Peregrine Pharmaceuticals has announced positive results from its randomised, double-blind, placebo-controlled Phase 2b trial investigating two dose levels of bavituximab plus docetaxel versus docetaxel plus placebo in patients with second-line, non-small cell lung cancer (NSCLC).

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that is currently being evaluated in seven clinical trials, including three randomised Phase 2 trials in front-line and second-line non-small cell lung cancer, front-line pancreatic cancer and four investigator-sponsored trials (ISTs) in additional oncology indications.

The Phase 2b trial enrolled 121 patients with second-line stage 3b or 4 (TNM Edition 7) non-squamous NSCLC, who were then randomised into one of three treatment arms: six cycles of docetaxel (75mg/m2) plus either placebo, 1mg/kg bavituximab, or 3mg/kg bavituximab until disease progression.

Patients treated in the bavituximab-containing arms showed a doubling of overall response rates (ORR), the primary endpoint, and an improvement in progression-free survival (PFS), a secondary endpoint, when compared to the control arm.

Joseph Shan, Peregrine clinical and regulatory affairs vice president, said the study data demonstrated that the combination of bavituximab and docetaxel is more active than docetaxel alone in treating second-line NSCLC.

"Patients treated in the bavituximab-containing arms showed a doubling of overall response rates (ORR)."

"We saw twice as many patients demonstrating an objective tumour response, increased progression-free survival and already promising survival trends in this refractory setting. These results give us a high level of confidence as we begin planning for Phase 3 development in this indication," Shan added.

Peregrine regulatory affairs head, Robert Garnick, said the results from the trial will be important in discussions with the Food and Drug Administration (FDA) regarding advancing bavituximab’s clinical development in second-line NSCLC.

"We look forward to working closely with the FDA to identify the most efficient path toward commercialisation for this promising candidate in this indication where new therapies are desperately needed," Garnick added.

Based on the review of safety and efficacy of the trial conducted by an independent Data Monitoring Committee, no safety issues or concerns were identified in the study when comparing the bavituximab containing arms with the docetaxel alone arm.