Still trail­ing far be­hind a block­buster ri­val, No­var­tis gath­ers an­oth­er round of pos­i­tive sur­vival da­ta for Kisqali

Just two months ago, No­var­tis’ team turned up at AS­CO with some clear­ly pos­i­tive im­proved sur­vival rates for a group of pre-menopausal breast can­cer pa­tients tak­ing the CDK 4/6 drug Kisqali. And now they’re back, say­ing they al­so scored in a sep­a­rate tri­al track­ing OS among an­oth­er group of post-menopausal women tak­ing the block­buster wannabe.

Su­sanne Schaf­fert No­var­tis

We won’t hear the de­tails on the Monaleesa-3 da­ta un­til they can be rolled out lat­er at a sci­en­tif­ic con­fer­ence, but in­ves­ti­ga­tors say the drug scored on the key end­point in first-line and sec­ond-line cas­es. And this ex­pands on their boast for hold­ing the first — though no longer the on­ly — pos­i­tive sur­vival re­sults in the field, some­thing No­var­tis on­col­o­gy chief Su­sanne Schaf­fert says she’s “thrilled” to see.

The key ques­tion, though, is what’s it go­ing to take to carve away mar­ket share from the dom­i­nant CDK 4/6 — Pfiz­er’s Ibrance — which hit the mar­ket sev­er­al years ago. De­spite flunk­ing their sur­vival end­point, Pfiz­er reaped a $1.26 bil­lion har­vest from their fran­chise drug in Q2 — com­pared to on­ly $111 mil­lion in rel­a­tive­ly ane­mic rev­enue for No­var­tis’ drug.

Eli Lil­ly’s ri­val in the CDK 4/6 field, Verzenio, al­so has yet to make much of an im­pact, but they still came out ahead of No­var­tis with $133 mil­lion in Q2 rev­enue for the drug.

Just 2 days ago Lil­ly her­ald­ed its own suc­cess on the OS front with their drug, al­so hold­ing back the da­ta for a fu­ture sci­en­tif­ic con­fer­ence. And their MONARCH-2 study in­clud­ed pre/peri- and post­menopausal women.

Here was the bot­tom line for No­var­tis at AS­CO: Kisqali com­bined with en­docrine ther­a­py spurred a 70.2% sur­vival rate among pre-menopausal women with hor­mone re­cep­tor-pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor-2 neg­a­tive (HR+/HER2-) ad­vanced or metasta­t­ic breast can­cer 42 months af­ter treat­ment be­gan. That’s sig­nif­i­cant­ly bet­ter — with a 27% drop in the risk of death — than the for­mer stan­dard of care, where 46% of pa­tients in the Monaleesa-7 con­trol arm were still alive.

No­var­tis has a pow­er­ful mar­ket­ing ma­chine, and you can ex­pect their team will do every­thing they can to go af­ter Ibrance. But Pfiz­er once again proves that be­ing the first to the mar­ket is a pow­er­ful ad­van­tage.

So­cial im­age: No­var­tis, AP Im­ages

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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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.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.