Roche says Lunsumio-Polivy combo significantly prolongs remission in study

Roche (RHHBY) presented results from the Phase 3 SUNMO study showing Lunsumio administered subcutaneously in combination with Polivy demonstrated a “clinically meaningful and statistically significant improvement” in its primary endpoints of progression-free survival and objective response rate compared to MabThera/Rituxan, gemcitabine and oxaliplatin, or R-GemOx, in people with relapsed or refractory large B-cell lymphoma who are not eligible for transplant. Primary analysis data were featured at the 18th International Conference on Malignant Lymphoma as a late-breaking oral presentation. At a median follow-up of 23.2 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to R-GemOx. Median PFS was three times longer with Lunsumio and Polivy at 11.5 months, compared to 3.8 months for R-GemOx and 12-month PFS was more than doubled at 48.5% vs.17.8%, respectively. This PFS benefit was consistent across subgroups, including in high-risk patients with primary refractory disease. At the interim analysis, overall survival data were not yet mature. OS numerically favored the Lunsumio and Polivy combination with a median of 18.7 months compared to 13.6 months for R-GemOx. Results from the SUNMO study will be submitted to global health authorities, including the Food and Drug Administration. “Lunsumio and Polivy represent the first combination of a bispecific antibody and antibody-drug conjugate, which could avoid chemotherapy and potentially provide an alternative option for some patients with relapsed or refractory LBCL,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are also encouraged by the favourable safety profile and potential for outpatient use of this regimen, which may suit diverse patient and healthcare system needs.”