BeiGene beefs up PD-1 da­ta with pos­i­tive PhI­II re­sults for tislelizum­ab, this time in metasta­t­ic NSCLC

BeiGene has been an­gling to dis­rupt the PD-1 mar­ket for quite some time, and on Tues­day ap­peared to take one step clos­er.

The Chi­nese biotech an­nounced that a Phase III study eval­u­at­ing its PD-(L)1 check­point in­hibitor tislelizum­ab in metasta­t­ic non-small cell lung can­cer met its pri­ma­ry end­point of over­all sur­vival. BeiGene didn’t pro­vide num­bers or p-val­ues with Tues­day’s re­sults, but not­ed that this was the drug’s third Phase III in NSCLC to go pos­i­tive at the in­ter­im read­out.

Yong Ben

“As we con­tin­ue to ad­vance tislelizum­ab in its broad clin­i­cal pro­gram,” CMO Yong Ben said in a state­ment, “we ex­pect to see a grow­ing body of clin­i­cal ev­i­dence that we be­lieve will help fur­ther eval­u­ate this po­ten­tial­ly dif­fer­en­ti­at­ed check­point in­hibitor and sup­port po­ten­tial reg­u­la­to­ry fil­ings in Chi­na and glob­al­ly.”

This tri­al en­rolled 805 pa­tients and com­pared tislelizum­ab to do­c­etax­el in the sec­ond- or third-line set­ting for those who had pro­gressed on plat­inum-based chemother­a­py. Pa­tients were ran­dom­ized 2 to 1 to the drug arm.

BeiGene said that the pri­ma­ry was over­all sur­vival in both the in­ten­tion-to-treat pop­u­la­tion — those with lo­cal­ly ad­vanced or metasta­t­ic NSCLC — and pa­tients with high PD-L1 ex­pres­sion. Though the biotech was al­so look­ing at key sec­on­daries such as ob­jec­tive re­sponse rate, du­ra­tion of re­sponse and pro­gres­sion-free sur­vival, they did not di­vulge any de­tails on these da­ta.

In terms of safe­ty, re­sults proved con­sis­tent with the “known risks” of the drug, and no new safe­ty sig­nals were de­tect­ed.

Tislelizum­ab was the fourth PD-(L)1 in­hibitor to be ap­proved by Chi­nese reg­u­la­tors in the span of about 12 months when it re­ceived the green light just be­fore 2019 end­ed. The drug is al­so the first to use a for­eign part­ner in Boehringer In­gel­heim to be mar­ket­ed un­der a re­formed con­tract man­u­fac­tur­ing reg­u­la­to­ry sys­tem.

The ini­tial in­di­ca­tion was third-line re­lapsed/re­frac­to­ry Hodgkin’s lym­phoma and it’s since been OK’d in blad­der can­cers with high PD-(L)1 ex­pres­sion. In ad­di­tion to metasta­t­ic NSCLC, BeiGene is eval­u­at­ing the drug in com­bi­na­tion with chemo for both ad­vanced squa­mous and non-squa­mous NSCLC.

Un­like in the metasta­t­ic are­na, which is for sec­ond- or third-line pa­tients, BeiGene is seek­ing ap­proval in the first-line set­ting for squa­mous and non-squa­mous NSCLC pa­tients.

Da­ta from those in­di­ca­tions have proved promis­ing, as the drug hit sim­i­lar PFS re­sults in both ar­eas ear­li­er this year when com­pared to chemo alone. At the time, SVB Leerink an­a­lyst An­drew Berens took a look at the big pic­ture, pre­dict­ing that, with ap­provals al­ready in two ar­eas and pos­i­tive out­comes in NSCLC, tislelizum­ab could end up with the broad­est la­bel among all Chi­nese do­mes­tic PD-(L)1 agents.

Giv­en that the drug has yet to be ap­proved out­side Chi­na, that could give BeiGene an ad­van­tage against its non-Chi­nese com­peti­tors, Berens said.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

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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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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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Vivek Ramaswamy (Jeff Rumans/JPM 2020)

Urovan­t's lead drug dis­ap­points in mid-stage study as first big FDA de­ci­sion looms

Just as Urovant gets ready for its first big FDA decision on vibegron, the drug has flopped in what would’ve been a follow-on indication.

In a Phase IIa trial involving women with abdominal pain due to irritable bowel syndrome, vibegron failed to meet the bar on improving “average worst abdominal pain” over 12 weeks, compared to placebo, among IBS-D patients.

There were actually slightly more responders in the placebo group than in the drug arm, with only 40.9% of those randomized to vigebron achieving at least a 30% decrease in “worst abdominal pain” in the past 24 hours. The trial enrolled 222 women but only 189 completed the study.

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.

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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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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

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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