AbbVie and Genmab’s innovation in bispecific antibodies, particularly Epkinly, faces a significant hurdle following its recent Phase III trial results. Although the study did not achieve the desired overall survival (OS) improvements for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), market analysts remain cautiously optimistic about the drug’s future.
Trial Overview and Results
The Phase III EPCORE DLBCL-1 trial involved 483 patients who were unable to undergo high-dose chemotherapy or autologous stem cell transplantation. The trial aimed to assess the effectiveness of Epkinly compared to the traditional investigator’s choice of chemotherapy. The results revealed a modest 4% improvement in OS, a finding that ultimately did not meet the statistical significance required for regulatory approval.
Analyst Reactions
Despite the disappointing OS endpoint, analysts have expressed continued faith in the Epkinly franchise. Analysts from Truist Securities noted that the results were disappointing but did not undermine their optimism for the ongoing frontline trial. Similarly, William Blair characterized the outcome as “unfortunate,” yet emphasized that it does not diminish the potential of upcoming key readouts in 2026.
Regulatory Considerations
William Blair highlighted that the FDA considers OS a primary endpoint for the EPCORE DLBCL-1 trial. This has stirred some concern among investors regarding the drug’s accelerated approval status, granted in May 2023. The ongoing verification of clinical benefits in this Phase III confirmatory study remains crucial for maintaining Epkinly’s approval.
Progression-Free Survival and Other Metrics
Despite the setback in overall survival, Epkinly demonstrated a significant improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 26% compared to chemotherapy. Moreover, the bispecific antibody achieved positive outcomes in additional endpoints, such as complete response rate, duration of response, and time to next treatment.
Future Pathways for Epkinly
In light of these findings, AbbVie and Genmab are preparing to engage with global health authorities to determine the most effective path forward for Epkinly in treating DLBCL. Their collaborative efforts in developing this bispecific antibody began in June 2020, and both companies share the responsibility for commercialization in the U.S. market.
Ongoing and Upcoming Studies
Beyond the EPCORE DLBCL-1 trial, AbbVie and Genmab are conducting the Phase III EPCORE-DLBCL-4 study. This trial evaluates the efficacy of Epkinly in combination with lenalidomide against traditional chemo-immunotherapy. Additionally, the late-stage EPCORE DLBCL-2 study examines the combination of Epkinly with rituximab and other chemotherapeutic agents. Results from both studies are anticipated later this year.
Conclusion
While the recent trial results pose challenges for Epkinly, the potential for improved outcomes in other key metrics offers a glimmer of hope. The ongoing studies may provide critical insights that could help solidify the bispecific antibody’s role in lymphoma treatment. As AbbVie and Genmab navigate these complexities, the future of Epkinly remains a focal point for investors and healthcare professionals alike.
- Key Takeaways:
- Epkinly missed its overall survival endpoint in a Phase III trial.
- Analysts remain optimistic about the drug’s future despite the setback.
- Significant improvements in progression-free survival were noted.
- Ongoing studies may provide further insights and potential for approval.
- AbbVie and Genmab continue to collaborate closely on Epkinly’s development.
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