Peregrine Pharmaceuticals, a biopharmaceutical company, has reported that updated preliminary data from the initial cohort of 21 patients in its Phase II trial evaluating bavituximab in combination with carboplatin and paclitaxel showed that 11 of 17 evaluable patients with locally advanced or metastatic non-small cell lung cancer achieved an objective tumor response according to RECIST criteria, after completing the maximum six treatment cycles.
The company has also reported that patient dosing is underway in the expansion stage of the trial, which will enroll an additional 28 patients for a total of 49 patients overall.
The primary objective of the multi-center, open-label Phase II study is to assess the overall response rate to bavituximab with carboplatin and paclitaxel. In the trial’s Simon two-stage design, 21 patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) were initially enrolled and 17 of these patients were deemed evaluable.
In this initial cohort, 11 of the 17 evaluable patients achieved an objective tumor response by the time that treatment with the combination of bavituximab, carboplatin and paclitaxel was completed. Approximately eight of the 11 objective tumor responses were confirmed by at least one repeat scan no less than four weeks after the criteria for response were first met.
Patients in the study are evaluated regularly for tumor response according to response evaluation criteria in solid tumors (RECIST) criteria. Patients may continue to receive bavituximab as monotherapy after completion of chemotherapy as long as the cancer does not progress and side effects are acceptable. The trial is being conducted in India according to international conference on harmonization and good clinical practices guidelines.
Steven King, president and CEO of Peregrine, said: We are very pleased to see these additional objective tumor responses in this difficult-to-treat cancer following the full regimen of six treatment cycles of bavituximab and chemotherapy. These updated results build on the impressive data we reported after only four treatment cycles, which had already exceeded the pre-defined number of objective tumor responses needed to expand the trial to the larger cohort.