#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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

UP­DAT­ED: Watch out Bay­er, Roche is com­ing for you with a dis­count price ri­val to the tu­mor ag­nos­tic drug you got from Loxo

Just ahead of schedule the FDA has come through with a key approval for Genentech’s tumor agnostic entrectinib — now headed to the market as Rozlytrek.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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