Telik Reports Positive Data Demonstrating Synergy in Combinationand Highly Statistically Significant Effect of Telcyta asMaintenance Therapy in First-Line Non-Small Cell Lung Cancer
PALO ALTO, Calif., April 17, 2007 /PRNewswire-FirstCall/ -- Telik, Inc. announced the presentation today of results from a Phase 2 clinical trial of the triplet combination of TELCYTA(R) (canfosfamide HCl, TLK286), carboplatin and paclitaxel in the first-line treatment of advanced non-small cell lung cancer. The results include highly statistically and clinically significant improvement in both progression-free survival and overall survival in responding patients who received TELCYTA maintenance therapy as compared with those who did not receive TELCYTA maintenance therapy. The data were presented at the 98th annual meeting of the American Association for Cancer Research (AACR) in Los Angeles.
The multicenter dose-ranging study enrolled 129 patients with Stage IIIB or IV non-small cell lung cancer. Patients received standard doses of carboplatin and paclitaxel and one of four doses of TELCYTA (400, 500, 750 or 1,000 mg/m2) for a planned course of four to six cycles. Patients with objective responses or stable disease following completion of combination therapy could elect to receive every three week maintenance cycles of TELCYTA as monotherapy until disease progression. Outcomes to be evaluated included safety, objective response and disease stabilization rates, progression-free survival and overall survival in the intent-to-treat population, and safety, progression-free survival and overall survival in patients receiving TELCYTA maintenance therapy.
In the intent-to-treat population (n = 129), the overall objective response rate was 34% (95% CI 26%, 43%), including one complete response. Fifty-six patients, or 43%, had disease stabilization, for an overall disease stabilization rate of 77% (95% CI 69%, 84%). Median progression-free survival was 4.9 months, and the overall median survival was 9.6 months.
One hundred patients (77% of enrolled patients) had objective responses or stable disease at the completion of combination therapy. Fifty of these patients received TELCYTA maintenance therapy and 50 did not receive maintenance therapy. Median progression-free survival for patients on TELCYTA maintenance therapy was 6.9 months, compared with 4.2 months for those who did not receive TELCYTA maintenance therapy (p< 0.0001, HR 0.36). Overall median survival for the TELCYTA-treated patients was 14.2 months compared with 8.4 months without TELCYTA maintenance therapy (p= 0.0003, HR 0.40).
The triplet combination was generally well-tolerated at all TELCYTA doses evaluated, with toxicities similar to those expected with each drug alone. There were no new, unexpected or cumulative toxicities. TELCYTA maintenance therapy was, as expected, well-tolerated, with Grade 1 or 2 toxicities observed in fewer than 5% of patients.
"Many approaches to maintenance therapy following first-line treatment for advanced non-small cell lung and ovarian cancer have been evaluated, with most adding little to efficacy while exposing patients to ongoing risks from toxic chemotherapy," said Gail L. Brown, M.D., senior vice president and chief medical officer. "The safety profile and clinical activity of TELCYTA, both in combination with carboplatin and paclitaxel and as monotherapy, suggest a potential role for this investigational agent as part of first-line combination treatment and as single agent maintenance therapy of non-small cell lung cancer. We will review these results with our expert advisors to discuss plans to expeditiously advance the TELCYTA program toward registration."
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.
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-K for the year ended December 31, 2006. 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.
Posted: April 2007