By: IPP Bureau
Last updated : June 21, 2025 11:10 am
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
Roche presented results from the phase III SUNMO [NCT05171647] study showing Lunsumio (mosunetuzumab) administered subcutaneously in combination with Polivy (polatuzumab vedotin) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to MabThera/Rituxan (rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) 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.
“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.”
“There remains a clear need for effective and well-tolerated treatments for people with this difficult-to-treat disease,” said Jason Westin, Professor of Lymphoma and Director of Lymphoma Clinical Research, The University of Texas, MD Anderson Cancer Center. “If approved, this off-the-shelf treatment combination of mosunetuzumab and polatuzumab vedotin could be administered over a fixed period of time, without mandatory hospitalisation or traditional chemotherapy, which could provide a meaningful option for patients with relapsed or refractory LBCL.”
Roche’s lymphoma portfolio is one of the broadest in the industry, providing a unique and much-needed opportunity to combine regimens with different and complementary mechanisms of action.