Mer­ck’s glo­ri­ous vic­to­ry in lung can­cer marks a Russ­ian win­ter for Bris­tol-My­ers

Sun­day was check­point in­hibitor day at ES­MO, with the three big play­ers now in the mar­ket out­lin­ing how they’re lin­ing up in the block­buster field of lung can­cer ther­a­py. Mer­ck was left in the en­vi­able po­si­tion of dri­ving home some im­pres­sive re­sults from its clin­i­cal study while Bris­tol-My­ers Squibb had to try to put its mis­er­able out­comes in a some­what pos­i­tive con­text and a de­ter­mined Roche/Genen­tech team an­gled in on its niche.

As­traZeneca CEO Pas­cal So­ri­ot, mean­while, had to stand on the side­lines de­vout­ly wish­ing he was in the game of block­busters.

Bris­tol-My­ers Squibb $BMY made a Napoleon­ic mis­cal­cu­la­tion when it de­cid­ed to see if Op­di­vo could beat chemother­a­py as a front­line treat­ment for a broad pa­tient pop­u­la­tion suf­fer­ing from non-small cell lung can­cer. We al­ready knew from the top-line an­nounce­ment that the tri­al failed — trig­ger­ing some­thing of a Russ­ian win­ter for Bris­tol stock. Now we know that it failed re­al­ly, re­al­ly bad­ly, and in­vestors weren’t hap­py, send­ing its shares down sharply Mon­day morn­ing.

Low­er­ing the bar to pa­tients with 5% or more of their can­cer cells ex­press­ing PD-L1, Bris­tol’s Op­di­vo de­layed tu­mor pro­gres­sion 4.2 months. Chemo? 5.9 months.

“We thought Op­di­vo could beat chemother­a­py, and we have an­swered the ques­tion — for the broad pop­u­la­tion it is not enough,” Fouad Namouni, on­col­o­gy de­vel­op­ment head at Bris­tol-My­ers, told David Crow at the Fi­nan­cial Times.

That’s ac­tu­al­ly a very valu­able point and in the sci­ence world it would and should be ap­plaud­ed. But even in sub­group analy­ses, Bris­tol’s in­ves­ti­ga­tors could find new ev­i­dence of suc­cess. To in­vestors ex­pect­ing Bris­tol-My­ers to con­tin­ue their dom­i­na­tion of the sec­tor, though, it all looks like an epic mis­cal­cu­la­tion and set­back with­out a sin­gle re­deem­ing fea­ture.

Mer­ck R&D chief Roger Perl­mut­ter $MRK made no such mis­take in mov­ing on the front­line mar­ket front. Play­ing Welling­ton in this R&D Wa­ter­loo, Perl­mut­ter fo­cused on pa­tients with a 50%-plus PD-L1 ex­pres­sion rate and round­ed up a 50% re­duc­tion in the risk of dis­ease pro­gres­sion and 40% plunge in risk of death com­pared to chemo in pre­vi­ous­ly un­treat­ed pa­tients.

This is what a new stan­dard of care for a seg­ment of front-line lung can­cer cas­es looks like. This drug is al­ready be­ing sold and you can bet that the phar­ma gi­ant will move as fast as it can to cap­i­tal­ize on this mar­ket. That’s a glo­ri­ous vic­to­ry by any bio­phar­ma stan­dard.

Over re­cent months Bris­tol-My­ers stock has re­treat­ed sig­nif­i­cant­ly while Mer­ck has ad­vanced. That’s how you can score the war. And Mon­day morn­ing Mer­ck stock bub­bled up an­oth­er 3% while Bris­tol-My­ers shares plunged 8%.

But Mer­ck won’t re­main un­chal­lenged. Steal­ing some of the thun­der at ES­MO is Genen­tech’s Tecen­triq. Roche’s big check­point, the third to be ap­proved and start spread­ing its wings, achieved a sol­id suc­cess in sec­ond-line NSCLC. Their 13.8 month me­di­an sur­vival rate com­pared fa­vor­ably with the 9.6 months record­ed for the chemo arm.

Dan Chen, who’s head­ed up can­cer im­munother­a­py de­vel­op­ment for Genen­tech, told Fier­cePhar­ma’s Car­ly Helfand that the da­ta were “es­sen­tial­ly un­prece­dent­ed.” But when you sin­gled out the high PD-L1 ex­pressers, the da­ta weighed even more heav­i­ly on Tecen­triq’s side: 20.5 months me­di­an sur­vival com­pared to 8.9 months in the chemo arm.

Now Roche $ROG can break out from its unique blad­der can­cer ap­proval and start to tear up the sec­ond-line lung can­cer mar­ket, look­ing for an ad­van­tage with all the high PD-L1 ex­pressers. A front­line pitch can’t be far off.

While Mer­ck, Bris­tol-My­ers and Roche are divvy­ing up the mar­ket, As­traZeneca is still side­lined af­ter its ef­forts fell well be­hind its ri­vals. But who was that stand­ing on the edge of the bat­tle­field?

“Sud­den­ly, this tri­al news opens quite some op­por­tu­ni­ties for us, in both monother­a­py and com­bi­na­tion ther­a­py,” a sun­ny As­traZeneca Chief Ex­ec­u­tive Pas­cal So­ri­ot told Reuters’ Ben Hirschler, siz­ing up the fast-chang­ing lung can­cer mar­ket.

As­traZeneca’s check­point pro­gram $AZN has been a lag­gard and will ar­rive to the fray very late. For So­ri­ot, though, it’s all char­ac­ter­ized as an ad­van­tage; a chance to see how oth­ers have done their stud­ies so they can match the best work. But af­ter a se­ries of clin­i­cal set­backs, As­traZeneca looks like its re­ced­ing from So­ri­ot’s promis­es of great ad­vances on the rev­enue front, 4 years af­ter he got the top job. He needs a piece of the check­point mar­ket—and fast.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Glax­o­SmithK­line scraps a LAG3 study, mark­ing an­oth­er fail­ure for the pipeline af­ter a crit­i­cal set­back

Another gap has appeared in GlaxoSmithKline’s pipeline.

Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.

The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.