Avid Bioservices Inc (CDMO)

[Tandberg1]

Does anyone else feel that the 1st line lung cancer results might not be that great based on the following Q/A with MLB?

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GZ: The event-driven Front-Line NSCLC trial, these patients, after they progress, they probably had a number of different subsequent therapies, which will also probably reflect, to some extent, and then some of them maybe have even gone into some clinical trials, I would imagine. How are you going to evaluate the overall survival of these patients based on the variety of drugs that they may have taken after they failed the Front-Line combination?
Joe Shan: Yes, I think that's a great question. And clearly, with the survival endpoint, subsequent treatment could affect the outcome. Yes, the FDA guidance basically weighs the next line of treatment as the primary driver, so our analysis will be looking at primarily what patients went on next, if anything, and if there's significant differences between 2 arms, that is a confounding factor when looking at survival.
GZ: I guess, you can group everyone, but I suppose if you have enough patients or multiple patients, I suppose, in any one particular subsequent chemotherapy, then you could maybe, whether it's 2 lines or 3 lines, you might be able to compare those, like you said, as a subgroup, is that correct?
Joe Shan: Yes, the study that we have is not terribly large. But if there are some patterns with different classes of chemotherapies, then yes, we'll be looking at sort of pooling those patients.
GZ: Of course, the most desirable result would be a difference in survival regardless of what subsequent therapy they went on?
Joe Shan: That's right.
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1. Confounding is not a good word to use in describing results.
2. Company seems to talk more about liver cancer and imaging trials than front line lung cancer
3. Delay in reporting 1st line MOS is not necessarily a positive. We had a ringside seat to 2nd line results as they unfolded.
4. Question may have been a plant to prepare us for the reason the results are not so good: if patients go on to second line treatment, survival is primarily attributable to the second line treatment in the FDA's view.

The only bone was the final exchange about the most desirable result being survival difference regardless of subsequent therapy.