I have been a PPHM shareholder since 1998 and practicing internist for 30 years. I have been following the science and have a few comments of note. Firstly, CTX/XRT have been the traditional choices in oncology for the last three decades and that is why PPHM chose to pursue the Sunrise trial after the reworking of the PII trial. I/O was not an approved treatment option at that time. Only in 2013 did I/O jump onto the radar. Sunrise was already set in motion and should and could not be stopped at that time. With the advent of the I/O molecules of Bristol Myers and Merck products being introduced to the market for melanoma and lung cancer, CTX and XRT lost significant steam as these forms of therapy were much less profitable. I know of two patients that were enrolled in the Sunrise trial that were terminated from the trial and treated with I/O therapy because they were doing poorly clinically in Sunrise. Give the stage and ECOG status in both the control and treatment arm were to be one and the same, I suspect these two patients were in the control arm. Any responsible oncologist is not going to allow his/her patient to die without a fight for the sake of a trial. Hence, they were terminated from the trial. If this decision was made for all patients who were doing poorly in the control arm, it is understandable to see why the control arm survival was much greater than historical data. Both the control and treatment arm survival is a bell shaped curve and if you remove the early deaths from the control arm, the curve shifts toward the treatment arm. Remember the treatment arm was performing as expected and hence the control arm was artificially skewed in that direction. If practicing oncologist had no I/O options things would have looked very differently. The I/O market will be the only market until the costs of therapy dictate otherwise. If PPHM does not understand that and pursue accordingly, we will all be losers.
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