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Telik Presents Results at ASCO From ASSIST-5 Trial of TELCYTA in Platinum Refractory and Resistant Ovarian Cancer
Date:5/31/2009

key ovarian cancer disease characteristics, including age, ECOG Performance Status, presence of bulky disease and history of prior taxane therapy. A greater number of patients (13, 20%) had platinum refractory disease on the TELCYTA plus PLD arm compared to (8, 13%) with the PLD arm.

Efficacy Results: On an Intent-to-Treat (ITT) basis for the entire 125 enrolled patients, including those affected by the hold, the median progression-free survival (PFS) was 5.6 months on the TELCYTA plus PLD arm compared to 3.7 months on the PLD control arm, p=0.7243 and hazard ratio (HR)=0.92. The overall response rate (ORR) as assessed by RECIST was 12%, including one complete response (CR) for the TELCYTA plus PLD arm vs. 8% for the PLD control arm. The PLD control arm treatment outcomes were consistent with that reported previously in the evidence-based literature of randomized trials in platinum refractory and resistant ovarian cancer in both safety and efficacy.

Efficacy Results - Prespecified Analysis: Of the 125 patients in the ITT population, a pre-specified analysis was conducted for 75 patients (60% of study participants) with platinum refractory or primary platinum resistant disease, including 40 patients (53%) on the TELCYTA plus PLD arm and 35 patients (47%) on the PLD control arm. The median PFS of these patients was 5.6 months for the TELCYTA plus PLD arm compared to 2.9 months for the PLD control arm, p=0.0425 and HR=0.55. The response rate was 15% including one CR for the TELCYTA plus PLD arm vs. 6% for the PLD control arm.

Although the study was not powered for survival, median survival in the platinum refractory and primary platinum resistant population showed a positive trend in survival for the TELCYTA plus PLD arm (11.8 months) vs. PLD alone (7.8 months). In addition, the TELCYTA plus PLD arm achieved shorter median time to response (2.8 vs. 5.5 months), and longer median duration of stable
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SOURCE Telik, Inc.
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