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.
Journaljournal of hematology & oncology11.059Date
2020 Jun 06
4 months ago
Research Support, Non-U.S. Gov't
Journal Article
2020-06-06 / 13 : 71
Sehn LH 1, Martelli M 2, Trněný M 3, Liu W 4, Bolen CR 5, Knapp A 6, Sahin D 6, Sellam G 6, Vitolo U 7
  • 2. Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
  • 3. Charles University General Hospital, Prague, Czech Republic.
  • 4. Roche Pharma Development, Shanghai, China.
  • 5. Genentech, Inc., South San Francisco, CA, USA.
  • 6. F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • 7. Candiolo Cancer Institute, FPO-IRCCS, (Turin), Candiolo, Italy.
BACKGROUND: Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) is the current standard therapy for diffuse large B cell lymphoma (DLBCL). Obinutuzumab (G), a glycoengineered, type II anti-CD20 monoclonal antibody, has shown activity and an acceptable safety profile when combined with CHOP (G-CHOP) in patients with advanced DLBCL. We present the final analysis results of the Phase III GOYA study (NCT01287741), which compared the efficacy and safety of G-CHOP versus R-CHOP in patients with previously untreated DLBCL.
METHODS: Patients aged ≥ 18 years with previously untreated advanced DLBCL were randomly assigned to receive eight 21-day cycles of R or G, plus six or eight cycles of CHOP. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival, other time-to-event endpoints, and safety; investigator-assessed PFS by cell of origin subgroup was an exploratory endpoint.
RESULTS: A total of 1418 patients were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; R-CHOP, N = 710). Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48). The results of the secondary efficacy endpoints did not show a benefit of G-CHOP over R-CHOP. In the exploratory analysis, a trend towards benefit with G-CHOP over R-CHOP was apparent in the patients with germinal center B cell DLBCL. The safety profile of G-CHOP was as expected, and no new safety signals were observed. More grade 3-5 (75.1% vs 65.8%), serious (44.4% vs 38.4%), and fatal (6.1% vs 4.4%) adverse events (AEs) were observed in the G-CHOP arm compared with the R-CHOP arm, respectively, with the most common fatal AEs being infections. A higher incidence of late-onset neutropenia occurred in the G-CHOP arm (8.7%) versus the R-CHOP arm (4.9%).
CONCLUSIONS: 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. The results of the secondary endpoints were consistent with the primary endpoint. Further exploratory analyses and investigation of biomarkers are ongoing.
Keywords: Diffuse large B cell lymphoma Immunochemotherapy Obinutuzumab Outcomes Rituximab
J Hematol Oncoljournal of hematology & oncology

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