That therapy, developed jointly with Denmark-based Genmab A/S, encountered a setback earlier in the month. On January 16, the companies announced that a phase III study evaluating epcoritamab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) failed to demonstrate a statistically significant overall survival benefit at the interim analysis. The randomized trial enrolled 483 adults who had previously received at least one line of therapy and were ineligible for intensive chemotherapy followed by stem-cell transplantation.
Despite the missed primary endpoint, secondary measures offered encouraging trends. Investigators reported higher complete-response rates among participants receiving epcoritamab, longer durability of response, and an extended median time to subsequent treatment compared with the control arm. AbbVie and Genmab stated that they will review the full dataset with regulators and intend to present additional findings at upcoming medical meetings.
Epcoritamab is a bispecific antibody that simultaneously targets CD3 on T cells and CD20 on B cells, aiming to direct the immune system to attack malignant lymphoma cells. The drug is already available for certain lymphoma indications in several regions, marketed as Epkinly in the United States and Japan and as Tepkinly in the European Union. Its initial U.S. authorization for patients with relapsed or refractory DLBCL who have received at least two prior lines of therapy was granted under the Food and Drug Administration’s accelerated approval pathway, which requires confirmatory studies to verify clinical benefit. Detailed regulatory information can be found on the U.S. Food and Drug Administration’s website.
The recent clinical update underscores the binary nature of late-stage drug development and highlights why Citi remains cautious on near-term share performance despite longer-term confidence in AbbVie’s pipeline. Continued evaluation of epcoritamab will determine whether the therapy can transition from accelerated to traditional approval in its existing indications and potentially expand into earlier-line settings.
Separately, AbbVie features on several long-term investment lists, including a group of 12 equities identified for their potential to generate sustained shareholder returns. Supporters emphasize the company’s established immunology franchise—anchored by Skyrizi and Rinvoq—as well as growth prospects in neuroscience and aesthetics. The expiration of market exclusivity for Humira in the United States during 2025 increased investor focus on the firm’s ability to offset revenue erosion with new products and cost controls.
Citi’s broader sector review acknowledged that, across biopharma, valuation multiples have compressed amid macroeconomic uncertainty and rising capital costs. However, the bank anticipates that stable demand for innovative medicines, incremental clarity on drug-pricing provisions, and a rebound in capital-market activity could help re-rate quality names. Within this context, AbbVie’s diversified revenue base and sizable dividend are seen as potential buffers against market volatility, though upcoming trial outcomes remain a swing factor.
For portfolio managers, the mixed signals surrounding epcoritamab exemplify the importance of balancing pipeline opportunity with execution risk. While the drug’s most recent trial result did not meet its primary goal, secondary efficacy markers suggest biological activity that could translate into future approvals or line-extension applications, pending further evidence.
Looking ahead, investors will monitor AbbVie’s first-quarter earnings release, additional oncology data presentations, and any guidance revisions tied to policy developments in the United States and major international markets. Citi indicated that confirmation of easing regulatory pressures, combined with clear milestones for late-stage assets, could lead to an upgraded view on the stock and the wider biopharma group.
Crédito da imagem: AbbVie Inc.
