Roche’s ‘suc­cess’ with its big Per­je­ta/Her­ceptin PhI­II falls flat at AS­CO, but it’s a boost for Puma

San­dra Horn­ing

CHICA­GO — Roche her­ald­ed a suc­cess for its close­ly-watched com­bi­na­tion breast can­cer study of Per­je­ta and Her­ceptin at AS­CO on Mon­day, but once the da­ta came in­to fo­cus there didn’t seem to be much to cheer about at the phar­ma gi­ant.

The two drugs to­geth­er per­formed bet­ter than Her­ceptin alone in im­prov­ing pa­tients’ odds of pre­vent­ing a re­cur­rence of the dis­ease — by a mar­gin of 0.9%. Af­ter three years of ther­a­py the score was 94.1% sur­vival in the com­bo arm with a 93.2% score for Her­ceptin.

“The goal of ad­ju­vant treat­ment is to help each per­son with can­cer have the best chance of a cure, and we come clos­er to this goal with each ad­vance,” said San­dra Horn­ing, chief med­ical of­fi­cer and head of glob­al prod­uct de­vel­op­ment. “In the APHIN­I­TY study, the Per­je­ta-based reg­i­men im­proved up­on the high bar set by Her­ceptin in peo­ple with HER2-pos­i­tive ear­ly breast can­cer. We look for­ward to work­ing with glob­al health au­thor­i­ties to bring this treat­ment op­tion to pa­tients.”

The new cock­tail ap­proach will cost sig­nif­i­cant­ly more than Her­ceptin alone, and that won’t sit well with pay­ers. Roche had been hop­ing to shore up its block­buster Her­ceptin fran­chise as that drug faces biosim­i­lar com­pe­ti­tion.

The big win­ner in all this? Puma Biotech, which saw its shares $PBYI shoot up 18% Mon­day morn­ing.

Their new drug ner­a­tinib demon­strat­ed a 34% re­duc­tion in the risk of re­cur­rence or death. It takes a leap to do these kinds of cross-tri­al analy­ses that dri­ve drug de­vel­op­ers a tad crazy now and then, but Wall Street an­a­lysts were quick to give Puma a thumbs up, par­tic­u­lar­ly af­ter it just hand­i­ly won an FDA pan­el vote en­dors­ing an ap­proval.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Yuval Cohen, Corbus CEO (Corbus via YouTube)

An­oth­er Cor­bus pro­gram hits the skids af­ter late-stage flop, plum­met­ing the small biotech's shares

Corbus Pharmaceuticals’ plans to position lenabasum as a pipeline-in-a-product aren’t going so well.

After shelving a program in scleroderma, the Norwood, MA-based biotech has revealed that its lead candidate failed both the primary and secondary endpoints in another Phase III trial.

Lenabasum failed to show a statistically significant difference in total improvement compared with placebo in treating dermatomyositis, a rare disease that causes muscle inflammation and skin rash, the company said Thursday. The news sent Corbus’ $CRBP stock spiraling around 30% early Thursday morning.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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Elizabeth Warren (Michael Brochstein/Sipa USA)(Sipa via AP Images)

Sen­a­tors call for hear­ing to ex­am­ine how Medicare will han­dle Bio­gen's new Alzheimer's drug

Two top Senate Finance committee senators on Thursday called for a hearing to examine the questions and challenges for Medicare arising from the FDA’s recent approval of Biogen’s Aduhelm, the controversial new drug approved to treat Alzheimer’s disease.

In a letter to Senate Finance chair Ron Wyden (D-OR) and ranking member Mike Crapo (R-ID), subcommittee chair Elizabeth Warren (D-MA) and Bill Cassidy (R-LA) hinted at making policy changes to enable Medicare to more directly connect prescription drug pricing to clinical effectiveness. They raised questions about the “dramatic implications for our health care system” from the approval, which they said “stretch well beyond the scope of FDA’s jurisdiction.”

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