This roundup of reports from the ASH 2024 convention first appeared in STAT’s “ASH in 30” e-newsletter.
Is it Tuesday already? That is the final day of the American Society of Hematology assembly. Thanks for stopping by to learn all of our protection. San Diego has been an exquisite host metropolis, and we sit up for being in Orlando subsequent December.
Biotech fights are very entertaining
The feud between Arcellx and Legend Biotech over their anti-BCMA CAR-T therapies for a number of myeloma is getting additional spicy.
On Sunday night time, Arcellx obtained a particular waiver from ASH officers to sidestep the convention’s information embargo coverage in order that it might situation an early press launch highlighting the shortage of any delayed neurotoxicity related to its experimental therapy referred to as anito-cel.
Arcellx timed the discharge to disrupt Legend’s investor and analyst assembly, the place the corporate was discussing the most recent analysis on Carvykti, its personal BCMA CAR-T remedy.
Legend has downplayed the importance of the delayed neurotoxicity — Parkinsonian signs and cranial nerve palsies — reported in sufferers receiving Carvykti, insisting it’s a receding situation, particularly now that Carvykti is establishing a task in treating sufferers with much less superior illness.
Whereas Arcellx rushes to get anito-cel filed and authorised, Legend is already a blockbuster industrial drug, establishing itself because the standard-of-care cell remedy in a number of myeloma.
On Monday, Legend CEO Ying Huang advised BiotechTV, “We’re not afraid of competitors that could be a me-too drug.”
A ‘nail within the coffin’ for stem cell transplants in mantle cell lymphoma
Most sufferers with mantle cell lymphoma appear to attain a deep remission from trendy focused or immune therapies like BTK inhibitors or CAR-T cell remedy. That’s made outcomes so significantly better in mantle cell lymphoma, that many oncologists have begun easing off providing autologous stem cell transplants as a part of frontline therapy for a lot of sufferers, questioning if such an intense and generally harmful process was all the time actually wanted.
The outcomes from a randomized trial assist to solidify the concept a transplant might be safely omitted from first line remedy if sufferers are already in a deep remission. “One other nail within the coffin for autologous stem cell transplant and consolidation for frontline mantle cell remedy,” mentioned Elise Chong, a hematologist-oncologist and researcher on the College of Pennsylvania who didn’t work on the examine.
Clinicians had already begun transferring away from transplants for sufferers that had been doing effectively after preliminary remedy — usually involving chemotherapy and focused remedy or immunotherapy — after the outcomes of the TRIANGLE examine, a special randomized trial revealed earlier this 12 months within the Lancet.
The brand new examine, offered by Timothy Fenske from the Medical Faculty of Wisconsin, randomized sufferers who had been MRD adverse after preliminary remedy to both obtain a transplant or simply get upkeep remedy, and it discovered no statistical variations between the 2 teams. The result was so stark, Fenske mentioned, that the information monitoring committee halted the trial early, “considering it wasn’t moral to proceed randomizing sufferers to a therapy that’s poisonous and might not be providing profit.”
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Amgen’s Blincyto improves disease-free survival in pediatric ALL
Illness-free survival improved markedly in youngsters with acute lymphoblastic leukemia when given blinatumomab — marketed by Amgen as Blincyto — along with a normal chemotherapy routine.
The examine enrolled 1,440 youngsters with newly identified standard-risk B-cell acute lymphoblastic leukemia. It discovered that the bispecific T-cell engager improved three-year disease-free survival to a charge of 96% in sufferers taking it with chemo, in comparison with 87.9% in these receiving chemotherapy alone.
Blinatumomab was first authorised by the Meals and Drug Administration in 2014 — and was the primary bispecific antibody drug to hit the market. The trial was funded partially by Amgen, and was revealed within the New England Journal of Drugs.
Including blinatumomab elevated the chance of sepsis and catheter-related infections in some sufferers, however there have been no treatment-related deaths within the examine. The authors famous that this routine could be particularly useful for racial and ethnic teams with traditionally poorer outcomes, with the biggest enhancements seen in Hispanic youngsters.
The takeaway? This drug mixture might probably enhance outcomes in pediatric B-cell ALL, notably by lowering bone marrow relapses in high-risk populations. Nonetheless, there’s no biosimilar but for Blincyto, and it stays a very costly therapy.
After different CLL therapies fail, Epkinly may provide an opportunity for a whole remission
Ultimately, it doesn’t matter what remedy sufferers with persistent lymphocytic leukemia get, the expectation is that they’ll relapse in the event that they dwell lengthy sufficient, Alexey Danilov, a hematologist-oncologist and most cancers researcher at Metropolis of Hope, mentioned in an interview. After BTK inhibitors like ibrutinib or CAR-T remedy like liso-cel, sufferers presently don’t have loads of choices, Danilov mentioned.
“We face a brand new downside the place sufferers who progress on focused remedy — they’ve develop into an unmet want,” he mentioned.
That’s why Danilov and his colleagues started testing whether or not Abbvie’s Epkinly, a bispecific T-cell engager additionally referred to as epcoritimab, may have the ability to provide one other probability at remission for relapsed or refractory sufferers with CLL. In a small section 1/2 trial offered at ASH, Danilov confirmed that 61% of 23 sufferers responded to the drug, and 39% had an entire response.
“The characteristic to focus on is that this examine enrolled a extremely refractory group of sufferers,” Danilov mentioned. Many additionally had high-risk mutations like TP53 aberrations as effectively. “It is a very troublesome group of sufferers to deal with. Having a response charge of 61% with a single agent is a really important achievement.”
Brian Koffman, a retired household doctor and the founding father of the affected person advocacy group the CLL Society, was the primary affected person enrolled on this trial. He’d beforehand had good responses to focused remedy and CAR-T remedy however, like many different CLL sufferers, finally relapsed.
Koffman is without doubt one of the sufferers who skilled an entire response. Hopefully, he mentioned, this one will final. “I’d be mendacity to say I don’t all the time hope that this would be the final remedy, no extra swings on the bat,” he mentioned. “The truth is you kick the can down the street. However you hope, by the tip, there’s one other can to kick.”