Lunsumio (mosunetuzumab) - (SUNMO)

June 18, 2026: Roche (SIX: RO, ROP; OTCQX: RHHBY) announced the FDA has accepted its supplemental BLA for Lunsumio VELO (mosunetuzumab) subcutaneous formulation in combination with Polivy (polatuzumab vedotin) to treat adults with relapsed/refractory large B-cell lymphoma (LBCL), including DLBCL, after at least one prior systemic therapy. The FDA decision is expected by February 9, 2027.

The filing is supported by the Phase III SUNMO trial (NCT05171647) in transplant-ineligible R/R LBCL, comparing Lunsumio VELO + IV Polivy vs rituximab + gemcitabine/oxaliplatin (R-GemOx). At a median follow-up of 23.2 months, the combination reduced risk of progression or death by 59% (PFS HR 0.41; 95% CI 0.28–0.61; p<0.0001) and improved median PFS to 11.5 months (95% CI 5.6–17.6) vs 3.8 months (95% CI 2.9–4.1) for R-GemOx. Safety was consistent with known profiles; CRS occurred in ~25% of patients, with <5% Grade 2/3 events.

Updated SUNMO data were presented at ASCO 2026 and EHA 2026, reporting continued PFS benefit (notably in second-line) with no new safety signals.