Telik Reports Top-Line Results From Phase III Ovarian Cancer Trial
Telik, a biopharmaceutical company, has announced top-line results from an interrupted Phase III randomized study of Telcyta in combination with pegylated liposomal doxorubicin versus PLD alone in second-line therapy in platinum refractory, primary platinum resistant or secondary platinum resistant ovarian cancer.
On an intent-to-treat basis for the 125 enrolled patients, the median progression-free survival was 5.6 months on the Telcyta plus pegylated liposomal doxorubicin (PLD) arm compared to 3.7 months on the PLD control arm, p = 0.7243 and hazard ratio (HR) = 0.92.
The study did not meet the statistical significance p less than or equal to 0.05. The overall response rate as measured by Recist was 12%, including one complete response for the Telcyta plus PLD arm and 8% for the PLD control arm.
The initial trial design provided for the enrollment of 244 patients. The trial was interrupted by a brief clinical hold, followed by a partial clinical hold from June 2007 until October 2007. At the time of the clinical hold, 125 patients had been enrolled in the trial. Although enrollment was permitted after the release of the clinical hold, Telik decided not to enroll additional patients, a decision which is said to have impacted the powering of the study.
The 125 patients randomized to the trial were well-balanced for patient demographics and key ovarian cancer disease characteristics. Telcyta was administered at 1000mg/m2 followed by PLD at 50mg/m2, the approved dose of PLD, every 28 days. Approximately 35 patients were not able to complete their assigned per-protocol therapy and discontinued due to the clinical hold, including 21 patients on the Telcyta plus PLD arm and 14 patients on the PLD control arm.
There was a higher incidence of hematologic adverse events in patients on the Telcyta plus PLD arm (66%) versus 44% on the PLD arm. The hematologic toxicities were manageable with dose reductions and growth factor support on both treatment arms.