As in the overall ITT population, compared with the PLD control arm, the TELCYTA plus PLD arm had a greater proportion of patients with a less favorable prognosis including more platinum refractory patients (13, 33% vs. 8, 23%) and lower prior best response rate (defined as CR plus PR) to platinum agents (17, 43% vs. 22, 63%).
Safety Results: The most common, non-hematologic adverse events, including nausea, fatigue, vomiting, and constipation, were similar in incidence and severity in both arms. In addition, 17% Grade 2-3 stomatitis and 9% Grade 2-3 palmar-plantar erythrodysesthesia (PPE) were observed in the TELCYTA plus PLD arm, compared to 23% Grade 2-3 stomatitis and 21% Grade 2-3 PPE in the PLD control arm. Grade 4 PPE (2%) was only observed in the PLD control arm. TELCYTA may ameliorate the incidence and severity of stomatitis and PPE known to be associated with PLD. There was a higher incidence of hematologic adverse events in patients on the TELCYTA plus PLD arm (66% vs. 44%). The hematologic adverse events were manageable with dose reductions and/or growth factor support in both treatment arms.
About Platinum Refractory and Resistant Ovarian Cancer
Platinum refractory or primary platinum-resistance is defined as those patients whose disease fails to respond or relapses within 6 months of completion of initial platinum-based treatment. Secondary platinum resistance is defined as those patients whose disease relapses after 6 months of completion of therapy and fails a re-induction platinum-based regimen.
Telik, Inc. of Palo Alto, CA, is a clinical stage drug development company focused on discovering and developing small molecule drugs to treat cancer and inflammatory diseases. The company's most advanced investigational drug candidates in clinical development are TELINTRA(R), a modified
|SOURCE Telik, Inc.|
Copyright©2009 PR Newswire.
All rights reserved