WILMINGTON, DE — AstraZeneca’s Imfinzi combined with Amgen’s tarlatamab significantly extended overall survival in a Phase III trial of first-line extensive-stage small cell lung cancer, potentially expanding treatment options for patients whose disease has not progressed after initial chemo-immunotherapy.
The planned interim analysis of the DeLLphi-305 trial showed the combination produced statistically significant and clinically meaningful improvements in overall survival compared with Imfinzi alone as maintenance treatment, AstraZeneca said.
The regimen also significantly improved progression-free survival and objective response rate, two secondary endpoints in the study.
The trial enrolled patients with extensive-stage small cell lung cancer who had not progressed after induction treatment with Imfinzi plus platinum chemotherapy — either carboplatin or cisplatin — and etoposide.
AstraZeneca did not provide numerical survival, progression-free survival or response-rate data in the high-level results. The company said the full findings will be presented at a forthcoming medical meeting and submitted to regulatory authorities.
The results test whether adding a bispecific T-cell engager after initial therapy can extend the benefit of Imfinzi in a disease where progression remains common despite advances in first-line treatment.
An estimated 195,000 people globally will be treated for extensive-stage small cell lung cancer in 2026, according to AstraZeneca. The company said median overall survival with the current standard of care is approximately one year.
“Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment,” said Jacob Sands, associate chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute.
Sands called the survival findings “among the most compelling” he has seen during his career treating extensive-stage small cell lung cancer.
The safety and tolerability profile of Imfinzi plus tarlatamab was consistent with the known profiles of the two drugs, AstraZeneca said, with no new safety signals identified.
Imfinzi, or durvalumab, is already approved in the U.S., European Union, Japan, China and other markets for extensive-stage small cell lung cancer based on the Phase III CASPIAN trial.
It is also approved for limited-stage small cell lung cancer based on the Phase III ADRIATIC trial.
The DeLLphi-305 results extend AstraZeneca’s effort to position Imfinzi as a core immunotherapy across multiple stages of small cell lung cancer while testing whether combination maintenance therapy can further delay progression and extend survival.
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