Advaxis, clinical stage biotechnology company developing cancer immunotherapies, has announced the commencement of Part B of the KEYNOTE-046 clinical trial evaluating Advaxis’ Lm immunotherapy candidate, ADXS-PSA, in combination with KEYTRUDA (pembrolizumab) in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). In Part A of the phase I/II study, 14 patients were treated with ADXS-PSA monotherapy across three dose levels, with no dose limiting toxicities, paving the way for initiating Part B of the study.

KEYNOTE-046 is a multicenter, open-label, nonrandomized, dose determining, phase I/II trial evaluating the safety of ADXS-PSA. Part B of the study is evaluating the tolerability of ADXS-PSA in combination with KEYTRUDA in 30 patients with mCRPC. Secondary objectives for this study are to evaluate antitumor activity and progression-free survival of ADXS-PSA. KEYNOTE-046 is the first-in-human study of Advaxis' Lm immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.

Advaxis also announced initiation of its phase III AIM2CERV study, a multicenter, placebo-controlled, randomized study of axalimogene filolisbac, or AXAL, administered in the adjuvant setting following chemotherapy and radiation in women with high-risk, locally advanced cervical cancer (HRLACC). The primary objective of the trial is disease-free survival, with secondary objectives including examining overall survival and safety. In July 2016, Advaxis received a Special Protocol Assessment for the AIM2CERV trial, as well as Fast Track designation for AXAL as an adjuvant therapy for HRLACC patients.

Several trial sites have been opened for both studies and locations are currently screening patients for enrollment.