Peregrine Pharmaceuticals has announced that interim data from its Phase II trial in refractory non-small cell lung cancer (NSCLC) patients demonstrates a statistically significant improvement in overall survival for patients receiving Bavituximab plus Docetaxel, versus Docetaxel alone.
The double-blind, placebo-controlled study evaluated two dose levels of bavituximab (bavituximab-containing arms) given with docetaxel, versus docetaxel plus placebo (control arm).
Peregrine clinical and regulatory affairs vice president Joseph Shan said the study yielded positive results in the most important endpoint: overall survival.
"The positive overall response rates and progression free survival in both bavituximab-containing arms seen earlier in the study has now translated into a statistically significant extension in overall survival for patients, a result rarely achieved in phase II clinical trials." Shan said.
"The quality of this data gives us a solid foundation for designing a phase III trial with an increased probability of success. We are planning for an end-of-phase II meeting with the FDA as we plan to initiate this trial by mid-2013."
The interim data showed a statistically significant improvement in overall survival (hazard ratio 0.524, p-value .0154) and a doubling of median overall survival (OS) in the bavituximab-containing arms compared to the control arm.
The interim results from the trial, which enrolled 121 patients with second-line non-squamous NSCLC following one prior chemotherapy regimen, showed no significant safety differences between the three treatment arms as determined by the trial’s independent data monitoring committee.
Baseline characteristics were well-balanced across the treatment arms while the tumour responses were determined in accordance with response evaluation criteria in solid tumours based on blinded central radiology review.
Peregrine president and chief executive officer Steven King said; "Robust data from this Phase II trial clearly demonstrate a significant benefit in overall survival with a good safety profile in patients receiving bavituximab plus docetaxel compared to those receiving docetaxel plus placebo."