Sorafenib Melanoma Trial Misses Primary Endpoint

WEST HAVEN, Connecticut—Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. (Emeryville, California) have announced that a phase III trial administering sorafenib (Nexavar) or placebo tablets in combination with carboplatin and paclitaxel in patients with advanced melanoma did not meet its primary endpoint of improving progression-free survival. The treatment effect was comparable in each arm.

"We are disappointed, first and foremost, for the patients with refractory metastatic melanoma for whom treatment options are so limited," said Hollings C. Renton, Onyx president. "However, this trial does not change our commitment to, and belief in, Nexavar. We hope to show utility in a wide variety of tumors, and we will continue to broaden our clinical program, including increasing our attention to the more common malignancies in which antiangiogenics have demonstrated activity."

The international phase III, double-blind, randomized, placebo-controlled trial evaluated sorafenib with a standard dosing schedule (21-day cycles) of carboplatin/paclitaxel in 270 patients with progressive melanoma after one previous systemic chemotherapeutic treatment, with either dacarbazine (DTIC) or temozolomide (Temodar).