Roche’s Tecen­triq scoops up a big win in small cell lung can­cer, grab­bing the lead in front­line cas­es

Roche’s Genen­tech has scored a land­mark suc­cess in treat­ing small cell lung can­cer, re­port­ing that its PD-L1 check­point Tecen­triq plus chemo helped pa­tients live longer when they re­ceived the com­bo as a front­line ther­a­py. And the score on IM­pow­er133  should put it in the lead in that sec­tor — for now. 

Falling on the heels of some set­backs, Genen­tech ex­ecs are re­port­ing that their com­bi­na­tion ap­proach of­fered sta­tis­ti­cal­ly sig­nif­i­cant re­sults for both over­all sur­vival as well as pro­gres­sion-free sur­vival. The beat over the con­trol arm was al­so iden­ti­fied at an in­ter­im stage, al­low­ing Roche to ac­cel­er­ate plans to get this in­to the hands of reg­u­la­tors.

The win here is cru­cial for Roche, which is play­ing catch-up with check­point lead­ers Bris­tol-My­ers Squibb and Mer­ck. And not all that ef­fec­tive­ly. The phar­ma gi­ant needs to get out well ahead of the com­pe­ti­tion in key ar­eas if they ex­pect to hold on to their third-ranked po­si­tion in the mar­ket, as As­traZeneca moves ahead with its ad­van­tage in one im­por­tant niche of non-small cell lung can­cer.

San­dra Horn­ing

We won’t see Roche’s da­ta un­til an up­com­ing con­fer­ence, stan­dard op­er­at­ing pro­ce­dure in drug de­vel­op­ment.

Ever­core ISI’s Umer Raf­fat and sev­er­al oth­er an­a­lysts have pegged IM­pow­er133 as one of the most sig­nif­i­cant read­outs in SCLC this year, with Bris­tol-My­ers lin­ing up Check­mate-451, where they are study­ing their I/O-I/O com­bo of Op­di­vo and Yer­voy as a main­te­nance ther­a­py.

Ab­b­Vie, mean­while, re­cent­ly con­ced­ed that their try against SCLC with Ro­va-T was a flop. And Mer­ck al­so has failed to ig­nite much en­thu­si­asm so far with its bas­ket study re­sults for Keynote-158 as a sec­ond-line ther­a­py for SCLC.

Mer­ck, mean­while, is ag­gres­sive­ly mov­ing to chal­lenge Roche here, with piv­otal re­sults be­ing as­sem­bled in Keynote-604 for a com­bi­na­tion of Keytru­da and chemo af­ter surg­ing in­to a dom­i­nant po­si­tion in front­line non-small cell lung can­cer.

Now Mer­ck is in the un­usu­al po­si­tion of be­ing sec­ond. Pa­tients, mean­while, can look for­ward to some progress in a dis­ease that has proved stub­born­ly dif­fi­cult to beat.

“These are the first pos­i­tive Phase III sur­vival re­sults for any im­munother­a­py-based com­bi­na­tion in the ini­tial treat­ment of ex­ten­sive-stage small cell lung can­cer, a par­tic­u­lar­ly dif­fi­cult-to-treat type of dis­ease,” said Roche CMO San­dra Horn­ing.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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What does $62B buy you these days? A lot, says Take­da ex­ecs as the phar­ma play­er promis­es a block­buster R&D fu­ture

First comes the $62 billion buyout. Then comes the asset auction and reorganization to pay down debt. Now comes the detailed pledge of a bigger, brighter future in drug development.

That’s where Takeda finds itself on R&D day today, about 11 months after closing on their Shire acquisition. R&D chief Andy Plump is joining CEO Christophe Weber and other top members of the team to outline a new set of priorities in the greatly expanded pipeline at Takeda, which has jumped into the top ranks of the world’s pharma giants in the wake of the Shire deal.

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BeiGene CEO John Oyler at an Endpoints event in Shanghai, October 2018 (Credit: Endpoints News/PharmCube)

UP­DAT­ED: Chi­na's BeiGene scores first-ever FDA ap­proval — but can they carve up J&J's block­buster fran­chise?

Weeks after Amgen took a $2.7 billion stake in BeiGene, the Beijing-based biotech has secured its first-ever FDA approval for zanubrutinib, a BTK inhibitor, months ahead of schedule.

BeiGene’s drug, branded as Brukinsa, has secured accelerated approval for adult patients with mantle cell lymphoma (MCL) — a typically aggressive, rare, form of blood cancer — who have received at least one prior therapy.

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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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GSK's asth­ma bi­o­log­ic Nu­cala scores in rare blood dis­or­der study

GlaxoSmithKline’s asthma drug Nucala, which received a resounding FDA rejection for use in chronic obstructive pulmonary disease (COPD) last year, has shown promise in a rare blood disorder.

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Mer­ck buys a fledg­ling neu­rode­gen­er­a­tive biotech spawned by an old GSK dis­cov­ery al­liance. What’s up with that?

Avalon Ventures chief Jay Lichter has a well-known yen for drug development programs picked up in academia. And what he found in Haoxing Xu’s lab at the University of Michigan pricked his interest enough to launch one of his umbrella biotechs in San Diego.

Xu’s work laid the foundation for Avalon to launch Calporta, which has been working on finding small molecule agonists of TRPML1 (transient receptor potential cation channel, mucolipin subfamily, member 1) for lysosomal storage disorders. And that pathway, they believe, points to new approaches on major market neurodegenerative diseases like Parkinson’s, ALS and Alzheimer’s.

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Carson Block. Muddy Waters via YouTube

Shorts ga­lore: Mud­dy Wa­ters sees slide for Pep­tiDream, tweets con­cerns about Fi­bro­Gen's new da­ta

The short seller Muddy Waters is taking aim at Japan’s most profitable biotech, projecting a slide for a company that has skyrocketed over the last four years. Meanwhile, the firm tweeted out an analysis accusing FibroGen of manipulating data to obscure safety concerns in their latest reveal, although some investors seem satisfied by the biotech’s explanation.

Muddy Waters shorted PeptiDream, a Japanese biotech-for-hire that leveraged its peptide library into partnerships with some of the world’s largest pharmaceutical companies, a 50% profit margin and $6 billion valuation. The firm noted that despite its esteem, PeptiDream has failed to bring a drug to market 13 years after its 2006 launch (although this is not especially rare for biotech).

Pin­cer move­ment: Cal­i­for­nia biotech gets $35M to suf­fo­cate can­cer in co­or­di­nat­ed at­tack

Having served in Afghanistan, the navy veteran leading California-based EpicentRx wants to leave no patient behind with his arsenal of anti-cancer drugs. On Thursday, the company was given a $35 million boost to further its mission.

The injection of funds will be used to shepherd its late-stage CD47 drug, RRx-001, to the FDA for marketing, and its oncolytic virus program into the clinic.

RRx-001, engineered as an agent that makes tumor cells more sensitive to therapy, is in a Phase III trial in combination with chemotherapy for use in third-line and beyond small cell lung cancer (SCLC). The drug has been granted orphan drug designation from FDA for SCLC, neuroendocrine cancer and glioblastoma.