#ES­MO17 ROUNDUP: Mer­ck’s da­ta on Keytru­da/chemo com­bo for lung can­cer takes ear­ly spot­light at ES­MO

MADRID — Mer­ck’s ab­stract $MRK on its big study of Keytru­da (pem­brolizum­ab) com­bined with chemo hit ear­ly at ES­MO, at­tract­ing con­sid­er­able at­ten­tion for the im­pres­sive pro­gres­sion-free sur­vival da­ta the phar­ma gi­ant post­ed as a front­line ther­a­py for non-small cell lung can­cer.

The scoop: The me­di­an PFS hit 19 months for the com­bo arm com­pared to 8.9 months for chemo alone. The 18-month over­all sur­vival rate was 70% with pem­bro + chemo and 56% with chemo. That was an easy win­ner at the FDA and the new mark to beat in the hottest com­pe­ti­tion in drug de­vel­op­ment.

Mer­ck’s suc­cess in lung can­cer has proven to be a game-chang­er in the ri­val­ry for PD-(L)1 check­point dom­i­nance with Bris­tol-My­ers Squibb, which is still work­ing at a come­back af­ter an ear­ly set­back on that front trig­gered a shake­up at the top of their R&D group.

Now that Mer­ck is the leader, though, they are al­so the pri­ma­ry tar­get not on­ly for Bris­tol-My­ers, but al­so As­traZeneca and oth­ers who are jock­ey­ing com­bo ther­a­pies with an eye for the lead po­si­tion. As­traZeneca was slammed re­cent­ly, though, when its com­bi­na­tion of Imfinzi (dur­vaum­ab) and treme­li­mum­ab failed at the first pri­ma­ry end­point on pro­gres­sion-free sur­vival, though re­searchers are stick­ing it out for over­all sur­vival re­sults in 2018.

More than half of pa­tients in the Keytru­da com­bi­na­tion arm re­spond­ed to treat­ment, says Mer­ck, com­pared to ap­prox­i­mate­ly one-third in the pem/car­bo arm.

“Lung can­cer is one of the most com­mon and dev­as­tat­ing can­cers, and these ad­di­tion­al da­ta con­firm that Keytru­da in com­bi­na­tion with peme­trexed and car­bo­platin has the po­ten­tial to have a mean­ing­ful im­pact in the lives of many of these pa­tients,” said Dr. Roger Dansey, se­nior vice pres­i­dent and ther­a­peu­tic area head, on­col­o­gy late-stage de­vel­op­ment, Mer­ck Re­search Lab­o­ra­to­ries.

Im­mune De­sign shows up at ES­MO with some en­cour­ag­ing, but ear­ly, com­bo da­ta

Im­mune De­sign $IMDZ got things start­ed at #ES­MO17 in Madrid with the first glimpse at some pos­i­tive pre­lim­i­nary da­ta to come out of its mid-stage com­bo us­ing its im­mune sys­tem ac­ti­va­tor CMB305 and Genen­tech’s check­point in­hibitor Tecen­triq (ate­zolizum­ab).

In a study that di­vid­ed 88 pa­tients with NY-ESO-1/pos­i­tive soft tis­sue sar­co­ma be­tween the com­bo and Tecen­triq alone, re­searchers teased out a few in­ter­im da­ta points that show some trends in their di­rec­tion.

Car­los Paya

With in­ter­im da­ta on 36 pa­tients, in­ves­ti­ga­tors high­light­ed a dis­ease con­trol rate of 61% for the com­bo — with one par­tial re­sponse — against 28% with no PRs.

Me­di­an PFS was 2.6 months vs 1.4 months and while sur­vival da­ta was not ma­ture enough to re­port at ES­MO there was al­so a dis­ease con­trol rate of 57% with 3 PRs (one un­con­firmed) ver­sus 38% in the full study group. Re­searchers al­so demon­strat­ed some key bio­mark­er da­ta, in­clud­ing far more tar­get­ed an­ti-NY-ESO-1 T cells and an­ti­bod­ies.

The ju­ry is still out ob­vi­ous­ly on just what kind of tan­gi­ble ben­e­fit pa­tients can ex­pect, but the biotech high­light­ed a trend to­ward im­proved over­all sur­vival. This kind of com­bo strat­e­gy to kick up an im­mune re­sponse with a check­point that dis­man­tles a front­line de­fense mech­a­nism for can­cer cells has gen­er­at­ed a lot of in­ter­est.

“We be­lieve the greater clin­i­cal ben­e­fit and more ro­bust im­mune re­sponse shown in the com­bi­na­tion study arm sup­ports the hy­poth­e­sis that the com­bi­na­tion of an ap­pro­pri­ate­ly-de­signed, next-gen­er­a­tion can­cer vac­cine such as CMB305 with a check­point in­hibitor is im­por­tant to pro­duce clin­i­cal ben­e­fit in a cold tu­mor such as STS, where check­point in­hibitors oth­er­wise may have lim­it­ed ef­fi­ca­cy,” said Im­mune De­sign CEO Car­los Paya. “In ad­di­tion, we are pleased to ob­serve the trend to­wards longer over­all sur­vival in pa­tients with an in­duced an­ti-NY-ESO-1 im­mune re­sponse, fur­ther sup­port­ing the pos­i­tive CMB305 monother­a­py da­ta we pre­sent­ed at AS­CO in June.”

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.