Conference Proceedings

Combination of Nilotinib and Pegylated Interferon Alfa-2B Results in High Rates of MR4.5 at 24 Months - Primary Analysis of the ALLG CML 11 Pinnacle Study

David T Yeung, Naranie Shanmuganathan, Andrew Grigg, Ilona Cunningham, Jake Shortt, Philip Rowling, John Reynolds, Rosemary Anne Harrup, David M Ross, David Kipp, Anthony K Mills, Christopher K Arthur, Anthony P Schwarer, Kathryn Jackson, Nicholas Viiala, Robert Weinkove, Agnes SM Yong, Deborah L White, Susan Branford, Timothy P Hughes

BLOOD | AMER SOC HEMATOLOGY | Published : 2019

Abstract

Pegylated interferon (Peg-IFN) increases molecular response rates when used in combination with imatinib (IM) and dasatinib compared with tyrosine kinase inhibitor (TKI) monotherapy in de novo chronic phase chronic myeloid leukemia (CP-CML). (Preudhomme NEJM 2010, Hjorth-Hansen Leukemia 2016). The phase II Pinnacle (ALLG CML 11) study evaluated the tolerability and molecular response rate of nilotinib (NIL) with Peg-IFN alfa-2B (PegIntron, MSD) in CP-CML patients. Co-primary end points were MMR (BCR-ABL1 ≤ 0.1%) at 12 mths and MR4.5 (BCR-ABL1 ≤ 0.0032%) at 24 mths. Key secondary end points were survival and overall molecular response. Patients were screened for cardiac / vascu..

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