Key Findings
In the Phase 3 DeLLphi-305 study, the combination of Imdelltra and Imfinzi significantly improved survival outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC). At a median follow-up of 16 months, the combination therapy reduced the risk of death by 58% compared to Imfinzi alone. Median overall survival (OS) was 21.1 months for the combination group versus 12.7 months for the monotherapy group.
Regarding disease progression, the combination lowered the risk of progression or death by 66% at a median follow-up of 13.9 months. Median progression-free survival (PFS) was 7.4 months for the combination versus 1.9 months for Imfinzi alone.
Technical Details
Imdelltra is a bispecific T cell engager targeting DLL3 and CD3 proteins to activate T cells against cancer cells. The DeLLphi-305 trial enrolled 563 ES-SCLC patients who had completed prior treatment with Imfinzi, platinum chemotherapy, and etoposide without disease progression. Results were presented at the ESMO Congress 2026 and published in The New England Journal of Medicine.
Safety data showed that 20.9% of patients in the combination arm experienced severe or medically significant treatment-emergent adverse events, compared to 10.8% in the Imfinzi arm. Nearly half of Imdelltra patients experienced cytokine release syndrome, though most cases were mild or moderate, and no deaths were reported.
Background and Context
Imdelltra was first approved in May 2024 for ES-SCLC, but its current label is limited to patients whose cancer progressed after platinum-based chemotherapy. Expanding into the first-line maintenance setting would increase the U.S. addressable market from 12,900 patients to approximately 21,600 patients.
Significance and Outlook
Amgen intends to submit these findings to global regulatory authorities with urgency. Beyond first-line ES-SCLC, Amgen is exploring combinations with antibody-drug conjugates (ADCs) in the DeLLphi-310 study (with YL201) and the DeLLphi-313 trial (with ZL-1310). Future development plans include testing Imdelltra in neuroendocrine carcinomas, melanoma, certain gliomas, and pediatric neuroblastomas.
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