>>Telik Announces Top-Line Results of TELCYTA(R) ASSIST-2 Trial
Sunday June 3, 7:00 pm ET
PALO ALTO, Calif., June 3 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) announced top-line results from the ASSIST-2 Phase 3 study of TELCYTA (canfosfamide HCl, TLK286) versus gefitinib in the third-line treatment of non-small cell lung cancer (NSCLC).
The Phase 3, international, randomized, active control study enrolled 530 patients with advanced NSCLC whose disease had progressed following first-line platinum-based therapy and a second-line treatment. Two hundred sixty-five patients were randomized to TELCYTA treatment and 265 patients were randomized to gefitinib. The two arms of the study were balanced for key NSCLC disease characteristics and other prognostic or predictive factors.
The trial did not meet the primary endpoint of demonstrating superiority in overall survival or the secondary endpoint of demonstrating superiority in progression-free survival for the TELCYTA arm as compared with gefitinib. Median survival for the TELCYTA arm was 4.6 months as compared with 6.1 months for the active control arm. Median progression-free survival was 2.2 months for the TELCYTA arm as compared with 2.3 months for the gefitinib arm.
TELCYTA was very well-tolerated with infrequent hematologic or non- hematologic adverse events in a heavily pretreated population.
"We thank the patients, investigators and staffs who participated in this large clinical trial," said Gail L. Brown, M.D., Senior Vice President and Chief Medical Officer. "We plan to submit the results for presentation at a medical meeting later this year."<<
snip
No better for NSCLC, either. Sheesh.
Cheers, Tuck |
