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ASH 2024 | A Phase II trial of the oral PI3Kδ inhibitor linperlisib in R/R T-cell lymphoma
Swaminathan Iyer, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, comments on a Phase II trial of the oral PI3Kδ inhibitor, linperlisib, in relapsed/refractory (R/R) T-cell lymphoma. Dr Iyer highlights that linperlisib is a novel molecule with a significantly improved safety profile compared to other PI3K inhibitors. The results of this trial showed a 45% response rate with 25-30% complete responses, leading to the upcoming Phase III trial. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
Linperlisib is a PI3Kδ inhibitor. It’s the third in class, if you will. There are several PI3 kinase inhibitors that have been studied in various lymphomas. They’ve shown efficacy, but they’ve also seen a lot of side effects due to the drugs. And so some of them have actually been withdrawn from the market. This, on the other hand, is new in class, and it is a novel molecule. Unlike the other drugs, its excretion is through the kidneys, and so that improves the safety profile dramatically...
Linperlisib is a PI3Kδ inhibitor. It’s the third in class, if you will. There are several PI3 kinase inhibitors that have been studied in various lymphomas. They’ve shown efficacy, but they’ve also seen a lot of side effects due to the drugs. And so some of them have actually been withdrawn from the market. This, on the other hand, is new in class, and it is a novel molecule. Unlike the other drugs, its excretion is through the kidneys, and so that improves the safety profile dramatically. You don’t see the colitis, you don’t see the transaminitis. So following the Chinese study that was reported at ASH last year as an oral presentation from Dr Song, we did a US-Europe international study that I led, and we had about 45 patients with T-cell lymphomas, and we saw about a 45% response with about 25 to 30% CRs. And so it recapitulated the data from the Chinese study. And the dosing was a little different. We started with 80 milligrams for the first four months and then went down to 40 milligrams. We didn’t see some of the pneumonia type side effects that were seen. More importantly, no transaminitis, no colitis. So we think this is probably the best in class, and it’s a different way of looking at PI3Kδ inhibitors, and it’s also going to a pivotal Phase III study very soon.
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Disclosures
Acrotech: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Ono: Research Funding; Merck: Research Funding; Yingli: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Astra Zeneca: Research Funding; IMPaRT.AI: Other: Stock, Founder; Salarius: Consultancy; Innate: Research Funding; Secura Bio: Membership on an entity’s Board of Directors or advisory committees; Legend: Research Funding; Trillium: Research Funding; Crispr: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Seagen/Pfizer: Membership on an entity’s Board of Directors or advisory committees, Research Funding; JCO-CCI: Other: Editor.
