NorthWest Biotherapeutics Inc (NWBO)

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Did anybody see this:
Trading places with Bristol-Myers, Merck hit with another late-stage setback on checkpoint star Keytruda


Close to a year after Merck $MRK won an ac­cel­er­ated FDA OK to use its PD-1 check­point star Keytruda for treat­ing sec­ond-line cases head and neck squa­mous cell car­ci­noma in com­bi­na­tion with plat­inum-con­tain­ing chemo, the pharma giant an­nounced that its big Phase III study for that in­di­ca­tion failed.

The piv­otal KEYNOTE-040 trial failed to meet the pri­mary end­point on over­all sur­vival in com­par­ing the block­buster check­point against stan­dard ther­a­pies, the pharma giant re­ported. But the cur­rent ap­proval stands nev­er­the­less, Merck said in a state­ment.

“The com­pany noted that the FDA re­mains com­fort­able with the drug’s cur­rent ac­cel­er­ated ap­proval in this in­di­ca­tion de­spite the trial re­sults,” ob­served Leerink’s Sea­mus Fer­nan­dez. “Im­por­tantly, Keytruda ap­pears to have an­other shot on goal for full ap­proval in H&N can­cer, as the Keynote-048 study in first-line pa­tients could, if pos­i­tive, serve as the con­fir­ma­tory trial.”


Roger Perl­mut­ter, Merck
Merck didn’t pro­vide a lot of de­tails, but this is the lat­est in a se­ries of set­backs in the field that have begun to show the outer lim­its of ef­fi­cacy for a new class of can­cer med that has trans­formed on­col­ogy ther­apy in the past two years. But right now, those outer lim­its of ef­fi­cacy run along a blurry line, with no clear ex­pla­na­tions for what is caus­ing these sud­den break­downs.

https://endpts.com/merck-hit-with-another-late-stage-setback-on-checkpoint-star-keytruda/