On November 6, 2019 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that it will share new, long-term data from the pivotal Phase III trial of Lumoxiti (moxetumomab pasudotox) at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida, December 7-10 (Press release, Innate Pharma, NOV 6, 2019, View Source [SID1234550593]).
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"At this year’s ASH (Free ASH Whitepaper), we look forward to providing important new follow-up data from the Lumoxiti phase III trial and engaging with the hemato-oncology community on improving treatment outcomes for patients with relapsed or refractory hairy cell leukemia," commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma.
Details of the poster presentation at ASH (Free ASH Whitepaper) are as follows:
Moxetumomab Pasudotox-tdfk in Heavily Pretreated Patients with Relapsed/Refractory Hairy Cell Leukemia (HCL): Long-Term Follow-up from the Pivotal Phase 3 Trial, [poster#2808]
Authors: Robert J Kreitman, Claire Dearden, Pier Luigi Zinzani, Julio Delgado, Tadeusz Robak, Philipp D le Coutre, Bjørn T Gjertsen, Xavier Troussard, Gail J Roboz, Lionel Karlin, Douglas E Gladstone, Nataliya Kuptsova-Clarkson, Shiyao Liu, Priti Patel, Wyndham H Wilson, Ira Pastan, Francis Giles, on behalf of the Study 1053 investigators
Date: Sunday December 8 | 6:00-8:00 pm ET
About Lumoxiti (moxetumomab pasudotox):
Lumoxiti is a CD22-directed cytotoxin and a first-in-class treatment in the US for adult patients with relapsed or refractory (r/r) hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is not recommended in patients with severe renal impairment (CrCl ≤ 29 mL/min). It comprises the CD22 binding portion of an antibody fused to a truncated pseudomonas exotoxin. The toxin inhibits protein synthesis and ultimately triggers apoptotic cell death. Lumoxiti received U.S. FDA approval in September 2018 and has been granted Orphan Drug Designation by the FDA for the treatment of r/r HCL. AstraZeneca is the current Biologics License Application (BLA) holder for Lumoxiti.
About the ‘1053’ Phase III trial:
The AstraZeneca-sponsored ‘1053’ trial is a single-arm, multicenter Phase III clinical trial assessing the efficacy and safety of Lumoxiti monotherapy in patients with r/r HCL who have received at least two prior therapies, including one purine nucleoside analog. The trial enrolled 80 patients and was conducted across 34 sites in 14 countries. The primary endpoint was durable complete response (CR), defined as CR with hematologic remission (blood count normalization) for >180 days. Secondary outcome measures included objective response rate, duration of complete and objective response, progression-free survival, safety/tolerability, pharmacokinetics and immunogenic potential.