Exelixis Shuts Down sNDA Plans for Cabometyx Following Negative 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.
Exelixis, Inc. is a genomics-based drug discovery company located in Alameda, California, and the producer of Cometriq, a treatment approved by the U.S. Food and Drug Administration (FDA) for medullary thyroid cancer with clinical activity in several other types of metastatic cancer. Exelixis was founded in 1994; the scientific founders were Spyridon Artavanis–Tsakonas, at Yale at that time, and Corey Goodman and Gerry Rubin who were then at the University of California, Berkeley. Cabozantinib, sold under the brand names Cometriq and Cabometyx among others.
March 17, 2022
