The teaming up of Advaxis, Inc. (NASDAQ:ADXS) and Merck & Co., Inc. (NYSE:MRK) has resulted in the completion of the first two dose-escalation cohorts for the KEYNOTE-046 prostate cancer trial. The third dose-escalation cohort will now begin.
The Phase 1/2 study is an assessment of the combination of ADXS-PSA and KEYTRUDA (pembrolizumab). Being the first anti-PD-1 (programmed death receptor-1) drug, KEYTRUDA has already gained approval from the FDA and can be used in patients suffering from previously treated metastatic castration-resistant prostate cancer (mCRPC).
The trial will be the first for ADXS-PSA in a multicenter, dose determining, open-label Phase 1/2 study. It is the first-in-human study of Advaxis’ Lm immunotherapy candidate for prostate cancer but second in the evaluation of KEYTRUDA in the treatment of advanced prostate cancer.
Part A of the study is designed in a way that will establish the maximum tolerated dose of ADXS-PSA as a monotherapy. Part B will begin by mid-year and will evaluate ADXS-PSA in combination with KEYTRUDA. The aim of the two studies is the establishment of safety and tolerability of the two immunotherapies and at the same time to assess anti-tumor activity and progression-free survival.
Advaxis President and Chief Executive Officer, Daniel J. O’Connor, expressed his satisfaction with the news. The collaboration between Advaxis and Merck is a step closer to evaluating their Lm platform in combination with a PD-1 antibody.
Prostate cancer is the second most common form of cancer in men in the United States yet very few options of treatment are in existence. The diagnosis estimate from the American Cancer Society indicates that there will be 180,890 new cases of prostate cancer this year which could result in 26,120 deaths.
Meanwhile, the two companies are now in the process of handing in an abstract at a key medical meeting on the dose-escalation portion of the study.