What will be schedule and dose for combination therapy, most likely in PIII trials? Are company rushing with PIII without good knowledge of the drug toxicity in combination with chemo????
Sunday May 19, 3:52 pm Eastern Time
Press Release
SOURCE: Telik, Inc.
Telik's TLK286 Shows Preliminary Improvement in Survival as a Single Agent In a Phase 2 Trial in Non-Small Cell Lung Cancer
Data Presented at American Society of Clinical Oncology Meeting
SOUTH SAN FRANCISCO, Calif., May 19 /PRNewswire-FirstCall/ -- Telik, Inc. (Nasdaq: TELK - News) presented preliminary results of the Phase 2 clinical trial of its TLK286 product candidate in patients with advanced, platinum resistant non-small cell lung cancer (NSCLC). TLK286 had significant single agent anti-tumor activity in patients with highly resistant disease. The results were presented at the 38th annual meeting of the American Society of Clinical Oncology in Orlando, Florida.
Fifty-two patients with advanced NSCLC were treated with TLK286 in a multicenter clinical trial. All patients were either refractory or resistant to platinum-based therapy, and 82% were also resistant to placitaxel therapy. In addition, 25% of patients were also resistant to second line docetaxel, and more than half had failed one or more third- or fourth-line therapies. Patients received TLK286 every three weeks until disease progression or unacceptable toxicities.
Forty-one patients were evaluable for efficacy at time of analysis. The median survival has not yet been reached and is greater than 39 weeks. Fifty-one percent of patients have had stabilization of disease. TLK286 was generally well-tolerated, without the toxicities associated with conventional chemotherapy. Most toxicities were classified as mild to moderate (Grades 1 and 2). There were few Grade 3 and no Grade 4 toxicities.
"There is significant need for new agents to treat resistant non-small cell lung cancer," said Vassiliki Papadimitrakopoulou, M.D., Assistant Professor of Thoracic Oncology at the University of Texas M.D. Anderson Cancer Center (Houston, TX), and Principal Investigator for the trial. "With the promising tolerability, disease control, improvement in clinical well-being and survival results presented today, TLK286 is emerging as a promising novel agent for further investigation in non-small cell lung cancer."
"The ten months' median survival seen so far in this trial compares favorably with standard second line therapies for non-small cell lung cancer and supports our plans to advance TLK286 into Phase 3 trials in this serious, difficult to treat cancer," said Michael M. Wick, M.D., Ph.D., Chairman and Chief Executive Officer. "The tolerability profile and lack of overlapping toxicities with standard chemotherapeutic drugs support advancement into clinical testing in combination regimens." |
