* 41 pct improvement in progression-free survival
* OSI CEO sees $500 mln opportunity with new approval
* 10-fold benefit seen in EGFR mutation patients
By Bill Berkrot
NEW YORK, May 14 (Reuters) - Lung cancer drug Tarceva was significantly better than a placebo in keeping the disease from worsening in patients whose cancer had not progressed after treatment with platinum-based chemotherapy, according to a late-stage clinical trial.
Tarceva, which is co-marketed by U.S. biotechnology company OSI Pharmaceuticals Inc OSIP.O and Swiss drugmaker Roche Holding AG ROG.VX, is approved for advanced lung cancer after at least one prior therapy has failed.
OSI Chief Executive Colin Goddard said approval as a so- called maintenance therapy following successful chemotherapy could add $500 million to annual U.S. Tarceva revenue, more than doubling sales of the oral biotech medicine.
Tarceva is expected to compete with Eli Lilly and Co’s (LLY.N) Alimta in patients following successful chemotherapy. It could be approved for that use in the United States by mid-January of 2010, OSI said.
In the 889-patient Saturn trial, which will be presented at the American Society of Clinical Oncology (ASCO) meeting in Orlando later this month, Tarceva had a 41 percent advantage over placebo on the time patients live without their disease worsening, or progression-free survival. Results of the Roche- sponsored study were deemed highly statistically significant.
“If we can offer patients a once-daily, oral therapy with a favorable safety profile right after chemotherapy to extend the time they live without their disease progressing, this is an important step forward in the treatment of lung cancer,” Federico Cappuzzo, the study’s principal investigator, said in a statement.
Roche said in November that the Saturn trial was successful, but details were not public until Thursday, when ASCO released summaries of hundreds of cancer studies that will be presented at its scientific meeting beginning on May 29.
After six months, 25 percent of patients treated with Tarceva had not seen the disease progress compared with 15 percent of those who received a placebo, OSI said.
The drug appeared to improve progression-free survival in both patients with non-squamous cell and the more aggressive squamous cell carcinomas, researchers said.
In an analysis of a sub-set of patients whose tumors had an active EGFR mutation, Tarceva demonstrated a statistically significant 10-fold increase in the amount of time patients lived without their disease progressing, researchers said.
Goddard figures the EGFR patient population alone could be worth an additional $280 million a year in Tarceva sales in the United States.
The average progression-free survival was 22.4 weeks for Tarceva compared with 16 weeks with placebo in the full study, Goddard said. By another measure, the benefit was only 12.3 weeks versus 11.1 weeks, but the company insisted that was not representative of the high statistical significance.
Adverse events in the study were consistent with those seen in prior Tarceva trials, including rash and diarrhea. Discontinuation because of adverse side effects was 4.6 percent for Tarceva and 1.6 percent in the placebo group. (Reporting by Bill Berkrot; Editing by Andre Grenon)