The possible reason for the trial completion date being pushed out is because there hasnt been enough events to reach the primary endpoint.
ie 50% of patients in each trial arm unfortunately need to pass away for us to get the median OS, so if not enough people have passed away in each arm it would extr time and explain why the date has been pushed out.
We all know that the PFS for AIPAC came back the exact same in each arm, but no increase in PFS does not necessarily translate to no overall survival benefit. It is actually quite common in immunotherapy (with keytruda being an example) for there to be major PFS benefit over existing SOC, but a much better OS. This is because the immunotherapy has the potential to rewire somebodies immune system and keep them alive for longer, so even though their tumour started to progress, they live much longer.
it would be great if this has happened with the efti + pac arm and we see a substantial increase in OS. Its even better because the market has written AIPAC off, but if it pulls through next month we would be looking at a huge gain. Ideally OS has been reached in the pac arm but yet to be reached in the combo arm.
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- Ann: Encouraging Phase II TACTI-002 data reported at SITC 2020
Ann: Encouraging Phase II TACTI-002 data reported at SITC 2020, page-46
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