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May 31,2009 - Telik, Inc. (Nasdaq: TELK | Quote | Chart | News | PowerRating) today announced presentation at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, of results from the ASSIST-5 Phase 3 randomized, multinational study of TELCYTA(R) (canfosfamide HCl) in combination with pegylated liposomal doxorubicin (PLD) vs. PLD alone in second-line therapy in platinum refractory or resistant ovarian cancer.
Study Design: Patients with platinum refractory or resistant ovarian cancer (platinum refractory, primary platinum resistant, secondary platinum resistant) by standard GOG criteria, with measurable disease were eligible for enrollment in the trial. A total of 125 patients at sites in the USA (44), Brazil (15), Belgium (8) and UK (6) were randomized with a 1:1 allocation to receive either TELCYTA in combination with PLD (administered IV at doses of 1000 mg/m2 and 50 mg/m2, respectively, every four weeks), or PLD alone (at 50 mg/m2 every four weeks). Patients were treated until tumor progression or unacceptable toxicity. Tumor assessments were conducted every 2 cycles or 8 weeks.
The trial design provided for the enrollment of 244 patients. The trial was interrupted by a clinical hold from June 2007 until October 2007. At the time of the clinical hold, 125 patients had been enrolled in the trial. As a result, 35 patients (21 on the combination treatment and 14 on PLD alone) were discontinued from their study treatment(s) and did not complete their assigned per protocol therapy. Although enrollment was permitted after the release of the clinical hold, Telik decided not to enroll additional patients, which impacted the powering of the study.
Patient Demographics: The treatment arms were well-balanced for patient demographics and 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 disease (7.4 vs. 4.1 months, HR=0.49, p=0.0439).
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.
About Telik
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 glutathione analog for the treatment of cytopenias due to myelodysplastic syndrome or chemotherapy, and TELCYTA, a tumor-activated prodrug for the treatment of advanced ovarian cancer and non-small cell lung cancer. Telik's product candidates were discovered using its proprietary drug discovery technology, TRAP(R), which enables the rapid and efficient discovery of small molecule drug candidates.
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