AMGEN PRESENTS NEW DATA FOR FIRST-IN-CLASS IMDELLTRA™ (TARLATAMAB-DLLE) IN SMALL CELL LUNG CANCER AT WCLC 2024
Amgen (NASDAQ:AMGN) presented new data for IMDELLTRA™ (tarlatamab-dlle), a first-in-class DLL3-targeting BiTE® molecule, at the 2024 World Conference on Lung Cancer. The DeLLphi-303 study showed promising results for IMDELLTRA in combination with PD-L1 inhibitors as first-line maintenance therapy in ES-SCLC. Key findings include:
- Disease control rate of 62.5% for both IMDELLTRA plus durvalumab and atezolizumab
- 9-month overall survival of 91.8% with durvalumab and 86.7% with atezolizumab
- Manageable safety profile with no new safety concerns
Extended follow-up data from the DeLLphi-301 Phase 2 study demonstrated sustained anticancer activity in previously treated ES-SCLC patients, with a 40% objective response rate and median overall survival of 15.2 months.
Amgen (NASDAQ:AMGN) ha presentato nuovi dati per IMDELLTRA™ (tarlatamab-dlle), una molecola BiTE® di prima classe mirata a DLL3, durante la Conferenza Mondiale 2024 sul Cancro del Polmone. Lo studio DeLLphi-303 ha mostrato risultati promettenti per IMDELLTRA in combinazione con inibitori di PD-L1 come terapia di mantenimento di prima linea per l'ES-SCLC. I risultati chiave includono:
- Tasso di controllo della malattia del 62,5% sia per IMDELLTRA più durvalumab che per atezolizumab
- Sopravvivenza complessiva a 9 mesi del 91,8% con durvalumab e 86,7% con atezolizumab
- Profilo di sicurezza gestibile senza nuove problematiche di sicurezza
Dati di follow-up estesi dallo studio DeLLphi-301 di Fase 2 hanno dimostrato un'attività anticancro sostenuta in pazienti con ES-SCLC precedentemente trattati, con un tasso di risposta obiettiva del 40% e una sopravvivenza media complessiva di 15,2 mesi.
Amgen (NASDAQ:AMGN) presentó nuevos datos para IMDELLTRA™ (tarlatamab-dlle), una molécula BiTE® de primera clase dirigida a DLL3, en la Conferencia Mundial sobre Cáncer de Pulmón 2024. El estudio DeLLphi-303 mostró resultados prometedores para IMDELLTRA en combinación con inhibidores de PD-L1 como terapia de mantenimiento de primera línea para el ES-SCLC. Los hallazgos clave incluyen:
- Tasa de control de la enfermedad del 62.5% tanto para IMDELLTRA más durvalumab como atezolizumab
- Supervivencia general a 9 meses del 91.8% con durvalumab y 86.7% con atezolizumab
- Perfil de seguridad manejable sin nuevas preocupaciones de seguridad
Datos de seguimiento extendido del estudio DeLLphi-301 de Fase 2 demostraron actividad anticancerígena sostenida en pacientes con ES-SCLC previamente tratados, con una tasa de respuesta objetiva del 40% y una supervivencia general media de 15.2 meses.
암젠(NASDAQ:AMGN)은 2024년 세계 폐암 회의에서 DLL3을 겨냥한 1세대 BiTE® 분자인 IMDELLTRA™(tarlatamab-dlle)에 대한 새로운 데이터를 발표했습니다. DeLLphi-303 연구는 PD-L1 억제제와 함께 IMDELLTRA의 1차 유지 요법 동안의 효과에 대한 유망한 결과를 보여주었습니다. 주요 발견 사항은 다음과 같습니다:
- IMDELLTRA와 durvalumab 및 atezolizumab 모두에 대한 질병 조절률이 62.5%
- durvalumab을 포함한 9개월 전체 생존률이 91.8%, atezolizumab이 86.7%
- 새로운 안전성 문제 없이 관리 가능한 안전성 프로필
DeLLphi-301 2상 연구의 확장된 추적 데이터는 지속적인 항암 효과를 보여주었으며, 이전에 치료를 받은 ES-SCLC 환자에서 객관적인 반응율이 40%이고 중위 전체 생존률이 15.2개월로 나타났습니다.
Amgen (NASDAQ:AMGN) a présenté de nouvelles données sur IMDELLTRA™ (tarlatamab-dlle), une molécule BiTE® de première classe ciblant DLL3, lors de la Conférence Mondiale sur le Cancer du Poumon 2024. L'étude DeLLphi-303 a montré des résultats prometteurs pour IMDELLTRA en combinaison avec des inhibiteurs de PD-L1 en tant que thérapie de maintenance de première ligne dans le cas de l'ES-SCLC. Les résultats clés incluent :
- Taux de contrôle de la maladie de 62,5 % pour IMDELLTRA associé à durvalumab et atezolizumab
- Survie globale à 9 mois de 91,8 % avec durvalumab et 86,7 % avec atezolizumab
- Profil de sécurité gérable sans nouvelles préoccupations de sécurité
Les données de suivi prolongé de l'étude DeLLphi-301 de Phase 2 ont démontré une activité anticancéreuse soutenue chez des patients atteints d'ES-SCLC préalablement traités, avec un taux de réponse objectif de 40 % et une survie médiane globale de 15,2 mois.
Amgen (NASDAQ:AMGN) stellte neue Daten für IMDELLTRA™ (tarlatamab-dlle) vor, eine erstklassige BiTE®-Moleküle, die DLL3 angreift, auf der 2024 Weltkonferenz über Lungenkrebs. Die DeLLphi-303-Studie zeigte vielversprechende Ergebnisse für IMDELLTRA in Kombination mit PD-L1-Inhibitoren als Erstlinientherapie zur Erhaltung bei ES-SCLC. Wichtige Ergebnisse umfassen:
- Krankheitskontrollrate von 62,5% sowohl für IMDELLTRA plus Durvalumab als auch Atezolizumab
- 9-monatige Gesamtüberlebensrate von 91,8% mit Durvalumab und 86,7% mit Atezolizumab
- Handhabbares Sicherheitsprofil ohne neue Sicherheitsbedenken
Die verlängerten Nachverfolgdaten der DeLLphi-301-Phase-2-Studie zeigten anhaltende antitumorale Aktivität bei zuvor behandelten ES-SCLC-Patienten, mit einer objektiven Ansprechrate von 40% und einer medianen Gesamtüberlebenszeit von 15,2 Monaten.
- IMDELLTRA combined with PD-L1 inhibitors showed a 62.5% disease control rate in first-line maintenance ES-SCLC therapy
- 9-month overall survival rates of 91.8% and 86.7% for IMDELLTRA plus durvalumab and atezolizumab, respectively
- 40% objective response rate in previously treated ES-SCLC patients from DeLLphi-301 Phase 2 study
- Median overall survival of 15.2 months in previously treated ES-SCLC patients
- Treatment-related adverse events led to dose interruptions in 15-17% of cases
- IMDELLTRA discontinuation rates of 8% and 4% when combined with durvalumab and atezolizumab, respectively
- Occurrence of cytokine release syndrome, mostly grade 1-2, primarily in cycle 1
Insights
The data from DeLLphi-303 and DeLLphi-301 studies are highly promising for IMDELLTRA in SCLC treatment. The 62.5% disease control rate and 91.8% 9-month overall survival in first-line maintenance therapy are impressive outcomes for this aggressive cancer. The sustained efficacy in previously treated patients, with a 40% objective response rate and 15.2-month median overall survival, is remarkable. These results suggest IMDELLTRA could become a game-changer in SCLC treatment, potentially improving patient outcomes across different stages of the disease.
The safety profile of IMDELLTRA is encouraging. With only 15-17% dose interruptions and 4-8% discontinuations due to treatment-related adverse events, it appears well-tolerated. The manageable cytokine release syndrome, mostly grade 1-2 and infrequent ICANS further support its safety. The long-term tolerability observed in the DeLLphi-301 extended follow-up is particularly noteworthy. These factors could contribute to better patient compliance and potentially improved overall treatment outcomes in the real-world setting.
For Amgen, IMDELLTRA represents a significant market opportunity. As a first-in-class BiTE therapy for SCLC, it has the potential to capture a substantial share of this underserved market. The positive data in first-line maintenance could expand its use beyond the current FDA-approved indication, potentially increasing its revenue potential. The ongoing Phase 3 trial (DeLLphi-305) could further solidify its position. If successful, IMDELLTRA could become a cornerstone therapy in SCLC, potentially driving long-term growth for Amgen in the oncology sector.
DeLLphi-303 Study Results Show Potential for IMDELLTRA in Combination with a PD-L1 Inhibitor as First-Line Maintenance Therapy in ES-SCLC
DeLLphi-301 Long-Term Follow-up Data Demonstrate Sustained Safety and Efficacy for IMDELLTRA
IMDELLTRA will be featured in two oral presentations at the "DLL3 Targeting BiTE Therapies in SCLC" session, taking place today at 2:00 p.m. PDT. New data from the global Phase 1b DeLLphi-303 study of IMDELLTRA combined with PD-L1 inhibitors in first-line maintenance extensive-stage small cell lung cancer (ES-SCLC) will be presented as a late-breaking abstract (#LBA OA10.04). Additionally, long-term results from the Phase 2 DeLLphi-301 study in previously treated ES-SCLC will be highlighted as an oral presentation (#OA10.03).
"Earlier this year, the FDA approved IMDELLTRA for patients with extensive-stage small cell lung cancer who progressed on or after platinum-based chemotherapy. Today, we are thrilled to share results showing long-term sustained benefit in this setting as well as initial evidence supporting a combination approach in front-line maintenance therapy," said Jay Bradner, M.D., executive vice president, Research and Development, and chief scientific officer at Amgen. "These data support our goal to deliver an effective targeted immunotherapy to more patients living with this aggressive cancer."
DeLLphi-303 Phase 1b Study Data in First-Line Maintenance Therapy
IMDELLTRA combined with a PD-L1 inhibitor as first-line maintenance therapy in ES-SCLC demonstrated a manageable safety profile with sustained disease control and positive survival outcomes. Key findings include:
- IMDELLTRA plus a PD-L1 inhibitor: demonstrated a positive benefit: risk profile with no new or unexpected safety findings
- IMDELLTRA plus durvalumab: disease control rate (DCR) of
62.5% (95% CI: 45.8-77.3) and median duration of disease control (DoDC) that was Not Estimable (95% CI: 3.9, NE) - IMDELLTRA plus atezolizumab: DCR of
62.5% (95% CI: 47.4-76.0) and median DoDC of 7.2 months (95% CI: 5.6, NE) - Following a median time of 3.5 months from first-line chemoimmunotherapy to first-line maintenance:
- IMDELLTRA plus durvalumab showed a 9-month overall survival (OS) of
91.8% (95% CI: 76.6-97.3) and median progression-free survival (mPFS) of 5.3 months (95% CI: 3.5-NE) - IMDELLTRA plus atezolizumab showed a 9-month OS of
86.7% (95% CI: 70.3-94.4) and mPFS of 5.6 months (95% CI: 3.5-8.5)
- IMDELLTRA plus durvalumab showed a 9-month overall survival (OS) of
"Tarlatamab has been a major breakthrough for patients with extensive-stage small cell lung cancer, who have had limited options for the past 30 years, and these data are impressive as a potential first-line maintenance treatment as well," said Sally Lau, M.D., oncologist and assistant professor of medicine, Perlmutter Cancer Center, NYU Grossman School of Medicine. "In particular, tarlatamab in combination with a PD-L1 inhibitor showed exciting safety and efficacy, which strongly supports continued evaluation in the ongoing Phase 3 DeLLphi-305 trial."
In patients receiving IMDELLTRA plus durvalumab, treatment-related adverse events (TRAEs) resulted in dose interruptions in
DeLLphi-301 Phase 2 Extended Follow-up Data in ES-SCLC
Extended follow-up data from the DeLLphi-301 Phase 2 study demonstrated sustained anticancer activity and a manageable safety profile with IMDELLTRA in patients with ES-SCLC previously treated with platinum-based chemotherapy.
Among 100 patients treated with IMDELLTRA 10 mg biweekly, the objective response rate (ORR) was
About DeLLphi-303 Study
Preclinical studies indicated that IMDELLTRA upregulated PD-L1 expression and demonstrated increased cytotoxic activity when combined with a PD-L1 inhibitor.1,2
The DeLLphi-303 study is a Phase 1b, multicenter, open-label study evaluating the safety and efficacy of first-line IMDELLTRA in combination with standard-of-care chemoimmunotherapy, followed by IMDELLTRA plus PD-L1 inhibitor, in patients with ES-SCLC.
DeLLphi-303 will also evaluate IMDELLTRA in combination with a PD-L1 inhibitor as first-line maintenance only following standard-of-care chemoimmunotherapy. This part of the study includes 88 patients assigned to receive either IMDELLTRA 10 mg administered intravenously (IV) every two weeks plus atezolizumab 1680 mg IV every four weeks (n=48), or IMDELLTRA 10 mg IV every two weeks plus durvalumab 1500 mg IV every four weeks (n=40). The study protocol allowed for switching of PD-L1 inhibitor for the maintenance treatment, from that received by the patient during initial first-line treatment with platinum-based chemotherapy.
The primary endpoint in DeLLphi-303 is safety and tolerability of IMDELLTRA in combination with a PD-L1 inhibitor, with or without chemotherapy. For the investigation of IMDELLTRA in front-line with chemoimmunotherapy followed by maintenance with a PD-L1 inhibitor, the secondary endpoints include ORR, duration of response (DoR), DCR, PFS and OS. For the investigation of IMDELLTRA in first-line maintenance following front-line standard-of-care chemoimmunotherapy, the secondary endpoints include DCR, PFS, and OS, beginning from the start of first-line maintenance.
About DeLLphi-301 Study
The U.S. Food and Drug Administration accelerated approval of IMDELLTRA is based on results from the Phase 2 DeLLphi-301 clinical trial, in which IMDELLTRA at 10 mg or 100 mg dosed once every 2 weeks was evaluated in patients with SCLC who were refractory to or relapsed after one platinum-based regimen, with or without a checkpoint inhibitor, and at least one other line of therapy. The primary efficacy endpoint was ORR per RECIST 1.1 by blinded independent central review. In part 2 of the study, additional patients were enrolled at the 10 mg dose until 100 patients were reached, and Part 3 was a safety sub-study that evaluated a shortened monitoring period at a medical facility following administration of the first two doses of IMDELLTRA. Across all parts, patients received an initial 1 mg step up dose on day 1, followed by the 10 mg or 100 mg target doses on days 8 and 15 of cycle 1, and then every two weeks in 28-day cycles until disease progression.
About IMDELLTRA™ (tarlatamab-dlle)
IMDELLTRA received accelerated approval from the
IMDELLTRATM (tarlatamab-dlle)
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.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
IMPORTANT SAFETY INFORMATION
WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME
- Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRATM. Initiate treatment with IMDELLTRATM using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRATM until CRS resolves or permanently discontinue based on severity.
- Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including serious or life-threatening reactions, can occur in patients receiving IMDELLTRATM. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRATM until ICANS resolves or permanently discontinue based on severity.
WARNINGS AND PRECAUTIONS
- Cytokine Release Syndrome (CRS): IMDELLTRATM can cause CRS including serious or life-threatening reactions. In the pooled safety population, CRS occurred in
55% of patients who received IMDELLTRATM, including34% Grade 1,19% Grade 2,1.1% Grade 3 and0.5% Grade 4. Recurrent CRS occurred in24% of patients, including18% Grade 1 and6% Grade 2.
Most events (43% ) of CRS occurred after the first dose, with29% of patients experiencing any grade CRS after the second dose and9% of patients experiencing CRS following the third dose or later. Following the Day 1, Day 8, and Day 15 infusions,16% ,4.3% and2.1% of patients experienced ≥ Grade 2 CRS, respectively. The median time to onset of all grade CRS from most recent dose of IMDELLTRATM was 13.5 hours (range 1 to 268 hours). The median time to onset of ≥ Grade 2 CRS from most recent dose of IMDELLTRATM was 14.6 hours (range: 2 to 566 hours).
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 IMDELLTRATM following the recommended step-up dosing and administer concomitant medications before and after Cycle 1 IMDELLTRATM infusions as described in Table 3 of the Prescribing Information (PI) to reduce the risk of CRS. Administer IMDELLTRATM in an appropriate health care facility equipped to monitor and manage CRS. Ensure patients are well hydrated prior to administration of IMDELLTRATM.
Closely monitor patients for signs and symptoms of CRS during treatment with IMDELLTRATM. At the first sign of CRS, immediately discontinue IMDELLTRATM infusion, evaluate the patient for hospitalization and institute supportive care based on severity. Withhold or permanently discontinue IMDELLTRATM based on severity. Counsel patients to seek medical attention should signs or symptoms of CRS occur. - Neurologic Toxicity, Including ICANS: IMDELLTRATM can cause serious or life-threatening neurologic toxicity, including ICANS. In the pooled safety population, neurologic toxicity, including ICANS, occurred in
47% of patients who received IMDELLTRATM, including10% Grade 3. The most frequent neurologic toxicities were headache (14% ), peripheral neuropathy (7% ), dizziness (7% ), insomnia (6% ), muscular weakness (3.7% ), delirium (2.1% ), syncope (1.6% ), and neurotoxicity (1.1% ).
ICANS occurred in9% of IMDELLTRATM-treated patients. Recurrent ICANS occurred in1.6% of patients. Most patients experienced ICANS following Cycle 2 Day 1 (24% ). Following Day 1, Day 8, and Day 15 infusions,0.5% ,0.5% and3.7% of patients experienced ≥ Grade 2 ICANS, respectively. The median time to onset of ICANS from the first dose of IMDELLTRATM was 29.5 days (range: 1 to 154 days). ICANS can occur several weeks following administration of IMDELLTRATM. The median time to resolution of ICANS was 33 days (range 1 to 93 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 IMDELLTRATM 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, in the event of any neurologic symptoms until they resolve.
Closely monitor patients for signs and symptoms of neurologic toxicity and ICANS during treatment. At the first sign of ICANS, immediately evaluate the patient and provide supportive therapy based on severity. Withhold IMDELLTRATM or permanently discontinue based on severity. - Cytopenias: IMDELLTRATM can cause cytopenias including neutropenia, thrombocytopenia, and anemia. In the pooled safety population, decreased neutrophils occurred in
12% including6% Grade 3 or 4 of IMDELLTRATM-treated patients. The median time to onset for Grade 3 or 4 neutropenia was 29.5 days (range: 2 to 213). Decreased platelets occurred in33% including3.2% Grade 3 or 4. The median time to onset for Grade 3 or 4 decreased platelets was 50 days (range: 3 to 420). Decreased hemoglobin occurred in58% including5% Grade 3 or 4. Febrile neutropenia occurred in0.5% of patients treated with IMDELLTRATM.
Monitor patients for signs and symptoms of cytopenias. Perform complete blood counts prior to treatment with IMDELLTRATM, before each dose, and as clinically indicated. Based on the severity of cytopenias, temporarily withhold, or permanently discontinue IMDELLTRATM. - Infections: IMDELLTRATM can cause serious infections, including life-threatening and fatal infections. In the pooled safety population, infections, including opportunistic infections, occurred in
41% of patients who received IMDELLTRATM. Grade 3 or 4 infections occurred in13% of patients. The most frequent infections were COVID-19 (9% , majority during the COVID-19 pandemic), urinary tract infection (10% ), pneumonia (9% ), respiratory tract infection (3.2% ), and candida infection (3.2% ).
Monitor patients for signs and symptoms of infection prior to and during treatment with IMDELLTRATM and treat as clinically indicated. Withhold or permanently discontinue IMDELLTRATM based on severity. - Hepatotoxicity: IMDELLTRATM can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in
42% , with Grade 3 or 4 ALT elevation occurring in2.1% . Elevated AST occurred in44% of patients, with Grade 3 or 4 AST elevation occurring in3.2% . Elevated bilirubin occurred in15% of patients; Grade 3 or 4 total bilirubin elevations occurred in1.6% of patients. Liver enzyme elevation can occur with or without concurrent CRS. Monitor liver enzymes and bilirubin prior to treatment with IMDELLTRATM, before each dose, and as clinically indicated. Withhold IMDELLTRATM or permanently discontinue based on severity. - Hypersensitivity: IMDELLTRATM 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 IMDELLTRATM and manage as clinically indicated. Withhold or consider permanent discontinuation of IMDELLTRATM based on severity.
- Embryo-Fetal Toxicity: Based on its mechanism of action, IMDELLTRATM 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 IMDELLTRATM and for 2 months after the last dose.
ADVERSE REACTIONS
- The most common (>
20% ) adverse reactions were CRS (55% ), fatigue (51% ), pyrexia (36% ), dysgeusia (36% ), decreased appetite (34% ), musculoskeletal pain (30% ), constipation (30% ), anemia (27% ) and nausea (22% ). The most common (≥2% ) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (57% ), decreased sodium (16% ), increased uric acid (10% ), decreased total neutrophils (6% ), decreased hemoglobin (5% ), increased activated partial thromboplastin time (5% ), decreased potassium (5% ), increased aspartate aminotransferase (3.2% ), decreased white blood cells (3.8% ), decreased platelets (3.2% ), and increased alanine aminotransferase (2.1% ). - Serious adverse reactions occurred in
58% of patients. Serious adverse reactions in >3% of patients included CRS (24% ), pneumonia (6% ), pyrexia (3.7% ), and hyponatremia (3.6% ). Fatal adverse reactions occurred in2.7% of patients including pneumonia (0.5% ), aspiration (0.5% ), pulmonary embolism (0.5% ), respiratory acidosis (0.5% ), and respiratory failure (0.5% ).
DOSAGE AND ADMINISTRATION: Important Dosing Information
- Administer IMDELLTRATM as an intravenous infusion over one hour.
- Administer IMDELLTRATM according to the step-up dosing schedule in the IMDELLTRATM PI (Table 1) to reduce the incidence and severity of CRS.
- For Cycle 1, administer recommended concomitant medications before and after Cycle 1 IMDELLTRATM infusions to reduce the risk of CRS reactions as described in the PI (Table 3).
- IMDELLTRATM 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 IMDELLTRATM infusion for 22 to 24 hours on 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 start of the infusion with IMDELLTRATM following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver.
- Prior to administration of IMDELLTRATM evaluate complete blood count, liver enzymes, and bilirubin before each dose, and as clinically indicated.
- Ensure patients are well hydrated prior to administration of IMDELLTRATM.
Please see IMDELLTRA™ full Prescribing Information, including BOXED WARNINGS
About Small Cell Lung Cancer
SCLC is one of the most aggressive and devastating solid tumor malignancies, with a median survival of approximately 12 months following initial therapy and a
About IMDELLTRA (taralatamab-dlle) Clinical Trials
Amgen's robust IMDELLTRA development program includes the DeLLphi clinical trials, which evaluate IMDELLTRA as both a monotherapy and in combination regimens in earlier lines of SCLC, and DeLLpro clinical trials, which evaluate the efficacy and safety of tarlatamab in neuroendocrine prostate cancer.
In the Phase 1 DeLLphi-300 study, IMDELLTRA showed responses in
Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard-of-care therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab monotherapy with standard-of-care chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 trial comparing tarlatamab in combination with durvalumab versus durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 trial of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; and DeLLpro-300, a Phase 1b study of tarlatamab in de novo or treatment-emergent neuroendocrine prostate cancer.18
For more information, please visit https://tarlatamabclinicaltrials.com/.
About Bispecific T-Cell Engager (BiTE®) Technology
BiTE technology is a targeted immuno-oncology platform that is designed to engage a patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different cancer types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T-cell treatment available to all providers when their patients need it. For more than a decade, Amgen has been advancing this innovative technology, which has demonstrated strong efficacy in hematological malignancies and now a solid tumor with the approval of IMDELLTRA. Amgen remains committed to progressing multiple BiTE molecules across a broad range of hematologic and solid tumor malignancies, paving the way for additional applications in more tumor types. Amgen is further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit BiTE® Technology 101.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
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Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the
Any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the
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References
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FAQ
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