Efficacy and Safety of Ibrutinib in Indian Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma: Cases from a Named Patient Program

• Published in: Indian journal of medical and paediatric oncology Vol. 38; no. 4; pp. 508 - 515
• Main Authors: Agarwal, Mohan B, Bhurani, Dinesh, Shah, Chirag, Sood, Nitin, Singhal, Manish, Kamat, Anil, Chezhian, Subash, Mishra, Suryaprakash, Nagrale, Dinesh
• Format: Journal Article
• Language: English
• Published: A-12, 2nd Floor, Sector 2, Noida-201301 UP, India Thieme Medical and Scientific Publishers Pvt. Ltd 01-10-2017; Medknow Publications and Media Pvt. Ltd; Medknow Publications & Media Pvt. Ltd; Medknow Publications & Media Pvt Ltd
• Subjects: Analysis; Bone marrow; Cancer therapies; Chronic lymphocytic leukemia; Clinical medicine; Development and progression; Dosage and administration; Drug dosages; Drug therapy; Family medical history; FDA approval; Genetic aspects; Hematology; Hospitals; Ibrutinib; Leukemia; Lymphoma; Mantle cell lymphoma; Medical prognosis; NMR; Nuclear magnetic resonance; Oncology; Original; Original Article; Pathogenesis; Patients; Safety and security measures; Studies; Targeted cancer therapy; Treatment outcome; India; ibrutinib; Indian; safety; efficacy; Bruton's tyrosine kinase inhibitor; B-cell malignancies
• ISSN: 0971-5851; 0975-2129
• DOI: 10.4103/ijmpo.ijmpo_43_17

Abstract
Context:
This named patient program evaluated the safety and efficacy of ibrutinib, a selective inhibitor of Bruton's tyrosine kinase in Indian patients with relapsed/refractory chronic lymphocytic leukemia (CLL, with/without chromosome 17 deletion [del17p]) and mantle cell lymphoma (MCL).
Subjects and Methods:
The eight enrolled patients (relapsed/refractory CLL: n = 6 [4/6 patients with del17p] and relapsed/refractory MCL: n = 2) had median age of 55 years (range, 52–60) and had received a median of 3 (CLL patients) and 4 (MCL patients) prior therapies. Patients received once-daily dose of ibrutinib (420 mg: CLL, 560 mg: MCL).
Results:
In CLL patients, the median time to response was 3 months (range, 0.5–7) and five of six patients had partial response (PR) whereas one achievedcomplete response (CR). Median time on treatment was 11.5 months (range, 8–14); five patients continued treatment and one was recommended stem cell transplantation (SCT). Of the two MCL patients, one achieved PR and one showed CR and advanced to SCT. In CLL patients, the median (range) hemoglobin level improved from 9.8 g/dL (7.2–11) at baseline to 12.0 g/dL (9.5–13.2) and median (range) platelet count improved from 150,000 cells/μL (21,000–195,000) at baseline to 190,350 cells/μL (130,000–394,000) at the time of analysis (July 2016). Most adverse events (AEs) reported were infections (n = 2). No Grade 3-4 or serious AEs, dose reductions, or treatment discontinuation due to AEs were reported.
Conclusions:
In this first real-world experience in Indian patients, ibrutinib demonstrated therapeutic efficacy in relapsed/refractory CLL (with/without del17p) and MCL. Safety results were consistent with the current known profile of ibrutinib.