Oncology News Central (ONC)FDA’s ODAC Votes for New Requirements Due to Overtreatment Concerns in NSCLC

Concerns Over Potential Overtreatment in Non-Small Cell Lung Cancer Lead to Calls for More Detailed Phase Analysis in Clinical Trials

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended that future perioperative clinical trials for resectable non-small cell lung cancer (NSCLC) include separate assessments of neoadjuvant and adjuvant treatment phases. This decision comes in response to AstraZeneca’s application for expanded use of durvalumab in NSCLC treatment, highlighting concerns about potential overtreatment and the need for more precise efficacy data in different treatment stages.

Key Points:

• The ODAC voted unanimously to require separate analyses of neoadjuvant and adjuvant treatment phases in future perioperative NSCLC trials.
• This recommendation stems from concerns about potential overtreatment, increased financial burdens, and toxicities for patients.
• AstraZeneca’s application for expanded use of durvalumab in resectable NSCLC is based on the phase 3 AEGEAN trial results.
• In the AEGEAN trial, patients receiving durvalumab showed a 17.2% pathological complete response rate compared to 4.3% in the placebo group.
• The median event-free survival (EFS) was not reached in the durvalumab group versus 25.9 months in the control group.
• FDA officials noted that a separate phase 3 study of adjuvant durvalumab did not show clear clinical benefit in early-stage resectable NSCLC.
• ODAC members stressed the importance of developing surrogate markers, such as circulating tumor DNA, to speed up clinical trial results.
• The committee acknowledged that new requirements may increase costs and delay drug development but emphasized potential value for patients.
• Some members suggested exploring post-approval dosing changes and alternative treatments as precedents for flexible drug development.

“When you look at the trial portfolio that was put up, which is very impressive from just [AstraZeneca], let alone many companies, there [are] a lot of trials going on in diseases like non-small lung cell cancer. So, I don’t agree that this is not a feasible option to be done. But if it’s not a requirement, it’s probably just not going to be done.”
– Daniel Spratt, MD, ODAC Acting Chairman

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