Just days af­ter Bris­tol-My­ers Squibb man­aged to sur­prise the an­a­lyst brigade with a Phase III flop for its PD-1 check­point Op­di­vo com­bined with chemo in lung can­cer, Mer­ck’s dom­i­nant team is back with an­oth­er sol­id hit for a par­tic­u­lar­ly tough-to-treat sub­group of breast can­cer pa­tients.

Mer­ck’s Phase III KEYNOTE-522 tri­al con­nect­ed on one of two pri­ma­ry end­points, with their Keytru­da/chemo com­bo elim­i­nat­ing all signs of triple-neg­a­tive breast can­cer — what’s called a patho­log­i­cal com­plete re­sponse — at a sig­nif­i­cant­ly high­er rate than chemo alone, re­gard­less of PD-L1 lev­els in the neo-ad­ju­vant set­ting.

That’s an­oth­er first for Mer­ck, which has been steadi­ly rack­ing up new Phase III suc­cess­es for the mar­quee PD-1. In­ves­ti­ga­tors are con­tin­u­ing the tri­al as they wait to see how Keytru­da/chemo did on event-free sur­vival.

As usu­al, we’ll have to wait for a sci­en­tif­ic con­fer­ence to see the hard num­bers. But it’s im­por­tant to note that Mer­ck’s string of suc­cess­es with Keytru­da is al­so a psy­cho­log­i­cal vic­to­ry that can’t be un­der­es­ti­mat­ed. When Bris­tol-My­ers re­leased its lat­est batch of da­ta on Op­di­vo, the com­pa­ny al­so claimed a suc­cess on Part 1a of the Check­mate -227 tri­al, which met the co-pri­ma­ry end­point of OS, “demon­strat­ing a sta­tis­ti­cal­ly sig­nif­i­cant ben­e­fit for Op­di­vo plus low-dose Yer­voy (ip­il­i­mum­ab) ver­sus chemother­a­py in pa­tients whose tu­mors ex­press PD-L1 ≥1%.”

An­a­lysts weren’t hav­ing it, though, skep­ti­cal that the drug would beat Keytru­da af­ter see­ing the Keynote-189 da­ta. At this stage of the PD-1 bat­tle, Bris­tol-My­ers is as­sumed to come in be­hind Mer­ck.

The string of suc­cess­es has an­a­lysts com­pet­ing in peak sales fore­casts for Keytru­da. Mizuho’s Mara Gold­stein re­cent­ly not­ed:

News of the fail­ure of BMY’s Check­mate-227 Part 2, OP­DI­VO + chemother­a­py in front­line NSCLC to demon­strate an OS ben­e­fit vs. chemother­a­py alone, fur­ther so­lid­i­fies KEYTRU­DA’s dom­i­nance in this mul­ti-bil­lion dol­lar mar­ket op­por­tu­ni­ty, in our view, and is sup­port­ive of our in­vest­ment the­sis. We es­ti­mate that KEYTRU­DA sales will sur­pass $20 bil­lion by 2024, and that KEYTRU­DA will re­main the dom­i­nant check­point in­hibitor in the mar­ket.

Gold­stein added this morn­ing that every­thing is still look­ing rosy for Mer­ck as the com­pa­ny looks to add to its lead in triple neg­a­tive breast can­cer. Plus, the Eu­ro­peans are help­ing with an­oth­er pos­i­tive opin­ion for Mer­ck.

In ad­di­tion to TNBC, MRK al­so an­nounced a pos­i­tive CHMP opin­ion for KEYTRU­DA+IN­LY­TA in 1L RCC based on piv­otal Phase III KEYNOTE-426 da­ta – im­proved OS, PFS, and ORR vs SU­TENT. We think this lends sup­port to our view that KEYTRU­DA should pull far­ther ahead of com­peti­tors as the lead­ing check­point in­hibitor, and is sup­port­ive of our in­vest­ment the­sis.

So­cial im­age: Shut­ter­stock

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.