Peregrine Pharmaceuticals has reported top-line results from a Phase II study evaluating bavituximab in combination with gemcitabine in stage IV pancreatic cancer patients.
The 70 patient open-label, randomised study demonstrated that the combination of bavituximab and gemcitabine showed more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm).
Peregrine medical oncology head Dr Kerstin Menander said; "Although the median overall survival improvement is modest, further analysis of the data including subgroups shows some very interesting and potentially promising trends."
According to the data, patients treated with a combination of bavituximab and gemcitabine had a 28% tumour response rate as compared to 13% in the control arm.
The primary endpoint of the trial is the median OS, which was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).
Bavituximab in combination with gemcitabine was safe and well-tolerated with the occurrence of similar adverse events in both arms.
Peregrine clinical and regulatory affairs vice president Joseph Shan said the company is evaluating the next steps to advance the bavituximab pancreatic programme.
"Subgroup analyses from the trial are yielding additional information that we believe will be important in guiding the anticipated future development of bavituximab in this challenging indication," Shan said.
"We are considering potential development pathways that would allow us to take advantage of bavituximab’s broad potential when combined with other cancer agents."