Roche's Tecen­triq ex­cels in an­oth­er lung can­cer study

Months af­ter se­cur­ing FDA ap­proval for Tecen­triq as a first line of de­fense — in com­bi­na­tion with chemother­a­py — in ex­ten­sive-stage small-cell lung can­cer pa­tients, Roche on Thurs­day said the im­munother­a­py helped cer­tain treat­ment-naive pa­tients with ad­vanced non-small cell lung can­cer (NSCLC) live longer ver­sus chemother­a­py, in a piv­otal study.

The 572-pa­tient tri­al, called IM­pow­er110, test­ed Tecen­triq monother­a­py against chemother­a­py (cis­platin or car­bo­platin and peme­trexed or gem­c­itabine) in pa­tients with ad­vanced non-squa­mous and squa­mous non-small cell lung can­cer in pa­tients with­out ALK or EGFR mu­ta­tions.

San­dra Horn­ing at an End­points News event dur­ing #JPM19 in San Fran­cis­co, Jan­u­ary 2019 End­points News

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The study met the main goal in an in­ter­im analy­sis show­ing that Tecen­triq monother­a­py sur­passed the ef­fect of chemother­a­py alone. “Tecen­triq monother­a­py has shown a sig­nif­i­cant sur­vival ben­e­fit over chemother­a­py as an ini­tial treat­ment in peo­ple with squa­mous or non-squa­mous non-small cell lung can­cer with high PD-L1 ex­pres­sion,” Roche’s out­go­ing CMO San­dra Horn­ing, said in a state­ment.

The study will con­tin­ue to con­duct the fi­nal analy­sis for pa­tients with low­er lev­els of PD-L1 ex­pres­sion, the Swiss drug­mak­er added. Roche is set to sub­mit the dataset — de­tails of which will be dis­closed at a fu­ture med­ical con­fer­ence — to health reg­u­la­tors in the Unit­ed States and Eu­rope.

Roche has nine Phase III lung can­cer stud­ies un­der­way eval­u­at­ing Tecen­triq as a monother­a­py or in com­bi­na­tion with oth­er med­i­cines across a pletho­ra of lung can­cer types.

Tecen­triq has al­ready se­cured US ap­proval in a num­ber of lung can­cer in­di­ca­tions. In March, it scored the ex­ten­sive-stage small cell lung can­cer (ES-SCLC) ap­proval, and last De­cem­ber the FDA en­dorsed the drug in com­bi­na­tion with Avastin for pa­tients with non-squa­mous non-small cell lung can­cer. The drug — which is al­so ap­proved for blad­der and breast can­cer — raked in sales of about $788 mil­lion in the first half of this year.

Lung can­cer is the lead­ing cause of can­cer death glob­al­ly, ac­cord­ing to the WHO. The two main types of lung can­cer are non-small cell and small cell, and NSCLC ac­counts for about 85% of all cas­es. Over­all, the NSCLC mar­ket is poised to grow to $14.6 bil­lion by 2024, ac­cord­ing to Glob­al­Da­ta es­ti­mates.

The Swiss drug­mak­er is carv­ing it­self a big­ger piece of the lu­cra­tive im­muno-on­col­o­gy mar­ket, which is large­ly mo­nop­o­lized by Mer­ck’s $MRK key­stone check­point in­hibitor Keytru­da, and to a less­er ex­tent Bris­tol-My­ers Squibb $BMY Op­di­vo. As­traZeneca’s $AZN Imfinzi is al­so gain­ing ground, par­tic­u­lar­ly in lung can­cer.

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 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.