Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial
Mené sur 208 patients atteints d'un lymphome à grandes cellules B réfractaire ou récidivant et inéligibles à une greffe (durée médiane de suivi : 23,2 mois), cet essai de phase III évalue l'efficacité, du point de vue du taux de réponse globale et de la survie sans progression, et la toxicité du mosunétuzumab en combinaison avec le polatuzumab védotin
Purpose: Prognosis for patients with refractory/relapsed large B-cell lymphoma (LBCL) considered ineligible for curative-intent therapy is poor. The combination of mosunetuzumab, a T-cell–engaging bispecific antibody, and polatuzumab vedotin, an antibody-drug conjugate (Mosun-Pola), represents a novel fixed-duration outpatient therapy.
Methods: In the phase III SUNMO trial, patients with refractory/relapsed LBCL who were ineligible for autologous stem-cell transplant were randomly assigned (2:1) to receive Mosun-Pola or rituximab, gemcitabine, and oxaliplatin (R-GemOx). Dual primary end points were centrally assessed overall response rate (ORR) and progression-free survival (PFS). Overall survival was a key secondary end point.
Results: A total of 208 patients were randomly assigned to receive Mosun-Pola (n = 138) or R-GemOx (n = 70). At a median follow-up of 23.2 months, the primary analysis of SUNMO demonstrated that the median PFS was significantly longer with Mosun-Pola than with R-GemOx (11.5 months [95% CI, 5.6 to 18] v 3.8 months [95% CI, 2.9 to 4.1]; hazard ratio for progression or death, 0.41 [95% CI, 0.3 to 0.6]; P < .0001). ORR was significantly greater with Mosun-Pola versus R-GemOx (70% v 40%; P < .0001), with complete response rates of 51% and 24%, respectively. In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome (CRS) and usage of tocilizumab occurred in <5% of patients and patient-reported outcomes were improved compared with R-GemOx.
Conclusion: Mosun-Pola demonstrated superior efficacy versus R-GemOx, with significant improvements in both ORR and PFS, and infrequent CRS events with a manageable safety profile.
Journal of Clinical Oncology , article en libre accès, 2025