Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Pharmacyclics has released promising preliminary results from an open-label phase II clinical trial of the company's non-small cell lung cancer therapeutic Xcytrin injection, for patients who have failed at least one platinum-based chemotherapy regimen.
Subscribe to our email newsletter
The interim results from the phase II trial showed that the response rate and survival are comparable to currently approved second-line therapies for non-small cell lung cancer (NSCLC), the company said.
The trial is evaluating the safety, tumor response and duration of response in patients with recurrent NSCLC who are treated with Xcytrin. Patients in the trial are randomized to receive either a 10mg/kg dose of Xcytrin every week, or a 15mg/kg dose every three weeks. Tumor response rate is being evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), the standard parameters used to document response for solid tumors.
Of 58 evaluable patients there was a confirmed response rate of 5.2%, or three partial responses. Twenty patients (34.5%) had stable disease. Median time to progression was seven weeks for all patients. Median survival was eight months, with 62% and 30% of patients alive at six and 12 months, respectively, while 13% were free from progression at six months. Xcytrin was well-tolerated in this study, Pharmacyclics added.
Richard Miller, president and CEO of Pharmacyclics, said: “The response rate and survival observed in this trial are comparable to currently approved second-line therapies for NSCLC and support our strategy to conduct multiple ongoing phase II studies of Xcytrin in combination with standard therapies and move into a pivotal trial for this indication early next year.
“In addition, we are continuing to pursue our new drug application for Xcytrin to treat patients with brain metastases from NSCLC. We believe Xcytrin’s selectivity, novel mechanism of action, magnetic resonance imaging detectability, and non-overlapping toxicity with other agents make it an appealing drug to study in combination with other therapies for a broad range of cancers.”