Mer­ck KGaA and their part­ners at Pfiz­er have an­oth­er big set­back to re­port for their PD-L1 check­point drug Baven­cio.

The check­point ei­ther alone or in com­bi­na­tion with chemother­a­py failed to hit ei­ther the over­all sur­vival or pro­gres­sion-free sur­vival end­points in their Phase III JAVELIN Ovar­i­an 200 study for drug-re­sis­tant ovar­i­an can­cer. The news comes 9 months af­ter re­searchers al­so re­port­ed a fail for their check­point on sec­ond-line lung can­cer, lead­ing some an­a­lysts to con­clude that their big Baven­cio pro­gram was look­ing like a run­ner-up in the in­tense­ly com­pet­i­tive field.

Lu­ciano Ros­set­ti, Mer­ck KGaA

Baven­cio al­so failed a Phase III study for gas­tric can­cer, putting a crimp in their plans to ramp up sales and rais­ing doubts about their abil­i­ty to com­pete against lead­ers like Mer­ck and Bris­tol-My­ers Squibb.

The haz­ard ra­tio in the lat­est study un­der­scored a mea­ger 5% re­duc­tion in risk on over­all sur­vival for Baven­cio alone and an 11% drop for the com­bi­na­tion arm. That was a flat fail­ure. But re­searchers al­so teased out a pos­i­tive p-val­ue for the com­bi­na­tion arm on pro­gres­sion-free sur­vival.

Key­ing on the pos­i­tive, Mer­ck KGaA R&D chief Lu­ciano Ros­set­ti said that they would con­tin­ue to ex­plore the num­bers.

It hasn’t all been bad news with Baven­cio. Just a cou­ple of months ago their drug came though for re­nal cell car­ci­no­ma pa­tients, set­ting up some speedy ap­pli­ca­tions for mar­ket­ing ap­proval. Re­searchers say it helped PD-L1 ex­press­ing pa­tients and the full pop­u­la­tion, demon­strat­ing a sig­nif­i­cant PFS ben­e­fit com­pared to a con­trol arm treat­ed with Su­tent.

Chris Boshoff

Chris Boshoff, the head of I/O at Pfiz­er Glob­al Prod­uct De­vel­op­ment, had this to say to­day:

We ini­ti­at­ed the JAVELIN Ovar­i­an 200 tri­al as the first Phase III study of a check­point in­hibitor in the plat­inum-re­sis­tant or -re­frac­to­ry set­ting rec­og­niz­ing these pa­tients have the most press­ing need for new treat­ment op­tions. The re­sults speak to the sig­nif­i­cant chal­lenges these women face.

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.