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

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.