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The first Phase 2 trial is evaluating the safety, tumor response andsurvival in patients with recurrent NSCLC who are treated with Xcytrin as asingle agent. Patients in the trial were randomized to receive either a10mg/kg dose of Xcytrin every week, or a 15mg/kg dose every three weeks. Of60 evaluable patients, there was a confirmed response rate of 5%, or threepartial responses (using Response Evaluation Criteria in Solid Tumors).Seventeen patients (30%) had stable disease. Median survival was 9.2 months,with one year survival of 34%. The most common severe (grade 3 or higher)side effects were hypophosphatemia (23%), fatigue (12%), dyspnea (8.3%),hypoxia (6.7%), and pneumonia (6.7%).
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A second ongoing study is evaluating Xcytrin in combination with Alimta(R)(pemetrexed) and has enrolled 52 patients of which 35 are evaluable forsurvival and 24 are evaluable for response at this time. Patients havereceived a median of three cycles (range of 1-12 cycles) of 15mg/kg Xcytrinwith a standard dose of Alimta every 21 days. Eighteen of the 24 patientswith response data receiving Xcytrin and Alimta have achieved stabilization oftheir tumors (75%), with three of the 18 still on treatment. Patients stillon treatment remain under evaluation for tumor response. For the 35 patientsevaluable for survival, the median survival time exceeds one year with anactuarial one year survival of 52%. The most common severe side effects wereasthenia (11.4%), pneumonia (8.6%), thrombocytopenia (8.6%), and neutropenia(8.6%).
The third ongoing study is testing the combination of Xcytrin plusTaxotere(R) (docetaxel) and has enrolled 35 patients of which 23 are evaluablefor response at this time. Patients have received a median of four cycles(range of 1-9 cycles) of 15 mg/kg Xcytrin with a standard dose of Taxotereevery 21 days. One patient (4%) receiving Xcytrin and Taxotere has a partialremission, and 17 patients (74%) have achieved stabilization of their tumors.Seven patients still on treatment remain under evaluation for tumor response.The median survival time is 8.6 months with a one year actuarial survival of34%. The most common severe side effects were neutropenia (19.4%), asthenia(12.9%), and febrile neutropenia (9.7%).
With currently available therapies, response rates to second-linetreatments for NSCLC range from 4% to 10% with median survivals of about 6months. Currently approved agents for second-line treatment of NSCLC includeAlimta, Tarceva(R) and Taxotere.
"These results support Xcytrin's activity in lung cancer, with patientswho failed previous treatment with a platinum therapy exhibiting tumorresponses and a high proportion of stable disease following single-agenttreatment with Xcytrin," said Richard A. Miller, M.D., president and CEO ofPharmacyclics. "Although early, the combination studies are very promisingwith stable disease and very encouraging survival seen in a substantialproportion of patients."
About Non-Small Cell Lung Cancer
The American Cancer Society estimates that there will be more than 213,000new cases of lung cancer in the United States in 2007. Lung cancer is theleading cause of cancer death, and accounts for over 160,000 deaths in theUnited States each year. The most common form of lung cancer, non-small cell,is incurab
