The Investor
08 Sep 2026, 17:20
Amgen’s IMDELLTRA Combination Delivers Overall Survival Win in Phase 3 Lung Cancer Trial
Amgen (NASDAQ: AMGN) announced positive Phase 3 results for IMDELLTRA in extensive-stage small cell lung cancer, reporting a statistically significant and clinically meaningful improvement in overall survival when the drug was combined with AstraZeneca’s Imfinzi.
The Phase 3 DeLLphi-305 trial evaluated IMDELLTRA plus Imfinzi as first-line maintenance therapy against Imfinzi alone in patients whose disease had not progressed following initial treatment with Imfinzi, platinum-based chemotherapy and etoposide.
The study met its primary overall survival endpoint at a pre-specified interim analysis. It also achieved statistically significant and clinically meaningful improvements in progression-free survival and objective response rate.
Importantly, Amgen said the combination’s safety profile was consistent with the known profiles of the individual drugs, with no new or unexpected safety signals identified.
The 563-patient trial represents the first Phase 3 study involving a Bispecific T-cell Engager therapy to demonstrate an overall survival benefit in the first-line maintenance setting for extensive-stage small cell lung cancer.
The results could significantly expand the commercial opportunity for IMDELLTRA, which is already FDA-approved for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. Success in DeLLphi-305 potentially moves the therapy into an earlier and considerably broader treatment setting.
Amgen plans to present detailed results at an upcoming international medical congress and submit the data to regulatory authorities.
Amgen (NASDAQ: AMGN) announced positive Phase 3 results for IMDELLTRA in extensive-stage small cell lung cancer, reporting a statistically significant and clinically meaningful improvement in overall survival when the drug was combined with AstraZeneca’s Imfinzi.
The Phase 3 DeLLphi-305 trial evaluated IMDELLTRA plus Imfinzi as first-line maintenance therapy against Imfinzi alone in patients whose disease had not progressed following initial treatment with Imfinzi, platinum-based chemotherapy and etoposide.
The study met its primary overall survival endpoint at a pre-specified interim analysis. It also achieved statistically significant and clinically meaningful improvements in progression-free survival and objective response rate.
Importantly, Amgen said the combination’s safety profile was consistent with the known profiles of the individual drugs, with no new or unexpected safety signals identified.
The 563-patient trial represents the first Phase 3 study involving a Bispecific T-cell Engager therapy to demonstrate an overall survival benefit in the first-line maintenance setting for extensive-stage small cell lung cancer.
The results could significantly expand the commercial opportunity for IMDELLTRA, which is already FDA-approved for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. Success in DeLLphi-305 potentially moves the therapy into an earlier and considerably broader treatment setting.
Amgen plans to present detailed results at an upcoming international medical congress and submit the data to regulatory authorities.
