After wrapping a pair of early-stage combination studies for melanoma using its PD-L1 checkpoint drug Tecentriq (atezolizumab), Roche now plans to hustle straight into Phase III for each of them as it looks to continue to ramp up its growing cancer franchise in the face of some tough competition from Merck and Bristol-Myers Squibb.
Combining Tecentriq with its MEK inhibitor Cotellic along with the BRAF inhibitor Zelboraf delivered an 83% overall response rate in their Phase Ib, with 3 of 24 — out of 29 total previously untreated patients with BRAF mutation-positive melanoma — seeing complete responses. There were no grade 5 adverse events in the study, but 40% did experience a grade 3 or 4 AE with the triple combo.
In previously treated melanoma patients, the combination of Tecentriq and Cotellic delivered an overall response rate of 45% among the 20 patients with non-ocular metastatic melanoma — 50 percent in BRAF wild-type and 40 percent in BRAF-mutant patients.
Grade 3/4 AEs occurred in 59% of the patients.
That’s good enough to warrant pivotal studies for both sets of combination therapies, which have become a central focus in the second-wave of clinical development plans for the leaders in this field. Merck has some 200 combination studies underway for Keytruda.
Tecentriq was recently OK’d for use in second-line non-small cell lung cancer, which followed its approval for bladder cancer. Bristol-Myers completes the set of three companies in the market with a checkpoint, while AstraZeneca and Pfizer/Merck KGaA follow up with checkpoints of their own in what has become a hectic race to seize and hold market share.
Roche, a leader in oncology, has no intention of falling behind now.
“We are encouraged by these early results which demonstrate a high proportion of people responded to these investigational combination therapies,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The results suggest that the combination of TECENTRIQ with our BRAF and MEK targeted agents may extend the established benefits of the approved monotherapy and combination approaches of these medicines.”
The best place to read Endpoints News? In your inbox.
Full-text daily reports for those who discover, develop, and market drugs. Join 19,000+ biopharma pros who read Endpoints News by email every day.Free Subscription