Roy Baynes, Merck Research Laboratories CMO (file photo)

Look­ing to re­bound from re­jec­tion in TNBC, Mer­ck­'s Keytru­da pass­es a new kid­ney can­cer test

Keytru­da has long been a dom­i­nant force in bio­phar­ma, rack­ing up bil­lions in sales for Mer­ck and con­tin­u­ing to ex­pand in­to more and more types of can­cer. And com­ing on the heels of a rare CRL in triple-neg­a­tive breast can­cer, the drug took an­oth­er step to­ward a po­ten­tial next in­di­ca­tion.

Mer­ck’s block­buster met its pri­ma­ry end­point in a Phase III study look­ing at Keytru­da as an ad­ju­vant ther­a­py for pa­tients with re­nal cell car­ci­no­ma fol­low­ing sur­gi­cal re­moval of a kid­ney, the Big Phar­ma an­nounced. Com­pared with place­bo, Keytru­da demon­strat­ed a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in dis­ease-free sur­vival.

“These new da­ta are the re­sult of our re­search to eval­u­ate the role of Keytru­da in help­ing pa­tients with ear­li­er stages of dis­ease,” Mer­ck Re­search Lab­o­ra­to­ries CMO Roy Baynes said in a state­ment, “and are the first pos­i­tive re­sults for an an­ti-PD-1 ther­a­py in the ad­ju­vant treat­ment of pa­tients with re­nal cell car­ci­no­ma.”

Mer­ck did not re­lease spe­cif­ic da­ta points or p-val­ues in their an­nounce­ment, but not­ed that the study en­rolled 950 who were ran­dom­ized in­to re­ceiv­ing ei­ther Keytru­da IV in­fu­sions once every three weeks up to 17 times, or place­bo.

The study is con­tin­u­ing to be eval­u­at­ed for sec­ondary end­points, which in­clude over­all sur­vival and safe­ty, Mer­ck said. Re­searchers did re­veal that safe­ty in this tri­al was con­sis­tent with pre­vi­ous stud­ies of the drug.

Re­nal cell car­ci­no­ma al­ready sits among Keytru­da’s swath of ap­provals, with the drug notch­ing an OK two years ago in com­bi­na­tion with ax­i­tinib for the first-line treat­ment in pa­tients with ad­vanced stages of the can­cer.

Thurs­day’s news comes a lit­tle over a week af­ter the FDA slapped down Mer­ck’s pitch to ex­pand the drug in­to triple-neg­a­tive breast can­cer as both a pre-op­er­a­tive (with chemo) and post-op (with­out chemo) treat­ment with a CRL. Mer­ck had ex­am­ined Keytru­da as a post-sur­gi­cal monother­a­py fol­low­ing a com­bo of Keytru­da and plat­inum-based chemother­a­py, but their da­ta were panned at an ODAC hear­ing in Feb­ru­ary.

The com­mit­tee unan­i­mous­ly rec­om­mend­ed wait­ing for fur­ther da­ta for Mer­ck’s I/O su­per­star, say­ing the phar­ma should wait for more de­fin­i­tive safe­ty da­ta from its Phase III study. At is­sue was that re­searchers hadn’t watched pa­tients long enough af­ter treat­ment to de­ter­mine EFS and OS, hav­ing seen just 53% of tar­get­ed EFS events and 32% of OS events.

But Mer­ck went ahead any­way, de­spite FDA con­cerns over the ma­tu­ri­ty of the dataset af­ter mul­ti­ple meet­ings. The CRL didn’t, how­ev­er, af­fect Keytru­da’s ap­proval as a com­bi­na­tion ther­a­py with chemo in lo­cal­ly ad­vanced, PD-1 ex­press­ing TNBC tu­mors that are metasta­t­ic or can­not be sur­gi­cal­ly re­moved.

The new RCC da­ta al­so come at a time when reg­u­la­tors are get­ting tougher on drug­mak­ers that miss their mark in con­fir­ma­to­ry stud­ies fol­low­ing ac­cel­er­at­ed ap­provals. Al­so last month, Mer­ck pulled a Keytru­da in­di­ca­tion for metasta­t­ic small cell lung can­cer, part of what it de­scribed as an “in­dus­try-wide eval­u­a­tion” by the FDA of such miss­es.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Christophe Weber, Takeda CEO (Kyodo via AP Images)

Take­da flesh­es out CNS pact with pep­tide drug­mak­er, set­ting aside $3.5B in fu­ture mile­stones

One of a suite of drugmakers looking to reinvest in the neuroscience space, Takeda has been aggressive in signing on new partners to help build up its pipeline in that space. But sometimes the best partner is the one you already have.

Takeda will set aside $3.5 billion in future milestones and an undisclosed upfront payment to build out its drug discovery deal with Japanese peptide conjugate maker PeptiDream, adding neurodegeneration to the partnership’s list of CNS targets, the companies said Tuesday.

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George Yancopoulos, Regeneron

Re­gen­eron's lat­est ge­net­ics dis­cov­ery hooks As­traZeneca — now all-in on de­vel­op­ing small mol­e­cules for obe­si­ty

Just weeks after its widely lauded genetics research arm tagged a promising new target for obesity, Regeneron has signed up an industry heavyweight to collaborate with on developing new drugs that can potentially act as a game-changer in what has proven to be a tough field for developers.

The Regeneron Genetics Center published a paper in Science at the beginning of this month highlighting how their work sequencing the genomes of 650,000 people highlighted how people with at least 1 inactive copy of the GPR75 gene weighed on average 12 pounds less than the rest of the population with a 54% reduction in risk of obesity.

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