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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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