Exelixis Shuts Down sNDA Plans for Cabometyx Following Negative Phase 3 Study Results

Exelixis announced that it has scrapped plans to submit a supplemental new drug application (sNDA) for its cancer therapy Cabometyx (cabozantinib) for the treatment of newly diagnosed hepatocellular carcinoma (HCC) after disappointing phase 3 study results.

The study enrolled 837 patients with previously untreated HCC who received either Cabometyx in combination with Genentech’s checkpoint inhibitor Tecentriq (atezolizumab) or Bayer’s chemotherapy Nexavar (sorafenib) alone. The Cabometyx/Tecentriq combo failed to achieve the key secondary endpoint of overall survival compared with Nexavar, the company said.

Last year, the drug combination did hit its primary target of progression-free survival, reducing the risk of disease progression or death by 37 percent compared with sorafenib.

Cabometyx, a blockbuster drug first greenlighted by the FDA in 2012, is currently approved for patients with previously treated HCC, medullary thyroid cancer and renal cell carcinoma. The drug earned $1.1 billion in 2021.