Bris­tol-My­ers stag­gered by a stun­ning check­point set­back, hands Mer­ck a free pass on front­line lung can­cer com­bo

Bris­tol-My­ers Squibb $BMY fans can scratch any hopes of an ac­cel­er­at­ed fil­ing for a com­bi­na­tion of Op­di­vo and Yer­voy as a front­line ther­a­py for lung can­cer. The big biotech an­nounced in a terse state­ment late Thurs­day that it will not pur­sue an ac­cel­er­at­ed ap­proval due to the “re­view of da­ta avail­able at this time.”

More in­sight? For­get about it. Says Bris­tol-My­ers:

“In or­der to pro­tect the in­tegri­ty of on­go­ing reg­is­tra­tional stud­ies, the com­pa­ny will not be pro­vid­ing ad­di­tion­al de­tails.”

The an­nounce­ment nix­es any hopes that the com­bo can pro­vide near-term re­lief from Mer­ck’s as­sault on the front­line fran­chise with its stun­ning ear­ly fil­ing on a com­bi­na­tion of Keytru­da and chemo for first line use. Bris­tol-My­ers’s work on Check­mate-227, the key clin­i­cal pro­gram that will de­cide the fate of Op­di­vo’s fu­ture, is ex­pect­ed to last in­to 2018.

Bris­tol-My­ers’ shares plunged 10% in ear­ly trad­ing Fri­day, elim­i­nat­ing more than $9 bil­lion in mar­ket cap. Its loss was Mer­ck’s gain, which saw its stock jump 4%. And As­traZeneca was caught in this vor­tex as well, with shares drop­ping 2% in pre-mar­ket trad­ing as an­a­lysts raised doubts about its strat­e­gy for dur­val­um­ab, which will play a crit­i­cal role in CEO Pas­cal So­ri­ot’s plan to make a come­back at the phar­ma gi­ant.

Mer­ck now has plen­ty of time to grab the lead with its own ear­ly com­bo ap­proach, as As­traZeneca still looks for a come-from-be­hind win on dur­val­um­ab and treme­li­mum­ab, with pro­gres­sion-free sur­vival da­ta slat­ed to ar­rive this sum­mer — though over­all sur­vival da­ta won’t like­ly ar­rive on that ex­per­i­men­tal com­bo un­til 2018 as well.

Sea­mus Fer­nan­dez, Leerink

Sea­mus Fer­nan­dez at Leerink had some time to con­sid­er the im­pact, and he was dis­turbed by the im­pli­ca­tions for Bris­tol-My­ers as well as As­traZeneca. He not­ed:

This is a clear set­back for BMY, par­tic­u­lar­ly in light of the agency’s re­cent ac­cep­tance of MRK’s (MP) fil­ing for the Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py reg­i­men. With the CM-227 tri­al ex­pect­ed to read­out in 1H:18, this al­so could give AZN (OP) a pot’l head start with its dur­val­um­ab (an­ti-PD-L1) + treme­li­mum­ab (an­ti-CT­LA-4) com­bi­na­tion in 1L NSCLC, as­sum­ing pos­i­tive da­ta from the MYS­TIC tri­al (ex­pect­ed in mid-2017). How­ev­er, if MRK and RHH­BY’s (NR) Phase 3 IO+Chemo tri­als are both suc­cess­ful and IO+IO com­bos fail to im­press, this would leave very lit­tle room for ei­ther BMY or AZN to dif­fer­en­ti­ate them­selves in the 1L NSCLC mar­ket. This would be par­tic­u­lar­ly sur­pris­ing and dis­ap­point­ing in the wake of our re­cent dis­cus­sions with lung can­cer KOLs.

In an­oth­er ma­jor set­back for Bris­tol-My­ers Squibb, its first piv­otal study for Op­di­vo in front­line lung can­cer failed last year, in part be­cause in­ves­ti­ga­tors de­cid­ed to tack­le a broad swathe of pa­tients. Its con­sis­tent­ly dis­ap­point­ing re­sponse on lung can­cer has ran­kled an­a­lysts and in­vestors, who once gam­bled that Bris­tol would be the king­pin in check­point drugs.

Mer­ck $MRK in the mean­time, is fol­low­ing up with dozens of stud­ies of Keytru­da com­bos. Just a few days ago the com­pa­ny turned heads once again with plans to com­bine Keytru­da with In­cyte’s IDO1 in­hibitor epaca­do­stat in lung can­cer and sev­er­al oth­er on­col­o­gy in­di­ca­tions.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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