#AACR18: Roche spot­lights promis­ing sub­group re­spons­es for lung can­cer com­bo with Tecen­triq

Mer­ck and Bris­tol-My­ers Squibb aren’t the on­ly big play­ers look­ing to make a splash in front­line lung can­cer. Roche is al­so look­ing to el­bow in, and it’s of­fered up a look at some ad­di­tion­al IM­pow­er150 da­ta at AACR to back up their shot.

Alan San­dler

We al­ready know that Roche ex­ecs gave a pre­lim­i­nary thumbs up for its piv­otal IM­pow­er150 tri­al, study­ing a com­bi­na­tion of Tecen­triq, Avastin and chemo in front­line non­squa­mous non-small cell lung can­cer and hit­ting a haz­ard ra­tio of 0.62 for the full group of pa­tients in the study. Pro­gres­sion Free Sur­vival in the main group was a me­di­an 8.3 months com­pared to 6.8 months in the con­trol, a mar­gin­al gain which isn’t like­ly to stir much ex­cite­ment. 

We’re find­ing out at AACR, though, that the line­up of ther­a­pies al­so stood out in some key sub­groups with par­tic­u­lar­ly en­cour­ag­ing pro­gres­sion-free sur­vival da­ta.

Look­ing at one EGFR/ALK+c sub­group, Roche is re­port­ing a me­di­an pro­gres­sion-free sur­vival rate of 9.7 months — and a haz­ard ra­tion of 0.59 — com­pared to the con­trol arm with a 6.1 month PFS rate. Among 59 pa­tients in the EGFR ex­on 19 dele­tion of L858R group the haz­ard ra­tio hit 0.42, with a 10.2 month PFS com­pared to 6.1 months. And in pa­tients with liv­er metas­tases the PFS was 8.2 months com­pared to 5.4 months, with an HR of 0.40. In pa­tients with­out liv­er metas­tases, the HR jumps to 0.64.

Those kinds of num­bers in these par­tic­u­lar sub­groups are huge­ly im­por­tant, says Alan San­dler, glob­al head of the lung can­cer fran­chise at Genen­tech, as this is the first time in­ves­ti­ga­tors are get­ting a close look at these pa­tients’ re­sponse.

San­dler al­so not­ed that they saw pos­i­tive re­sults for both low and high PD-L1 ex­pressers, un­der­scor­ing a trend where the high ex­pressers are like­ly to see an en­hanced ben­e­fit from lung can­cer com­bos, with low ex­pressers still gain­ing a sig­nif­i­cant re­sponse as well.

I talked to San­dler ahead of the post­ing at AACR. One ob­jec­tion that’s been raised to the three-drug reg­i­men is that it adds a cost­ly ther­a­py to the mix. But he doesn’t think that price will be a bar­ri­er to fu­ture use.

“If there’s a clin­i­cal ben­e­fit,” says San­dler, “there will be us­age.”

There are al­so plen­ty of ways that a price on a par­tic­u­lar com­bi­na­tion can be worked so that there isn’t nec­es­sar­i­ly a cost hur­dle to over­come, he adds.

Roche still has fur­ther to go in col­lect­ing more ma­ture sur­vival da­ta from the study. That will ar­rive at a fu­ture con­fer­ence. But they’re in the mix to­day, even as Mer­ck steals the show with its Keytru­da/chemo com­bo.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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