Just had another look at the presentation. There is some mention of the potential for accelerated approval pathway for HNSCC due to unmet need (slides 22 and 23). So did some more googling and found:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5507654/ which describes the accelerated approval of Keytruda (pembro) in HNSCC based on the Keynote-012 clinical trial which is only an open-label Phase I study in 197 patients (ORR = 16%).
https://clinicaltrials.gov/ct2/show/NCT01848834?term=KEYNOTE%E2%80%90012&draw=2&rank=1
I'm not very familiar with the accelerated approval pathways, but they are described:
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
Strikes me as being interesting.
encouraging progress !, page-35
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