New trial of investigational immunotherapy in men on active surveillance

There appears to be a high degree of confidence that Barvarian Nordic’s Prostvac will show positive results in the ongoing Phase III clinical trial in men with metastatic, castration-resistant prostate cancer. An early stage trial has now been initiated among men with much less advanced disease disease.

The National Cancer Institute has put in place a randomized Phase II trial of Prostvac in men with early stage, localized prostate cancer who are on active surveillance. The trial started enrolling patients this June at six major centers. The proposed enrollment will be 150 patients who are to be randomized to treatment with Prostvac (now properly known by the biologic name rilimogene-galvacirepvec) or with a placebo.

To be eligible for this trial, patients must

  • Have a PSA level of < 15 ng/ml
  • Have been diagnosed with prostate cancer based on a needle biopsy of ≥ 10 cores
  • Have a clinical stage of ≤ T2a
  • Have a Gleason score of ≤ 3 + 4 = 7
  • Have ≤ 50 percent of the random biopsy cores positive for cancer
  • Also meet a number of other specific but relatively straightforward criteria outlined in the trial protocol

What is extremely interesting about this trial is that — as far as we are aware — this is the first time that anyone has put in place a randomized Phase II trial of this type for the management of low-risk and “favorable” intermediate-risk prostate cancer. There are likely to be a lot of men currently on active surveillance who might be interested in participating in this study, especially if they live near to any of the six centers enrolling patients.

The other thing that is interesting is that Barvarian Nordic has (presumably) been willing to assist in the execution of this trial … skipping directly from a trial in men with very advanced disease to a trial in men with very early stage and much lower risk disease! There are currently no randomized trials of Prostvac alone ongoing in, for example, men with progressive disease after first-line treatment or in men with metastatic but hormone sensitive prostate cancer.

Other ongoing trials of Prostvac currently include the following:

5 Responses

  1. Thanks for posting!

  2. Has Bavarian Nordic indicated an end date for the PROSPECT phase III trial yet? I saw recently mid 2016 with initial results end of 2015.

    All very encouraging!


  3. The last statement from the company that I am aware of was this one reported by Reuters. I can’t confirm what you say you heard.

  4. Assuming that this small trial shows good results and they go on to a larger randomized trial… what endpoint(s) would they have to achieve to convince the FDA to approve Prostvac for this use? (In this population overall survival benefit would seem to be a difficult target.) And would they even need FDA approval, or might doctors go ahead and prescribe it without FDA approval?

  5. Dear Tom:

    If Prostvac gets approved by the FDA and other regulators for the treatment of mCRPC based on the current, ongoing Phase III trial (results of which are expected some time in late 2016 or early 2017), then physicians have the right to prescribe it to anyone they believe to be an appropriate patient. However, insurance providers (Medicare included) here in the USA only have to pay for its use in the approved indication or other indications that are supported by strong medical evidence reported in the so-called “compendia” (a prime example of which — for cancer treatments — is the NCCN Drugs & Biologics Compendium, also known as just the NCCN Compendium®).

    With respect to a large, Phase III trial in the treatment of men otherwise on active surveillance, it is very hard to know what the FDA and other regulators might accept as a meaningful endpoint, but the most likely possibilities are (a) a very clear reduction in rates of and/or time to disease progression and the need for active therapy and (b) a significant reduction in rates of evident clinical progression based on markers like PSA and circulating tumor cells (CTCs). However, no one has ever tried (that I know of) to seek an indication for a therapeutic use of a drug or a biologic agent this early in the management of prostate cancer, so the therapeutic effect would need to be significant, and the level of product safety would need to be high.

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