Advaxis, Inc. ADXS, a clinical-stage biotechnology company developing
cancer immunotherapies, and Merck MRK, known as MSD outside the U.S.
and Canada, announced that enrollment has initiated in the Phase 1/2 clinical
trial evaluating the combination of ADXS-PSA (ADXS31-142), an investigational
Lm-LLO immunotherapy, and KEYTRUDA^® (pembrolizumab), the first anti-PD-1
(programmed death receptor-1) therapy approved in the United States, in
patients with previously treated, metastatic castration-resistant prostate
cancer (mCRPC). The clinical trial, KEYNOTE-046, is the first-in-human study
of Advaxis's lead Lm-LLO immunotherapy candidate for prostate cancer. It is
the second study initiated to evaluate the use of KEYTRUDA in the treatment of
advanced prostate cancer.
ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as
immuno-oncology therapies. Data from preclinical studies suggest that Advaxis
Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an
enhanced anti-tumor immune response. The results from KEYNOTE-046 will
determine the future clinical development program for the combination.
"A synergistic anti-tumor immune response has been observed in preclinical
studies evaluating the combination of a PD-1 antibody with an Lm-LLO
immunotherapy, and we look forward to the possibility of seeing these results
in patients. This immunotherapy combination could be a promising alternative
treatment option to current standards of care," said Naomi B. Hass, M.D.,
Associated Professor of Medicine and Director of the Prostate and Kidney
Cancer Program at the University of Pennsylvania Abramson Cancer Center and
principal investigator for KEYNOTE-046.
"The KEYNOTE-046 combination immunotherapy study is a significant clinical
development milestone for our Lm-LLO immunotherapy platform, as well as the
advancement of ADXS-PSA as a potential treatment for advanced prostate
cancer," said Daniel J. O'Connor, President and Chief Executive Officer of
Advaxis. "Further, for Advaxis, the initiation of this clinical program
continues what has been a rapid progression of our pipeline, which we hope
will further demonstrate the value of our immunotherapy technology alone and
in combination with checkpoint inhibitors."
"The initiation of new combination studies with KEYTRUDA is an example of our
focus on advancing breakthrough science in the field of immuno-oncology," said
Eric Rubin, M.D., vice president and therapeutic area head, early-stage
oncology development, Merck Research Laboratories. "We are pleased this study
with Advaxis has begun and we look forward to gaining a better understanding
of the potential of KEYTRUDA and ADXS-PSA, two immunotherapies with varying
mechanisms, in advanced prostate cancer."
KEYNOTE-046 is a multicenter, dose determining, open-label Phase 1/2 study
designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and
in combination with KEYTRUDA in approximately 51 mCRPC patients. Part A of the
study will be a dose escalating study designed to establish the maximum
tolerated dose of ADXS-PSA as a monotherapy. Part B will consist of a dose
escalating trial of ADXS-PSA in combination with KEYTRUDA, followed by an
expansion cohort phase. The primary objective is to evaluate safety and
tolerability of the two immunotherapies, with the secondary objective to
evaluate anti-tumor activity and progression-free survival (PFS). Further
information about KEYNOTE-046 can be found on ClinicalTrials.gov, using
Identifier NCT02325557.
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