Your premise is it didn't work. My premise is it did, it may have taken a little longer to start and because it was working so well the PFS will need more time in the trial to prove what was actually progression and what was immune based inflammation. So you may be right somewhat PFS is probably not the correct primary end point for this type of drug. Maybe they are using this trial to learn what would be a better surrogate for long term survival. DCVAX is round peg trying to fit into square chemo/rad hole.
WTL is to Solid(Hetero Tumors) what CAR(T)s are to to blood (Homo Tumors).
"If WTL worked" - If it didn't work, explain the the long term survivors we have to date.
I think armed with what they know now about the nature and trajectory of an immunotherapy, including immune induced progression and the measures that matter with respect to reimbursements they would have opted for 2 and 3 year survival percentages as primary endpoints. Nothing stops them from capturing that story in this trial now that they know it is probably a more important measure. MPFS and MOS can allow a company to run a shorter trial. But don't you think actual 3 and 4 year survival data vs estimates is a more accurate measure? It is also easier to explain to regular people. "If you take this drug you will have 35% chance of living 3 years compared to 12% and 25% chance or living 5 years or longer compared to 5%" VS. "The drug showed a median survival of 4 months" to the lay person it means: "I take this drug and live 4 months?", when he could be 1 of the 40% that the drug really works well for.
Look if it really works well for 35-40% of the people, that 40% is beyond the 50% median. Immunotherapies should probably measure the time difference for 70 percent of the population to die. These immune based therapies can take longer to start having an impact(measured in months) and expressed as delayed separation. When applied in real life this would have a more profound impact because you will likely get those that are not as sick like grade 3's that will have greater window opportunity.
Without this long term follow up information, the FDA would have to guess using imprecise measures like proportional hazards. How do you prove the hazards start to slow when you are looking backwards? They a more complete data set now and I think they are also setting the table for future indications armed with the proof of this trial. This would mean that they will not have to spend as much time on other indications if the found a suitable early surrogate like immune inflammation and staining and followed by regression or stable disease. At this point it is water under the bridge - we are not going to get 2 years back, but those 2 years may pay dividends.
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