Advaxis Announces Publication of ADXS-PSA Data in The Oncologist

ADXS-PSA in combination with KEYTRUDA^® in metastatic castration-resistant prostate cancer (mCRPC) is associated with prolonged overall survival in this population, particularly in patients with visceral metastasis

Median overall survival of 16.4 months for patients with visceral metastases treated with ADXS-PSA in combination with KEYTRUDA^® compared to ~9 months from historical data with KEYTRUDA^® alone

Median overall survival of 33.7 months in all mCRPC patients treated with ADXS-PSA in combination with KEYTRUDA^®, as previously reported

Excerpt from the Press Release:

MONMOUTH JUNCTION, N.J., April 08, 2022 (GLOBE NEWSWIRE) — Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announced the publication of results of their KEYNOTE-46 Phase 1/2 open-label, double-arm trial of ADXS-PSA with KEYTRUDA^® (pembrolizumab) in patients with metastatic, castration-resistant prostate cancer (mCRPC). The paper, titled “ADXS31­142 Immunotherapy ± Pembrolizumab Treatment for Metastatic Castration-Resistant Prostate Cancer: Open-Label Phase I/II KEYNOTE-046 Study,” has been published online in The Oncologist. The article can be found online here.

The KEYNOTE-46 trial was conducted in conjunction with Merck (known as MSD outside the U.S. and Canada) and evaluated ADXS-PSA, one of Advaxis’ Listeria monocytogenes (Lm)-based immunotherapies, alone and in combination with KEYTRUDA^®, Merck’s anti-PD-1 therapy.

“The published clinical and immunogenicity data demonstrate that ADXS-PSA in combination with KEYTRUDA^® has the potential to provide meaningful increases in median overall survival in patients with advanced, metastatic, castration-resistant prostate cancer,” said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. “Furthermore, these demonstrated improvements in survival in an advanced patient population encourage us to continue researching and developing the next generation of Lm-immunotherapies such as our off-the shelf, multineoantigen drug construct, ADXS-504, currently being studied in biochemically recurrent prostate cancer. ADXS-504 is a novel treatment alternative for these earlier stage prostate cancer patients, that has the potential to delay androgen blockade therapy initiation, improve quality of life and increase life expectancy.”

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