Biotech Values

[NP1986]

Robert, I don't think anyone is unduly downplaying the results of the trial. You have to remember that the full results have not yet been presented at a scientific meeting, and there are still many unanswered questions.

Firstly, as others have already pointed out, overall survival was not a primary endpoint of the trial. Thus, self-acclaimed "PPHMites" who describe it as having a "gold standard design" are mistaken. If measuring overall survival was the main objective of the trial, unblinding would not have occured until a pre-specified number of deaths had occured. Measuring OS after unblinding introduces potential bias.

Secondly, there are still a lot of unanswered questions about the trial. For instance, were baseline factors such as performance status, EGFR status, etc balanced between all three treatment arms? Furthermore, were there differences in treatment that patients received post-progression in each arm? Are the OS results consistent across all geographic regions?

If the treatment arms were well-balanced and the results are consistent across different subgroups, then it certainly warrants further exploration in a phase III study that is actually designed to assess OS.

Finally, don't forget that this is still a relatively small trial (only ~40 patients in the control arm). There have been a number of instances where promising results in randomized phase II studies weren't replicated in a larger phase III study.

By the way, has PPHM offered hints as to whether there is a difference in OS in the 1st line NSCLC trial?