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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Vas Narasimhan's 'Wild Card' drugs: No­var­tis CEO high­lights po­ten­tial jack­pots, as well as late-stage stars, in R&D pre­sen­ta­tion

Novartis is always one of the industry’s biggest R&D spenders. As they often do toward the end of each year, company execs are highlighting the drugs they expect will most likely be winners in 2021.

And they’re also dreaming about some potential big-time lottery tickets.

As part of its annual investor presentation Tuesday, where the company allows investors and analysts to virtually schmooze with the bigwigs, Novartis CEO Vas Narasimhan will outline what he thinks are the pharma’s “Wild Cards.” The slate of five experimental drugs are those that Novartis hopes can be high-risk, high-reward entrants into the market over the next half-decade or so, and cover a wide range of indications.

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