Million dollar question(s).Please take my opinions and...

Million dollar question(s).

Please take my opinions and especially predictions with a grain of salt. We are all prone to confirmation bias.

My take with the new studies announced is that Imugene are pivoting away from this initial Her-Vaxx Phase II study involving chemotherapy specifically. The primary aim (as per their study design) is to assess if OS is superior for treatment compared to control. We don't have those results yet. I don't think Imugene are in the business of using their Her-Vaxx solely as an adjuvant to chemotherapy despite Herceptin being used as an adjuvant drug.

I don't think this will be approved in the short term due to the lack of statistical significance in PFS alone. Statistical significance is the gold standard in clinical research with effect sizes being important too. I would assume the likes of the heavy hitter companies (i.e. Merck, Pfizer, Amgen etc) and the regulatory bodies (i.e. FDA, TGA etc) take p values into consideration as part of their feasibility assessment - not alone but as part of multiple factors for commercial engagement. For that reason, the endeavour to move Her-Vaxx into additional Phase II studies with checkpoint inhibitor space is to accumulate additional data to see if there's any added clinical benefit using hot immunotherapy drugs. If there is, it should theoretically put them in a better position to pursue Phase III studies and/or seek interest about approval. There's then another challenge - is this Her-Vaxx + checkpoint inhibitor combination superior than that previously reported by other similar published studies?

I don't have the answer obviously and there is still a question about the magnitude of OS difference for Her-Vaxx. What is true is we'll be waiting a long time for results to be published around these new Phase II studies.

Hope this helps. DYOR.