Today's data was very impressive, and considering we are getting responses when combining Efti with Keytruda that are better than current standard of care, it bodes well for future trials with bigger cohorts.
But the main thing I wanted to take away was the durability of the responses seen in the NSCLC trial - 59% of patients still on treatment, and median PFS not reached. Even though the cohort is small, these patients aren't progressing. When you think about this in conjunction with all the Ph1 data on breast cancer, where after 6 months only 10% of patients progressed, with a very high DCR, it is giving us a fair indication that Efti causes tumours to shrink and stay shrunk, or at least stabilise without growing again. This is what the all important metric PFS measures. Therefore, this durability of response will hopefully translate to a longer median PFS in the Ph2b AIPAC trial.
The biggest spanner in the works is patients in the Ph2b trial were on Ibrance before going into the trial. The effect Ibrance has on the tumours (in terms of building up resistance to further treatments, as well as destroying the immune system) is the only point of concern for the Ph2b readout for me. I am almost certain that due to the advanced stage of the disease in the MBC patients, median PFS for the control arm will only be approx 2-3 months, because unfortunately these patients are already very so far gone, and paclitaxel on it's own won't do much. However, if the addition of Efti can stabilise the patients, or even cause tumours to shrink, while providing the durable response, we could potentially see median PFS of 5-6 months in the combo arm. In my opinion, this would be enough to bring in the p-value we need.
What would be even better is if median Overall Survival has been reached in the control arm, and is yet to be reached in the combo arm.
I am very confident with how AIPAC is shaping up off this Tacti-002 update and all the data we have so far on breast cancer patients. I think the market is still a long ways off from valuing this stock correctly prior to the data, and we could easily see 60c+ before AIPAC. If AIPAC is positive, its anyone's guess what the market cap will be, but I think it will make a run up to $2.50+ (market cap of approx $1bn).
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