Lilly’s Necitumumab Demonstrates Positive Benefit-Risk Ratio, FDA Panel Says

The FDA’s Oncologic Drugs Advisory Committee largely appeared to agree that Eli Lilly’s lung cancer drug necitumumab offers some late-stage lung cancer patients increased survival time, despite an increased risk of adverse events, but didn’t vote on whether to recommend the product for approval.

The panel’s assessment, gleaned during a meeting at the agency’s White Oak campus, focused on whether the drug should be approved for use as a first-line treatment, in combination with gemcitabine and cisplatin, in patients with locally advanced or metastatic squamous non-small cell lung cancer.

The FDA team reviewing Lilly’s NDA convened the panel to gather additional input on two questions: whether results from the company’s INSPIRE clinical trial in the nonsquamous NSCLC population impact the benefit-risk assessment of necitumumab for squamous NSCLC and whether efficacy and safety results from the SQUIRE trial support a positive benefit-risk assessment of the three-drug cocktail.

In the SQUIRE trial, patients who were administered necitumumab with the other two drugs had a median overall survival of 11.5 months — 1.6 months more than patients receiving the chemotherapy combo alone.

However, patients in the necitumumab arm also experienced an increased incidence of vein thrombosis and pulmonary embolism events — 9 percent versus 5 percent of controls — and a higher incidence sudden deaths, 2.2 percent versus 0.5 percent. The INSPIRE study also showed a higher rate of blood clots events in patients taking necitumumab, causing Lilly to halt the trial.

Panel member Tito Fojo, director of the Medical Oncology Fellowship Program at NIH’s Center for Cancer Research, expressed concern that the SQUIRE trial data suggest patients in the control arm received less chemo than those in the experimental arm. Lilly disagreed with Fojo’s assessment.

Panelist Bernard Cole, with the University of Vermont, said he would like to know how long patients experience the adverse events, including skin rashes. That way, patients can know what to expect regarding quality of life and make a decision as to whether the gain in overall survival is worth the negative effects.

Lilly said the study didn’t look at duration of rashes, but that the overall discontinuation rate shows patients tolerated them. — Jonathon Shacat