These Telcyta response rates are excellent, although absolute numbers are still small:
Press Release Source: Telik, Inc.
Telik Reports Positive Interim Results of TELCYTA in Combination With Carboplatin and Paclitaxel in First-Line Non-Small Cell Lung Cancer
Friday May 13, 1:00 pm ET
PALO ALTO, Calif., May 13 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) reported positive interim data from a multicenter Phase 1-2a clinical study evaluating TELCYTA(TM) (TLK286) in combination with carboplatin and paclitaxel in the first-line treatment of advanced non-small cell lung cancer (NSCLC) at the annual meeting of the American Society of Clinical Oncology. In the trial, a 62% objective response rate (by RECIST), including one complete response and seven partial responses and a disease stabilization rate of 92% were observed in the evaluable patients at the time of the interim analysis.
ADVERTISEMENT
At the time of analysis, all 13 patients in the Phase 1 stage of the trial were evaluable for safety and efficacy. Four dose levels of TELCYTA were evaluated (400, 500, 750 and 1,000 mg/m2) along with standard doses of carboplatin (AUC 6) and paclitaxel (200 mg/ m2), administered every three weeks.
Responses were accompanied by improvement in clinical symptoms as well as performance status. Objective responses were observed in both squamous cell and adenocarcinoma subtypes, in males and females, and in current, former and never smokers. Overall the TELCYTA combination was generally well tolerated, without unanticipated toxicities. Median survival has not yet been reached
"While it is early, I am very encouraged by the responses seen with the combination of TELCYTA, carboplatin and paclitaxel," said Thomas J. Lynch, M.D., Medical Director, Center for Thoracic Cancers, Massachusetts General Hospital, Associate Professor of Medicine, Harvard Medical School and Principal Investigator of the study. "TELCYTA is a new type of tumor-activated chemotherapeutic that may add activity to the widely used carboplatin/paclitaxel regimen. Non-small cell lung cancer is the leading cause of cancer death in America, and it is essential that we confirm these exciting preliminary data."
About TELCYTA
TELCYTA is a novel, small molecule tumor-activated drug candidate. It is 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 has been evaluated in multiple Phase 1 and 2 clinical trials as a single agent and in combination regimens in advanced ovarian, non-small cell lung, breast and colorectal cancer.
Three Phase 3 registration trials of TELCYTA are underway: ASSIST-1, a single agent trial in platinum refractory or resistant ovarian cancer; ASSIST- 2, a single agent trial in platinum resistant non-small cell lung cancer; and ASSIST-3, a trial to evaluate TELCYTA in combination with carboplatin in second line platinum refractory or resistant ovarian cancer. TELCYTA was discovered through the application of Telik's proprietary drug discovery technology, TRAP. For additional information on the ASSIST trials in ovarian cancer, visit www.ASSIST-ovarian.com; additional information on the ASSIST trial in non-small cell lung cancer may be found at www.ASSIST-2trial.com
Conference Call and Webcast
Telik will host a conference call today at 4:30 p.m. Eastern time (1:30 pm. Pacific time). The conference call will be accessible via Telik's website at www.telik.com or by telephone at 877-209-0397 or 612-332-1025. An archive of the conference call will be available on the Telik website or by telephone at 800-475-6701 or 320-365-3844, access code 780992, from approximately 8:00 p.m. Eastern time on May 13 through May 20, 2005.
By way of comparison, Paclitaxel/Carboplatin ± Erlotinib (Tarceva) in advanced treatment-naive NSCLC had a response of 21.5% vs 19.3% for pac/carbo alone.
medscape.com
(I own TELK)
Peter |
