Mer­ck in­creas­es grip on its lead in lung can­cer, win­ning ap­proval for Keytru­da/chemo com­bo as first-line ther­a­py

Mer­ck has won its bid to ad­vance its lead­er­ship in treat­ing the cru­cial non-small cell lung can­cer mar­ket, gain­ing an FDA ap­proval to start mar­ket­ing a com­bi­na­tion of its PD-1 drug Keytru­da with chemother­a­py as a first-line ther­a­py. And its shares im­me­di­ate­ly popped, surg­ing 4% on the news in af­ter-mar­ket trad­ing while ri­val Bris­tol-My­ers Squibb took an­oth­er beat­ing, slid­ing 2%.

Mer­ck built its bid for an ac­cel­er­at­ed ap­proval around Phase II da­ta demon­strat­ing that the chemo/check­point com­bo spurred a much high­er con­cen­tra­tion of over­all re­spons­es for NSCLC than chemo alone — 55% vs. 29%, P = 0.0016. High PD-L1 ex­pressers did even bet­ter, though the ap­proval comes through for all pa­tients re­gard­less of bio­mark­er sta­tus. Here’s the link to the new la­bel.

That all trans­lates in­to bil­lions in rev­enue, with con­sen­sus sales fore­cast of $3.6 bil­lion for 2017 rev­enue. And climb­ing.

Roger Perl­mut­ter, Mer­ck

Bris­tol-My­ers un­wit­ting­ly gave Mer­ck’s ri­val ther­a­py a big leg up when its big bid for a front­line ap­proval col­lapsed in Phase III, forc­ing the big biotech to shake up its R&D group and re­fo­cus on its biggest sin­gle pipeline ef­fort. While the check­points have been muscling in­to a va­ri­ety of mar­kets, Mer­ck’s R&D team un­der Roger Perl­mut­ter has won at least a tem­po­rary ad­van­tage in a block­buster are­na. And an­a­lysts have been acute­ly aware of the rev­enue po­ten­tial — though noth­ing is writ­ten in stone in this fast-chang­ing can­cer field.

That les­son was re­in­forced Wednes­day morn­ing, when Roche an­nounced the stun­ning fail­ure of Tecen­triq in a Phase III blad­der can­cer study, af­ter it had al­ready won an ac­cel­er­at­ed ap­proval.

Sea­mus Fer­nan­dez at Leerink re­cent­ly not­ed just how sig­nif­i­cant this de­ci­sion was for Mer­ck, writ­ing:

We con­tin­ue to look to­wards the 5/10/17 PDU­FA da­ta for the Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemo com­bo in first-line (1L) non-small cell lung can­cer (NSCLC) for a mean­ing­ful ac­cel­er­a­tion in the drug’s US sales. Al­though this will help to dri­ve top- and bot­tom-line growth to­wards the end of the year and in­to 1H:18, the large num­ber of IO+IO and IO+chemo tri­als re­port­ing dur­ing that pe­ri­od could dra­mat­i­cal­ly al­ter the 1L NSCLC land­scape.

When it comes to check­points, with 5 ap­proved and more pil­ing in, every new goal is at­tract­ing a swarm of ri­vals.

As­traZeneca, which just gained an un­ex­cep­tion­al first ap­proval for dur­val­um­ab in blad­der can­cer, has been putting all of its chips on the MYS­TIC tri­al, which com­bines dur­val­um­ab with its ex­per­i­men­tal CT­LA-4 ther­a­py treme­li­mum­ab for lung can­cer. But an­a­lysts have been in­creas­ing­ly leery about CT­LA-4 as a com­bi­na­tion, not­ing its high lev­els of tox­i­c­i­ty — which may prove an easy tar­get for a next-gen suc­ces­sor.

“This ap­proval marks an im­por­tant mile­stone in the treat­ment of lung can­cer. Now, pem­brolizum­ab in com­bi­na­tion with peme­trexed and car­bo­platin can be pre­scribed in the first-line set­ting for pa­tients with metasta­t­ic non­squa­mous non-small cell lung can­cer, ir­re­spec­tive of PD-L1 ex­pres­sion,” said Dr. Corey Langer, di­rec­tor of tho­racic on­col­o­gy and pro­fes­sor of med­i­cine at the Hos­pi­tal of the Uni­ver­si­ty of Penn­syl­va­nia, in a state­ment. “Physi­cians should con­tin­ue to use each pa­tient’s in­di­vid­ual char­ac­ter­is­tics – in­clud­ing bio­mark­er sta­tus, his­tol­ogy, and oth­er clin­i­cal fac­tors – to de­ter­mine the best treat­ment plan for each per­son.”

To­day Mer­ck winds up one big step for­ward in NSCLC. How long it keeps that lead, though, is any­body’s guess.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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In­cyte’s PD-(L)1 in­hibitor head­ed for an ODAC show­down next month

The FDA’s Oncologic Drugs Advisory Committee will spend a half day on June 24 reviewing Incyte’s PD-(L)1 inhibitor retifanlimab as a treatment for locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) for those who have progressed on or who are intolerant of platinum-based chemotherapy.

The eighth PD-(L)1 entrant in January nabbed a priority review and an orphan designation from the FDA, which sets the agency’s final decision date as July 25.