AbbVie Bolsters Oncology Franchise with Strong Epkinly Data
Pivotal Phase 3 results for its blood cancer drug, developed with Genmab, show a 79% reduction in disease progression, solidifying its recent full FDA approval.
AbbVie (NYSE: ABBV) is cementing its position in the competitive blood cancer market after its partner Genmab presented stellar data from a pivotal Phase 3 trial for the drug Epkinly (epcoritamab). The results, unveiled Sunday, showed the combination therapy reduced the risk of disease progression or death by 79% in patients with a common type of non-Hodgkin's lymphoma.
The data provides a powerful clinical backing for Epkinly's recent full approval from the U.S. Food and Drug Administration (FDA) in November, positioning the treatment as a potential best-in-class option and a key growth driver for AbbVie's formidable oncology division. The company, with a market capitalization of nearly $400 billion, is aggressively expanding its portfolio to offset the eventual decline of its blockbuster immunology drug, Humira.
The EPCORE FL-1 trial evaluated Epkinly in combination with the standard care chemotherapy regimen of rituximab and lenalidomide (R2) for patients with relapsed or refractory (R/R) follicular lymphoma (FL). Follicular lymphoma is a slow-growing but incurable type of non-Hodgkin's lymphoma, and patients who relapse after initial treatment have limited options. According to the press release from Genmab, the positive results (HR 0.21; P<.0001) were statistically significant and clinically meaningful.
This strong confirmatory data was crucial for the FDA's decision on November 18, 2025, to grant Epkinly full approval for adult patients with R/R FL who have received at least one prior line of therapy. The decision, announced by AbbVie last month, converted a previous accelerated approval into a full one, making Epkinly the first and only bispecific antibody approved in combination for this patient population.
Analysts see significant commercial potential for the drug, with global sales forecasts for Epkinly projected to exceed $2.5 billion by 2030. The broader market for follicular lymphoma treatments is expected to grow from $1.7 billion in 2025 to over $3 billion by 2034, driven by new and more effective therapies. Epkinly, a subcutaneously administered bispecific antibody, is now well-positioned to capture a substantial share of that expanding market.
The drug's success places AbbVie in a strong competitive posture against other major players in the space. Roche's Lunsumio (mosunetuzumab) and Regeneron's odronextamab are also targeting similar patient populations. However, Epkinly's approval as a second-line combination therapy provides a key strategic advantage, potentially allowing for its use earlier in the treatment paradigm compared to competing monotherapies often reserved for later-stage disease.
Epkinly is a cornerstone of the strategic partnership between AbbVie and Danish biotechnology firm Genmab. Under the terms of their agreement, the companies share commercial responsibilities and profits in the U.S. and Japan, while AbbVie takes the lead on global commercialization elsewhere. This collaboration leverages AbbVie’s global marketing muscle with Genmab’s antibody development expertise.
For AbbVie, the continued success of its oncology pipeline, which also includes the blockbuster Imbruvica, is paramount. The company's stock, trading around $226 a share, is up significantly over the past year, reflecting investor confidence in its ability to navigate the loss of exclusivity for Humira. Wall Street's consensus price target for AbbVie sits at approximately $243, suggesting further upside as drugs like Epkinly ramp up commercially. The positive clinical data not only de-risks the drug's future revenue stream but also validates AbbVie's strategy of building a diversified portfolio of high-value specialty drugs.