Pfiz­er and Mer­ck KGaA are ce­ment­ing in their dis­tant run­ner-up sta­tus for Baven­cio (avelum­ab), a PD-L1 check­point that just failed its fourth late-stage tri­al. And the drum­beat of set­backs — at a time check­points are pro­lif­er­at­ing around the world — will hurt their prospects for mak­ing this the block­buster they both need.

This time around re­searchers sim­ply said that Baven­cio in com­bi­na­tion with or fol­low­ing chemo in front­line ovar­i­an can­cer cas­es had failed the pri­ma­ry end­point on pro­gres­sion-free sur­vival, forc­ing them to draw a halt to the work.

The drug al­so failed the Ovar­i­an 200 study a month ago, test­ing Baven­cio in pa­tients with drug-re­sis­tant cas­es. That fol­lowed a flop for sec­ond-line lung can­cer as well as an ear­li­er set­back on gas­tric can­cer.

The lat­est fail­ure fol­lows a se­ries of steady ad­vances at Mer­ck, which has come out of a round of chemo-com­bo stud­ies as the clear leader in the megablock­buster PD-1/L1 check­point mar­ket. Just two days ago the FDA of­fered Keytru­da an­oth­er add-on ap­proval for Merkel cell car­ci­no­ma. Bris­tol-My­ers Squibb has fall­en be­hind but still is a con­tender.

Al­to­geth­er 6 check­points have reached ap­proval in the US, and a sev­enth just got an OK in Chi­na, where dozens of ad­di­tion­al check­points are in de­vel­op­ment. Gain­ing a rep for fail­ure in can­cer stud­ies, af­ter win­ning an OK for Merkel cell car­ci­no­ma and ad­vanced blad­der can­cer, could se­ri­ous­ly dam­age the Pfiz­er/Mer­ck KGaA team’s prospects in an in­creas­ing­ly crowd­ed field of ri­vals.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.