Mer­ck, In­cyte map a Phase III pipeline of their own for a front­line com­bo of Keytru­da and epaca­do­stat

Keytru­da (pem­brolizum­ab)

Last fall In­cyte and Mer­ck whipped up con­sid­er­able en­thu­si­asm for a match-up of their IDO1 en­zyme in­hibitor and Keytru­da in an ear­ly-stage study of melanoma. They fol­lowed up with a com­mit­ment to ex­pand their part­ner­ship to go af­ter a range of can­cers. And this morn­ing the part­ners out­lined ag­gres­sive plans to take the com­bo through sev­en piv­otal tri­als.

Re­searchers for these two com­pa­nies got ex­cit­ed about the po­ten­tial for this com­bi­na­tion af­ter see­ing pro­gres­sion-free sur­vival rates of 74 per­cent and 57 per­cent at 6 months and 12 months among the ad­vanced melanoma pa­tients they treat­ed last year in a Phase I. Their melanoma part­ner­ship was ex­pand­ed to in­clude a Phase III melanoma tri­al. Now they are push­ing ahead in the clin­ic to see if In­cyte’s epaca­do­stat and Keytru­da can make a sig­nif­i­cant dif­fer­ence in front­line use against non-small cell lung can­cer, blad­der can­cer, re­nal can­cer and squa­mous cell car­ci­no­ma of the head and neck (SC­CHN).

Al­ready in a Phase III melanoma study, in­ves­ti­ga­tors are adding:

• Two Phase III stud­ies in first-line NSCLC, in­clud­ing both PD-L1 high-ex­press­ing and PD-L1 un­s­e­lect­ed pop­u­la­tions.
• Two Phase III stud­ies in blad­der can­cer, in­clud­ing one in first-line blad­der can­cer and one in sec­ond-line blad­der can­cer.
• A Phase III study in first-line RCC.
• And a Phase III study in first-line SC­CHN.

Mer­ck is man­ag­ing the tri­al work while the two com­pa­nies share ex­pens­es.

When RBC’s Simos Sime­oni­dis saw the first cut of the Phase I da­ta, he con­clud­ed that In­cyte and Mer­ck have an ex­cel­lent shot of beat­ing out Bris­tol-My­ers Squibb’s piv­otal com­bi­na­tion study of Yer­voy and Op­di­vo for first-line use in non-small cell lung can­cer. And right now, Mer­ck’s abil­i­ty to ma­neu­ver past Bris­tol-My­ers and seize the lead on NSCLC con­tin­ues to stag­ger an­a­lysts.

Mer­ck, of course, is spar­ing no ex­pense in push­ing dozens of piv­otal stud­ies of Keytru­da, in­tent on cap­i­tal­iz­ing on a ma­jor mar­ket op­por­tu­ni­ty and un­will­ing to let a grow­ing field of com­peti­tors ham­per its pur­suit of block­buster rev­enue.

Most re­cent­ly Pfiz­er and Mer­ck KGaA gained an ap­proval for the fourth check­point ther­a­py — com­ing in right be­hind Roche — which un­leash­es an im­mune sys­tem at­tack on can­cer cells. As­traZeneca, mean­while, re­jigged its de­vel­op­ment ef­fort to amp up its work on a com­bi­na­tion of dur­val­um­ab and treme­li­mum­ab.

Ri­vals in the field are pay­ing rapt at­ten­tion to every new move.

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.

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.

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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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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Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday 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.