FDA Committee Recommends Splitting NSCLC Trials

FDA Committee Recommends Splitting NSCLC Trials

FDA's Oncologic Drugs Advisory Committee (ODAC) recently suggested splitting clinical trials for these treatments into two parts – one before surgery and one after. This change was proposed during a meeting where AstraZeneca suggested using Imfinzi (durvalumab) alongside chemotherapy, both before and after surgery.

The committee didn't vote on approving Imfinzi for this specific use, but most members leaned towards approval. They discussed the necessity of another trial, with some experts feeling it would be too complicated for patients to wait. The current study revealed that using Imfinzi during the perioperative period reduced the risk of cancer recurrence by 32% compared to just chemotherapy. However, which part of the treatment – pre- or post-surgery – was the most effective remains unclear as the study didn't separate these phases.

Before the meeting, the FDA had advised AstraZeneca to design the study to assess the treatment's benefits separately for each phase, but this advice wasn't followed. This oversight raised concerns about potential overtreatment and unnecessary side effects without fully understanding the benefits.

Imfinzi, initially approved for bladder cancer in 2017, has since been expanded to include other cancer types. In September 2023, the FDA accepted a new application for Imfinzi in the perioperative setting, and it's already approved in the UK and Switzerland based on the AEGEAN trial. AstraZeneca is eager to work with the FDA to bring this treatment to patients, emphasizing its flexibility with chemotherapy.

MSD's Keytruda, another popular treatment, received FDA approval last year for perioperative use in NSCLC based on a different study with slightly different goals. So, while both treatments aim to tackle NSCLC around the time of surgery, the specifics of how they're tested and what they measure can vary.

Key Takeaways

• ODAC recommends separate evaluation of pre- and post-operative treatment effectiveness in NSCLC trials.
• AstraZeneca's Imfinzi, proposed for perioperative use, awaits FDA approval despite committee majority support.
• AEGEAN study showed Imfinzi reduced cancer recurrence risk by 32%, but lacked separate phase evaluations.
• FDA expressed concerns over potential overtreatment with perioperative immune checkpoint inhibitors.
• Imfinzi already approved in UK and Switzerland for perioperative NSCLC, pending US decision.### AnalysisThe FDA's recommendation to split NSCLC trials into pre- and post-surgery phases could impact AstraZeneca, whose Imfinzi awaits approval. This change aims to clarify treatment efficacy and reduce overtreatment risks. If approved, Imfinzi's market share could rise, challenging MSD's Keytruda. Long-term, clearer trial data might standardize perioperative treatments, benefiting patients but potentially complicating pharma strategies.### Did You Know?
  • Perioperative Period: The perioperative period refers to the time immediately before, during, and shortly after a surgical procedure. In the context of cancer treatment, it involves administering therapies to enhance the effectiveness of the surgery and reduce the risk of cancer recurrence.
• Immunotherapy and Checkpoint Inhibitors: Immunotherapy is a type of cancer treatment that boosts the body's natural defenses to fight cancer. Checkpoint inhibitors, like AstraZeneca's Imfinzi (durvalumab), are a type of immunotherapy that works by blocking certain proteins on immune cells that prevent them from attacking cancer cells, thereby enhancing the immune response against the cancer.
• Oncologic Drugs Advisory Committee (ODAC): ODAC is a committee within the U.S. Food and Drug Administration (FDA) that provides recommendations on the safety and efficacy of drugs for use in cancer treatment. Their role is crucial in guiding the FDA's decisions on whether to approve new cancer treatments based on clinical trial data.