Two Imfinzi combinations cut risk of death in lung and bladder cancer trials

Key Facts

AstraZeneca presented results from two separate Phase III trials at the European Society for Medical Oncology congress, showing a lower risk of death with two Imfinzi-containing combinations in patients with extensive-stage small-cell lung cancer and muscle-invasive bladder cancer. In DELFI-305, the combination of Imfinzi and tarlatamab cut the risk of death by 58% compared with Imfinzi alone, and median overall survival was 21.1 months versus 12.7 months. VOLGA tested Imfinzi with enfortumab vedotin around surgery and recorded a 42% reduction in the risk of death compared with the control arm. The results concern two combination treatments and different patient groups; they do not represent an effect of Imfinzi alone in either cancer. The congress was held in Madrid from October 23 to 27, 2026, according to the European Society for Medical Oncology’s schedule.

DELFI-305 enrolled patients whose lung cancer had not progressed after induction treatment with Imfinzi, platinum-based chemotherapy and etoposide, then tested first-line maintenance treatment. AstraZeneca said 563 patients completed induction treatment and were randomly assigned to the two trial groups. The study compared Imfinzi plus tarlatamab with Imfinzi alone, linking the recorded survival difference to the addition of the combination treatment at this stage of care. Median overall survival was 21.1 months among patients receiving the combination, compared with 12.7 months among those receiving Imfinzi alone. In a planned interim analysis, the reduction in the risk of death reached 58%, the company said. The comparison places the results in the context of maintenance treatment after a response to induction therapy, rather than Imfinzi alone from the start of treatment.

The difference in the lung cancer trial extended to progression-free survival: the combination cut the risk of disease progression or death by 66% compared with Imfinzi alone. Median progression-free survival was 7.4 months with the combination, versus 1.9 months in the Imfinzi-alone group, according to AstraZeneca. Safety data showed treatment-related Grade 3 or 4 adverse events in 20.9% of patients receiving the combination, compared with 10.8% in the control group. No treatment-related deaths were recorded in the combination group, according to the company’s disclosure. These figures show that the efficacy results came alongside a higher rate of severe treatment-related adverse events in the combination group. The efficacy and safety measures cited apply to DELFI-305 alone.

In bladder cancer, VOLGA studied perioperative treatment combining Imfinzi and enfortumab vedotin in patients who were ineligible for or declined cisplatin-based chemotherapy. The trial compared the combination with cystectomy, with or without approved adjuvant treatment, according to AstraZeneca’s description. The company estimated two-year overall survival at 78% with the combination, versus 69% in the control arm, alongside a 42% reduction in the risk of death in a planned interim analysis. The risk of progression, recurrence, not undergoing surgery or death also fell by 49%. The two-year event-free survival rate was 64% with the combination, compared with 45% in the control arm. Median event-free survival had not been reached in the combination group at the time of analysis, while it was 12.1 months in the control arm.

Thomas Powles, international coordinating investigator for the VOLGA trial, said the results "support this approach as a potential new standard of care that puts the patient at the center." The trial results were published in The New England Journal of Medicine alongside their presentation at the European Society for Medical Oncology congress. The results come in a treatment market with other approved options: on July 10, 2026, the U.S. Food and Drug Administration expanded approval of pembrolizumab, alone or with enfortumab vedotin, to include all candidates for cystectomy. In the regulatory review process, the agency granted priority review to AstraZeneca’s supplemental application for Imfinzi with enfortumab vedotin in patients who are ineligible for or decline cisplatin. The company expects an agency decision in the fourth quarter of 2026, the next regulatory milestone for the bladder cancer combination.