Peregrine Pharmaceuticals announced results from its 70 patient open-label, randomized Phase 2 clinical trial of bavituximab, used in combination with gemcitabine, in patients with previously untreated, advanced Stage IV pancreatic cancer. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression. Results showed that the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm).
In the trial, patients treated with a combination of bavituximab and gemcitabine had a 28 percent tumor response rate as compared to 13 percent in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).
"We are pleased with the results seen in this very difficult to treat patient population," said Kerstin Menander, head of medical oncology at Peregrine. "Although the median overall survival improvement is modest, further analysis of the data including subgroups shows some very interesting and potentially promising trends. We look forward to presenting the full data set from this trial later this year at an upcoming scientific meeting."
The pancreatic cancer trial is a randomized, open-label Phase 2 trial evaluating bavituximab with gemcitabine versus gemcitabine alone in up to 70 patients with previously untreated stage IV pancreatic cancer. The trial allowed the enrollment of patients 18 and older without any age limit, distant organ involvement and ECOG performance status of 0-2. In this trial, bavituximab was generally safe and well tolerated in combination with gemcitabine with similar adverse events occurring in both arms.
"In light of this data, as well as other recent developments in the treatment of pancreatic cancer, we are actively evaluating the next steps for advancing the bavituximab pancreatic program," said Joseph Shan, vice president of clinical and regulatory affairs at Peregrine. "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. We are considering potential development pathways that would allow us to take advantage of bavituximab's broad potential when combined with other cancer agents. We look forward to providing updates as these plans come together."
Bavituximab is being evaluated by Peregrine and individual clinical investigators in a variety of treatment settings for patients with non-small cell lung cancer in both the front and second-line settings, as well as breast, prostate, liver and rectal cancers, in combination with approved chemotherapies and radiation.
Date: February 13, 2013