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.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”