$20B-plus? Mer­ck keeps rack­ing up PhI­II suc­cess­es, scor­ing on triple neg­a­tive breast can­cer chal­lenge as an­a­lysts dri­ve up peak sales es­ti­mates

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

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Deborah Dunsire. Lundbeck

Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation for a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.