Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx1This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community careThese data demonstrate Roche's commitment to providing options for diverse patient and healthcare system needs in this difficult-to-treat lymphoma Basel, 20 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today results from the phase III SUNM ...

Core Insights - Roche's phase III SUNMO study results indicate that the combination of Lunsumio® (mosunetuzumab) and Polivy® (polatuzumab vedotin) significantly improves progression-free survival (PFS) and objective response rate (ORR) in patients with relapsed or refractory large B-cell lymphoma (LBCL) compared to the standard treatment R-GemOx [1][2][5] Study Results - The combination therapy showed a 59% reduction in the risk of disease progression or death (hazard ratio [HR] 0.41, p<0.0001) with a median PFS of 11.5 months, which is three times longer than the 3.8 months observed with R-GemOx [2][4] - The 12-month PFS rate was 48.5% for the combination therapy compared to 17.8% for R-GemOx [2][3] - Objective response rates were 70.3% for the combination versus 40.0% for R-GemOx, with complete response rates of 51.4% compared to 24.3% [3][4] Safety Profile - The safety profile of the Lunsumio and Polivy combination was consistent with known profiles of the individual drugs, with low incidence of cytokine release syndrome (CRS) and similar rates of grade 3-4 adverse events compared to R-GemOx [4][5] - Fewer patients in the combination group discontinued treatment due to adverse events (2.2% vs. 4.7%) [4] Clinical Implications - The combination therapy may provide a well-tolerated alternative to traditional chemotherapy, suitable for outpatient settings, addressing the urgent need for effective treatments in difficult-to-treat LBCL [3][6] - The National Comprehensive Cancer Network (NCCN) has included Lunsumio and Polivy in its guidelines as a category 2A recommendation for second-line treatment of diffuse large B-cell lymphoma [2][3] Roche's Commitment - Roche aims to enhance treatment options for patients with lymphomas through its extensive portfolio and ongoing clinical trials, including the STARGLO study evaluating Columvi® (glofitamab) [7][8] - The company has a strong focus on developing innovative therapies for hematologic diseases, with a robust pipeline that includes various bispecific antibodies and antibody-drug conjugates [13][14]