PMID- 35359000
OWN - NLM
STAT- MEDLINE
DCOM- 20221024
LR  - 20230106
IS  - 2473-9537 (Electronic)
IS  - 2473-9529 (Print)
IS  - 2473-9529 (Linking)
VI  - 6
IP  - 20
DP  - 2022 Oct 25
TI  - Safety and efficacy of atezolizumab with obinutuzumab and bendamustine in 
      previously untreated follicular lymphoma.
PG  - 5659-5667
LID - 10.1182/bloodadvances.2021006131 [doi]
AB  - Obinutuzumab (G) chemoimmunotherapy demonstrated improved progression-free 
      survival (PFS) vs rituximab-based chemoimmunotherapy in patients with previously 
      untreated follicular lymphoma (FL) in the GALLIUM trial. Atezolizumab (atezo) is 
      a programmed death-ligand 1 inhibitor with a complementary mechanism of action to 
      G by restoring cytotoxic T-cell function. We evaluated the safety and efficacy of 
      atezo-G-bendamustine in patients with previously untreated FL in a phase Ib/II 
      trial (#NCT02596971). A safety run-in phase was followed by an expansion phase 
      with atezo-G-bendamustine induction and atezo-G maintenance for </=24 months. Forty 
      patients with previously untreated FL were enrolled and treated with 
      atezo-G-bendamustine. The primary endpoint, complete response (CR) rate, assessed 
      by an independent review committee (IRC; modified Lugano 2014 criteria) was 75.0% 
      (95% confidence interval [CI], 61.3% to 85.8%). Three-year investigator-assessed 
      PFS and overall survival rates were 80.9% (95% CI, 63.9% to 90.5%) and 89.3% (95% 
      CI, 73.9% to 95.9%), respectively. At baseline, 21/40 patients had circulating 
      lymphoma-specific clonotypes and underwent repeat testing at end of induction; 
      all were minimal residual disease negative (10-5 sensitivity), with 16 (76.2%) 
      CRs, 3 (14.3%) partial responses, and 2 (9.5%) with stable disease (IRC 
      assessed). Grade 5 (fatal) adverse events (AEs) were reported in 5 patients. The 
      efficacy of atezo-G-bendamustine in previously untreated FL did not 
      appear superior to G-bendamustine efficacy as seen in the GALLIUM trial, and the 
      addition of atezo to G-bendamustine was associated with an increased risk of AEs. 
      Particularly due to the unfavorable safety profile, this regimen cannot be 
      recommended in patients with previously untreated FL. This trial was registered 
      at www.clinicaltrials.gov as #NCT02596971.
CI  - (c) 2022 by The American Society of Hematology. Licensed under Creative Commons 
      Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), 
      permitting only noncommercial, nonderivative use with attribution. All other 
      rights reserved.
FAU - Younes, Anas
AU  - Younes A
AD  - Memorial Sloan-Kettering Cancer Center, New York, NY.
FAU - Burke, John M
AU  - Burke JM
AUID- ORCID: 0000-0002-5144-6710
AD  - US Oncology Research, The Woodlands, TX.
AD  - Rocky Mountain Cancer Center, Aurora, CO.
FAU - Diefenbach, Catherine
AU  - Diefenbach C
AUID- ORCID: 0000-0003-1116-3246
AD  - Perlmutter Cancer Center of NYU Langone Health, New York, NY.
FAU - Ferrari, Silvia
AU  - Ferrari S
AD  - Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.
FAU - Khan, Cyrus
AU  - Khan C
AD  - Allegheny Health Network Cancer Institute, Pittsburgh, PA.
FAU - Sharman, Jeff P
AU  - Sharman JP
AD  - US Oncology Research, The Woodlands, TX.
AD  - Willamette Valley Cancer Institute, Eugene, OR.
FAU - Tani, Monica
AU  - Tani M
AD  - Ospedale Santa Maria delle Croci, Ravenna, Italy.
FAU - Ujjani, Chaitra
AU  - Ujjani C
AD  - Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center, Seattle, WA.
FAU - Vitolo, Umberto
AU  - Vitolo U
AUID- ORCID: 0000-0001-7772-2747
AD  - Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, 
      FPO-IRCCS, Candiolo, Turin, Italy.
FAU - Yuen, Sam
AU  - Yuen S
AD  - Calvary Mater Newcastle Hospital, Newcastle, NSW, Australia.
FAU - Raval, Aparna
AU  - Raval A
AD  - Genentech, Inc., South San Francisco, CA.
FAU - Shivhare, Mahesh
AU  - Shivhare M
AD  - Roche Products, Welwyn Garden City, United Kingdom.
FAU - Nielsen, Tina G
AU  - Nielsen TG
AD  - F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Sellam, Gila
AU  - Sellam G
AD  - F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Gilbertson, Michael
AU  - Gilbertson M
AD  - School of Clinical Sciences, Monash Health, Monash University, Melbourne, VIC, 
      Australia.
AD  - Department of Haematology, Monash Health, Monash University, Melbourne, VIC, 
      Australia.
LA  - eng
SI  - ClinicalTrials.gov/NCT02596971
GR  - P30 CA008748/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Blood Adv
JT  - Blood advances
JID - 101698425
RN  - 52CMI0WC3Y (atezolizumab)
RN  - 981Y8SX18M (Bendamustine Hydrochloride)
RN  - CH46OC8YV4 (Gallium)
RN  - O43472U9X8 (obinutuzumab)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - *Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Bendamustine Hydrochloride/adverse effects
MH  - Gallium/therapeutic use
MH  - *Lymphoma, Follicular/drug therapy
MH  - Rituximab/therapeutic use
MH  - Antibodies, Monoclonal, Humanized/adverse effects
PMC - PMC9582582
EDAT- 2022/04/01 06:00
MHDA- 2022/10/22 06:00
PMCR- 2022/03/29
CRDT- 2022/03/31 20:17
PHST- 2022/03/08 00:00 [accepted]
PHST- 2021/10/22 00:00 [received]
PHST- 2022/04/01 06:00 [pubmed]
PHST- 2022/10/22 06:00 [medline]
PHST- 2022/03/31 20:17 [entrez]
PHST- 2022/03/29 00:00 [pmc-release]
AID - 484508 [pii]
AID - 10.1182/bloodadvances.2021006131 [doi]
PST - ppublish
SO  - Blood Adv. 2022 Oct 25;6(20):5659-5667. doi: 10.1182/bloodadvances.2021006131.