John Oyler at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018. (Credit: Endpoints News, PharmCube)

Plough­ing through a crowd­ed PD-(L)1 mar­ket, BeiGene loads up on promis­ing lung can­cer da­ta

BeiGene’s en­try to the PD-1 mar­ket — as the fourth do­mes­tic drug­mak­er to score ap­proval in Chi­na, lag­ging months be­hind multi­na­tion­al play­ers — might have been un­re­mark­able. But the fol­low-up act is where it plans to shine.

Three months af­ter post­ing pos­i­tive top-line pro­gres­sion-free sur­vival re­sults for their piv­otal Chi­nese study with tislelizum­ab and chemo for front­line squa­mous non-small cell lung can­cer, BeiGene said the PD-1 an­ti­body hit the same mark for non-squa­mous cas­es of NSCLC. In both tri­als, the drug was paired with chemother­a­py and the reg­i­men was com­pared to chemo alone.

Why does it mat­ter? SVB Leerink an­a­lyst An­drew Berens summed it up this way:

This pos­i­tive out­come in non-squa­mous NSCLC, and pri­or suc­cess in squa­mous NSCLC, along with ap­proved in­di­ca­tions in blad­der can­cer and clas­sic Hodgkin’s lym­phoma, could po­ten­tial­ly en­able Tisle to have the broad­est la­bel among all Chi­na do­mes­tic PD-1/L1 agents, which could give the com­pa­ny a com­pet­i­tive ad­van­tage and broad na­tion­al re­im­burse­ment, which could ul­ti­mate­ly chal­lenge the multi­na­tion­al agents.

The com­pa­ny has in­di­cat­ed that it plans to sub­mit an sN­DA for first-line squa­mous NSCLC in Chi­na in 2020. Once the over­all sur­vival re­sults, which con­sti­tute one of the sec­ondary end­points in these tri­als, are in, Berens ex­pects BeiGene to lever­age the datasets to sup­port po­ten­tial fil­ing in the US.

Yong Ben

Tislelizum­ab is be­ing stud­ied in more than 25 tri­als world­wide, added Yong Ben, CMO of im­muno-on­col­o­gy. They in­clude a Phase III pit­ting the drug against do­c­etax­el in sec­ond-line or third-line NSCLC, ex­pect­ed by ear­ly 2021, in ad­di­tion to tri­als in he­pa­to­cel­lu­lar car­ci­no­ma and esophageal can­cer.

Berens es­ti­mates peak rev­enues at $460 mil­lion in Chi­na, with $28 mil­lion in 2020 — which he said “could prove to be very con­ser­v­a­tive if the com­pa­ny is able to cap­ture a sig­nif­i­cant por­tion of the rapid­ly grow­ing PD-1 mar­ket.”

CEO John Oyler is go­ing all out. Just days ago BeiGene nabbed its first sol­id tu­mor OK in lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma. Chi­na’s Na­tion­al Med­ical Prod­uct Ad­min­is­tra­tion, which grant­ed the sN­DA pri­or­i­ty re­view pre-pan­dem­ic, based its de­ci­sion on a sin­gle-arm piv­otal Phase II.

It marked tislelizum­ab’s sec­ond in­di­ca­tion af­ter the ini­tial ap­proval for clas­si­cal Hodgkin’s lym­phoma in De­cem­ber 2019.

Like urothe­lial can­cer, pa­tients with Stage II­IB or Stage IV non-squa­mous NSCLC are al­so in need of more treat­ment op­tions, BeiGene said. Its ri­vals at In­novent and Hen­grui ev­i­dent­ly agree, lin­ing up their own pro­grams to tack­le the mar­ket.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Ku­ra flash­es pos­i­tive HRAS da­ta on once-failed J&J drug

Troy Wilson was working with J&J on their KRAS inhibitor and periodically thumbing through their publications when he spotted an old drug called tipifarnib that looked promising. So promising, in fact, that the large pharma had run it through over 5,000 patients across 70 trials, hoping they would at some point be able to nail down who were the small slice of patients who responded in some studies.

Af­ter star­ring at ASH last fall, Gilead’s new Forty Sev­en crew col­ors in more promis­ing da­ta for ma­grolimab at AS­CO

We now know the full, early-stage story behind the drug that inspired Gilead CEO Dan O’Day’s recent $5 billion acquisition of Forty Seven.

Following up on their ASCO abstract from a couple of weeks ago, the team at Forty Seven is making their return appearance this week holding clearly promising early-stage data on their lead drug magrolimab as they ponder whether they should roll on a quest to obtain an accelerated approval.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfizer and Merck KGaA have detailed the Phase III data that inspired FDA regulators to designate Bavencio a “breakthrough” for first-line advanced bladder cancer and offered an early glance at how the PD-L1 can help patients with a rare gynecological cancer — carving out niches in the checkpoint space for itself after being shut out of numerous others.

In JAVELIN Bladder 100, Bavencio led to a 31% reduction in risk of death compared to standard care alone. It also extended median survival by more than seven months — a historic feat in this setting, according to investigators at Queen Mary University of London.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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