Mer­ck scores an­oth­er win for King Keytru­da, this time in HER2-neg­a­tive can­cer

Mer­ck’s an­ti-PD1 on­col­o­gy megablock­buster Keytru­da is plan­ning on adding an­oth­er in­di­ca­tion to its ar­ray, tout­ing a Phase III win in its march to reg­u­la­tors.

Mer­ck put out word Tues­day that one of its Phase III tri­als, KEYNOTE-859, nailed the pri­ma­ry end­point of over­all sur­vival in pa­tients with a spe­cif­ic type of HER2-neg­a­tive ade­no­car­ci­no­ma. Keytru­da com­bined with chemother­a­py beat out chemo at a pre-de­ter­mined in­ter­im analy­sis. Mer­ck added that sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful im­prove­ments in PFS and ORR were al­so ob­served.

In terms of safe­ty, the com­pa­ny said Keytru­da showed no new safe­ty sig­nals.

A Mer­ck spokesper­son tells End­points News that the full re­sults in pa­tients with lo­cal­ly ad­vanced un­re­sectable or metasta­t­ic gas­troe­sophageal junc­tion (GEJ) ade­no­car­ci­no­ma will be pre­sent­ed at an undis­closed med­ical meet­ing, and that it plans to “dis­cuss these in­ves­ti­ga­tion­al da­ta with glob­al reg­u­la­to­ry au­thor­i­ties with the in­tent to sub­mit mar­ket­ing au­tho­riza­tion ap­pli­ca­tions based on these re­sults.”

This is not Mer­ck’s first for­ay with Keytru­da in­to HER2 on­col­o­gy.

Ear­li­er last year, the FDA hand­ed down an ac­cel­er­at­ed ap­proval for Keytru­da for HER2-pos­i­tive gas­tric can­cer in the first-line set­ting, in com­bi­na­tion with trastuzum­ab, flu­o­ropy­rim­i­dine- and plat­inum-based chemo. That reg­u­la­to­ry green light came af­ter pos­i­tive re­sults emerged from a 264-pa­tient study with in­di­vid­u­als who had not pre­vi­ous­ly re­ceived treat­ment for their dis­ease. Pa­tients were ran­dom­ized 1-to-1 to re­ceive Keytru­da or place­bo every three weeks in ad­di­tion to the chemother­a­py reg­i­men.

The drug arm reg­is­tered an over­all re­sponse rate of 74% com­pared to 52% tak­ing the con­trol, good for a p-val­ue of p<0.0001. Re­searchers al­so saw a me­di­an du­ra­tion of re­sponse of 10.6 months with Keytru­da ver­sus 9.5 months in the con­trol arm.

Mer­ck is not the on­ly com­pa­ny look­ing at HER2-neg­a­tive GEJ ade­no­car­ci­no­ma. Astel­las an­nounced just last week that one of its drug can­di­dates, zol­be­tux­imab, com­bined with chemo reg­i­men mFOL­FOX6 met the pri­ma­ry end­point in pro­gres­sion-free sur­vival in that dis­ease.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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