AstraZeneca (LSE:AZN) said its immunotherapy Imfinzi, combined with Amgen's Imdelltra (tarlatamab), delivered a statistically significant and clinically meaningful improvement in overall survival versus Imfinzi alone in a planned interim analysis of the Phase III DeLLphi-305 trial.
The trial tested the combination as first-line maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC), an aggressive form of the disease affecting an estimated 195,000 people globally in 2026, where median overall survival on current standard-of-care sits at approximately one year.
The combination also hit its secondary endpoints, improving progression-free survival and objective response rate, with a safety profile consistent with the individual drugs and no new signals identified.
Imfinzi is already the standard-of-care treatment for ES-SCLC and limited-stage disease, approved across the US, EU, Japan and China, and more than 470,000 patients have received it since its first approval in 2017.
"These are among the most compelling survival results I have seen, indicating the potential to reshape the natural history of small cell lung cancer," said Jacob Sands, associate chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute.
The trial, sponsored by Amgen with partial funding and Imfinzi supplied by AstraZeneca, randomised 563 patients who had completed Imfinzi-based induction therapy.
Full data will be presented at a forthcoming medical meeting and submitted to global regulatory authorities.
News Intelligence what this means for the company
AstraZeneca's Imfinzi combined with Amgen's Imdelltra achieved statistically significant overall survival improvement in a Phase III trial of extensive-stage small cell lung cancer, a disease with median survival of approximately one year under current standard care. The combination hit secondary endpoints (progression-free survival and objective response rate) with no new safety signals, positioning it as a potential new first-line maintenance standard in a disease affecting an estimated 195,000 patients globally in 2026.
- Amgen, as trial sponsor and Imdelltra supplier, gains regulatory pathway validation for tarlatamab in ES-SCLC maintenance, potentially expanding its addressable market in lung oncology.
Imfinzi, already standard-of-care in ES-SCLC with over 470,000 patients treated since 2017 approval, gains a validated combination partner that could extend its market position and duration of use in first-line maintenance. Full data presentation and regulatory submission remain pending, so the magnitude of commercial benefit depends on regulatory acceptance and reimbursement decisions.
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