Evidence map›Paper›PMID 34914545›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Single-Agent Mosunetuzumab Shows Durable Complete Responses in Patients With Relapsed or Refractory B-Cell Lymphomas: Phase I Dose-Escalation Study.

Lihua E Budde, Sarit Assouline, Laurie H Sehn, Stephen J Schuster, Sung-Soo Yoon, Dok Hyun Yoon, Matthew J Matasar, Francesc Bosch, Won Seog Kim, Loretta J Nastoupil and 11 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02500407 (An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab), which is not on this map. Cited by 186 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
186citing papers in PubMed, 7 pooled it
30.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02500407 phase1 / phase2completednot on this map

An Open-Label, Multicenter, Phase I/II Trial Evaluating the Safety, Efficacy, and Pharmacokinetics of Escalating Doses of Mosunetuzumab (BTCT4465A) as a Single Agent and Combined With Atezolizumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

TypeinterventionalSponsorGenentech, Inc.Ran2015 to 2025Enrolled713ConditionsLymphocytic Leukemia, Chronic, Lymphoma, Non HodgkinArmsBTCT4465A (Mosunetuzumab) IV, Atezolizumab, BTCT4465A (Mosunetuzumab) SC
3 · Its place in the literature

Who cites it

186 citing papers in PubMed, 7 syntheses or guidelines pooled it, 283 citations in OpenAlex.

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  5. SEOM-GOTEL clinical guidelines on diffuse large B-cell lymphoma (update 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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126 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 15 institutions in 4 countries.

Lihua E BuddeCity of Hope National Medical Center, Duarte, CA.ORCID 0000-0003-1464-5494
Sarit AssoulineJewish General Hospital and McGill University, Montreal, Quebec, Canada.ORCID 0000-0002-7638-1589
Laurie H SehnBC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, British Columbia, Canada.ORCID 0000-0003-1860-9765
Stephen J SchusterLymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Sung-Soo YoonSeoul National University Hospital, Seoul, South Korea.
Dok Hyun YoonAsan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.ORCID 0000-0002-8289-3548
Matthew J MatasarMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-4581-3721
Francesc BoschUniversity Hospital Vall d'Hebron and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.ORCID 0000-0001-9241-2886
Won Seog KimSungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, South Korea.ORCID 0000-0002-5400-0466
Loretta J NastoupilMD Anderson Cancer Center, Houston, TX.
Ian W FlinnSarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.ORCID 0000-0001-6724-290X
Mazyar ShadmanFred Hutchinson Cancer Research Center, Seattle, WA.
Catherine DiefenbachPerlmutter Cancer Center at NYU Langone Health, New York, NY.ORCID 0000-0003-1116-3246
Carol O'HearGenentech, Inc, South San Francisco, CA.
Huang HuangF. Hoffmann-La Roche Limited, Mississauga, Ontario, Canada.ORCID 0000-0003-3976-4115
Antonia KwanGenentech, Inc, South San Francisco, CA.
Chi-Chung LiGenentech, Inc, South San Francisco, CA.ORCID 0000-0002-9590-3450
Emily C PiccioneGenentech, Inc, South San Francisco, CA.
Michael C WeiGenentech, Inc, South San Francisco, CA.
Shen YinGenentech, Inc, South San Francisco, CA.
Nancy L BartlettSiteman Cancer Center, Washington University School of Medicine, St Louis, MO.ORCID 0000-0001-8470-394X
City Of Hope National Medical Center · USFred Hutch Cancer Center · USJewish General Hospital · CAMemorial Sloan Kettering Cancer Center · USNYU Langone Health · USRoche (Canada) · CASamsung Medical Center · KRSarah Cannon · USSeoul National University Hospital · KRThe University of Texas MD Anderson Cancer Center · USUlsan College · KRUniversity of British Columbia · CAUPMC Hillman Cancer Center · USVall d'Hebron Hospital Universitari · ESWashington University in St. Louis · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeMosunetuzumab is a bispecific antibody targeting CD20 and CD3 that redirects T cells to engage and eliminate malignant B cells and is being developed for relapsed or refractory (R/R) B-cell non-Hodgkin lymphomas (B-NHLs).

methodsThis first-in-human trial (ClinicalTrials.gov identifier: NCT02500407) evaluated the safety and tolerability and efficacy of mosunetuzumab in patients with R/R B-NHL and established the recommended phase II dose. Data from dose escalation are presented. Single-agent mosunetuzumab was administered intravenously in 3-week cycles, at full dose in cycle 1 day 1 (group A) or with ascending (step-up) doses during cycle 1 on days 1, 8, and 15 (group B), for eight or 17 cycles on the basis of tumor response.

resultsTwo hundred thirty patients were enrolled. Doses up to 2.8 mg and 60 mg were assessed in groups A and B, respectively; maximum tolerated dose was not exceeded. In group B (n = 197), common adverse events (≥ 20% of patients) were neutropenia (28.4%), cytokine release syndrome (27.4%), hypophosphatemia (23.4%), fatigue (22.8%), and diarrhea (21.8%). Cytokine release syndrome was mostly low-grade (grade ≥ 3: 1.0%) and mainly confined to cycle 1. Across the doses investigated (group B), best overall response rates were 34.9% and 66.2% in patients with aggressive and indolent B-NHL, respectively, and complete response rates were 19.4% and 48.5%. Among patients with a complete response, the median duration of response was 22.8 months (95% CI, 7.6 to not estimable) and 20.4 (95% CI, 16 to not estimable) in patients with aggressive and indolent B-NHL, respectively.

conclusionMosunetuzumab, administered with step-up dosing, has a manageable safety profile and induces durable complete responses in R/R B-NHL. The expansion stage of the study is ongoing at the dose level of 1/2/60/60/30 mg selected for further study.

Indexed as

Administration, IntravenousAdultAgedAged, 80 and overAntibodies, BispecificAntineoplastic Agents, ImmunologicalCanadaDrug Administration ScheduleFemaleHumansLymphoma, B-CellMaleMiddle AgedRemission InductionTime FactorsTreatment OutcomeAntibodies, BispecificAntineoplastic Agents, Immunological

Identifiers

PMID34914545
PMCPMC8824395
OpenAlexW4200255107

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.