Peregrine Pharmaceuticals' Bavituximab, in combination with carboplatin and paclitaxel, has demonstrated 50% improvement in overall tumour response rates (ORR) in a Phase II trial evaluating non-small cell lung cancer (NSCLC) patients.
Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody, that binds to PS and inhibit the immunosuppressive signal, enabling the immune system to recognise and fight the tumour.
The randomised Phase II trial is intended to compare the ORR of carboplatin and paclitaxel in presence or absence of Bavituximab in 86 patients with front-line, Stage IV metastatic NSCLC.
The secondary endpoints of the trial include median progression-free survival (PFS), duration of response, median overall survival (OS), and safety parameters, which are expected to be reported during 2012.
In the study, patients treated with Bavituximab combination therapy showed an ORR of 39% compared to 26% in patients treated with carboplatin and paclitaxel alone, which was determined using Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
The efficacy of Bavituximab is being investigated in three randomised Phase II trials in front-line NSCLC, second-line NSCLC, and front-line pancreatic cancer, including four investigator-sponsored trials (ISTs).
In an earlier Phase II study Bavituximab along with carboplatin and paclitaxel has demonstrated ORR data of 43%, median PFS of 6.1 months, and median OS of 12.4 months.
Peregrine Pharmaceuticals Medical oncology head Kerstin Menander said the first randomised clinical data showed that Bavituximab is an active anti-tumour agent, targeting a specific marker on tumour blood vessels but not on healthy vessels, resulting in broad potential in the treatment of cancer patients.
''These results go a long way toward supporting our PS-targeting platform in a randomised trial setting, indicating bavituximab's anti-tumour activity in combination with chemotherapy," Menander added,
Peregrine president and CEO Steven King said the unblinding of the randomised Phase II trial in second-line NSCLC patients is anticipated in the first half of 2012.
Caption: Bavituximab is used to treat non-small cell lung cancer