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US FDA Sending AZ, Other Cancer Sponsors Trial Design Message With Imfinzi AdComm

 
• By Sarah Karlin-Smith

The Oncologic Drugs Advisory Committee will vote on a product agnostic question related to perioperative trial designs during a 25 July meeting after discussing whether AstraZeneca needs an additional trial for its Imfinzi perioperative regimen in non-small cell lung cancer.

red bullhorn with sign underneath that says "attention please"
The FDA's 25 July ODAC meeting appears important for many sponsors developing immunotherapies. • Source: Shutterstock

AstraZeneca PLC looks unlikely to nab a supplemental perioperative indication for Imfinzi (durvalumab) in resectable non-small cell lung cancer (NSCLC) after failing to heed FDA’s trial design advice in 2018, briefing documents and an addendum released ahead of a 25 July FDA Oncologic Drugs Advisory Committee Meeting suggest.

Key Takeaways

  • The FDA likely will require an additional trial before approving AstraZeneca’s Imfinzi in resectable NSCLC for perioperative use due to the inability to distinguish whether the drug's efficacy is related to the neoadjuvant phase, the adjuvant phase, or both.

  • AstraZeneca’s situation is being used to highlight a broader FDA concern with trial designs for perioperative regimens and ODAC will vote on whether new agency requirements for NSCLC are needed

The FDA also appears prepared to use the application as a case study to justify formally requiring different trial designs for perioperative regimens in NSCLC. Commissioner Robert Califf has indicated his desire to use advisory panels to influence multiple drug development programs rather than specific application decisions

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