A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

Summary

This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

Timeline

Start

2011-07-26

Primary completion

2016-04-29

Completion

2018-01-31

Outcome

Missed primary endpoint

Stopped: “The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.”

registry Rituximab+Chemotherapy vs Obinutuzumab+Chemotherapy; p = 0.4753; Hazard Ratio (HR) 0.94 (95% CI 0.78 to 1.12); Log Rank NCT01287741 ↗

paper The final analysis, similar to the primary analysis, did not show a PFS benefit of G-CHOP over R-CHOP in previously untreated patients with DLBCL. PMID 32505213 ↗

release “GOYA study did not meet its primary endpoint of improvement in progression-free survival with Gazyva plus CHOP chemotherapy versus Rituxan plus CHOP chemotherapy” gene.com ↗

release “a separate trial (Goya) of the medicine in diffuse large B-cell lymphoma, did not reach its primary study goal.” roche.com ↗

release “GOYA試験で、主要評価項目である無増悪生存期間の延長は未達” nippon-shinyaku.co.jp ↗

Publications

• Torkaman M, Jemaa S, Fredrickson J, Fernandez Coimbra A, De Crespigny A, Carano RAD. Comparative analysis of intestinal tumor segmentation in PET CT scans using organ based and whole body deep learning. BMC Med Imaging. 2025 Feb 17;25(1):52. doi: 10.1186/s12880-025-01587-3.
• Jemaa S, Ounadjela S, Wang X, El-Galaly TC, Kostakoglu L, Knapp A, Ku G, Musick L, Sahin D, Wei MC, Yin S, Bengtsson T, De Crespigny A, Carano RAD. Automated Lugano Metabolic Response Assessment in 18F-Fluorodeoxyglucose-Avid Non-Hodgkin Lymphoma With Deep Learning on 18F-Fluorodeoxyglucose-Positron Emission Tomography. J Clin Oncol. 2024 Sep 1;42(25):2966-2977. doi: 10.1200/JCO.23.01978. Epub 2024 Jun 6.
• Yan JT, Bel C, Trask PC, Lo E. Are changes in patient-reported outcomes prognostic for diffuse large B-Cell lymphoma survival? Results from the GOYA trial. J Patient Rep Outcomes. 2024 Mar 18;8(1):31. doi: 10.1186/s41687-024-00708-w.
• Ho RS, Launonen A. Comparison of statistical methods for extrapolating survival in previously untreated diffuse large B-cell lymphoma: results based on the POLARIX study. J Med Econ. 2023 Jan-Dec;26(1):1178-1189. doi: 10.1080/13696998.2023.2259107. Epub 2023 Sep 13.
• Jemaa S, Paulson JN, Hutchings M, Kostakoglu L, Trotman J, Tracy S, de Crespigny A, Carano RAD, El-Galaly TC, Nielsen TG, Bengtsson T. Full automation of total metabolic tumor volume from FDG-PET/CT in DLBCL for baseline risk assessments. Cancer Imaging. 2022 Aug 12;22(1):39. doi: 10.1186/s40644-022-00476-0.
• Nowicka M, Hilton LK, Ashton-Key M, Hargreaves CE, Lee C, Foxall R, Carter MJ, Beers SA, Potter KN, Bolen CR, Klein C, Knapp A, Mir F, Rose-Zerilli M, Burton C, Klapper W, Scott DW, Sehn LH, Vitolo U, Martelli M, Trneny M, Rushton CK, Slack GW, Farinha P, Strefford JC, Oestergaard MZ, Morin RD, Cragg MS. Prognostic significance of FCGR2B expression for the response of DLBCL patients to rituximab or obinutuzumab treatment. Blood Adv. 2021 Aug 10;5(15):2945-2957. doi: 10.1182/bloodadvances.2021004770.
• Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.
• Kostakoglu L, Martelli M, Sehn LH, Belada D, Carella AM, Chua N, Gonzalez-Barca E, Hong X, Pinto A, Shi Y, Tatsumi Y, Knapp A, Mattiello F, Nielsen T, Sahin D, Sellam G, Oestergaard MZ, Vitolo U, Trneny M. End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA. Blood Adv. 2021 Mar 9;5(5):1283-1290. doi: 10.1182/bloodadvances.2020002690.
• Bolen CR, Klanova M, Trneny M, Sehn LH, He J, Tong J, Paulson JN, Kim E, Vitolo U, Di Rocco A, Fingerle-Rowson G, Nielsen T, Lenz G, Oestergaard MZ. Prognostic impact of somatic mutations in diffuse large B-cell lymphoma and relationship to cell-of-origin: data from the phase III GOYA study. Haematologica. 2020 Sep 1;105(9):2298-2307. doi: 10.3324/haematol.2019.227892.
• Sehn LH, Martelli M, Trneny M, Liu W, Bolen CR, Knapp A, Sahin D, Sellam G, Vitolo U. A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-Cell lymphoma: final analysis of GOYA. J Hematol Oncol. 2020 Jun 6;13(1):71. doi: 10.1186/s13045-020-00900-7.
• Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.
• McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602.
• Klanova M, Sehn LH, Bence-Bruckler I, Cavallo F, Jin J, Martelli M, Stewart D, Vitolo U, Zaja F, Zhang Q, Mattiello F, Sellam G, Punnoose EA, Szafer-Glusman E, Bolen CR, Oestergaard MZ, Fingerle-Rowson GR, Nielsen T, Trneny M. Integration of cell of origin into the clinical CNS International Prognostic Index improves CNS relapse prediction in DLBCL. Blood. 2019 Feb 28;133(9):919-926. doi: 10.1182/blood-2018-07-862862. Epub 2019 Jan 7.
• Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obinutuzumab	Monoclonal antibody	1000 mg	Intravenous
Comparator	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	100 mg	Oral
Background	Vincristine	Small molecule	1.4 mg/m2	Intravenous

Indications