Dou­bling down on the Keytru­da fran­chise, Mer­ck pays $300M and promis­es $5B-plus to part­ner with Ei­sai on its bud­ding can­cer star

Im­pressed by the po­ten­tial of a com­bo fea­tur­ing Keytru­da with Ei­sai’s star can­cer drug Lenvi­ma (lenva­tinib me­sy­late), Mer­ck $MRK has stepped up with $300 mil­lion in cash and a com­mit­ment of more than $5 bil­lion in mile­stones to kick off a full slate of tri­als for the duo.

Roger Perl­mut­ter, Mer­ck

An oral TKI al­ready ap­proved for thy­roid can­cer and in com­bi­na­tion with everolimus for kid­ney can­cer, Ei­sai not­ed a lit­tle more than a month ago that their drug scored well in a Phase III study for first-line liv­er can­cer. And Mer­ck sees a big fu­ture for this drug tied to Keytru­da, which is now in­volved in more than 700 clin­i­cal tri­als.

In this pact, Ei­sai and Mer­ck will de­vel­op Lenvi­ma as a monother­a­py and in com­bi­na­tion with the check­point, with the two shar­ing de­vel­op­ment costs. Ei­sai will book glob­al sales while the two com­pa­nies share rev­enue. And they’ll work to­geth­er now on a pipeline of their own tar­get­ing en­dome­tri­al can­cer, non-small cell lung can­cer, he­pa­to­cel­lu­lar car­ci­no­ma, head and neck can­cer, blad­der can­cer and melanoma, as well as a bas­ket tri­al tar­get­ing mul­ti­ple can­cer types.

This deal fol­lows Mer­ck CEO Ken Fra­zier’s vow to fol­low up on his $8.5 bil­lion part­ner­ship with As­traZeneca on Lyn­parza with more such rev­enue-gen­er­at­ing pacts.

In a break­down of the mon­ey at stake, Mer­ck will be on the hook for $650 mil­lion for op­tions through 2020 and will pro­vide $450 mil­lion to re­im­burse Ei­sai on its share of the re­search costs. There’s an­oth­er $385 mil­lion on the ta­ble in de­vel­op­ment mile­stones and close to $4 bil­lion for sales goals.

What got them here?

In the RCC co­hort of Study 111/KEYNOTE-146, re­searchers tracked an ORR af­ter 24 weeks of treat­ment of 63%, with tu­mor re­gres­sion ob­served in 93% (28/30) of RCC pa­tients since the ini­ti­a­tion of treat­ment.

From their state­ment:

The re­sults of the in­ter­im analy­sis (n=23) of the en­dome­tri­al can­cer co­hort in Study 111/KEYNOTE-146 as of De­cem­ber 1, 2016, in­di­cat­ed ORR Week 24 of 52.2 per­cent (95% CI, 30.6-73.2) based on in­de­pen­dent ra­di­o­log­ic re­view and 47.8 per­cent (95% CI, 26.8-69.4) based on in­ves­ti­ga­tor re­view. Ad­di­tion­al­ly, tu­mor re­gres­sion was ob­served re­gard­less of the state of mi­crosatel­lite in­sta­bil­i­ty (MSI). An­ti-PD-1 an­ti­bod­ies are gen­er­al­ly less ef­fec­tive in pa­tients with low fre­quen­cy of MSI, which is a bio­mark­er for the in­abil­i­ty to re­pair er­rors in the base se­quence of DNA, or who are MSI neg­a­tive.

“To­geth­er with Ei­sai, we aim to max­i­mize the val­ue of Lenvi­ma for its cur­rent in­di­ca­tions while joint­ly pur­su­ing ad­di­tion­al ap­provals in com­bi­na­tion with Keytru­da across a wide range of can­cers,” said Mer­ck R&D chief Roger Perl­mut­ter. “There is strong sci­en­tif­ic ev­i­dence sup­port­ing syn­er­gis­tic ef­fects of Keytru­da when used in com­bi­na­tion with Lenvi­ma, and the com­pa­nies have al­ready re­ceived Break­through Ther­a­py Des­ig­na­tion from the U.S. FDA for the Keytru­da/Lenvi­ma com­bi­na­tion in re­nal cell car­ci­no­ma. Through this col­lab­o­ra­tion, we will both broad­en our on­col­o­gy port­fo­lio and have the op­por­tu­ni­ty to help even more can­cer pa­tients around the world.”

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.