Chugai Pharmaceutical has announced that it has received regulatory approval from the Ministry of Health, Labour and Welfare for an additional indication of the combination therapy of Lunsumio (mosunetuzumab) and Polivy (polatuzumab vedotin) for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). The approval marks the first time globally that this combination therapy has been authorised for this indication.

The decision is based on data from the global Phase III SUNMO trial, which evaluated the efficacy and safety of the combination therapy compared to a chemotherapy regimen in patients who are not eligible for autologous hematopoietic stem cell transplantation.

According to trial results, the combination therapy demonstrated a significantly higher objective response rate (ORR) of 69.7 percent compared to 44.1 percent in the control group. Additionally, the treatment reduced the risk of disease progression or death by 59 percent, with median progression-free survival of 11.5 months versus 3.8 months for the comparator arm.

Company leadership highlighted that treatment options for patients with relapsed or refractory LBCL remain limited, making this approval a critical advancement in addressing unmet medical needs.

The safety profile of the Lunsumio–Polivy combination was consistent with known data for each drug. Common adverse events included injection site reactions, neutropenia, anaemia and cytokine release syndrome, with overall incidence rates comparable to existing therapies.

Lunsumio is a bispecific antibody designed to engage T cells and target CD20-expressing B cells, activating immune-mediated tumour cell destruction. Polivy, an antibody-drug conjugate targeting CD79b, delivers a cytotoxic agent directly to cancer cells, minimising damage to healthy tissue.

Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), is the most common form of aggressive non-Hodgkin lymphoma. While many patients respond to initial treatment, up to 40 percent experience relapse or become resistant to therapy, underscoring the need for more effective treatment options.

With this approval, Chugai aims to expand access to innovative therapies and improve outcomes for patients with advanced lymphoma.