This one was even worse. I think this sets the standard for the worst outcome I've ever seen. Goal was superiority :-)
<<Telik Reports Results of TELCYTA(R) ASSIST-1 Trial
Sunday June 3, 7:00 pm ET
PALO ALTO, Calif., June 3 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) reported results of the TELCYTA (canfosfamide HCl, TLK286) ASSIST-1 trial today at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO).
The Phase 3, international, randomized, active control study enrolled 461 women with advanced, platinum refractory or resistant ovarian cancer whose disease had progressed following first-line platinum-based therapy and second- line treatment with either liposomal doxorubicin or topotecan. Two hundred thirty-two women were randomized to TELCYTA treatment and 229 women were randomized to treatment with one of the active control drugs (pegylated liposomal doxorubicin (PLD) or topotecan), depending upon their second-line treatment. The two arms of the study were balanced for key ovarian cancer disease characteristics, platinum refractory or resistant status, 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 on the TELCYTA arm as compared with the active control arm. Median survival on the TELCYTA arm was 8.5 months compared with 13.6 months on the active control arm (p <0.01). Median progression-free survival was 2.3 months on the TELCYTA arm compared with 4.3 months on the active control arm.
The performance of the drugs on the active control arm, PLD or topotecan, was unexpected based on reported data, and no known prognostic or predictive factors accounted for this result. In addition, patients treated with PLD tended to have superior overall survival as compared with patients treated with topotecan, also an unexpected result as published reports suggest that survival outcomes in platinum refractory or resistant ovarian cancer patients are similar for both agents.
TELCYTA was very well-tolerated with infrequent hematologic or non- hematologic adverse events in a heavily pretreated population.
"The known in vitro synergism with carboplatin, paclitaxel and anthracyclines and the excellent tolerability profile of canfosfamide in heavily pretreated, third-line ovarian cancer patients support further studies with canfosfamide in combination regimens in second line therapy," said Professor Dr. Ignace Vergote, Chairman, Department of Obstetrics and Gynecology, University Hospitals Leuven, Belgium, principal investigator for the ASSIST-1 trial. Dr. Vergote also is principal investigator for the ongoing ASSIST-5 Phase 3 trial which is evaluating the combination of TELCYTA plus PLD to PLD alone in second-line platinum refractory or resistant ovarian cancer.>>
Noticed the bod just granted themselves stock grants a few weeks ago. Job well done. |
