A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

NCT05171647 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 1 other identifier: GO43643
• Study Type: interventional
• Target: 208
• Locations: 13 countries
• Sites: 53

Brief Summary

This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) as Determined by the Independent Review Facility (IRF), According to Lugano Response Criteria 2014 (LRC) Using Positron Emission Tomography-computed Tomography (PET-CT) or CT Scans in Interim Analysis Population (IAP)

  ORR was defined as the percentage of participants with complete response (CR)/partial response (PR), per IRF, per Lugano Response Criteria. Percentages have been rounded off.

  Up to approximately 23.8 months

• Progression-free Survival (PFS) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

  PFS was defined as the time from randomization to first occurrence of disease progression (PD) or death from any cause, whichever occurred first, per IRF, per Lugano Response Criteria.

  Up to 32 months

Secondary Outcomes (18)

• ORR as Determined by the IRF, According to LRC Using PET-CT or CT Scans in ITT Population

  Up to 32 months

• ORR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans in ITT Population

  Up to approximately 58 months

• Duration of Response (DoR) as Determined by the IRF, According to LRC Using PET-CT or CT Scans

  Up to 32 months

• DoR as Determined by the Investigator, According to LRC Using PET-CT or CT Scans

  Up to approximately 58 months

• Overall Survival (OS)

  Up to 32 months

Study Arms (2)

M+P (Arm A)

EXPERIMENTAL

Participants will receive subcutaneous (SC) mosunetuzumab plus intravenous (IV) polatuzumab vedotin (M+P). Mosunetuzumab will be administered on Days 1, 8, and 15 of Cycle 1, and thereafter on Day 1 of Cycles 2-8. Polatuzumab vedotin will be administered on Day 1 of each cycle up to Cycle 6. Cycle length = 21 days.

Drug: Mosunetuzumab; Drug: Polatuzumab vedotin; Drug: Tocilizumab

R-GemOx (Arm B)

ACTIVE COMPARATOR

Participants will receive IV rituximab, IV gemcitabine, and IV oxaliplatin (R-GemOx) on Day 1 of each cycle for 8 cycles. Cycle length = 14 days.

Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

Mosunetuzumab DRUG

Participants will receive SC mosunetuzumab on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-8 (cycle length = 21 days).

M+P (Arm A)

Polatuzumab vedotin DRUG

Participants will receive IV polatuzumab vedotin every three weeks (Q3W) for 6 cycles (cycle length = 21 days).

M+P (Arm A)

Tocilizumab DRUG

Participants will receive IV tocilizumab as needed to manage cytokine release syndrome (CRS) events.

M+P (Arm A)

Rituximab DRUG

Participants will receive IV rituximab on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

R-GemOx (Arm B)

Gemcitabine DRUG

Participants will receive IV gemcitabine on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

R-GemOx (Arm B)

Oxaliplatin DRUG

Participants will receive IV oxaliplatin on Day 1 of each cycle for 8 cycles (cycle length = 14 days).

R-GemOx (Arm B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• CD20+ aggressive lymphoma as determined by the local hemopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); high-grade B-cell lymphoma (NOS or double/triple hit); transformed follicular lymphoma; follicular lymphoma Grade 3b
• Have disease relapsed or refractory to at least one prior systemic therapy for aggressive non-Hodgkin's lymphoma (aNHL)
• Participants who have received only one prior line of therapy must be ineligible for autologous stem cell transplant (ASCT)
• Measurable disease
• Adequate hepatic, hematologic, and renal function
• Estimated creatinine clearance (CrCl) ≥ 30 mL/min by Cockroft-Gault method or other institutional standard methods
• Negative HIV test at screening. Participants with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count of at least 200 microliters, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months

You may not qualify if:

• Pregnant or breast feeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months after the final dose of tocilizumab, as applicable
• Inability to comply with protocol-mandated activity restrictions
• Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, or R-GemOx or Gem-Ox
• Prior treatment with polatuzumab vedotin, with the following exceptions: participants who have a documented response (partial response or complete response) to polatuzumab vedotin and an absence of PD within 12 months from the last dose of polatuzumab vedotin; participants who received up to 2 doses of a polatuzumab vedotin-containing regimen as bridging to CAR-T therapy, and either has a documented disease control (stable disease, partial response, or complete response), or were not assessed for response following treatment with polatuzumab vedotin
• Contraindication to any component of the study treatment
• Grade \> 1 peripheral neuropathy
• Participants with Grade \> 1 persistent toxicity related to prior anti-lymphoma treatment (except for alopecia and anorexia, or other toxicities not considered a safety risk for the participant per investigator's judgment)
• Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugates or antibody-drug conjugates (ADCs) within 4 weeks before the first dose of study treatment
• Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of study treatment
• Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
• ASCT within 100 days prior to the first study treatment administration
• Prior treatment with chimeric antigen receptor (CAR) T cell therapy within 30 days before the first study treatment administration
• Prior allogenic stem cell transplant (SCT)
• Have had a solid organ transplantation
• Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (53)

City of Hope Cancer Center

Duarte, California, 91010, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Ascension Seton Infusion Center

Austin, Texas, 78712, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hospital Aleman

Buenos Aires, 1118, Argentina

Location

Instituto Alexander Fleming

Buenos Aires, 1426, Argentina

Location

FUNDALEU

Buenos Aires, C1114AAN, Argentina

Location

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, C1181ACH, Argentina

Location

Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil

Location

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital das Clínicas FMRP-USP

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Hospital Sao Jose

São Paulo, São Paulo, 01323-030, Brazil

Location

D'or Instituto de Pesquisa e Educação

São Paulo, DUMMY_VALUE, Brazil

Location

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Chum Hopital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

Fujian Medical University Union Hospital

Fuzhou, 350001, China

Location

Cancer Center, Sun Yat-sen University of Medical Sciences

Guangzhou, 510060, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

Wuhan, 430030, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Soroka Medical Center

Beersheba, 8410101, Israel

Location

Ichilov Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Kyushu University Hospital

Fukuoka, 812-8582, Japan

Location

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Kindai University Hospital

Osaka, 589-8511, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), 03100, Mexico

Location

Superare Centro de Infusion S.A. de C.V.

Mexico City, Mexico CITY (federal District), 11550, Mexico

Location

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Instituto Nacional de Cancerologia

Distrito Federal, 14080, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

México, DUMMY_VALUE, Mexico

Location

Middlemore Clinical Trials

Auckland, DUMMY_VALUE, New Zealand

Location

Instituto Regional de Enfermedades Neoplásicas del Sur

Arequipa, 5154, Peru

Location

Oncosalud Sac

Lima, 41, Peru

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

Location

Chulalongkorn University Hospital

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Chiang Mai Uni Hospital

Chiang Mai, 50200, Thailand

Location

Srinagarind Hospital, Khon Kaen Uni

Khon Kaen, 40002, Thailand

Location

Ankara University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Medipol Mega Üniversite Hastanesi Göztepe

Istanbul, 34214, Turkey (Türkiye)

Location

Anadolu Health Center

Kocaeli, 41400, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Tip Fakultesi

Lzmir, 35340, Turkey (Türkiye)

Location

Ondokuz Mayis Univ. Med. Fac.

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (1)

• Budde LE, Zhang H, Kim WS, Maruyama D, Rego EM, Norasetthada L, Hong H, Ozcan M, Jeon YW, Leao Cordeiro de Farias D, Fogliatto LM, Pavlovsky A, Goto H, Olszewski AJ, Shah N, Hu B, Yin S, Wu H, To I, Ead WS, Ashby J, Janousek M, Pham S, Wang J, Kwan A, Batlevi CL, Wei MC, Westin J. Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial. J Clin Oncol. 2025 Dec 20;43(36):3799-3811. doi: 10.1200/JCO-25-01957. Epub 2025 Oct 2.

  PMID: 41037766 DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

polatuzumab vedotin; tocilizumab; Rituximab; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 29, 2021
• Study Start: April 25, 2022
• Primary Completion: February 17, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

KR (6); NZ (1); US (4); CN (6); TH (4); TU (5); JP (6); CA (3); AR (4); ME (5); PE (2); IL (2); BR (5)