Look­ing for a come-from-be­hind win, Roche touts its piv­otal suc­cess for Tecen­triq com­bo in front-line lung can­cer

Trail­ing far be­hind Mer­ck $MRK and Bris­tol-My­ers Squibb $BMY, the lead­ers in the heat­ed show­down for mar­ket su­prema­cy in the PD-1/L1 com­mer­cial race, Roche is mak­ing its move in the key lung can­cer mar­ket with a set of promis­ing, pro­gres­sion-free sur­vival da­ta for a com­bi­na­tion us­ing Tecen­triq.

Their close­ly watched Phase III IM­pow­er150 study of a triple com­bo of Tecen­triq, Avastin and chemo demon­strat­ed a dou­bling in 12-month pro­gres­sion-free sur­vival rates among a broad group of front­line lung can­cer pa­tients, set­ting the stage for a quick reg­u­la­to­ry OK on both sides of the At­lantic.

“We have a re­al chance to be at the fore­front here,” Roche CEO Sev­erin Schwan told Reuters ahead of the da­ta re­lease. “Our am­bi­tion is to be­come a clear leader in the field of can­cer im­munother­a­pies.”

Com­par­ing the triple against Avastin and chemo alone, re­searchers tracked a 38% re­duc­tion in the risk of dis­ease pro­gres­sion, with the pro­gres­sion-free sur­vival rate hit­ting 8.3 months for the triple against 6.8 months for the dou­ble. The haz­ard ra­tio (HR) was 0.62. In a sub­group of peo­ple de­fined by a bio­mark­er (T-ef­fec­tor “Teff” gene sig­na­ture ex­pres­sion Teff WT), the PFS hit an im­pres­sive 11.3 months for the triple.

Roche’s bot­tom line:

Im­por­tant­ly, a dou­bling of the 12-month land­mark PFS rate was ob­served with the com­bi­na­tion of Tecen­triq and Avastin plus chemother­a­py (37 per­cent) com­pared to Avastin plus chemother­a­py (18 per­cent). The rate of tu­mor shrink­age (over­all re­sponse rate, ORR), a sec­ondary end­point in the study, was high­er in peo­ple treat­ed with Tecen­triq and Avastin plus chemother­a­py com­pared with Avastin plus chemother­a­py (64 per­cent vs. 48 per­cent).

“Dou­bling PFS (pro­gres­sion-free sur­vival) at one year is some­thing we have not seen with any tar­get­ed ther­a­py in un­s­e­lect­ed pa­tients to date,” Solange Pe­ters, the head of Med­ical On­col­o­gy at the Cen­tre Hos­pi­tal­ier Uni­ver­si­taire Vau­dois in Lau­sanne, told the wire ser­vice.

San­dra Horn­ing

Not every­one was ready to call the play as en­tire­ly in Roche’s fa­vor, though. Ever­cor­eISI’s Uber Raf­fat rushed to Mer­ck’s de­fense this morn­ing. And Leerink’s Sea­mus Fer­nan­dez sees Mer­ck re­main­ing in the lead for lung can­cer.

On the neu­tral to neg­a­tive side, the ben­e­fit ap­pears to be dri­ven large­ly by bio­mark­er pos­i­tive pa­tients – al­low­ing for a wide range of ques­tions in­clud­ing com­par­isons to MRK’s Keytru­da as monother­a­py in PDL1 high pa­tients. How­ev­er, the unique ben­e­fit of Tecen­triq + Avastin in EGFR/ALK mu­ta­tion pos­i­tive pa­tients may se­cure a place for this com­bi­na­tion in 15-20% of pa­tients glob­al­ly as a sec­ond or third line treat­ment op­tion.

Roche faces a big chal­lenge on the check­point front. Top ex­ecs be­lieve that Tecen­triq is key to the com­pa­ny’s abil­i­ty to re­place rev­enue lost as its big three fran­chise drugs see gener­ic com­pe­ti­tion build up and carve away rev­enue. But the phar­ma gi­ant has al­so had its own set­backs with their PD-L1 ther­a­py, with a sting­ing fail­ure on blad­der can­cer that spurred fresh de­bate over the rel­a­tive val­ue of a PD-1 ver­sus a PD-L1.

To­day, they suc­cess­ful­ly coun­tered that dis­cus­sion, though this de­bate is far from over.

“This Tecen­triq study is the first pos­i­tive Phase III com­bi­na­tion tri­al that showed a can­cer im­munother­a­py re­duced the risk of the dis­ease get­ting worse when used as an ini­tial treat­ment in a broad group of peo­ple with ad­vanced non-squa­mous NSCLC,” said San­dra Horn­ing, Roche’s chief med­ical of­fi­cer. “The IM­pow­er150 study rep­re­sents an im­por­tant ad­vance in lung can­cer treat­ment, and we will sub­mit these re­sults to reg­u­la­to­ry au­thor­i­ties around the world to po­ten­tial­ly bring a new stan­dard of care to peo­ple liv­ing with this dis­ease as soon as pos­si­ble.”


Im­age: Roche CEO Sev­erin Schwan Ap Im­ages

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19, but follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.

Pfiz­er, Bris­tol My­er­s' Eliquis flops in post-heart surgery pa­tients, spurring an 'un­ex­plained sig­nal' in cer­tain deaths

Pfizer and Bristol Myers Squibb’s non-warfarin blood thinner Eliquis has raced out to become the most prescribed drug of its class on the market — even overtaking warfarin’s long-time lead. But in tricky-to-treat patients after a valve replacement, an investigator-sponsored study couldn’t turn up benefit and raised a troubling safety signal.

Eliquis failed to show benefit over standard of care in preventing serious clinical outcomes after a transaortic valve replacement (TAVR) and was linked to an “unexplained signal” in a subset of populations with a higher rate of non-CV deaths who did not need blood thinners apart from the surgery, according to data presented Saturday at the virtual American College of Cardiology meeting.

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.