#AS­CO21: Gilead­'s Trodelvy reads out new sub­group da­ta show­ing ben­e­fit in ear­li­er-line TNBC pa­tients

With As­traZeneca and Dai­ichi sniff­ing at its trail, Gilead has worked hard to hold an ad­van­tage for ADC Trodelvy in par­tic­u­lar­ly hard-to-treat breast can­cer pa­tients. Now, the drug­mak­er is read­ing out more late-stage da­ta show­ing some ben­e­fit in ear­li­er-line pa­tients, and it could help carve a path for­ward to a big­ger mar­ket share.

Gilead’s Trodelvy ex­tend­ed sur­vival in a sub­group analy­sis of re­lapsed or re­frac­to­ry triple-neg­a­tive breast can­cer pa­tients in the sec­ond line, a pos­i­tive sign Gilead hopes could spell ear­li­er lines of ther­a­py for its TROP2-di­rect­ed ADC, ac­cord­ing to da­ta from the Phase III AS­CENT study set to be pre­sent­ed at this week­end’s #AS­CO21.

Trodelvy re­ceived a full ap­proval from the FDA in April to treat metasta­t­ic TNBC pa­tients in the sec­ond line or lat­er as well as an ac­cel­er­at­ed nod in urothe­lial car­ci­no­ma the same month.

In sec­ond-line pa­tients who re­port­ed dis­ease pro­gres­sion with­in 12 months of (neo)ad­ju­vant chemo. Trodelvy cut the risk of dis­ease wors­en­ing or death by 59% over chemo with a PFS of 5.7 months com­pared with 1.5 months on chemo. The ther­a­py al­so post­ed a me­di­an OS of 10.9 months com­pared with 4.9 months for pa­tients on chemo.

Trodelvy al­so showed a high­er over­all re­sponse rate com­pared with chemo — 30% com­pared with 3% — and a safe­ty pro­file in the sub­group that was con­sis­tent with oth­er stud­ies, Gilead said. There were no treat­ment-re­lat­ed deaths in the sub­group.

Read­ing out in ear­li­er lines of ther­a­py will be a ma­jor fo­cus point for Gilead as it looks to build its lead over As­traZeneca and Dai­ichi Sankyo, which are look­ing for ap­proval for a TROP2-di­rect­ed ADC of their own.

In ear­ly May, the part­ners read out Phase I co­hort da­ta for their next-gen ADC datopotam­ab derux­te­can show­ing a 43% re­sponse rate and five con­firmed com­plete or par­tial re­spons­es among 21 pa­tients with TNBC. The vast ma­jor­i­ty of those pa­tients were treat­ed with 6-mg dos­es of the drug while two re­ceived an 8-mg high dose. On top of the five con­firmed re­spons­es, the part­ners were await­ing con­fir­ma­tion on four ad­di­tion­al re­spons­es at the Jan. 8 cut­off date. Datopotam­ab post­ed a dis­ease con­trol rate of 95%.

Gilead won a full ap­proval for Trodelvy in TNBC based on the strength of AS­CENT, which showed Trodelvy re­duced the risk of death in TNBC pa­tients by 49%, with a me­di­an OS of 11.8 months, as op­posed to the 6.9 months achieved by stan­dard sin­gle-agent chemother­a­py. PFS came in at a me­di­an of 4.8 months, com­pared to 1.7 months on chemother­a­py.

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


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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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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Bolt Bio CEO Randy Schatzman

Bolt Bio goes bust as in­vestors boo sin­gle re­sponse in ear­ly test against HER2-ex­press­ing tu­mors

Bolt Bio’s BDC-1001, an antibody conjugate drug designed to amp up the body’s innate immune system response to tumors, posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of “clinical activity,” the biotech said Monday.

BDC-1001 links a HER2-targeting biosimilar of Herceptin with a TLR7/8 agonist, which is designed to activate myeloid cells in the innate immune system and drive tumor cytotoxicity, Bolt said. But the early results paint the picture of a drug with little effect on HER2 tumors, one of the most highly validated tumor targets in drug development.

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Biohaven CEO Vlad Coric (Photo Credit_ Andrew Venditti)

Bio­haven shakes up lead­er­ship team as it feels the heat from mi­graine com­peti­tors

As Biohaven Pharma comes off a rollercoaster pipeline year, its CEO will take on more responsibility in a full C-suite makeover.

Vlad Coric was unanimously elected to the role of chairman of the board of directors, after Declan Doogan’s retirement. Matthew Buten will take over the role of CFO after James Engelhart’s retirement, and director Michael Heffernan has been appointed lead independent director. All of the appointments are effective immediately, a company press release said.

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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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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