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BIO DEEP 2 sources· 4 min· cluster 1· updated 10:06 UTC

IMDELLTRA® IN COMBINATION WITH IMFINZI® REDUCED RISK OF DEATH BY AN UNPRECEDENTED 58% IN FIRST-LINE EXTENSIVE STAGE SMALL CELL LUNG CANCER

Amgen reported Phase 3 results for a maintenance combination in extensive-stage small cell lung cancer.

TL;DR

  1. Amgen reported that its Phase 3 DeLLphi-305 trial found a 58% lower risk of death for IMDELLTRA plus IMFINZI than IMFINZI alone.
  2. The company reported median overall survival of 21.1 months versus 12.7 months at a median follow-up of about 16 months.
  3. The results were presented at ESMO and remain clinical evidence for a treatment combination, not a new approval.

Amgen reported interim Phase 3 results for IMDELLTRA (tarlatamab) combined with AstraZeneca’s IMFINZI (durvalumab) as maintenance treatment for extensive-stage small cell lung cancer. The company said the combination reduced the risk of death by 58% compared with IMFINZI alone. [1] [2]

Amgen reported median overall survival of 21.1 months in the combination group and 12.7 months in the comparison group, at a median follow-up of approximately 16 months. The Independent also reported the survival figures and described the study as a 563-patient Phase 3 trial. [1] [2]

The study enrolled patients whose cancer had not progressed after initial treatment with durvalumab, platinum-based chemotherapy, and etoposide. The findings therefore concern a defined maintenance-treatment setting, not all small cell lung cancer patients. [1] [2]

The results were presented at the European Society for Medical Oncology meeting and published in The New England Journal of Medicine, according to Amgen. Follow-up and regulatory review remain relevant; the release cautions that no conclusions about safety or effectiveness of product candidates should be drawn as if they were approved. [1] [2]

Why it matters

A Phase 3 survival result can affect the clinical and regulatory path for a combination in an aggressive cancer, but its scope is limited to the studied population and regimen.

Editor's note

Company-reported interim results are identified as such. The story does not offer treatment guidance or imply a new approval.

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