By Randall Osborne

West Coast Editor

Three months after the first Phase III trial of its cancer drug Tarceva (OSI-774) began, OSI Pharmaceuticals Inc. and its partners have started two more ¿ these for metastasized pancreatic cancer and refractory non-small-cell lung cancer.

¿It¿s a comprehensive program the alliance [of companies] has worked up and we¿ve chosen to go after a broad program,¿ said Kathy Galante, manager of corporate communications for Uniondale, N.Y.-based OSI.

The 750-patient pancreatic cancer trial, with improvement in patient survival as the primary endpoint, is testing Tarceva, a small-molecule, anti-epidermal growth factor receptor drug candidate, with Gemzar (gemcitabine), which is the only approved drug for the disease.

Because of pancreatic cancer¿s virulence, Galante said, ¿we¿re looking at the pancreatic study with a rapid strategy,¿ although time lines for none of the studies has been disclosed.

About 29,200 patients will be diagnosed with pancreatic cancer this year, estimates the American Cancer Society, and between 60 percent and 90 percent have tumors that overexpress the EGFR gene. Of the total patients, about 28,900 will die this year, which makes pancreatic cancer the fourth leading cause of cancer death in the U.S.

Only about 19 percent of patients with cancer of the pancreas survive at least one year after diagnosis, and the five-year survival rate is only 4 percent.

The 330-patient NSCLC trial, with the same endpoint as the pancreatic cancer trial, will compare Tarceva as a single agent with the best supportive care in patients who have failed at least one regimen of chemotherapy, but no more than two regimens.

¿Phase II data have been encouraging,¿ Galante said, noting results disclosed at the American Society of Clinical Oncology meeting in San Francisco this spring. (See BioWorld Today, May 15, 2001.)

Both randomized, global, multicenter, placebo-controlled studies are being conducted as part of a three-way alliance between OSI, Genentech Inc., of San Francisco, and Roche Holdings Inc., of Basel, Switzerland, formed in the first part of this year. (See BioWorld Today, Jan. 9, 2001.)

In that deal, Roche and Genentech bought $35 million worth of OSI stock, and paid undisclosed up-front fees. Roche and Genentech will co-develop and commercialize Tarceva, with OSI retaining certain co-promotion rights in the U.S., and Genentech will be primarily responsible for commercializing the drug. Roche will seek regulatory approval and marketing outside the U.S.

The 1,000-patient trial begun in July is studying Tarceva in combination with carboplatin and paclitaxel for NSCLC, the most common form of lung cancer.

¿That¿s the front-line study, the registration study,¿ Galante told BioWorld Today. NSCLC afflicts about 150,000 people in the U.S. every year, many of whom express the EGFR gene. Other lung cancer patients are known to have a mutant form, EGFRVIII, of the same gene.

Roche is planning another, international study of Tarceva to begin ¿very soon,¿ Galante said, adding that OSI is ¿conducting a number of Phase Ib studies in combination with various chemotherapies.¿

OSI¿s stock (NASDAQ:OSIP) closed Wednesday at $42.99, up 37 cents. Genentech¿s shares (NASDAQ:DNA) ended the day at $49.20, up $1.70.