Japan Grants First Global Approval To Chugai’s Lunsumio–Polivy Combination For Relapsed Large B-Cell Lymphoma

Chugai Pharmaceutical Co., Ltd. has received approval from Japan’s Ministry of Health, Labour and Welfare for an expanded indication covering the combination use of Lunsumio® and Polivy® in patients with relapsed or refractory large B-cell lymphoma. The decision marks the first global regulatory approval for this dual-antibody regimen in the specified blood cancer setting. Lunsumio (mosunetuzumab) is a CD20/CD3 bispecific antibody, while Polivy (polatuzumab vedotin) targets CD79b through an antibody–drug conjugate mechanism.

The approval is supported by findings from the global, multicenter, randomised Phase III SUNMO study. The trial compared the Lunsumio–Polivy combination with the rituximab, gemcitabine, and oxaliplatin (R-GemOx) regimen in patients who were ineligible for autologous hematopoietic stem cell transplantation. R-GemOx is not approved in Japan, but served as the comparator arm in the study.

“For patients with relapsed or refractory large B-cell lymphoma, treatment options remain limited and unmet medical needs persist. The Lunsumio and Polivy combination therapy achieved responses in approximately 70% of patients and reduced the risk of disease progression or death by 59% compared with the chemotherapy control arm. We are committed to delivering this treatment to patients as quickly as possible by providing timely information to healthcare professionals and promoting appropriate use,” said Dr Osamu Okuda, Chugai’s President and CEO.

Interim results showed a significantly higher objective response rate in the combination therapy group (69.7%) compared with the R-GemOx arm (44.1%), representing a meaningful treatment advantage. In the primary analysis, progression-free survival was 11.5 months for patients receiving the antibody combination, compared with 3.8 months for those on R-GemOx, translating into a 59% reduction in the risk of disease progression or death.

Safety outcomes were aligned with the known profiles of both medicines when used individually. Treatment-emergent adverse events were reported in most patients across both arms. In the combination group, commonly observed events included injection-site reactions, neutropenia, anaemia, and cytokine release syndrome, consistent with expected immune-mediated and hematologic effects.