Key Takeaways:
EC approved AbbVie's TEPKINLY combo for relapsed follicular lymphoma after a Phase 3 trial showed a 79% lower progression risk.
"Follicular lymphoma remains incurable, and patients often relapse with shorter remissions each time," Catherine Thieblemont, head of hemato-oncology at Paris Cité University and Hôpital Saint-Louis APHP, said. "The results show the potential for TEPKINLY plus R2 to offer a durable response with a chemotherapy-free option."
In the EPCORE FL-1 trial, 74% of patients receiving TEPKINLY plus R2 achieved a complete response, compared with 43% on R2 alone. The overall response rate reached 96% versus 81%. Serious adverse reactions occurred in 44% of patients, including cytokine release syndrome, pneumonia, COVID-19 and febrile neutropenia.
FL is the second most common form of non-Hodgkin lymphoma, accounting for 20% to 30% of cases, with higher incidence in European populations. The approval gives AbbVie a chemotherapy-free option in the second-line setting, where no bispecific therapy was previously available in Europe.
The approval strengthens AbbVie's oncology portfolio as it competes with Roche and Johnson & Johnson in the lymphoma market. Investors will watch for additional regulatory decisions as the company pursues approvals for TEPKINLY in earlier lines of therapy and in diffuse large B-cell lymphoma.
This article is for informational purposes only and does not constitute investment advice.
