Advaxis, Inc. announced encouraging updated data from its ongoing phase I/II study — KEYNOTE-046 — evaluating its pipeline candidate, ADXS-PSA, in combination with Merck’s (MRK - Free Report) stellar drug, Keytruda, in heavily pre-treated patients with metastatic, castration-resistant prostate cancer (mCRPC).
Data showed that efficacy achieved by the combination therapy compares favorably with current standard of care and results from studies in patient populations with bone-predominant disease. These factors support further evaluation of the combination therapy.
Data from the study was also presented at the American Association for Cancer Research (“AACR”) Annual Meeting.
Investors cheered the data as shares of the company rallied 10.2% on Apr 1. The company’s shares have gained 128.5% so far this year compared with the industry’s increase of 12.5%.
The KEYNOTE-046 is an open-label study, which is being conducted in two parts, one part evaluating ADXS-PSA monotherapy and another evaluating it in combination with Keytruda, for safety, tolerability and dosing.
Median overall survival was 21.1 months in the combination arm at the data cut-off date (Feb 1). Broader immune stimulation was observed in the combination arm compared to the monotherapy arm. T-cell responses and antigen spreading was observed in 75% and 85% of patients in the study, respectively. Moreover, combination therapy was well tolerated in the patient population.
ADXS-PSA is a Listeria monocytogenes (Lm)-based immunotherapy, which delivers antigens to cancerous cells and generate immune response. On the other hand, Keytruda is an anti PD-1 therapy that inhibits cancer cells’ ability to stop body’s immune response. A combination of these therapies holds potential as it may generate better immune response and is likely to target and kill cancer cells more effectively. However, further evaluation in advanced stages of development will establish the efficacy and safety of the combination therapy – ADXS-PSA plus Keytruda – which is likely to take a few more years.
Meanwhile, several other biotech/pharma companies are developing their pipeline candidates, based on different mechanisms, for treating mCRPC. These include Clovis Oncology (CLVS - Free Report) and AstraZeneca’s (AZN - Free Report) PARP inhibitors — Rubraca and Lynparza — respectively as well as Novartis’ radioligand candidate, 177Lu-PSMA-617.
Apart from ADXS-PSA, Advaxis also has three other pipeline candidates, ADXS-HPV for cervical cancer, ADXS-NEO for multiple cancers, ADXS-503 for non-small cell lung cancer, in different stages of clinical development.
Advaxis currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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