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Overview

The phase 3 trial of DCVax-L in newly diagnosed glioblastoma is continuing even though it has passed the 248 PFS events (mPFS is a primary endpoint) and has probably surpassed 233 OS events (mOS is an independent co-primary endpoint). Reaching either or both of these events is not an automatic stopping point for the trial. Rather it means that if assumptions on how DCVax-L plus SOC behaves in the trial as compared to SOC are correct, the trial will achieve statistical significance on both endpoints. While trials are often stopped when such event levels are reached, I agree with NWBO management that there are very strong reasons for not stopping and unblinding the trial.

Let me start by providing some important background information. Bristol-Myers Squibb recently presented updated date for Opdivo (nivolumab) from the CHECKMATE-017 and CHECKMATE-057 trials in advanced stage, non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology (ESMO). These trials compared Opdivo to the chemotherapy drug docetaxel which Opdivo and other checkpoint inhibitors have since replaced as standard of care (SOC). The clinical results from checkpoint inhibitors are revolutionizing the treatment of cancer and are ushering in the new era of immunotherapies. The hope is that immunotherapy can largely remove toxic chemotherapy drugs from cancer treatment regimens. Because DCVax-L is also an immunotherapy, there may be some learnings from checkpoint inhibitor results even though the mechanism of action is quite different than DCVax-L.

One purpose of this note is give you an idea of the type of survival data that has so excited oncologists about Opdivo and other checkpoint inhibitors. In some very aggressive, advanced cancers, they provide a long term survival benefit over standard of care in a small but meaningful percentage of patients. I think we can use this as a benchmark to speculate on the type of outcomes that NWBO’s immunotherapy drug DCVax-L might have to achieve in its phase 3 trial in newly diagnosed glioblastoma to be considered a medical breakthrough on a par with the checkpoint inhibitors

I want to make very clear that the mechanism of action of DCVax-L is quite different from Opdivo although both stimulate the immune response to cancer. Also, advanced non-small cell lung cancer that is addressed in the CHECKMATE-017 and CHECKMATE-057 trials and newly diagnosed glioblastoma addressed by DCVax-L are very different diseases. The commonality is that both drugs are immunotherapies and that both cancers are very aggressive with short median overall survival expectations.

Opdivo Results in CHECKMATE-017 and CHECKMATE-057 Trials in Non-Small Cell Lung Cancer

The Opdivo results are what we have come to expect with immunotherapies which achieve therapeutic benefits very differently than chemotherapy drugs. Chemotherapy drugs are much faster acting than immunotherapy drugs. Effects on cancer mPFS usually can be seen in a matter of months and effects on mOS are also much faster. Importantly, there have been cases in which immunotherapy drugs when compared to chemotherapy have failed to show superiority on mPFS but were successful in showing statistical significance in mOS. It is also the case that it takes longer for the survival benefits to be seen. This was true of Provenge, one of the pioneers in immunotherapy drug development and we have seen the same phenomenon with checkpoint inhibitors.

With this in mind, let’s look at the results of CHECKMATE-017 and CHECKMATE-057.