PI3K-delta inhibitor idelalisib success in CLL

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Published: 18 Dec 2013
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Dr Jennifer Brown - Dana-Farber Cancer Institute, Boston, USA

Dr Brown talks to ecancertv at ASH 2013 about the study "Clinical Activity Of Idelalisib (GS-1101), a Selective Inhibitor Of PI3Kδ, In Phase 1 and 2 Trials In Chronic Lymphocytic Leukemia (CLL): Effect Of Del(17p)/TP53 Mutation, Del(11q), IGHV Mutation, and NOTCH1 Mutation"

Idelalisib shows robust activity independent of the four genetic markers evaluated and patients can be considered for idelalisib-based treatment in clinical trials regardless of these high-risk features.

The next step is approval from the FDA.

ASH 2013 - New Orleans, LA, USA

PI3K-delta inhibitor idelalisib success in CLL

Dr Jennifer Brown - Dana-Farber Cancer Institute, Boston, USA

Idelalisib is one of these very potent targeted inhibitors that we’ve been studying for the last couple of years as a single agent. It’s a PI3 kinase delta inhibitor and this study combined it with rituximab and then randomised patients to that combination or placebo plus rituximab and profound effects of the idelalisib were seen – a marked improvement in overall response rate, progression free survival and even an improvement in overall survival, even though the follow-up is currently quite short. The adverse event profile was balanced in the two arms as well so it’s really a very impressive study.

Does this study move this compound towards active use in the future?

This drug is not approved for any indication yet but it is expected that it will likely be approved based on these data next year. Then it will be approved in relapsed CLL or refractory CLL.

How do you see these highly targeted therapies impacting CLL?

It’s true that some patients at diagnosis don’t need to be treated but over time the great majority of patients do need to be treated and about half progress rapidly to treatment over the first couple of years. We know that generally once treated, patients have a relapsing and remitting but steadily progressive course so we need more effective, more tolerated agents for them at all phases of the disease. Adding idelalisib to that armamentarium will be profoundly helpful.

What is your take home message for clinicians?

Keep an eye out, next year we expect approval of idelalisib with rituximab for relapsed CLL. A very effective agent, you can bring it into your practice in place of chemotherapy for these patients.