UPDATED RESULTS OF A PHASE 3 RANDOMIZED, CONTROLLED STUDY OF IDELALISIB IN COMBINATION WITH OFATUMUMAB FOR PREVIOUSLY TREATED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
Author(s): ,
Tadeusz Robak
Affiliations:
Medical University of Lodz,Lodz,Poland
,
Jeffrey Jones
Affiliations:
The Ohio State University,Columbus, OH,United States
,
Malgorzata Wach
Affiliations:
Medical University of Lublin,Lublin,Poland
,
Jennifer Brown
Affiliations:
Dana-Farber Cancer Institute,Boston, MA,United States
,
Alexander Menter
Affiliations:
Kaiser Permanente Medical Group,Denver, CO,United States
,
Elizabeth Vandenberghe
Affiliations:
Saint James's Hospital,Dublin,Ireland
,
Loic Ysebaert
Affiliations:
Centre Hospitalier Universitaire Purpan,Toulouse,France
,
Nina Wagner-Johnston
Affiliations:
Johns Hopkins School of Medicine,Baltimore, MD,United States
,
Jonathan Polikoff
Affiliations:
Kaiser Permanente Medical Group,San Diego, CA,United States
,
Farrukh Awan
Affiliations:
The Ohio State University,Columbus, OH,United States
,
Xavier Badoux
Affiliations:
St. George Hospital,Kogarah,Australia
,
Steven Coutre
Affiliations:
Stanford University School of Medicine,Stanford, CA,United States
,
Stephen Spurgeon
Affiliations:
Oregon Health and Science University,Portland, OR,United States
,
Javier Loscertales
Affiliations:
Hospital Universitario de La Princesa,Madrid,Spain
,
Guan Xing
Affiliations:
Gilead Sciences, Inc.,Foster City, CA,United States
,
Ronald Dubowy
Affiliations:
Gilead Sciences, Inc.,Foster City, CA,United States
,
Ian Flinn
Affiliations:
Sarah Cannon Research Institute,Nashville, TN,United States
Carolyn Owen
Affiliations:
Alberta Health Services,Calgary,Canada
(Abstract release date: May 19, 2016) EHA Learning Center. Robak T. Jun 10, 2016; 133201
Disclosure(s): Research support, Gilead Sciences, Inc.
Prof. Tadeusz Robak
Prof. Tadeusz Robak

Access to EHA Members only content is an EHA membership benefit. Click here to join EHA or renew your membership here.


EHA 22nd Madrid Congress Participants? Enjoy a FREE access by filling out this Quick Registration Form here.

Abstract
Discussion Forum (0)
Rate & Comment (0)
Abstract: P213

Type: Poster Presentation

Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45

Location: Poster area (Hall H)

Background
Idelalisib (IDELA) is an oral PI3Kδ inhibitor approved within the EU for use with rituximab in pts with relapsed CLL and as first-line treatment of CLL with either del(17p) or TP53 mutation in patients unsuitable for chemo-immunotherapy. This open-label study (NCT01659021) compared IDELA + ofatumumab (OFA) vs OFA in pts with relapsed CLL. Results of the primary endpoint analysis were previously reported (Robak et al, EHA 2015) and are updated here with an additional 8.5 mos of follow-up. In the primary analysis, the combination yielded superior PFS and the KM estimated median OS was 20.9 and 19.4 mos in the IDELA + OFA and OFA arms, respectively.

Aims
To evaluate the safety and efficacy of IDELA + OFA vs. OFA alone in patients with relapsed CLL.

Methods
Pts with CLL progressing ≤ 24 mo from last therapy, who had received ≥ 2 cycles of a purine analogue or bendamustine, were randomized 2:1 to either Arm A (IDELA 150 mg BID continuously plus OFA, 300 mg IV wk 1, then 1 g IV q wk x 7 and q 4 wk x 4) or Arm B (OFA, same as Arm A except 2 g was substituted for 1 g dosing) with stratification factors relapsed vs refractory, del(17p) and/or TP53 mutation, and IGHV mutation. The primary endpoint was PFS as determined by an Independent Review Committee using modified IWCLL 2008 criteria.

Results
Pt characteristics were balanced in the 2 arms: med age 67; Rai II/III/IV 18/13/51%, med no. prior regimens 3, refractory 49%, del(17)p/TP53mut 40%, IGHV unmut 78%. Exposure, disposition, and efficacy are shown in the table. Results were consistent across risk groups. Gr ≥ 3 AEs in Arm A included diarrhea/colitis (23.1%), pneumonia (19.7%), and pneumonitis (4.6%).

Conclusion
With > 8 mos longer follow-up, IDELA + OFA vs OFA continues to show superior PFS and ORR, and now demonstrates superior OS in pts with del(17p)/TP53mut and a trend of improvement of OS in the ITT population.



Session topic: CLL - Efficacy and safety of new treatments 1

Keyword(s): Chronic lymphocytic leukemia, Phase III, PI3 kinase
Code of conduct/disclaimer available in General Terms & Conditions