Combination immunotherapy for men with mCRPC: another new trial proposed


Late yesterday, Advaxis Immunotherapies announced the potential initiation of human trials of another new form of immunotherapy for the treatment of metastatic, castration-resistant prostate cancer (mCRPC).

ADXS31-142  — a so-called Listeria monocytogenes-LLO immunotherapeutic agent — is designed to target prostate-specific antigen (PSA). It is proposed that ADX31-142 may have clinical activity against mCRPC when used in combination with pembrolizumab (also known as Keytruda®). Pembrolizumab is another but very different form of immunotherapy, and was approved earlier this year as the first anti-programmed death receptor-1 (anti-PD-1) agent; it is currently approved only for the treatment of patients with melanoma (a malignant form of skin cancer), and treatment with this drug does come with risk for some significant side effects.

According to the media release from Advaxis, assuming that the FDA accepts the company’s submission (an Investigational New Drug submission commonly referred to as an IND) to initiate trials in humans, the company intends to conduct a so-called Phase I/II trial which will do two things:

  • The Phase I component of the trial will investigate and seek to identify recommended doses of ADXS31-142 when used alone and of ADXS31-142 when used in combination with pembrolizumab.
  • The Phase II component of the trial will offer initial assessment of the safety and the activity of the combination of ADXS31-142 + pembrolizumab in the treatment of mCRPC.

The proposed trial will be conducted in collaboration by Advaxis and Merck (the developer of pembrolizumab) and the companies are hoping to be able to enroll the first patients in early 2015. The precise details of this trial have not yet been posted to the ClinicalTrials.gov web site.

Always assuming that there are no glitches in the plan laid out in Advaxis’s media release, this will be another attempt to investigate whether combination immunotherapy can be beneficial in the treatment of very late-stage prostate cancer. Preclinical data has suggested that this particular combination of immunotherapeutic agents might be able to induce a significant anti-tumor immune response in men with advanced prostate cancer.

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