Dr Richard Furman reports on Idelalisib and Rituximab Phase III study outcomes at ASH2013

Dr Richard Furman reports on Idelalisib and Rituximab Phase III study outcomes at ASH2013

At the American Society of Hematology (ASH) 2003, Lead author Richard Furman, MD, reported that "combination treatment with the PI3K-delta inhibitor idelalisib and rituximab (Rituxan) was associated with a >70% improvement in overall survival (OS) in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL), according to phase III data from Study 116 presented at the 55th Annual Meeting of the American Society of Hematology.

The idelalisib combination also improved progression-free survival (PFS), the primary endpoint of the trial, by >80% compared with the comparator arm of rituximab plus placebo.

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On average, patients had received three prior regimens and were considered ineligible for additional chemotherapy. Between 80% and 90% of the patients had a Cumulative Illness Rating Score >6; 40% to 45% had a 17p deletion or TP53 mutation; 80% to 85% had unmutated IGHV; and about 40% of the patients had a creatinine clearance of <60 mL/min.

The trial was halted and crossover was allowed following a positive risk-benefit review from an independent data monitoring committee at an interim analysis.

When the trial stopped, the median PFS in the placebo group was 5.5 months, whereas the median had yet to be reached in the idelalisib arm. The difference in PFS translated into an 85% reduction in the hazard for the idelalisib group versus the placebo group."

onclive.com/conference-cove...

(Includes brief OncLive TV statement by Dr. Richard Furman on Avoiding Chemotherapy with Idelalisib)

Also see the Patient Power interview of Dr Peter Hillmen taken in August 2013 at the iwCLL in Collogne Germany on his ideas on the role of Idelalisib

healthunlocked.com/cllsuppo...

Neil

4 Replies

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  • Thanks Neil,

    The good news just keeps getting better; some excellent trial results.

    Additional videos and an article from ASH, from following Neil's links above, to save you digging through many many pages of ASH information....

    Dr Furman on avoiding chemotherapy, as listed by Neil above but on separate page with info.

    onclive.com/conference-cove...

    Dr. Byrd Provides an Update on Ibrutinib in CLL Short Video

    onclive.com/onclive-tv/Dr-B...

    Dr. John Byrd on Bruton's Tyrosine Kinase in CLL Short Video

    onclive.com/onclive-tv/Dr-B...

    Dr. John Byrd Discusses Ibrutinib in CLL, ASH 2012 Short Video

    onclive.com/conference-cove...

    Latest Data Further Support Ibrutinib’s Efficacy in CLL Written article.

    Doctors Jan Burger, Jennifer Brown and Phillip McCarthy

    onclive.com/conference-cove...

    Dr. Jennifer Brown on Ibrutinib and Idelalisib for CLL Short video

    onclive.com/onclive-tv/Dr-B...

    Dr. Brown on Idelalisib Plus Rituximab in CLL Short video

    onclive.com/conference-cove...

    Dr. Jennifer Brown Discusses Rituximab and Ibrutinib in CLL Short video

    onclive.com/onclive-tv/Dr-J...

    Dr. Jennifer Brown on Mutations and Targets in CLL Short video

    onclive.com/onclive-tv/Dr-J...

    Dr. Jennifer Brown on Gauging Response in CLL Short video

    onclive.com/onclive-tv/Dr-J...

    Dr. Tendler on Breakthrough Designation for Ibrutinib Short video

    onclive.com/onclive-tv/Dr-T...

    Dick

  • Thanks Neil and Dick

    A long way to go and financial obstacles to overcome too, but definately hope.

    That spoonbill certainly has his eye on you Neil

    Bub

  • Thanks for this, Neil. And I love the spoonbill photo... an amazing eye and beak

  • And here is Medscape's report on this Idelalisib trial now that details from the trials on relapsed CLL and refractory indolent lymphoma have been published online on January 22nd in the New England Journal of Medicine:

    Idelalisib Shows Efficacy in Relapsed CLL and Lymphoma

    medscape.com/viewarticle/81...

    You'll need to establish an account (free) to access the Medscape article.

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