By Chris Delporte
OSI Pharmaceuticals Inc. initiated the first Phase III trial of its OSI-774 (Tarceva) cancer therapy.
Tarceva will be evaluated in combination with carboplatin and paclitaxel for non-small-cell lung cancer (NSCLC). Tarceva is a small-molecule, anti-epidermal growth factor receptor drug candidate.
The trial will be one of two randomized, controlled Phase III trials in NSCLC to be conducted by the alliance formed by OSI, Genentech Inc., of San Francisco, and Roche Holdings Inc., of Basel, Switzerland, earlier this year. (See BioWorld Today, Jan. 9, 2001.)
The first trial, to be held in the U.S. and conducted by Genentech, is a multicenter, 1,000-patient study to assess the value of adding Tarceva to two of the most commonly used front-line combination chemotherapy regimens for NSCLC. The primary endpoint is duration of patient survival.
According to OSI, in the near future, Roche will conduct an international Phase III study assessing the addition of Tarceva to combination chemotherapy with gemcitabine and cisplatin in NSCLC.
OSI reported that Tarceva demonstrated encouraging anticancer activity in single-agent, open-label Phase II studies in NSCLC, head and neck cancer and ovarian cancer.
The company continues to analyze safety, tolerability and activity data, but has said that Tarceva can be administered to most patients with advanced cancer. Treatment, OSI said, was generally well tolerated at the Phase II dose of 150 mg/day, with mild side effects reported.
¿We are very pleased with the speed with which the alliance project team has been able to initiate this registration-oriented Phase III study,¿ Colin Goddard, chairman and CEO of OSI, said in a prepared statement. ¿The front-line NSCLC program forms a key part of the comprehensive global development plan for Tarceva being conducted by the OSI/Genentech/Roche alliance.¿
Under the terms of the alliance, Roche and Genentech purchased $35 million worth of OSI stock, in addition to paying undisclosed up-front fees. Roche and Genentech will co-develop and commercialize Tarceva. OSI retains certain co-promotion rights in the U.S., but Genentech will be primarily responsible for commercializing the drug. Roche is responsible for regulatory approval and marketing outside the U.S.
Genentech will split the cost and profit sharing in the U.S., and Roche will pay royalties to OSI on net sales. Overall costs will be split equally, according to Kathy Galante, manager of corporate communications for OSI.
OSI officials would not comment further about the study. Genentech officials could not be reached for comment.
OSI¿s stock (NASDAQ:OSIP) gained $3.14 Wednesday to close at $40.25. Genentech¿s shares (NYSE:DNA) gained $2.15 to close at $40.92.