Amgen’s Imdelltra Demonstrates Significant Overall Survival Improvement in Small Cell Lung Cancer
In the Phase III DeLLphi-304 trial, patients with small cell lung cancer administered Imdelltra achieved a statistically significant and clinically meaningful improvement in overall survival compared to standard-of-care chemotherapy.
Image Credit: Adobe Stock Images/pakbung
Results from the Phase III DeLLphi-304 trial show that Amgen’s Imdelltra (tarlatamab-dlle) significantly improved overall survival (OS) in patients with small cell lung cancer (SCLC) who had progressed following platinum-based chemotherapy. The immunotherapy demonstrated superiority over standard-of-care chemotherapy, comprised of topotecan, lurbinectedin, or amrubicin depending on the region.1
"[SCLC] is one of the most aggressive malignancies, with a high unmet need for more effective therapies. The topline results from DeLLphi-304 demonstrate overwhelming clinical benefit for people living with this devastating disease and affirm Imdelltra as standard of care," said Jay Bradner, MD, EVP, research and development, Amgen, in a press release. "We look forward to sharing these results with the scientific community and health authorities as we continue our efforts to bring Imdelltra to patients worldwide."
The randomized, controlled, open-label DeLLphi-304 trial is evaluating the efficacy and safety of Imdelltra in approximately 700 patients with relapsed SCLC. In addition to OS, secondary endpoints include progression-free survival as assessed by investigators using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria, along with patient-reported outcomes such as symptom burden, physical function, and overall quality of life.
Enrollment criteria included presence of measurable lesions per RECIST 1.1 within the 21-day screening period and demonstration of adequate organ function. Key exclusion criteria included a history of severe immune-related adverse events from prior immune checkpoint inhibitor use, untreated or symptomatic central nervous system metastases, and a history of non-small cell lung cancer.1,2
Imdelltra is also being evaluated across several clinical trials, including the Phase Ib DeLLphi-303 trial assessing its use with standard therapies in first-line extensive-stage SCLC; the Phase III DeLLphi-304 trial comparing Imdelltra monotherapy to standard chemotherapy in the second-line SCLC setting; the Phase III DeLLphi-305 trial comparing Imdelltra in combination with Imfinzi (durvalumab) vs. Imfinzi monotherapy as first-line maintenance in extensive stage SCLC; the a placebo-controlled Phase III DeLLphi-306 trial investigating Imdelltra following chemoradiotherapy in limited-stage SCLC; the Phase Ib DeLLphi-308 trial examining subcutaneous administration of Imdelltra in second-line or later extensive stage SCLC; and the Phase II DeLLphi-309 trial exploring alternative intravenous dosing schedules in second-line extensive stage SCLC.1
According to the American Cancer Society, lung cancer remains the leading cause of cancer-related death in the United States, accounting for one in five cancer deaths. An estimated 226,650 new lung cancer cases and 124,730 related deaths are expected in 2025. While SCLC comprises only about 1% of all lung cancer cases, it remains particularly aggressive and difficult to treat.
Lung cancer is more common in older adults, with a median age at diagnosis of 70 years. Though rare, some individuals are diagnosed under 45 years of age. Lifetime risk differs slightly by gender—men face a one in 17 chance, while women have a one in 18 chance. Notably, Black men are 12% more likely than White men to develop lung cancer, whereas Black women are 16% less likely than their White counterparts.3
Detailed results from the DeLLphi-304 trial will be presented at an upcoming medical congress.1
References
1. IMDELLTRA® DEMONSTRATED SUPERIOR OVERALL SURVIVAL IN SMALL CELL LUNG CANCER. Amgen. April 11, 2025. Accessed April 15, 2025. https://www.amgen.com/newsroom/press-releases/2025/04/imdelltra-demonstrated-superior-overall-survival-in-small-cell-lung-cancer?_gl=1*1y6gmo3*_up*MQ..*_ga*MjAxNTgxMTgxNi4xNzQ0NzIwMzg2*_ga_CBMSV0J9VL*MTc0NDcyMDM4NS4xLjEuMTc0NDcyMDM5Ni4wLjAuMA..
2. Randomized phase 3 study of tarlatamab, a DLL3-targeting bispecific T-cell engager (BiTE), compared to standard of care in patients with relapsed small cell lung cancer (DeLLphi-304). ASCO. Accessed April 15, 2025. https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS8611
3. Key Statistics for Lung Cancer. American Cancer Society. Accessed April 15, 2025. https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html
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