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Abrisqueta, P.1; Kahl, B.2; Banerjee, L.3; McMillan, A.4; Ramchandren, R.5, 6; Miall, F.7; Briones, J.8; Cordoba, R.9; Gonzalez-Barca, E.10; Panizo, C.11; Hirata, J.12; Chang, N.13; Musick, L.12; Diefenbach, C.14

doi: 10.1097/01.HS9.0000558628.70462.93
Simultaneous Sessions I: Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

1Department of Hematology, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Barcelona, Spain

2Division of Oncology, Washington University, St Louis, MO, United States

3Oncology Centre, Maidstone and Tonbridge Wells NHS Trust, Kent

4Centre for Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom

5Division of Oncology, University of Tennessee, Knoxville, TN

6Barbara Ann Karmanos Cancer Institute, Detroit, MI, United States

7Department of Haematology, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom

8Department of Hematology, Hospital Santa Creu i Sant Pau, Barcelona

9Fundacion Jimenez Diaz, Madrid

10Instititut Catala D'Oncologia, Barcelona

11Clínica Universidad de Navarra, Pamplona, Spain

12Genentech, Inc., South San Francisco, CA, United States

13F. Hoffmann-La Roche Ltd, Mississauga, Canada

14Perlmutter Cancer Center at NYU Langone Health, New York, NY, United States

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Pola-G-Len has the potential to enhance anti-tumor immune response in R/R FL. Here, we report a pre-planned interim analysis of a phase Ib/II study (NCT02600897) of Pola-G-Len in pts with R/R FL.

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To assess the safety and efficacy of induction and maintenance with Pola-G-Len in pts with R/R FL.

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This is an ongoing, open-label, multicenter study of pts with R/R FL (excluding grade [Gr] 3b) who have received ≥1 prior anti-CD20 antibody-containing chemo-immunotherapy regimen. The study comprises an initial 3+3 dose-escalation (DE) phase (to determine the recommended phase II dose [RP2D] of both Pola and Len for the Pola-G-Len regimen) followed by an expansion phase to assess the RP2D of Pola and Len. Pts received induction treatment with 6x 28-day (D) cycles (C) of: G 1000 mg IV (C1: D1, D8, D15; C2-6: D1); Pola 1.4 mg/kg or 1.8 mg/kg (DE) or RP2D (expansion) IV (D1); and Len 10-20 mg (DE) or RP2D (expansion) PO (D1-21). Pts with complete response (CR)/partial response (PR)/stable disease (SD) at the end of induction (EOI) received G 1000 mg (D1 every 2mo, for 24mo), and Len (10 mg, D1-21 monthly, 12mo). Primary endpoints were C1 dose-limiting toxicities (DLTs), safety/tolerability, CR rate at EOI (modified Lugano criteria).



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At the interim data cut-off (6 July 2018), 52 pts were enrolled: 9 discontinued the study (adverse events [AE], n = 3; death due to PD, n = 4; pt withdrawal, n = 1; other, n = 1). At baseline, the median pt age was 62 (range 32-87) years; 60% were male; 58% had FLIPI Gr 3-5; 79% had received ≥2 prior therapy lines; 50% were refractory to their last treatment; 17% had bulky disease (≥7 cm). Two DLTs were reported in the cohort receiving Pola 1.8 mg/kg + Len 10 mg during the DE period (Gr 4 lipase/amylase elevation; asymptomatic, resolved with supportive care; Gr 3 thrombocytopenia leading to a delay in the initiation of cycle 2). Therefore, Pola 1.4 mg/kg + Len 20 mg was selected as the RP2D for expansion. Gr ≥3 AEs were experienced by 75% of pts: neutropenia (46%), thrombocytopenia (17%), anemia (12%) and infections (12%) were the most common AEs. AEs leading to Len dose reduction or interruption occurred in 31% and 52% of pts, respectively. One Gr 5 AE was reported (septic shock after PD in pt receiving subsequent therapy). The RP2D was determined as Pola 1.4 mg/kg + Len 20 mg. Preliminary efficacy data suggest high activity, with an independent review committee-assessed Modified Lugano response rate of 89% and a CR rate of 67% (Table). Median progression-free survival was not reached (median follow-up duration 8.95 mo in the efficacy-evaluable population).

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The safety profile of Pola-G-Len is consistent with known profiles of the individual drugs. Response rates at EOI with Pola-G-Len are promising, with high CR compared with available R/R FL treatments.

Copyright © 2019 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the European Hematology Association.