The committee did not vote on Imfinzi’s approval in this indication, but the overall majority suggested that it should be approved. Credit: Inside Creative House via Shutterstock.

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has called for changes in how clinical trials are conducted for treatments involving surgery for early-stage non-small cell lung cancer (NSCLC). 

In the 25 July meeting, the ODAC highlighted that it’s important to separately evaluate the effectiveness of each part of the treatment process, which includes pre-operative and post-operative phases. 

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The committee meeting – which ended with a 11–0 vote in favour of changing how perioperative trials are run– came after AstraZeneca proposed to use Imfinzi (durvalumab) as a treatment with chemotherapy both before and after surgery. The pharma giant conducted the Phase III AEGEAN study (NCT03800134) to support this label expansion. 

The committee did not vote on Imfinzi’s approval in this indication, but the overall majority suggested that it should be approved. Following a lengthy discussion as to whether there should be another trial, Ravi Madan, medical oncologist at the National Cancer Institute said: “I think to delay this at this point is very complicated for patients and their providers.”   

The perioperative period refers to the time before, during and after surgery. The study showed that the perioperative use of the treatment reduced the risk of cancer returning, progressing, or causing death by 32% compared to using chemotherapy alone. However, the study did not allow for separate evaluation of the pre- and post-surgery phases, so it was unclear which part of the treatment was most effective. 

In a briefing document released prior to the meeting, the FDA said it had advised AstraZeneca to design the study in a way that could assess the individual benefits of the treatment in both pre- and post-surgery settings, but this advice was not followed. The concern is that without this information, there could be unnecessary side effects from the treatment without understanding the additional benefits. 

The FDA also highlighted its concern for “the potential for overtreatment for perioperative immune checkpoint inhibitor (ICI) regimens,” in the briefing document. 

Imfinzi was first approved for treating bladder cancer in 2017. Its label later was expanded to include more indications including unresectable NSCLC, small-cell lung cancer, metastatic NSCLC, and endometrial cancer, which came through in June 2024. 

In September 2023, the FDA accepted the supplemental Biologics License Application (sBLA) for Imfinzi in the perioperative setting. It is already approved in the UK and Switzerland for this indication based on the AEGEAN trial. In a 25 July statement, the pharma giant highlighted these approvals and that the FDA is not bound by the ODAC’s recommendation. 

“We are committed to working closely with the FDA to bring this novel immunotherapy option to patients that offers a flexible chemotherapy backbone,” said Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, in its statement.  

MSD’s blockbuster drug Keytruda (pembrolizumab) plus chemotherapy gained FDA approval as a perioperative treatment for NSCLC in October 2023 based on the Phase III KEYNOTE-671 study (NCT03425643). Similar to AstraZeneca’s AEGEAN, KEYNOTE-671 evaluated the drug for its neoadjuvant and adjuvant use or in the perioperative setting. However, the two coprimary endpoints in the MSD trial, which were met, were overall survival (OS) and investigator-assessed event free survival (EFS). AEGEAN on the other hand, measured EFS and pathological Complete Response (pCR) as coprimary endpoints, both in modified intent-to-treat (mITT) population.