Roche hails an­oth­er PhI­II win on Tecen­triq com­bo, re­ports promis­ing kid­ney can­cer da­ta

Roche is ped­al­ing hard from be­hind in the race for PD-1/L1 mar­ket su­prema­cy, an­nounc­ing news at mar­ket close Mon­day that it’s wrapped up yet an­oth­er promis­ing Phase III com­bo study us­ing Tecen­triq.

With heavy­weights like Mer­ck and Bris­tol-My­ers Squibb lead­ing the mar­ket, Roche $RHH­BY and its sub­sidiary Genen­tech are step­ping up their game. The lat­est Phase III study test­ed Tecen­triq with Avastin against ad­vanced or metasta­t­ic re­nal cell car­ci­no­ma or kid­ney can­cer.

San­dra Horn­ing

The study, called IM­mo­tion 151, met one of its co-pri­ma­ry end­points of pro­gres­sion-free sur­vival (PFS) in peo­ple whose dis­ease ex­pressed the PD-L1 pro­tein. Those on the com­bo had a 26% re­duced risk of dis­ease wors­en­ing or death com­pared to peo­ple treat­ed with chemother­a­py drug suni­tinib (me­di­an PFS: 11.2 months vs 7.7 months; p=0.02).

As for the oth­er end­point, the com­pa­ny said over­all sur­vival ob­ser­va­tions were “en­cour­ag­ing, but still im­ma­ture.”

“This is the sec­ond pos­i­tive Phase III study that in­cludes Tecen­triq and Avastin as part of a treat­ment reg­i­men, pro­vid­ing fur­ther ev­i­dence to sup­port the po­ten­tial of this unique com­bi­na­tion,” said San­dra Horn­ing, Genen­tech’s CMO and head of glob­al prod­uct de­vel­op­ment, in a state­ment. “We are en­cour­aged that ini­tial treat­ment with Tecen­triq and Avastin sig­nif­i­cant­ly re­duced the risk of dis­ease wors­en­ing or death in peo­ple with ad­vanced kid­ney can­cer, while al­so pro­vid­ing more time be­fore dis­ease symp­toms in­ter­fered with day-to-day life com­pared with suni­tinib, a cur­rent stan­dard of care. We look for­ward to dis­cussing these re­sults with reg­u­la­to­ry au­thor­i­ties world­wide.”

Sev­erin Schwan

This kid­ney can­cer da­ta fol­lows promis­ing Phase III da­ta of a Tecen­triq com­bo in lung can­cer an­nounced just months ago. The com­pa­ny’s 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 front-line 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.”

The IM­mo­tion151 da­ta will be pre­sent­ed at the 2018 Gen­i­touri­nary Can­cers Sym­po­sium on Sat­ur­day, Feb 10.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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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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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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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.