Nearly 80% of Patients Were Alive at One Year Versus 53% with IMFINZI Alone and Progression-Free Survival More Than Tripled
Late-Breaking Phase 3 DeLLphi-305 Results
Presented in ESMO Presidential Symposium and Simultaneously Published in
The New England Journal of Medicine
Longer DeLLphi-303 Follow-Up Data Showed Median Overall Survival Exceeded 37 Months in First-Line Maintenance with IMDELLTRA and Either IMFINZI or TECENTRIQ®
THOUSAND OAKS, Calif., Oct. 24, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced landmark interim Phase 3 results showing that IMDELLTRA® (tarlatamab-dlle) in combination with AstraZeneca's IMFINZI® (durvalumab) reduced the risk of death by 58% as a first-line maintenance treatment for extensive stage small cell lung cancer (ES-SCLC) (hazard ratio [HR]: 0.42; 95% confidence interval [CI]: 0.32, 0.54; P < 0.001) at a median follow-up of approximately 16 months. The DeLLphi-305 study found that IMDELLTRA in combination with durvalumab extended median overall survival (OS) by more than eight months to 21.1 months compared with 12.7 months with durvalumab alone for patients with ES-SCLC who had not progressed following initial treatment with durvalumab, platinum-based chemotherapy and etoposide. The clinical implications of these findings are substantial and suggest that earlier use of IMDELLTRA could markedly alter the trajectory of a disease previously considered extremely difficult to control. The data are being presented during a Presidential Symposium (abstract LBA3) at the European Society for Medical Oncology (ESMO) Congress 2026 and simultaneously published in The New England Journal of Medicine.1
"These results represent an unprecedented advance for patients with extensive-stage small cell lung cancer, demonstrating a magnitude of survival benefit rarely seen in this aggressive disease," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "Extending median overall survival beyond 21 months while reducing the risk of death by 58% reinforces the potential to revolutionize the standard of survival and redefine expectations for patients by introducing IMDELLTRA earlier in the course of treatment. These findings underscore our ambition to fundamentally change the trajectory of small cell lung cancer, and we are moving with urgency to share these results with regulatory authorities worldwide."
"For a disease where durable survival has remained extremely difficult to achieve, the magnitude and consistency of benefit in DeLLphi-305 are striking," said Jacob Sands, M.D., Associate Chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute. "Importantly, the benefit was seen across clinically relevant groups, including patients with brain metastases. Today's remarkable results demonstrate substantial progress in our work to achieve meaningfully longer disease control and survival for patients with extensive-stage small cell lung cancer, further highlighting the importance of effective treatment at the earliest possible opportunity."
The DeLLphi-305 study showed:
At one year, nearly 80% of patients treated with IMDELLTRA in combination with durvalumab remained alive compared to 53% with durvalumab alone (95% CI: 74.2, 83.7 vs. 47.3, 59.0).
At a median follow-up of 13.9 months, IMDELLTRA in combination with durvalumab reduced the risk of disease progression or death by 66% compared to durvalumab alone (HR: 0.34; 95% CI: 0.28, 0.42; P < 0.001), with a median progression-free survival of 7.4 months versus 1.9 months.
IMDELLTRA in combination with durvalumab demonstrated substantial anti-tumor activity, with more than six times as many patients achieving an objective response (26.4%; 95% CI: 20.9, 32.5) compared with durvalumab alone (4.1%; 95% CI: 2.0, 7.4) (P < 0.001).
Overall and progression-free survival benefits were observed across prespecified subgroups, including patients with brain or liver metastases, populations historically associated with poorer outcomes.
Overall, the safety profile of IMDELLTRA in combination with durvalumab was consistent with the known safety profiles of the individual medicines.
In DeLLphi-305, Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 20.9% of patients treated with IMDELLTRA in combination with durvalumab and 10.8% of patients treated with durvalumab alone. The most common Grade 3 or greater TRAEs with IMDELLTRA in combination with durvalumab were decrease in neutrophil count (3.2%), decreased appetite (2.1%), neutropenia (2.1%), asthenia (1.8%) and weight loss (1.8%). The study design included monitoring in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe) following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8. Cytokine release syndrome (CRS) was reported in 49.6% of patients who received IMDELLTRA and was predominantly Grade 1 (41.8%) or Grade 2 (7.4%) with only one Grade 3 event (0.4%) and no Grade 4 or greater events. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 1.1% of patients treated with IMDELLTRA, and there were no Grade 3 or higher ICANS events.
Growing IMDELLTRA Evidence Across the SCLC Treatment Continuum
Additional data presented at ESMO reinforce sustained outcomes with IMDELLTRA across multiple lines of ES-SCLC treatment.
Sustained Survival in First-Line Maintenance: Updated OS data with a median follow-up of 30.8 months in the Phase 1b DeLLphi-303 trial (abstract 3821P) showed median OS was 37.9 months from the start of first-line maintenance therapy with IMDELLTRA plus standard-of-care anti-PD-L1 therapy (95% CI: 22.5-NE). At two years, 58.1% of patients remained alive. The safety profile remained consistent with the known profile of IMDELLTRA, with no new safety signals observed.
Durable Benefit in Previously Treated ES-SCLC: Updated data from the Phase 3 DeLLphi-304 trial (abstract 3808O) demonstrated that the survival benefit with IMDELLTRA was sustained with 23 months of follow-up. Patients receiving IMDELLTRA lived approximately five months longer than those receiving chemotherapy (13.6 versus 8.4 months), with a 38% reduction in the risk of death (HR 0.62; 95% CI, 0.51–0.76). No new safety signals were observed during extended follow-up.
"For too long, patients with small cell lung cancer have had too few treatment advances and too little time," said Andrea Ferris, MBA, President and CEO of LUNGevity Foundation. "For the patients we serve, today's results represent not only the potential to substantially improve outcomes for patients before they progress on first-line treatment, but also a tangible source of hope – hope for more life milestones, more moments of joy, and, ultimately, more time."
Amgen will host a virtual event with the investment community on Saturday, October 24, 2026, at 8:30 p.m. CEST / 2:30 p.m. EDT / 11:30 a.m. PDT in conjunction with the ESMO Congress 2026. The call will be accessible via investors.amgen.com and will discuss Amgen's oncology portfolio and selected data being presented at ESMO 2026.
About the Phase 3 DeLLphi-305 Study
The DeLLphi-305 trial is sponsored by Amgen, with partial funding and durvalumab provided by AstraZeneca. It is a global Phase 3, randomized, open-label clinical trial evaluating the efficacy and safety of IMDELLTRA in combination with durvalumab compared to durvalumab alone as first-line maintenance treatment for patients with ES-SCLC who had not progressed following treatment with durvalumab, platinum-based chemotherapy and etoposide. Five hundred and sixty-three patients who completed initial treatment with durvalumab, platinum-based chemotherapy and etoposide were randomized 1:1 to receive either IMDELLTRA in combination with durvalumab or durvalumab alone until progression or unacceptable toxicity. Following IMDELLTRA infusion on Cycle 1 Day 1 and Cycle 1 Day 8, patients were monitored in a healthcare setting for 1 to 2 hours (6 to 8 hours in certain regions including Europe). The trial included patients with both treated and untreated asymptomatic brain metastases at baseline. The primary outcome measure of the trial is OS. Secondary endpoints include progression-free survival (PFS) and objective response rate (ORR).2
About Tarlatamab Clinical Trials
Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard-of-care (SOC) therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 study comparing tarlatamab monotherapy with SOC chemotherapy in second-line treatment of SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone as first-line maintenance treatment in ES-SCLC; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201 with or without durvalumab in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of tarlatamab in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; DeLLphi-312, a randomized Phase 3 study evaluating tarlatamab in combination with durvalumab, carboplatin and etoposide as an induction and maintenance therapy in first-line treatment of ES-SCLC; DeLLphi-313, a Phase 1b study of tarlatamab in combination with zocilurtatug pelitecan, a DLL3 targeting antibody drug conjugate, with and without durvalumab in patients with ES-SCLC, and DeLLphi-315, a Phase 3 study of subcutaneous tarlatamab in patients with second-line ES-SCLC.3
For more information, please visit .
About Small Cell Lung Cancer (SCLC)
SCLC is one of the most aggressive and devastating forms of solid tumor cancers. Each year, SCLC accounts for approximately 13-15% of the more than 2.6 million cases of lung cancer diagnosed worldwide.4-6 Despite advances in the treatment of ES-SCLC, outcomes remain poor, with a median survival of approximately one year from the start of first-line maintenance treatment and only about 40% of patients receiving second-line therapy.7-10
About IMDELLTRA
®
(tarlatamab-dlle)
IMDELLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell.11,12 DLL3 is a protein that is expressed on the surface of SCLC cells in ~85-96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.13,14
U.S. 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.
IMDELLTRA 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 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.
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 and after treatment with IMDELLTRA®. At the first sign of CRS during treatment, immediately discontinue IMDELLTRA® infusion. If CRS occurs during or after treatment, evaluate the patient for hospitalization and manage based on severity. Withhold or permanently discontinue IMDELLTRA® based on severity. Counsel patients and caregivers to seek immediate medical attention should signs or symptoms of CRS occur after discharge.
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 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 6 to 8 hours following Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.
Perform patient assessment including vital signs check on Cycle 1 Days 2 and 9.
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®.
Please see IMDELLTRA
®
full Prescribing Information
, including BOXED WARNINGS.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.
More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.
Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. 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.
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REFERENCES
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ClinicalTrials.gov. DeLLphi-305 clinical trial listing. Accessed July 16, 2026. .
ClinicalTrials.gov. Tarlatamab clinical trial listings. US National Library of Medicine. Accessed September 2026. .
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Shaw J, Pundole X, Balasubramanian A, et al. Recent treatment patterns and real-world survival following first-line anti-PD-L1 treatment for extensive-stage small cell lung cancer. Oncologist. 2024;29(12):1079-1089. doi:10.1093/oncolo/oyae234.
Paz-Ares L, Borghaei H, Liu SV, et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025;405(10495):2129-2143. doi:10.1016/S0140-6736(25)01011-6.
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Giffin MJ, Cooke K, Lobenhofer EK, et al. AMG 757, a half-life extended, DLL3-targeted bispecific T-cell engager, shows high potency and sensitivity in preclinical models of small-cell lung cancer. Clin Cancer Res. 2021;27(5):1526-1537. doi:10.1158/1078-0432.CCR-20-2845.
Baeuerle PA, Kufer P, Bargou R. BiTE: Teaching antibodies to engage T-cells for cancer therapy. Curr Opin Mol Ther. 2009;11(1):22-30.
Ahn MJ, Cho BC, Felip E, et al. Tarlatamab for patients with previously treated small-cell lung cancer. N Engl J Med. 2023;389(22):2063-2075. doi:10.1056/NEJMoa2307980.
Rojo F, Corassa M, Mavroudis D, et al. International real-world study of DLL3 expression in patients with small cell lung cancer. Lung Cancer. 2020;147:237-243. doi:10.1016/j.lungcan.2020.07.026.
SOURCE Amgen
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