Healthcare Industry News: ASSIST-3
News Release - June 3, 2007
Telik Reports Results of TELCYTA(R) Assist-3 TrialPALO ALTO, Calif., June 3 (HSMN NewsFeed) -- Telik, Inc. (Nasdaq: TELK ) reported results of the TELCYTA (canfosfamide HCl, TLK286) ASSIST-3 trial today at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO).
The Phase 3, randomized, active control study enrolled 247 women with advanced, platinum refractory or resistant ovarian cancer whose disease had progressed following first-line platinum-based therapy. One hundred twenty- three women were randomized to treatment with the combination of TELCYTA and carboplatin and 124 women were randomized to treatment with pegylated liposomal doxorubicin (PLD). 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. All patients had platinum refractory or resistant disease, with a platinum-free interval (PFI, from the date of last treatment with platinum-based chemotherapy to the date of documented disease progression) of six months or less.
Patients were treated until disease progression, as determined by radiologic evaluations at each site, or unacceptable toxicity. A central, blinded independent radiology review also was conducted.
Assessment of the primary endpoint, objective response rate by RECIST, may have been compromised because approximately 25% of patients were prematurely discontinued from the study for disease progression, as assessed by the independent radiology review. Median progression-free survival, the secondary endpoint of the trial, assessed by independent radiology review, was 3.5 months on both arms.
As expected with a platinum-containing regimen, there were more hematologic toxicities on the TELCYTA plus carboplatin arm as compared with the PLD arm. These toxicities were well managed with growth factor support or dose reductions as clinically appropriate. Febrile neutropenia occurred only on the PLD arm. Non-hematologic toxicities were more common on the PLD arm, also as expected. Patient-reported quality of life outcomes consistently favored the TELCYTA plus carboplatin arm over the PLD arm, although the differences were not statistically significant.
A multivariate analysis of prognostic factors was conducted including all prespecified patient characteristics and stratification factors. There were statistically significant differences between the two arms of the study in patients who had a drug-free period (DFP, from the date of last treatment with any anti-cancer treatment to the first study treatment) of greater than or equal to six months. Thirty-eight patients, 19 on each arm, had a DFP of six months or more. In this group, median progression-free survival was 3.5 months on the PLD arm versus not yet reached on the TELCYTA plus carboplatin arm (p . 0.01). Median survival was 11.1 months on the PLD arm versus not yet reached on the TELCYTA plus carboplatin arm. The objective response rate (as assessed by the independent radiology review) was 31.6% on the TELCYTA plus carboplatin arm, as compared with 10.5% on the PLD arm.
"The combination of TELCYTA and carboplatin has demonstrated promise and is an active regimen in platinum refractory or resistant ovarian cancer, a significant unmet need," said Peter Rose, M.D., Section Head, Gynecologic Oncology, Cleveland Clinic, and principal investigator for the ASSIST-3 trial. "Survival follow-up in the overall trial and in the patients with a DFP of six months or more is in progress."
"New agents to treat women with advanced ovarian cancer are greatly needed, particularly for women whose disease is platinum refractory or resistant," said Sherry Salway Black, Executive Director of the Ovarian Cancer National Alliance. "While it is disappointing that this trial did not meet its primary endpoint, we are encouraged by the ongoing Phase 3 study of TELCYTA plus standard chemotherapy in the second-line therapy of ovarian cancer."
"We thank the patients, investigators and staff who participated in this trial," said Gail L. Brown, M.D., Senior Vice President and Chief Medical Officer. "We are exploring the biology of platinum resistance and resensitization to identify optimal drug-free periods following platinum exposure," said Dr. Brown
Telik, Inc. of Palo Alto, CA is a biopharmaceutical company focused on discovering, developing and commercializing novel small molecule drugs to treat serious diseases. The company's most advanced drug development candidate is TELCYTA, a tumor-activated small molecule product candidate in clinical development for the treatment of advanced ovarian cancer and non-small cell lung cancer. A second drug development candidate, TELINTRA(TM) (TLK199), is in clinical development for myelodysplastic syndrome. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP(TM), which enables the rapid and efficient discovery of small molecule drug candidates. Additional information is available at www.telik.com
The Ovarian Cancer National Alliance is a survivor-led, umbrella organization uniting ovarian cancer activists, women's health advocates and health care professionals in the effort to increase public and professional understanding of ovarian cancer and to advocate for more effective diagnostics, treatments and a cure. Additional information is available at www.ovariancancer.org
This press release contains "forward-looking" statements, including statements regarding the potential for TELCYTA to treat one or more types of cancer. There are important factors that could cause Telik's results to differ materially from those indicated by these forward-looking statements, including, among others, that none of Telik's product candidates have been determined to be safe or effective in humans or been approved for marketing, clinical trials of Telik's product candidates may take several years to complete and may not be successful, success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful and interim results of clinical trials do not necessarily predict final results. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Telik's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its annual report on Form 10-Q for the quarter ended March 31, 2007. Telik does not undertake any obligation to update forward-looking statements contained in this press release.
TELIK, the Telik logo, TELCYTA, TELINTRA and TRAP are trademarks or registered trademarks of Telik, Inc.
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