Roche and Genentech have announced outcomes from the randomised, multi-centre, international Phase III SUNMO trial for those with relapsed or refractory large B-cell lymphoma (LBCL) who are ineligible for transplant.
Results indicated that the subcutaneous administration of Lunsumio (mosunetuzumab) with Polivy (polatuzumab vedotin) improved the primary goal of progression-free survival (PFS) and objective response rate (ORR).
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The results compared the combination to MabThera/Rituxan (rituximab), gemcitabine, and oxaliplatin (R-GemOx).
The primary analysis data were presented at the 18th International Conference on Malignant Lymphoma, with plans to submit the findings to worldwide health authorities, including the US Food and Drug Administration.
Both companies noted that, at a median 23.2-month follow-up, the combination therapy showed a 59% decrease in disease progression or mortality risk compared to R-GemOx.
The median PFS was notably longer at 11.5 months for the combination group, versus 3.8 months for R-GemOx.
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By GlobalDataThe 12-month PFS rate was more than double at 48.5%, compared to 17.8% for R-GemOx, with benefits consistent across various patient subgroups.
Although overall survival (OS) data were not mature at the interim analysis, it was numerically higher for the combination therapy at a median of 18.7 months, versus 13.6 months for R-GemOx.
The objective response was achieved by 30% more subjects in the combination group, with a complete response rate of 51.4%, doubling the rate observed with R-GemOx.
The safety profile of the combination aligned with the known profiles of the individual trial medicines.
Lunsumio and Polivy are a CD20×CD3 T-cell-engaging bispecific antibody and an anti-CD79b antibody-drug conjugate (ADC), respectively.
Roche global product development head and chief medical officer Levi Garraway said: “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.
“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.”
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