Scot Ebbinghaus, Merck Research Laboratories VP of clinical research

Mer­ck touts a con­fir­ma­to­ry Keytru­da win for liv­er can­cer as 'dan­gling' ac­cel­er­at­ed ap­proval saga march­es on

Ac­cel­er­at­ed ap­proval for Mer­ck’s Keytru­da in a com­mon form of liv­er can­cer looked ten­u­ous af­ter a con­fir­ma­to­ry study whiffed on two sur­vival mea­sures. But af­ter ODAC rec­om­mend­ed to keep the drug on the mar­ket back in April, the phar­ma gi­ant said Mon­day an­oth­er tri­al has brought bet­ter tid­ings.

The block­buster PD-1 met its pri­ma­ry end­point in sta­tis­ti­cal­ly sig­nif­i­cant over­all sur­vival com­pared to place­bo, Mer­ck an­nounced Mon­day morn­ing, in a study eval­u­at­ing Keytru­da plus chemother­a­py in 453 he­pa­to­cel­lu­lar car­ci­no­ma pa­tients from Asia. Though Mer­ck didn’t re­port any spe­cif­ic fig­ures, the com­pa­ny not­ed Keytru­da al­so hit sec­ondary end­points for pro­gres­sion-free sur­vival and ob­jec­tive re­sponse rate.

“Fre­quent­ly di­ag­nosed at an ad­vanced stage, he­pa­to­cel­lu­lar car­ci­no­ma has one of the high­est mor­tal­i­ty rates of sol­id can­cers,” Mer­ck Re­search Lab­o­ra­to­ries VP Scot Ebbing­haus said in a state­ment. “[W]e look for­ward to en­gag­ing with reg­u­la­to­ry au­thor­i­ties as quick­ly as pos­si­ble.”

He­pa­to­cel­lu­lar car­ci­no­ma was among a group of can­cer in­di­ca­tions in which Keytru­da had nabbed an ac­cel­er­at­ed OK ex­am­ined by the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee across a three-day span in April. Even though the drug missed the ear­li­er study’s dual pri­ma­ry end­points, ODAC vot­ed unan­i­mous­ly 8-0 to keep Keytru­da on the mar­ket as a sec­ond-line treat­ment for HCC.

Mer­ck and the FDA went back and forth at the ad­comm, with Mer­ck as­sert­ing the Keytru­da reg­i­men was still nec­es­sary for sec­ond-line pa­tients de­spite a re­cent ap­proval for a Tecen­triq-Avastin com­bo in first-line HCC. Richard Finn, a pro­fes­sor of med­i­cine at UCLA and paid con­sul­tant for Mer­ck, said at the time that pulling the HCC ap­proval didn’t make sense giv­en Mon­day’s study had been ex­pect­ed to read out with­in a few months.

As such, the new tri­al es­sen­tial­ly func­tioned as a sec­ond con­fir­ma­to­ry study af­ter the ad­comm dis­cus­sions. Had the new tri­al proven neg­a­tive, it’s un­clear whether ODAC or the FDA would re­main as le­nient as in the April hear­ing.

Keytru­da has al­ready run in­to some head­winds over its sta­ble of ac­cel­er­at­ed ap­provals this year, af­ter flop­ping sev­er­al con­fir­ma­to­ry stud­ies. It al­so met a rare reg­u­la­to­ry re­buke in a ma­jor in­di­ca­tion. In March, the FDA is­sued a CRL to the best-sell­ing drug af­ter Mer­ck went against reg­u­la­tors’ wish­es in sub­mit­ting its da­ta pack­age too ear­ly. But Mer­ck re­turned lat­er in the year and scored a full, first-line ap­proval in Ju­ly.

Al­so dur­ing the April ODAC marathon, pan­elists rec­om­mend­ed against keep­ing Keytru­da’s ac­cel­er­at­ed OK in third-line stom­ach can­cer, an in­di­ca­tion where Mer­ck sub­se­quent­ly pulled the drug in Ju­ly. The move came af­ter Bris­tol My­ers Squibb won full ap­proval for Op­di­vo in the first-line set­ting. FDA of­fi­cials high­light­ing how the chang­ing treat­ment land­scape swayed their think­ing.

Mer­ck saw more straight­for­ward suc­cess in blad­der can­cer, with Keytru­da earn­ing a nar­row 5-3 ODAC vote to stay on the mar­ket. The FDA ex­tend­ed full ap­proval for first-line treat­ment here last month.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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