Nexavar trial falls short of primary endpoint

Emeryville, Calif.-Bayer Pharmaceuticals Corp., West Haven, Conn., and Onyx Pharmaceuticals, based here, have announced that a phase 3 trial administering Nexavar or placebo tablets combined with the chemotherapeutic agents carboplatin and paclitaxel in patients with advanced melanoma did not meet the trial’s primary goal of improving progression-free survival (PFS).

Bayer and Onyx are jointly developing Nexavar.

The double-blind, randomized, placebo-controlled trial evaluated Nexavar when administered in combination with a standard dosing schedule of carboplatin and paclitaxel. Two hundred seventy patients progressing after one previous systemic chemotherapeutic treatment (with either dacarbazine (DTIC) or temozolomide) were enrolled into the study. The study was designed to measure the safety and efficacy of Nexavar when co-administered with chemotherapy, and had PFS as its primary endpoint. PFS is defined as the time that a patient lives without meaningful tumor growth. The safety profile of these agents in combination was comparable to levels previously reported for these agents in combination.