Dive Brief:
- Cambridge, MA-based biotech Epizyme plans to test its experimental blood cancer drug in combination with Roche's newly-approved anti-PDL1 inhibitor, the company said Wednesday.
- The companies will evaluate Epizyme's tazemetostat and Roche's Tecentriq as a possible treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
- Epziyme stock has fallen by over 8% this week as markets reacted to early data from a separate Phase 2 trial of tazemetostat. While the data showed a tumor response rate of 28% among the 47 trial participants, Epziyme may need higher efficacy to compete with existing drugs.
Dive Insight:
Epizyme and Roche plan to begin enrolling for the Phase 1b trial sometime in the second half of 2016, aiming to build out a clinical case for the combination.
"The goal of this collaboration is to generate clinical proof-of-concept for the combination, building on tazemetostat’s activity as a monotherapy in a Phase 1 study of NHL and preclinical observations that EZH2 inhibition may have a priming effect on the immune system and improve the activity of checkpoint inhibitors,” said Peter Ho, chief medical officer at Epizyme.
Genentech, a subsidiary of Roche, will manage study operations for the trial.
By combining tazemetostat with Tecentriq, Epizyme is hitching itself to the much-heralded class of checkpoint inhibitors. With its May approval, Tecentriq is the third checkpoint inhibitor targeting the PD1/PDL1 pathway to reach the U.S. market. (It is, however, the first explicitly anti-PDL1 drug approved.)
The clinical and commercial success to date of Bristol-Myers Squibb's Opdivo and Merck's Keytruda have raised hopes that these types of drugs can raise the standard of care for cancer.
Tecentriq's initial indication was for bladder cancer, but Roche is pursuing a slew of other approvals, including non-small cell lung cancer, breast cancer, and some solid tumors.