Genmab shares advanced by over 6% on Tuesday after the Danish biotechnology firm released interim data from a Phase III trial evaluating Epkinly in combination with lenalidomide as a second-line therapy for diffuse large B-cell lymphoma (DLBCL).
The study compared the Epkinly-plus-lenalidomide regimen against the chemotherapy combination R-GemOx and reported a progression-free survival (PFS) hazard ratio (HR) of 0.40 in favor of the Epkinly combination. The company stated that both results were statistically significant.
Analysts at Bank of America, led by Charlie Haywood, said the very strong PFS HR - which exceeded expectations in the c0.5-0.6 range - bolsters the view that Epkinly can offer a competitive efficacy profile in the second-line DLBCL setting. The bank quantified the second-line opportunity at roughly $0.8 billion in potential peak sales.
Bank of America noted that this readout helps address lingering questions after Epkinly missed in an earlier second-line monotherapy Phase III study. The bank attributed that prior miss primarily to the confirmatory nature of the study and potential confounding effects tied to COVID-19.
Beyond the efficacy numbers, the bank highlighted safety disclosures in Genmab’s announcement as being consistent with previously reported data. They suggested that the chemo-free combination - delivered through a mix of subcutaneous injection and oral medication - could present a commercial advantage over Roche’s intravenous STARGLO regimen. The bank added that STARGLO shows a comparable efficacy signal but is generally used in a different patient population, according to physician feedback cited by the analysts.
While Bank of America emphasized that second-line lymphoma is not the largest commercial opportunity for Epkinly, the positive interim data are seen as supportive of the program overall. The bank said the result aligns with its view that the larger first-line trial has not yet reached its interim analysis, and that the first-line readout remains expected around the middle of this year.
For the first-line study, Bank of America indicated a success bar of a hazard ratio below 0.65 and estimated the first-line opportunity at about $2 billion in peak sales. The bank also pointed to two other wholly owned Genmab assets - Rina-S in platinum-resistant ovarian cancer and Petosemtamab in head and neck cancer - each viewed as roughly $2 billion peak opportunities.
Bank of America suggested that positive outcomes across Epkinly’s first-line program and the two other assets in development could materially change sentiment for the company, estimating that successful readouts across the three programs might translate into up to a 40% upside to its 2035 earnings per share forecast.
Context for markets and investors
The interim PFS result appears to have been the immediate catalyst for the share-price move, with investors responding to a data point that both exceeded analyst expectations and helped alleviate concerns raised by a prior trial miss. The announcement also recasts commercial positioning considerations for Epkinly relative to competing regimens, given the potential convenience of a subcutaneous and oral chemo-free approach.
Looking ahead, markets will remain attentive to the timing and outcomes of the pending first-line interim analysis and the upcoming data from Genmab’s Rina-S and Petosemtamab studies later in the year.