Roche’s Columvi (glofitamab), in combination with GemOx (gemcitabine and oxaliplatin), has demonstrated sustained survival benefit in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT).
Results from the phase 3 STARGLO study compared the Columvi-GemOx combination treatment with a combination of MabThera/Rituxan (rituximab) and GemOx.
The study found that, after a median follow-up period of 35.1 months, overall survival remained twice as long for patients treated with Columvi-GemOx versus patients treated with MabThera/Rituxan-GemOx.
Of the patients treated with Columvi-GemOx who had received one prior line of therapy, 54.6% were still alive at 36 months.
Median progression-free survival for Columvi-GemOx-treated patients was 20.4 months, compared with 5.5 months in the MabThera/Rituxan-GemOx group.
Extended follow-up identified no new safety signals associated with the Columvi-GemOx combination, and the safety profile of the combined treatment was consistent with each drug’s individual safety profile.
Jeremy Abramson, principal investigator of the STARGLO study, said: “The data continues to underscore the meaningful benefit of glofitamab plus GemOx for patients after initial relapse.”
DLBCL is an aggressive and fast-growing form of non-Hodgkin lymphoma, and approximately 160,000 cases are diagnosed worldwide each year. Even though DLBCL is broadly responsive to first-line treatment, up to 40% of patients will have a relapse or become refractory to treatment, highlighting the importance of discovering new second- or third-line treatments for R/R DLBCL.
The Columvi-GemOx combination is already approved in the UK, Canada, Australia, China, Mexico and various EU countries.
Levi Garraway, chief medical officer and head of global product development at Roche, said: “By prolonging survival, this Columvi combination could offer people with R/R DLBCL long-term remission, and potential additional time to spend with their loved ones without signs of disease or the need for continuous therapy.
“The potential of Columvi in combination with GemOx continues to be recognised globally, with approvals in more than 50 countries around the world and inclusion in multiple international treatment guidelines.”