Bris­tol My­er­s' CAR-T Breyanzi busts out a win in ear­li­er-line lym­phoma, po­ten­tial­ly crack­ing open an ex­pand­ed mar­ket

De­spite be­ing third to the field in B cell lym­phoma, Bris­tol My­ers Squibb has re­peat­ed­ly ar­gued its CAR-T Breyanzi could have the juice to over­take its old­er com­peti­tors. Go­ing in­to ear­li­er lines of ther­a­py may be the gold­en tick­et on that front, and now Breyanzi has a late-stage win to back up that ef­fort.

Bris­tol My­ers’s Breyanzi beat out physi­cians’-choice sal­vage ther­a­py fol­lowed by high-dose chemo and a stem cell trans­plant — what the drug­mak­er called a “gold stan­dard treat­ment” — in sec­ond-line pa­tients with re­lapsed or re­frac­to­ry large B cell lym­phoma, ac­cord­ing to topline da­ta from the Phase III TRANS­FORM study re­leased Thurs­day.

The CAR-T hit its pri­ma­ry end­point of event-free sur­vival, ac­cord­ing to an IRC in­ter­im re­view, as well as sec­ondary end­points of com­plete re­sponse rate and pro­gres­sion-free sur­vival com­pared with stan­dard of care. OS da­ta was deemed im­ma­ture at the in­ter­im analy­sis cut­off.

Breyanzi, cur­rent­ly ap­proved in the third-line LB­CL set­ting or lat­er, was Bris­tol My­ers’ first ap­proved CAR-T back in Feb­ru­ary, which has since been fol­lowed by BC­MA CAR-T Abec­ma in March. With the third LB­CL CAR-T on the mar­ket, Bris­tol My­ers has looked to take Breyanzi in­to ear­li­er lines of ther­a­py as part of its chal­lenge to old­er drugs from No­var­tis and Gilead’s Kite.

The drug­mak­er tout­ed the TRANS­FORM re­sults as the first time a CAR-T has shown ben­e­fit over the “gold stan­dard” in this pop­u­la­tion and the on­ly CD19-tar­get­ed CAR-T to show ben­e­fit in sec­ond-line pa­tients. The study in­clud­ed a wide range of po­ten­tial sal­vage ther­a­pies, in­clud­ing rit­ux­imab plus dex­am­etha­sone, high-dose cy­tara­bine, and cis­platin (R-DHAP); rit­ux­imab plus ifos­famide, car­bo­platin and etopo­side (R-ICE); or rit­ux­imab plus gem­c­itabine, dex­am­etha­sone and cis­platin (RGDP).

All pa­tients were re­lapsed or re­frac­to­ry from with­in one year of first-line ther­a­py with a CD20 an­ti­body and an­thra­cy­cline.

On the safe­ty front, Breyanzi’s re­sults held up with tri­als in the third-line set­ting, adding a lit­tle more weight to its ef­forts there. The drug comes with a black box warn­ing for cy­tokine re­lease syn­drome, a safe­ty flag shared across the CAR-T class.

Bris­tol My­ers said it in­tends to share the full re­sults from TRANS­FORM at an up­com­ing med­ical meet­ing as well as with reg­u­la­to­ry au­thor­i­ties.

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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James Sabry

'We're in': Roche and Genen­tech join forces on a multi­bil­lion-dol­lar dis­cov­ery pact with a brash AI up­start

Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level.

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Chen Schor, Adicet CEO

Adicet un­veils ear­ly re­spons­es for off-the-shelf drug lever­ag­ing rare T cells. Will dura­bil­i­ty hold up?

On the hunt for the next generation of “off-the-shelf” cell therapies, biotech players like Adicet Bio have looked to leverage some of the less-obvious members of the immune system as potent cancer fighters. In Adicet’s case, scarce gamma delta T cells are on the menu, and an early cut of data is showing some promise.

Adicet’s AD-001, an off-the-shelf cell therapy developed by engineering a CD20-targeting chimeric antigen receptor (CAR) onto a donor’s gamma delta T cells, posted two complete responses across four patients in an early Phase I study testing the drug in patients with heavily pretreated B cell non-Hodgkin’s lymphoma, the biotech said Monday.

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