ORLANDO, Fla. -- Tarceva, the
drug, lets advanced pancreatic cancer patients live longer, according to trial data presented at the American Society of Clinical Oncology annual meeting Saturday.
The addition of Tarceva to gemcitabine chemotherapy improved overall survival by 23.5% compared with patients receiving the chemotherapy alone. The phase III safety and efficacy trials involved 569 patients, spanning 17 countries and 140 study centers.
Median survival for patients receiving Tarceva plus chemotherapy was 6.4 months vs. 5.9 months for those who took the gemcitabine and a placebo. Of patients who received Tarceva instead of a placebo, 72% reported a rash, compared with 29% in the placebo arm of the trial. Diarrhea was reported by 56% of patients who received Tarceva plus gemcitabine and by 41% of patients who received gemcitabine plus a placebo.
Tarceva is currently approved as a monotherapy for locally advanced or metastatic non-small cell lung cancer after at least one prior drug has failed. Two earlier clinical trials in first-line advanced NSCLC patients showed no clinical benefit when Tarceva was added to combination chemotherapy using either carboplatin and paclitaxel or gemcitabine and cisplatin.
In April, OSI submitted a supplemental new drug application with the Food and Drug Administration for use of Tarceva plus gemcitabine chemotherapy for the treatment of advanced pancreatic cancer in patients who have not received any previous treatment.
Tarceva is marketed by