ADXS-PSA/Keytruda Combo Prolongs Survival in mCRPC, Early Trial Results Suggest

ADXS-PSA/Keytruda Combo Prolongs Survival in mCRPC, Early Trial Results Suggest
Adding ADXS-PSA, an investigational cancer vaccine, to Keytruda (pembrolizumab) is showing positive signs of safety and efficacy in patients with metastatic, castration-resistant prostate cancer (mCRPC), and appears to prolong survival compared with standard-of-care therapy, early results from an ongoing Phase 1/2 trial show. The results were announced by Advaxis, the company developing ADXS-PSA, and presented in a poster at the recent American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta. Its title was “Effects of ADXS-PSA With or Without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients.” ADXS-PSA is a potential immunotherapy targeting PSA, a protein overproduced in prostate cancers. It contains live attenuated bacteria (Listeria monocytogenes, Lm) bioengineered to release a hybrid protein that combines a bacterial immune-stimulating molecule (tLLO), and human PSA. The product was designed to work as a cancer vaccine that helps boost the immune system’s ability to specifically recognize and attack prostate tumors. In animal models, combining ADXS Lm-based immunotherapies with PD-1 blocking antibodies, such as Keytruda, has been shown to improve efficacy. Keytruda is a checkpoint inhibitor immunotherapy that blocks a cellular pathway known as PD-1/PD-L1, which helps cancer cells evade the immune system. The medicine is approved for several cancer types, including prostate cancers with a specific genetic marker, referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). A two-part Phase 1/2 trial, called KEYNOTE-046 (NCT02325557), is underway to evaluate the safety, tolerability, and recommended doses of ADXS-PSA alone (part A)
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