Roche released detailed data at the European Hematology Association congress for its CD20xCD3 bispecific antibody Columvi in earlier lines of large B cell lymphoma, showing just how much the drug improved overall survival over a comparator.
The trial compared a combination of Columvi plus gemcitabine and oxaliplatin (Glofit-GemOx) against rituximab plus the chemotherapies (R-GemOx). At primary analysis in early 2023, Glofit-GemOx showed a “significant” overall survival benefit with a hazard ratio of 0.59, with a p-value of p=0.011. With a median follow-up of 11.3 months, median OS was not reached for Glofit-GemOx, compared to nine months for R-GemOx.
Roche unveiled topline data in April for the trial as part of its path toward full approval and potentially a label expansion into earlier lines of therapy. It already won FDA accelerated approval for relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of therapy in June 2023. In the first quarter of 2024, Columvi (glofitamab) pulled in $27.9 million (25 million CHF).
In the trial, 172 patients (62.8%) were included who had one prior therapy and 102 patients (37.2%) after more than two prior therapies. Columvi was given as a fixed-duration monotherapy in patients with relapsed or refractory DLBCL in patients who have had at least one prior line of therapy and are not eligible for autologous stem cell transplant.
For progression-free survival, a secondary endpoint, Glofit-GemOx notched a hazard ratio of 0.37 (p<0.0001) and the complete response rate was 50.3% for Glofit-GemOx versus 22% for R-GemOx (p<0.0001).
In a follow-up analysis with a later cutoff date, investigators noted that Glofit-GemOx median overall survival was 25.5 months versus 12.9 months for the comparator; median progression-free survival was 13.8 months versus 3.6 months for the comparator; and complete response rate was still superior for Glofit-GemOx with 58.5% versus 25.3% for R-GemOx.
Adverse events were higher with Glofit-GemOx, however, including grade 3 and 4 events — 69.4% for Glofit-GemOx versus 36.4% on R-GemOx. More patients died on the Glofit-GemOx group (8.3%) than the other group (4.5%), which researchers say was “primarily driven by an imbalance” of Covid-19 adverse events.
According to Roche, Columvi is the first CD20xCD3 bispecific antibody to show a survival benefit in this type of the disease in a randomized Phase 3 trial.