Evidence map›Paper›PMID 38072960›Full record

Trial reportNature medicine2024

Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial.

Lihua E Budde, Adam J Olszewski, Sarit Assouline, Izidore S Lossos, Catherine Diefenbach, Manali Kamdar, Nilanjan Ghosh, Dipenkumar Modi, Waleed Sabry, Seema Naik and 14 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03671018 (An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab), which is not on this map. Cited by 70 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed, 9 pooled it
17.9field-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.

NCT03671018 phase1 / phase2active not recruitingnot on this map

An Open-Label, Randomized, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in Patients With B-Cell Non-Hodgkin Lymphoma

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2025Enrolled422ConditionsB-cell Non-Hodgkin LymphomaArmsMosunetuzumab (IV), Mosunetuzumab (SC), Polatuzumab vedotin, Tocilizumab, Rituximab
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 9 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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10 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

24 authors at 17 institutions in 3 countries.

Lihua E BuddeCity of Hope Comprehensive Cancer Center, Duarte, CA, USA. ebudde@coh.org.ORCID 0000-0003-1464-5494
Adam J OlszewskiBrown University, Providence, RI, USA.ORCID 0000-0002-6472-6658
Sarit AssoulineJewish General Hospital, McGill University, Montreal, Quebec, Canada.
Izidore S LossosSylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL, USA.ORCID 0000-0002-9346-9013
Catherine DiefenbachPerlmutter Cancer Center at NYU Langone Health, New York, NY, USA.
Manali KamdarUniversity of Colorado, Aurora, CO, USA.
Nilanjan GhoshHematologic Oncology and Blood Disorders, Atrium Health Levine Cancer Institute, Charlotte, NC, USA.
Dipenkumar ModiKarmanos Cancer Institute/Wayne State University, Detroit, MI, USA.
Waleed SabrySaskatoon Cancer Center, Saskatoon, Saskatchewan, Canada.
Seema NaikPenn State Cancer Institute, Hershey, PA, USA.
Amitkumar MehtaUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Shazia K NakhodaFox Chase Cancer Center, Philadelphia, PA, USA.
Stephen D SmithFred Hutchinson Cancer Center, Seattle, WA, USA.
Kathleen DorritieUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.
Ting JiaRoche (China) Holding Ltd, Shanghai, China.
Song PhamF. Hoffmann-La Roche Ltd, Mississauga, Ontario, Canada.
Ling-Yuh HuwGenentech, Inc., South San Francisco, CA, USA.
Jing JingGenentech, Inc., South San Francisco, CA, USA.
Hao WuGenentech, Inc., South San Francisco, CA, USA.
Wahib S EadGenentech, Inc., South San Francisco, CA, USA.
Iris ToGenentech, Inc., South San Francisco, CA, USA.
Connie Lee BatleviGenentech, Inc., South San Francisco, CA, USA.
Michael C WeiGenentech, Inc., South San Francisco, CA, USA.
Julio C ChavezMoffitt Cancer Center, Tampa, FL, USA. Julio.C.Chavez@moffitt.org.ORCID 0000-0002-2045-6238
Brown University · USCity of Hope · USFox Chase Cancer Center · USFred Hutch Cancer Center · USJewish General Hospital · CALevine Cancer Institute · USMoffitt Cancer Center · USNYU Langone Health · USPenn State Milton S. Hershey Medical Center · USRoche (Canada) · CARoche (China) · CNSaskatchewan Cancer Agency · CAUniversity of Alabama at Birmingham · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Miami Health System · USUPMC Hillman Cancer Center · USWayne State University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Relapsed/refractory aggressive large B cell lymphoma (LBCL) remains an area of unmet need. Here we report the primary analysis of a phase 1b/2 trial of outpatient mosunetuzumab (a CD20xCD3 T-cell-engaging bispecific antibody) plus polatuzumab vedotin (an anti-CD79B antibody-drug conjugate) in relapsed/refractory LBCL. The phase 2 component is a single arm of an ongoing multi-arm trial. The primary endpoint during dose expansion was independent review committee (IRC)-assessed best overall response rate. Secondary endpoints included investigator-assessed overall response rate, complete response, duration of response, progression-free survival and overall survival. At data cutoff, 120 patients were enrolled (22 dose escalation, 98 dose expansion). The primary endpoint was met during dose expansion, with IRC-assessed best overall response rate and complete response rates of 59.2% (58/98; 95% confidence interval (CI): 48.8-69.0) and 45.9% (45/98; 95% CI: 35.8-56.3), respectively (median follow-up, 23.9 months). Median duration of complete was not reached (95% CI: 20.5-not estimable (NE)). Median progression-free survival was 11.4 months (95% CI: 6.2-18.7). Median overall survival was 23.3 months (95% CI: 14.8-NE). Across dose escalation and expansion, the most common grade 3 or higher adverse events were neutropenia (25.0%, 30/120) and fatigue (6.7%, 8/120). Any-grade cytokine release syndrome occurred in 16.7% of patients. These data demonstrate that mosunetuzumab plus polatuzumab vedotin has a favorable safety profile with highly durable responses suitable as second-line therapy in transplant-ineligible relapsed/refractory LBCL. ClinicalTrials.gov identifier: NCT03671018 .

Indexed as

Antineoplastic AgentsImmunoconjugatesLymphoma, Large B-Cell, DiffuseAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsHumansAntibodies, MonoclonalAntineoplastic AgentsImmunoconjugatespolatuzumab vedotin

Identifiers

PMID38072960
PMCPMC10803244
OpenAlexW4389519919

What OpenQuestion holds

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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.