patients should always consult with their healthcare provider regarding medical decisions or treatment concerns.
Now, it is helpful for patients and caregivers to have access to resources available each step of the way for each site of care. This can include educational resources on treatments and patient support programs.
Additional patient resources, including the Amgen SupportPlus Co-Pay Program, financial support, and Amgen Patient Navigators can be found at IMDELLTRA.com.

Narrator: IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Cytokine Release Syndrome (CRS): IMDELLTRA^® can cause CRS including life-threatening or fatal reactions. In the pooled safety population, CRS occurred in 57% (268/473) of patients who received IMDELLTRA^®, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4. Recurrent CRS occurred in 24% of IMDELLTRA^®-treated patients including 20% Grade 1 and 3.4% Grade 2; one patient experienced recurrent Grade 3.
Among the 268 patients who experienced CRS, 73% had CRS after the first dose, 60% had CRS after the second dose, and 15% had CRS following the third or later dose. Following the Cycle 1 Day 1, Day 8, Day 15 infusions, 24%, 8%, and 1% of patients experienced Grade ≥ 2 CRS, respectively. From Cycle 2 onwards, 1.5% of patients experienced Grade ≥ 2 CRS. Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab. The median time to onset of all grade CRS from most recent dose of IMDELLTRA^® was 16 hours (range: start of infusion to 15 days). The median time to onset of Grade ≥ 2 CRS from most recent dose of IMDELLTRA^® was 15 hours (range: start of infusion to 15 days).
Clinical signs and symptoms of CRS included pyrexia, hypotension, fatigue, tachycardia, headache, hypoxia, nausea, and vomiting. Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC).
Administer IMDELLTRA^® following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRA^® in an appropriate healthcare facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRA^®. Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRA^®. At the first sign of CRS, immediately discontinue IMDELLTRA^® infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRA^® based on severity. Counsel patients and caregivers to seek medical attention should signs or symptoms of CRS occur.
Neurologic Toxicity, Including ICANS: IMDELLTRA^® can cause life-threatening or fatal neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity occurred in 65% of patients who received IMDELLTRA^®, with Grade 3 or higher events in 7% of patients including fatal events in 0.2%. The most frequent neurologic toxicities were dysgeusia (34%), headache (17%), peripheral neuropathy (9%), dizziness (9%), and insomnia (8%). The incidence of signs and symptoms consistent with ICANS was 10% in IMDELLTRA^®-treated patients including events with the preferred terms: ICANS (4.7%), muscular weakness (3.2%), cognitive disorder (0.6%), aphasia (0.6%), depressed level of consciousness (0.4%), seizures (0.4%), encephalopathy (0.4%), and leukoencephalopathy (0.2%). There was one fatal reaction of ICANS. Recurrent ICANS occurred in 1.5% of patients. Of the patients who experienced ICANS, most experienced the event following Cycle 1 Day 1 (2.5%) and Cycle 1 Day 8 (3.6%). Following Day 1, Day 8, and Day 15 infusions, 1.3%, 1.3% and 0.4% of patients experienced Grade ≥ 2 ICANS, respectively. ICANS can occur several weeks following administration of IMDELLTRA^®. The median time to onset of ICANS from the first dose of IMDELLTRA^® was 16 days (range: 1 to 862 days). The median time to resolution of ICANS was 4 days (range: 1 to 40 days).
The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia.
Patients receiving IMDELLTRA^® are at risk of neurologic adverse reactions and ICANS resulting in depressed level of consciousness. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until neurologic symptoms resolve.
Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment with IMDELLTRA^®. At the first sign of ICANS, immediately discontinue the infusion, evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRA^® or permanently discontinue based on severity.
Cytopenias: IMDELLTRA^® can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, based on laboratory data, decreased neutrophils occurred in 16% of patients, including 9% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased neutrophil count was 41 days (range: 2 to 306 days). Decreased platelets occurred in 30% including 2.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 67 days (range: 3 to 420 days). Decreased hemoglobin occurred in 56% of patients, including 4.7% Grade 3 or 4. Febrile neutropenia was reported as an adverse event in 1.5% of patients treated with IMDELLTRA^®.
Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with all doses of IMDELLTRA^®, up through Cycle 5 Day 15 and then prior to administration on Day 1 of each cycle starting with Cycle 6. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRA^®.
Infections: IMDELLTRA^® can cause serious infections, including life-threatening and fatal infections.
In the pooled safety population, infections, including opportunistic infections, occurred in 43% of patients who received IMDELLTRA^®, including 14% Grade 3 or 4. The most frequent infections were pneumonia (11%), urinary tract infection (9%), COVID-19 (6%), upper respiratory tract infection (4.7%), respiratory tract infection (4%), candida infection (2.1%), oral candidiasis (2.1%), and nasopharyngitis (2.1%).
Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRA^® and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRA^® based on severity.
Hepatotoxicity: IMDELLTRA^® can cause hepatotoxicity. In the pooled safety population, based on laboratory data, elevated ALT occurred in 39% of patients who received IMDELLTRA^®, including 2.5% with Grade 3 or 4 ALT. Elevated AST occurred in 43% of patients, including 3.2% Grade 3 or 4. Elevated bilirubin also occurred in 16% of patients, including 1.3% Grade 3 or 4. Liver enzyme elevation can occur with or without concurrent CRS.
Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRA^®, and as clinically indicated. Withhold IMDELLTRA^® or permanently discontinue based on severity.
Hypersensitivity: IMDELLTRA^® can cause severe hypersensitivity reactions. Clinical signs and symptoms of hypersensitivity may include, but are not limited to, rash and bronchospasm. Monitor patients for signs and symptoms of hypersensitivity during treatment with IMDELLTRA^® and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRA^® based on severity.
Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRA^® may cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMDELLTRA^® and for 2 months after the last dose.
ADVERSE REACTIONS
The pooled safety population reflects exposure to intravenous IMDELLTRA^®, as a single agent, at the recommended dosage of IMDELLTRA^® 1 mg on Cycle 1 Day 1 followed by 10 mg on Days 8 and 15, and then every 2 weeks until disease progression or intolerable toxicity in 473 patients with small cell lung cancer enrolled in three clinical trials: DeLLphi-300, DeLLphi-301 and DeLLphi-304. Among 473 patients who received IMDELLTRA^®, 40% were exposed for 6 months or longer and 19% were exposed for greater than one year.
The most common (≥ 20%) adverse reactions were CRS (57%), fatigue (48%), decreased appetite (38%), dysgeusia (34%), pyrexia (33%), constipation (31%), musculoskeletal pain (31%), and nausea (25%).
The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (43%), decreased sodium (12%), decreased total neutrophils (9%), and increased uric acid (6%).
DOSAGE AND ADMINISTRATION: Important Dosing Information
Administer IMDELLTRA^® as an intravenous infusion over 1 hour.
Administer IMDELLTRA^® according to the step-up dose and schedule in the IMDELLTRA^® PI (Table 1) to reduce the incidence and severity of CRS.
Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA^® up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA^® on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated.
For Cycle 1, administer recommended concomitant medications before and after Cycle 1 Day 1 and Cycle 1 Day 8 IMDELLTRA^® infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
IMDELLTRA^® should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including ICANS.
Due to the risk of CRS and neurologic toxicity, including ICANS, monitor patients from the start of the IMDELLTRA^® infusion for 22 to 24 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Recommend that patients remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA^® following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
Inform both the patient and the caregiver on the signs and symptoms of CRS and ICANS prior to discharge.
Ensure patients are well hydrated prior to administration of IMDELLTRA^®.
INDICATION
IMDELLTRA^® (tarlatamab-dlle) is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Please see IMDELLTRA^® full Prescribing Information, including BOXED WARNINGS.