Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Bris­tol My­er­s' Op­di­vo notch­es a dou­ble win against chemo in esophageal can­cer, po­ten­tial­ly set­ting up 1st-line nod

Bris­tol My­ers Squibb is one of a group of drug­mak­ers prep­ping for a tense FDA ad­comm lat­er this month to re­view a host of ac­cel­er­at­ed ap­provals. Look­ing to start the month on the right note, the drug­mak­er rolled out new da­ta for its PD-(L)1 check­point in­hibitor Op­di­vo show­ing more promise in esophageal can­cer.

Op­di­vo in com­bi­na­tion with chemother­a­py and a com­bi­na­tion of Op­di­vo and Yer­voy beat out chemo alone in ex­tend­ing the lives of first-line esophageal squa­mous cell car­ci­no­ma pa­tients whose tu­mors are metasta­t­ic or can’t be sur­gi­cal­ly re­moved, ac­cord­ing to in­ter­im re­sults re­leased Thurs­day.

A com­bi­na­tion of Op­di­vo and chemo hit its pri­ma­ry OS and PFS end­points over chemo alone in PD-(L)1 ex­press­ing tu­mors at a pre­spec­i­fied check-in on the Phase III CHECK­MATE-648 study. Mean­while, Op­di­vo plus Yer­voy showed more mixed re­sults, hit­ting its OS pri­ma­ry end­point but miss­ing the PFS co-pri­ma­ry end­point, Bris­tol My­ers said.

Bris­tol My­ers is tout­ing the re­sults as the first time a PD-(L)1 check­point in­hibitor has shown first-line ef­fi­ca­cy across all up­per GI tu­mor lo­ca­tions, in­clud­ing in the stom­ach, gas­troe­sophageal junc­tion, and esoph­a­gus. The study backed up re­sults from CHECK­MATE-649, which test­ed Op­di­vo plus chemo in first-line pa­tients with ad­vanced or metasta­t­ic gas­tric can­cer, gas­troe­sophageal junc­tion can­cer or esophageal ade­no­car­ci­no­ma.

The FDA agreed to re­view re­sults from that study as part of a pri­or­i­ty re­view grant­ed in Feb­ru­ary, with an ac­tion date set for May 25. Earn­ing a nod in those ear­ly pa­tients would be a clear leg up on Mer­ck’s su­per­star check­point in­hibitor Keytru­da, which sports an ap­proval in third-line pa­tients with the PD-(L)1 bio­mark­er dat­ing back to Sep­tem­ber 2017 but has since flopped con­fir­ma­to­ry tri­als in first- and sec­ond-line use.

CHECK­MATE-648 is an­oth­er win un­der Bris­tol My­ers’ belt as it pre­pares for a three-day ad­comm in April to re­view a broad range of im­mune check­point in­di­ca­tions with ac­cel­er­at­ed ap­provals that flopped con­fir­ma­to­ry stud­ies, in­clud­ing a sin­gle Op­di­vo in­di­ca­tion.

In De­cem­ber, Bris­tol walked on Op­di­vo’s third-line-or-lat­er FDA ap­proval for small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod in that in­di­ca­tion back in 2018 failed to show ben­e­fit in ex­tend­ing pa­tients’ lives. Based on find­ings from its Check­mate-451 and -331 tri­als, which found Op­di­vo failed to hit its OS pri­ma­ry end­points as both a monother­a­py and com­bo treat­ment with Yer­voy, Bris­tol de­cid­ed to pull its ap­proval based on the FDA’s rec­om­men­da­tions to fol­low post-mar­ket­ing sci­ence.

Just a week be­fore that, Bris­tol opt­ed to for­go its chances in brain can­cer glioblas­toma, an­oth­er chron­i­cal­ly dif­fi­cult-to-treat in­di­ca­tion, fol­low­ing mul­ti­ple clin­i­cal fails. The drug­mak­er ad­mit­ted a com­bo of Op­di­vo on top of stan­dard-of-care temo­zolo­mide plus ra­di­a­tion couldn’t beat place­bo in ex­tend­ing over­all sur­vival in pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme who pre­vi­ous­ly had their tu­mor sur­gi­cal­ly re­moved.

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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