- Cotellic (cobimentinib), which was discovered by CA-based Exelixis, is being co-developed with Roche.
- In a phase 3 clinical trial, Cotellic combined with Zelboraf (vemuratenib) improved outcomes in some melanoma patients compared with Zelboraf alone, according to Roche.
- In September, an E.U. advisory panel recommended approval of the Cotellic/Zelboraf combination therapy for treatment of advanced melanoma.
Last month, Roche reported results from a phase 3 study involving 495 patients with advanced melanoma. In this study, researchers found that combining Cotellic and Zelboraf increased progression-free survival (PFS) by more than a year.
Now as the final results of the study are released, researchers say that patients with BRAF V600 mutation-positive advanced melanoma benefit the most from the combo. Things are looking good for an approval of this combo in the E.U. in the near future, with analysts anticipating sales of rougly $800 million.
Roche hopes that approval of this combo therapy will bolster sales of Zelboraf, which was originally approved in late 2011 but has had declining sales lately because of competition from newer oncologic drugs. The Cotellic/Zelboraf combo was approved in Switzerland in late August. A decision from the European Medicines Agency is expected by November 11.