Immunotherapy combo extends survival for patients with aggressive small cell lung cancer, based on trial results
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In patients with extensive-stage small cell lung cancer (ES-SCLC), tarlatamab, a bispecific T-cell engager, plus durvalumab as first-line maintenance therapy extended median overall survival by more than eight months, more than tripled progression-free survival and reduced the risk of death by 58% compared to durvalumab alone, according to results of the phase 3 open-label, multicenter, randomized DeLLphi-305 study.
The results were presented by Jacob Sands, M.D., associate chief of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute, during the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain, on Oct. 24. Overall survival benefits were consistent across subgroups, including patients with brain and liver metastases.
The interim phase 3 results were simultaneously published in the New England Journal of Medicine.
"This trial is positive in every way. We have seen substantial improvement in median progression-free survival, substantial improvement in median overall survival, and we're improving the time of disease control substantially for a broader group of patients than what we've seen from any prior study and any prior treatment," says Sands. "This immunotherapy combination sets a new standard of care with tarlatamab plus durvalumab in the maintenance setting after induction chemotherapy plus durvalumab."
DeLLphi-305 is the first phase 3 study including a bispecific T-cell engager therapy to demonstrate an overall survival benefit in the first-line maintenance setting for ES-SCLC. Tarlatamab is already approved by the U.S. Food and Drug Administration as a later line of therapy, and this study shows it may be even more effective in the first-line maintenance setting.
ES-SCLC is one of the most aggressive forms of lung cancer and advances to metastatic disease earlier than other types of lung cancer. Approximately 80% of patients with SCLC are diagnosed with extensive-stage disease. Standard initial treatment combines chemotherapy and an immune checkpoint inhibitor. Median survival with first-line therapy has been 12 to 13 months, and frontline gains have been limited. This is what makes the median overall survival in DeLLphi-305 of 21.1 months so meaningful.
The trial included 563 patients with ES-SCLC who had received standard first-line treatment with durvalumab plus platinum and etoposide chemotherapy and had not progressed. Patients were randomized one-to-one to receive first-line maintenance therapy with either tarlatamab plus durvalumab or durvalumab alone.
Tarlatamab is a bispecific T-cell engager designed to bind to CD3 proteins on immune cells called T cells and to DLL3 proteins on small cell lung cancer cells. The drug is designed to pull the cell types closer together and enhance the anticancer effects of the immune system.
At one year, nearly 80% of patients treated with the combination therapy remained alive compared to 53% with durvalumab alone. At a median follow-up of 13.9 months, the combination therapy reduced the risk of disease progression or death by 66% compared to durvalumab alone, with a median progression-free survival of 7.4 months versus 1.9 months. Six times as many patients showed anticancer activity with the combination compared with durvalumab alone.
"Given the aggressive nature of small cell lung cancer, many patients quickly relapse on current therapy and never reach second-line treatment," says Sands. "These patients do not have time to wait, making substantial progress in the first-line setting critically important. Today's remarkable results signify the opportunity to help significantly more patients with extensive-stage small cell lung cancer achieve meaningfully longer survival."
Side effects of the combination therapy were consistent with individual agents and included low and abnormally low neutrophil counts, decreased appetite, fatigue and weight loss. Cytokine release syndrome (CRS) occurred in 49.6% of patients and was most commonly grade 1 or 2, and most cases resolved with supportive care.
Publication details
Maurice Pérol et al., Tarlatamab–Durvalumab Maintenance for Extensive-Stage Small-Cell Lung Cancer, New England Journal of Medicine (2026). DOI: 10.1056/nejmoa2609482
Journal information: New England Journal of Medicine
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Citation: Immunotherapy combo extends survival for patients with aggressive small cell lung cancer, based on trial results (2026, October 26) retrieved 27 October 2026 from https://medicalxpress.com/news/2026-10-immunotherapy-combo-survival-patients-aggressive.html This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.