As a spate of researchers work diligently on next-gen CAR-T cell therapies, the big players in the current generation of those drugs are still angling for more market share. Getting to patients earlier is now the game plan, and Gilead’s Kite has uncorked some impressive data backing up its case in lymphoma.
Kite’s Yescarta (axicabtagene ciloleucel) cut the risk of disease progression, death or the need for additional therapy by a little more than 60% compared with standard of care in second-line patients with relapsed or refractory large B cell lymphoma, according to full data from the Phase III ZUMA-7 study revealed Saturday at #ASH21.
Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.
Kicking off this weekend’s #ASH21, Gilead’s Kite and Bristol Myers Squibb have released competing data for their current-gen CAR-T drugs in second-line B cell lymphoma patients. It’s a heated contest to move these drugs into earlier lines of therapy, and Bristol Myers thinks these fuller data will keep the pressure on.
Bristol Myers’ Breyanzi (lisocabtagene maraleucel) cut the risk of disease progression, death and other events by 65% over standard of care in second-line relapsed or refractory LBCL patients, according to data from the Phase III TRANSFORM study presented Saturday.
Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
The bulk of this week’s report is brought to you by Endpoints editors Nicole DeFeudis and Max Gelman, who are covering for me as I take a few days off after the big Women in Biopharma R&D event. We are really proud of both the special report and the live panel, which featured some great stories from trailblazing leaders and insights on gender diversity in biotech. Do check them out below if you haven’t had a chance.
Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.
Stéphane Bancel, Moderna CEO (AP Images, Boston Herald)
Moderna says that it’s on its way to having an mRNA vaccine against not one, but two different seasonal viruses.
The biotech released the first early data from its flu program Friday morning, announcing that all doses of the shot significantly boosted antibodies in younger and older adults without ‘significant safety findings.’
A 500-person Phase II will confirm dose levels and compare it to an approved flu vaccine, the company said, and preparations for a large pivotal trial are underway. Moderna said it is also advancing new designs that can have potentially broader coverage of different flu strains than current shots.
House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images)
Back in January 2019, the late House Oversight Committee chair Elijah Cummings kicked off a nearly 3-year-long drug pricing investigation that culminated today in a major new report detailing how prices for vital drugs have risen substantially since their launch, while calling on the Senate to pass a bill that will allow Medicare to negotiate some prices.
The committee’s investigation focused on 12 of the most expensive drugs for Medicare, showing massive price spikes that have accumulated over the years and made some drugs, like insulin, entirely unaffordable for some, to the point where some diabetics have had to ration their life-saving insulin, and some have died.
Back in August, Servier revealed that a Phase III study for Tibsovo saw results so efficacious that investigators recommended stopping the trial early. Now at ASH, observers are getting a view at what exactly caused the halt.
Looking at Tibsovo in combination with chemo compared to placebo and chemo, Servier reported Saturday that their drug combination resulted in statistically significant improvements in event-free survival and overall survival. The p-values came in solid as well, with Tibsovo notching values of p=0.0011 and p=0.0005 for each of the respective measures.
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.
Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Andreas and Thomas Strüngmann (via Agreus Group)
While the ultimate fate of Novartis’ big generics arm Sandoz may still be up in the air, there’s no doubt it’s in play as a potential buyout target.
Overnight, Reuters picked up on a report out of Germany that EQT and the billionaire Strüngmann brothers — enjoying a huge windfall from the overnight success of BioNTech’s mRNA Covid vaccine — are kicking the tires at Sandoz. And Novartis CEO Vas Narasimhan confirmed they’ve seen some M&A interest, even if no hard offers are on the table.
Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.
Stéphane Bancel, Moderna CEO (Endpoints JPM20/Jeff Rumans)
Last fall, as their Covid-19 vaccine crossed the finish line, Moderna unveiled plans to take its newly proven mRNA platform and use it to effectively change how the world blocks humanity’s most persistent viral foes.
In addition to their pre-existing vaccine programs, executives announced new ones for flu, where vaccines have chronically underperformed, and HIV, which has eluded every inoculation effort over nearly 40 years. In flu, the other mRNA vaccine companies — BioNTech (with Pfizer), Translate Bio (under Sanofi), and CureVac (with GSK) — all had similar ambitions, hoping to make shots that were as high as 80% effective.
Roche’s Genentech got a leg up in the packed anti-TIGIT race earlier this year when the FDA granted it the first breakthrough designation in the field based on some upbeat mid-stage data in non-small cell lung cancer. Now, looking to keep its lead, the pharma giant is offering a two-and-a-half-year look at the same patient group — but will two deaths crush its chances?
A combination of Genentech’s anti-TIGIT cancer tiragolumab plus PD-L1 inhibitor Tecentriq reduced patients’ risk of disease progression or death by 38% compared to those who received Tecentriq alone at a median follow-up of 2.5 years, the company said on Friday. In a pre-specified exploratory analysis of participants with high levels of PD-L1, the combo reduced the risk of disease worsening or death by 71% compared to the Tecentriq group.
Unlock this story instantly and join 125,300+ biopharma pros reading Endpoints daily — and it’s free.
https://endpts.com/gileads-kite-unveils-more-data-on-yescartas-win-in-second-line-lymphoma-patients-setting-up-battle-for-soc/
