Set your calendars.
Second line median survival in ovarian cancer is about 9 months, so at a minimum, the control arm for ASSIST-1 may have a median survival of 9 months max. So Q4 for results. The full enrollment of ASSIST-1 also confirms Prudential's Zhang as nothing but a useless mouthpiece analyst.
The company presses on for ASSIST-2 in 3rd line NSCLC against Iressa despite recent results.
And finally, their third ASSIST trial is up and running but with no SPA. From hearing the company talk, I suspect that this was done for two reasons:
- to speed up the start date of the trial (no time spend negotiating SPA)
- company thinks that the results will be a no-brainer.
Earlier, they had mentioned that the primary endpoint will be objective response rate. They previously stated that the trial will end once everyone has received their full treatment and been monitored for an objective response. I suspect that once the objective response data is available (prob late Q3, early Q4), only the PFS data will be mature. I find it unlikely that the overall survival data will be mature by q4. We'll see if their decision to ignore an SPA for this trial costs them in the long run.
Telik Completes Enrollment in ASSIST-1, Initiates ASSIST-3 and Reviews Status of ASSIST-2 Clinical Trials
PALO ALTO, Calif., Dec. 29 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) announced the completion of enrollment for the ASSIST-1 clinical trial of TELCYTA(TM) (TLK286), and the initiation of a new randomized Phase 3 trial of TELCYTA called ASSIST-3, in second line platinum refractory or resistant ovarian cancer.
ASSIST-1 is a randomized Phase 3 study designed to enroll 440 women in the third line treatment of platinum refractory or resistant ovarian cancer. Enrollment is complete.
ASSIST-3 is a randomized Phase 3 study designed to enroll 244 women with 122 to be treated with the combination of TELCYTA plus carboplatin, and 122 to be treated with Doxil®. The trial endpoints are objective response rate, progression-free survival and overall survival. The study is based on a positive multicenter Phase 2 study of the combination of TELCYTA plus carboplatin in platinum refractory or resistant ovarian cancer, first presented at the annual meeting of the American Society of Clinical Oncology earlier this year and later updated at the Tenth Biennial International Gynecologic Cancer Society meeting. The initial participating institutions are the Harvard Affiliated Hospitals including the Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Beth Israel Deaconess Medical Center.
ASSIST-2 is a randomized Phase 3 study designed to enroll 520 patients in the third line treatment of platinum resistant non-small cell lung cancer. Enrollment continues as planned and the company anticipates completion of enrollment in the first quarter of 2005.
TELCYTA is a small molecule drug candidate designed to be activated by GST P1-1, an enzyme present in cancer cells. Upon activation, an intracellular process known as apoptosis, or programmed cell death, occurs. TELCYTA was discovered through the application of Telik's proprietary drug discovery technology, TRAP. TELCYTA has been successfully tested alone and in combination with approved cancer drugs in Phase 2 clinical trials in ovarian, non-small cell lung, breast and colorectal cancer.
Patients and caregivers may receive more information about ASSIST-3 by calling 866-485-5286. For information on ASSIST-2, visit www.assist-2trial.com; for ASSIST-1, visit www.assist-1trial.com.
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