Just days after AbbVie unveiled a major new oncology play in the form of its high-dollar RemeGen collab, the Illinois drugmaker closed out the week with some mixed news for its marketed cancer offering Epkinly.
Friday afternoon, the company and its partner Genmab shared word that the phase 3 Epcore DLBCL-1 trial missed on its primary endpoint of overall survival. Specifically, the partners' Epkinly failed to mount a statistically significant OS benefit among patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
The trial enrolled 483 adult patients with relapsed/refractory DLBCL, 73% of whom had previously tried at least two prior lines of therapy. Investigators tested AbbVie and Genmab's CD3xCD20 bispecific antibody, Epkinly, as a monotherapy compared with investigator's choice of chemoimmunotherapy.
OS is the trial's primary outcome measure, according to the study plan shown on ClinicalTrials.gov.
Despite the primary endpoint miss, AbbVie and Genmab were quick to point out that the trial showed a 26% improvement in the risk of disease progression or death, a secondary measure.
Besides demonstrating an improvement in progression-free survival, Epkinly also showed improvements in complete response rates, duration of response and time to next treatment, the partners said. Those are secondary outcome measures, as well, according to the ClinicalTrials.gov listing.
The partners didn't share the full phase 3 data but said they would be presented at an upcoming medical meeting. In the Friday release, the companies said they "will engage global regulatory authorities to discuss next steps."
In addition, the companies plan to look at how "various factors," including the pandemic and the availability of novel anti-lymphoma agents, may have played into the results. The trial started in early 2021 and is ongoing.
Epkinly already carries an accelerated approval as a third-line treatment for relapsed/refractory DLBCL, based on overall response rate (ORR) and duration of response (DOR) results from a prior trial, its FDA label shows. Specifically, in the open-label phase 1/2 Epcore NHL-1 trial, the overall response rate was 61%. Of those responders, the median duration of response was 15.6 months.
While the Epcore DLBCL-1 result may raise more questions than answers, the companies have another major shot on goal for Epkinly underway with the Epcore DLBCL-2 trial. The phase 3 study in first-line DLBCL is expected to read out this year after starting in 2023, which should make its results free from pandemic-era variability. The study includes the R-CHOP treatment regimen in both the Epkinly and control arms.
While Epkinly isn't AbbVie's largest sales driver, the drug has continued its commercial upswing since its initial nod back in 2023. Worldwide sales reported by AbbVie through the first nine months of 2025 were $190 million compared with $146 million during all of 2024.
The drug in November scored an approval in second-line follicular lymphoma (FL) when combined with rituximab and lenalidomide, further expanding its reach in the lymphoma space. Before that, it was cleared as a third-line FL therapy.