The FDA approved AstraZeneca’s checkpoint inhibitor Imfinzi for use in certain lung cancers before and after surgery, as the pharma company follows in the footsteps of Merck’s Keytruda.
The approval comes after an advisory committee meeting in July, where outside experts to the FDA voted unanimously that drug developers should in the future design more informative studies for how cancer drugs are used around surgery, but stopped short of suggesting that AstraZeneca should run a new trial for Imfinzi.
Imfinzi was approved Thursday evening for certain adults with early-stage non-small cell lung cancer, where it would be used before surgery in combination with a platinum-based chemotherapy and as a single agent after surgery. An exception is patients with certain mutations in their cancers where there are other targeted treatments available.
In later stages of cancer, the goal is to extend life for as long as possible, as a cure is elusive. However, here, the goal is to cure patients of the disease. In a pivotal clinical study, AEGEAN, patients who received Imfinzi before and after surgery saw a 32% decrease in the risk of events, including cancer recurrence, compared to those who received chemotherapy alone. At the interim analysis, overall survival was not statistically significant.
The approval boosts AstraZeneca’s push to move its checkpoint inhibitor into earlier stages of cancer, which other pharma companies are also doing. Merck won approval in 2023 for Keytruda before and after lung cancer surgery, and Bristol Myers Squibb is expecting an FDA decision by Oct. 8 on Opdivo around surgery in similar stages of lung cancer.
However, the debate in the cancer field on exactly when, and how much, immunotherapy should be given around surgery persists. The clinical studies underlying the FDA applications for these immune checkpoint inhibitors before and after cancer surgery don’t separate out how much of the benefit is coming from each portion of treatment.
Top FDA cancer drug regulators have raised concerns of the potential for over-treatment with these agents since they don’t have information on how much each part of the treatment regimen contributes to the benefit seen in the clinical trials. At the advisory committee meeting, the agency pointed to recent results from a study sponsored by a Canadian group suggesting Imfinzi did not improve outcomes when given after surgery in certain early-stage lung cancer patients.
FDA staff said during the advisory committee meeting that they had recommended AstraZeneca run a trial that could discern the effects of giving Imfinzi before and after surgery, but the drugmaker did not. Such a trial likely would have taken more time, more patients and more money.
It remains to be seen whether the advisory committee’s recommendation for better study designs will be enforced in future trials of cancer drugs given before and after surgery.