Roche Bispecific T-Cell Engager Improves Survival in Lymphoma, Teeing up Label Expansion

 Roche's Genentech subsidiary on Monday announced that its bispecific T-cell engager Columvi (glofitamab) improved survival in a Phase III lymphoma trial, with the company planning to seek a full, expanded label in a potential challenge to AbbVie and Genmab’s Epkinly (epcoritamab). 

Columvi targets CD3 on T cells and CD20 on B cells, which are malignant in some blood cancers. The bispecific mechanism is designed to put T cells in a position to kill cancerous B cells. Roche received accelerated FDA approval in June 2023 and kept collecting Phase III data to confirm the effects of the therapy.

Roche designed the Phase III trial to compare the effects of Columvi and Rituxan (rituximab) in 270 patients with diffuse large B-cell lymphoma (DLBCL) who had received at least one prior line of therapy and were ineligible for autologous stem cell transplants. Participants received either Columvi or Rituxan on top of a regimen of two chemotherapy drugs, gemcitabine and oxaliplatin.

Overall survival was significantly longer in the Columvi cohort than the Rituxan arm, causing the study to hit its primary endpoint. Roche has yet to share the survival data or discuss the secondary endpoints. The company said the Columvi-chemotherapy combination “appeared consistent” with the safety profiles of the individual medicines without providing additional details.

Roche will share the data at an upcoming medical meeting and plans to submit the results to regulatory authorities. The submissions could enable the Swiss drugmaker to convert the accelerated FDA approval into a full authorization and extend the label to cover earlier lines of treatment.

The FDA granted Roche accelerated approval in people who have received two or more lines of systemic therapy. Roche Pharmaceuticals CEO Teresa Graham said on an earnings call in February 2024 that the launches of Columvi and Lunsumio, another lymphoma drug authorized in later-line patients, “continue to go well” but predicted that upcoming readouts could unlock the products’ full commercial potential.

“I think we have always said that the real opportunity for these drugs is moving into earlier lines of treatment,” Graham said. “We would expect CHF 200 million ($219 million) of additional sales here in the third-line plus indications. But we do get that second line DLBCL data for both of these products this year, and that is really where the additional growth will come from.”

Roche reported CHF 28 million ($30.7 million) in Columvi sales last year. Genmab reported $64 million for its rival AbbVie-partnerd T-cell engager Epkinly. Columvi and Epkinly won their respective accelerated approvals on the strength of Phase I/II results and their developers are running confirmatory studies that could move their therapies into earlier lines of treatment. AbbVie and its partner Genmab began a Phase III DLBCL study one month before Roche started its confirmatory trial.

https://www.biospace.com/article/roche-bispecific-t-cell-engager-improves-survival-in-lymphoma-teeing-up-label-expansion/