ASCO Connection

July 2017

Issue link: http://read.uberflip.com/i/845028

Contents of this Issue

Navigation

Page 60 of 67

Now Enrolling: Copanlisib a Clinical Trials in Indolent Non-Hodgkin's Lymphoma (iNHL) Copanlisib is a pan-class I phosphatidylinositol 3-kinase pathway inhibitor with predominant activity against the alpha and delta isoforms. 1-3 LEARN ABOUT THESE ONGOING STUDIES INVESTIGATING COPANLISIB IN PATIENTS WITH RELAPSED/REFRACTORY iNHL Learn about the complete trial information at www.chronostrials.com © 2017 Bayer. All rights reserved. BAYER and the Bayer Cross are registered trademarks of Bayer. PP-860-US-0036 1/17 Printed in USA References: 1. Bayer. Copanlisib and rituximab in relapsed indolent B-cell non-Hodgkin's lymphoma (iNHL) (CHRONOS-3): NCT02367040. https://clinicaltrials.gov/ct2/show/NCT02367040. Accessed October 12, 2016. 2. Bayer. Study of copanlisib in combination with standard immunochemotherapy in relapsed indolent non-Hodgkin's lymphoma (iNHL) (CHRONOS-4): NCT02626455. https://clinicaltrials.gov/ct2/show/NCT02626455. Accessed October 12, 2016. 3. Liu N, et al. Mol Cancer Ther. 2013;12(11):2319-2330. 1L= rst-line; 2L=second-line; C=copanlisib; CHOP=a combination of cyclophosphamide, hydroxydaunomycin, Oncovin, prednisone; CLL=chronic lymphocytic leukemia; CR=complete response; DOR=duration of response; ECOG=the Eastern Cooperative Oncology Group; FL=follicular lymphoma; IV=intravenous; LPL=lymphoplasmacytic lymphoma; MZL=marginal zone lymphoma; ORR=objective response rate; OS=overall survival; PD=progressive disease; PI3K=phosphatidylinositol 3-kinase; QOL=quality of life; QW=once weekly; R=rituximab; RB=rituximab and bendamustine; RCHOP=rituximab and chemotherapy; SLL=small lymphocytic lymphoma; TTP=time to progression; WM=Waldenstrom macroglobulinemia. b To see full patient inclusion and exclusion criteria, visit https://clinicaltrials.gov/ct2/show/NCT02367040. c To see full patient inclusion and exclusion criteria, visit https://clinicaltrials.gov/ct2/show/NCT02626455. A phase III, randomized study of copanlisib in combination with rituximab in patients with iNHL who have relapsed after ≥1 prior line of rituximab-containing therapy. The primary endpoint of the study is progression-free survival (PFS). A phase III, randomized study of copanlisib in combination with standard immunochemotherapy in patients with iNHL who have relapsed after ≥1 prior line of therapy, including rituximab and alkylating agents. The primary endpoint of the study is PFS. a Copanlisib is an investigational agent currently in clinical trials and is not approved by the FDA, EMA, or other health authorities. The ef cacy and safety of copanlisib have not been established, and this information is being provided only for the purpose of providing an overview of clinical trials for recruitment. Contact us for more information on clinical trials 1-844-229-3710 Bayer@emergingmed.com N=567 2:1 Randomization Patient population: • 2L iNHL (after R-containing therapies) 2° = TTP, ORR, CR, DOR, OS, QOL Rituximab + copanlisib Rituximab + placebo 1° PFS Copanlisib: IV 60 mg QW (3 on, 1 off) until PD Rituximab: IV at 375 mg/m 2 QW (Days 1, 8, 15, and 22 of cycle 1; Day 1 of cycles 3, 5, 7, and 9; max 8 cycles) N=676 1:1 Randomization 1° PFS Patient population: • Patients who have received 1L rituximab (R) + chemo 2 dose-finding and safety cohorts: • C + RB • C + RCHOP 2° = TTP, ORR, CR, DOR, OS, QOL R + bendamustine (or CHOP) + copanlisib R + bendamustine (or CHOP) + placebo CHRONOS-3: Now enrolling 1 CHRONOS-4: Now enrolling 2 Selected inclusion criteria b : Patients ≥18 years with iNHL (FL Grade 1-3a, SLL, LPL/WM, MZL); relapsed after ≥1 prior lines of therapy, including R and alkylating agents; ECOG performance status ≤2; ≥12 months after completion of the last R-containing treatment or be considered un t to receive chemotherapy. Selected exclusion criteria b : FL Grade 3b, disease transformation, or CLL; resistance to prior treatment with idelalisib or other PI3K inhibitors. Selected inclusion criteria c : Patients ≥18 years with iNHL (FL Grade 1-3a, SLL, LPL/ WM, MZL); relapsed after ≥1 prior line of therapy, including R and alkylating agents; ECOG performance status ≤2. Selected exclusion criteria c : FL Grade 3b, transformed disease, or CLL; R resistance at any line of therapy; type I or II diabetes mellitus with HbA1c >8.5% or fasting plasma glucose >160 mg/dL at screening; uncontrolled hypertension.

Articles in this issue

Links on this page

Archives of this issue

view archives of ASCO Connection - July 2017