Roche's Bispecific Agent Extends Lymphoma Survival, Paving Way for Label Expansion

Roche's Genentech division revealed that its bispecific T-cell engager, Columvi (glofitamab), demonstrated improved survival rates in a Phase III lymphoma trial. In light of these results, Roche intends to pursue a full, expanded label which may potentially rival AbbVie and Genmab’s Epkinly (epcoritamab).

Columvi operates by targeting CD3 on T cells and CD20 on B cells, both of which are implicated in certain blood cancers. This bispecific function essentially positions T cells to annihilate malignant B cells. Approved by the FDA on an accelerated basis in June 2023, Roche has continued collecting Phase III data to validate the therapy’s effectiveness.

The Phase III clinical trial was constructed by Roche to contrast the outcomes of Columvi and Rituxan (rituximab) among 270 patients suffering from diffuse large B-cell lymphoma (DLBCL) who had previously undergone at least one line of therapy and were not qualified for autologous stem cell transplants. Subjects received either Columvi or Rituxan, coupled with the chemotherapy drugs gemcitabine and oxaliplatin.

Results showed a marked improvement in overall survival for the Columvi group when compared to the Rituxan group, achieving the primary endpoint of the study. Although Roche has not yet released survival data or commented on secondary endpoints, it noted that the safety profiles of the Columvi-chemotherapy combination were consistent with those of the individual medications, without providing further specifics.

Roche plans to present the data at an upcoming medical conference and will submit the findings to regulatory bodies. Such submissions could allow Roche to convert the FDA's accelerated approval into a full authorization, expanding the label to incorporate earlier lines of treatment.

Previously, the FDA had granted accelerated approval for patients who had received two or more lines of systemic therapy. In a February 2024 earnings call, Roche Pharmaceuticals CEO Teresa Graham shared that the launches of Columvi and another lymphoma treatment, Lunsumio, were progressing positively, suggesting that future data readings could unlock the full commercial potential of these therapies.

Graham stated, “We have always believed the true potential for these drugs lies in moving into earlier lines of treatment. We foresee an additional CHF 200 million ($219 million) in sales within the third-line plus indications. However, securing second-line DLBCL data for both products this year will truly drive further growth.”

Roche reported CHF 28 million ($30.7 million) in Columvi sales last year, while Genmab reported $64 million for its competitor, the AbbVie-partnered Epkinly. Both Columvi and Epkinly obtained their accelerated approvals based on promising Phase I/II results, and their developers are undertaking confirmatory studies aimed at moving these therapies into earlier lines of treatment. AbbVie and Genmab initiated a Phase III DLBCL study a month ahead of Roche's confirmatory trial.