Comparative effectiveness between mosunetuzumab monotherapy clinical trial and real-world data in relapsed/refractory follicular lymphoma in third or subsequent lines of systemic therapy

Abstract

A comparison of clinical outcomes in the third or subsequent line (3 L+) of systemic therapy between a real-world data (RWD) external control cohort and a mosunetuzumab single-arm clinical trial cohort is presented. Data for 3 L + patients with relapsed/refractory follicular lymphoma (FL) were obtained from the mosunetuzumab single-arm trial (n = 90) and a US electronic health records database (n = 158), with patients meeting key eligibility criteria from the trial, balanced on pre-specified prognostic factors. Overall response and complete response rates were 80% and 60% in the mosunetuzumab cohort and 75% and 33% in the RWD cohort, odds ratios of 1.23 (95% CI, 0.52–2.93) and 3.18 (95% CI, 1.41–7.17), respectively. Hazard ratios for progression-free survival and overall survival were 0.82 (95% CI, 0.53–1.27) and 0.43 (95% CI, 0.19–0.94). These findings support a clinically meaningful benefit of mosunetuzumab monotherapy as a chemotherapy-free option for the 3 L + FL population.

Keywords:

• Comparative effectiveness
• follicular lymphoma
• mosunetuzumab
• real-world data
• external control

Acknowledgments

NCT02500407 is sponsored by F. Hoffmann-La Roche Ltd. Third party medical writing assistance was provided by Louise Profit, PhD, of Ashfield MedComms, an Inizio company, and was funded by Genentech, Inc. The authors would like to thank the patients and their families, as well as the study investigators, study coordinators, nurses, and representatives of the sponsor who were involved in data collection and analyses.

Authors’ contributions

Conception and design: SFM, NS, MJ, BS, MHBZ, BL, JP, AS. Collection and assembly of data: SFM, NS, JW, AS. Data analysis and interpretation: SFM, NS, JW, MCW, AS. Manuscript writing, final approval of manuscript, and accountable for all aspects of the work: all authors.

Disclosure statement

SFM, NS, JW, AS: employment (Genentech), stock or stock options (Roche), BL: employment (Roche), MHBZ, MJ, BS, JP: employment and stock or stock options (Roche), MCW: employment (Genentech), stock or stock options, and patents and royalties (Roche).

Data availability statement

Qualified researchers may request access to individual patient level data through the clinical study data request platform (https://vivli.org/). Further details on Roche’s criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Additional information

Funding

NCT02500407 and this study are sponsored by F. Hoffmann-La Roche Ltd.