Sunmo: phase iii trial of mosunetuzumab plus polatuzumab vedotin versus rituximab plus gemcitabine and oxaliplatin in relapsed/refractory aggressive non‐hodgkin lymphoma

Introduction: Aggressive non-Hodgkin lymphomas (aNHL) are a diverse group of neoplasms, of which diffuse large B-cell lymphoma (DLBCL) is the most common subtype (Thandra, 2021). Patients (pts) with relapsed/refractory (R/R) DLBCL after one prior therapy who are unable to receive, or relapsed after, an autologous stem cell transplant (ASCT) and/or chimeric antigen receptor T-cell therapy have a poor prognosis (Salles, 2019; Di Blasi, 2022). Mosunetuzumab (Mosun) is an off-the-shelf CD20xCD3 T-cell engaging bispecific antibody that redirects T cells to eliminate malignant B cells (Sun, 2015), with promising efficacy and safety as a single agent, as shown in a Phase I trial in pts with B-cell NHL, including aNHL (Budde, 2022). Mosun has also shown promising safety and efficacy in combination with polatuzumab vedotin (Pola), a CD79b targeted antibody-drug conjugate that delivers the microtubule-disrupting agent monomethyl auristatin E directly to B cells (Dornan, 2009), in a Phase Ib/II trial in pts with R/R aNHL (Budde, ASH 2021). Encore Abstract—previously submitted to ASCO 2023 The research was funded by: SUNMO (NCT05171647) is sponsored by F. Hoffmann-La Roche Ltd. Third-party medical writing assistance, under the direction of all authors, was provided by Martha Warren MSci of Ashfield MedComms, an Inizio company, and was funded by F. Hoffmann-La Roche Ltd. Keywords: aggressive B-cell non-Hodgkin lymphoma, immunotherapy Conflicts of interests pertinent to the abstract J. Westin Consultant or advisory role Novartis, Kite/Gilead, Janssen, ADC Therapeutics, Iksuda Therapeutics, BMS/Celgene/Juno, AstraZeneca, Genentech/Roche, Abbvie, Merck, Monte Rosa Therapeutics, Morphosys/Incyte, Seattle Genetics Research funding: Janssen, Genentech, Novartis, Kite/Gilead, BMS, AstraZeneca, Morphosys/Incyte, ADC Therapeutics A. J. Olszewski Employment or leadership position: Brown Physicians, LLC Consultant or advisory role Genmab, Schrodinger Research funding: Genentech, Adaptive Biotech, Precision Bio, Kymera Therapeutics, Schrodinger W. S. Kim Research funding: Sanofi, Beigene, Boryong, Roche, Kyowa-kirin, Donga H. Shin Employment or leadership position: Pusan National University Hospital D. Leão Employment or leadership position: Legal Person (Beneficencia Portuguesa De São Paulo) Other remuneration: Travel, accommodation, expenses—Janssen, Novartis, Takeda, AMGEN, Roche, Libbs, ABBVIE, AstraZeneca, Zodiac, Kite/Gilead; Leadership—Chronic lymphoproliferative diseases clinic at Beneficencia Portuguesa de Sao Paulo L. Norasetthada Employment or leadership position: Chiang Mai University Research funding: MSD, Astra Zeneca, Roche E. Rego Employment or leadership position: Rede D ́Or/University of São Paulo Consultant or advisory role Astellas, Abbvie Honoraria: Astellas, Abbvie, Pfizer, Novartis Research funding: Astellas Other remuneration: Travel, accommodation, expenses—Astellas, Abbvie, Pfizer, Novartis H. Wu Employment or leadership position: Genentech; Ended employment in past 24 months—Amgen S. Yin Employment or leadership position: Genentech Inc. Stock ownership: Genentech Inc. Other remuneration: Patents, royalties, other intellectual property—Genentech Inc.; Travel, accommodation, expenses—Genentech Inc. C. L. Batlevi Employment or leadership position: Roche/Genentech Stock ownership: Roche/Genentech S. Pham Employment or leadership position: Roche Canada E. Penuel Employment or leadership position: Genentech Stock ownership: Genentech J. Jing Employment or leadership position: Genentech M. C. Wei Employment or leadership position: Genentech Stock ownership: Roche Other remuneration: Travel, accommodation, expenses—Genentech/Roche L. E. Budde Consultant or advisory role Roche/Genentech, Kite/Gilead, Novartis, BeiGene Research funding: Merck, Amgen, MustangBio, AstraZeneca Other remuneration: Patents, royalties, other intellectual property—CCR4 CAR T cells for treatment of patients with CCR4 positive cancer, CD33CAR for treatment of patients with CD33+ acute myeloid leukemia; Travel, accommodation, expenses—Roche/Genentech, Kite/Gilead