Positive Trial Results Point to Second Chance for Exelixis’ Cancer Drug
Exelixis’ Cometriq improved patient outcomes in a pivotal Phase 3 trial for metastatic kidney cancer — signaling new life for the drug, which failed another study last fall.
Data on overall survival were preliminary at the trial’s cutoff point, but an interim analysis of the first 375 randomized patients showed Cometriq (cabozantinib) improved progression-free survival — the study’s primary endpoint — by 42 percent compared with everolimus, the drugmaker says.
The interim analysis also shows Cometriq besting everolimus in overall survival. A final analysis of overall survival is expected in 2016.
The trial is evaluating 658 patients with metastatic renal cell cancer whose disease progressed following treatment with a VEGF receptor tyrosine kinase inhibitor.
The news could signal a new lease for Cometriq, whose Phase 3 evaluation as a treatment for prostate cancer was halted last September after the drug failed to significantly improve overall survival.
The FDA granted Cometriq fast-track status in April as a second-line treatment for patients with advanced RCC. Exelixis intends to complete US and EU regulatory filings for the indication in early 2016. — Jonathon Shacat