AbbVie, Genmab Promote Epkinly Combos for Early-Stage Non-Hodgkin Lymphoma

AbbVie and Genmab are highlighting the potential of their bispecific antibody, Epkinly, in treating non-Hodgkin lymphoma, showcasing positive outcomes from ongoing trials. At the American Society of Hematology's annual gathering, the two companies presented long-term data from their Phase 1b/2 trial, which involves combining Epkinly with other established treatments for diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL).

In the case of DLBCL, Epkinly was tested alongside the standard R-CHOP regimen, which includes rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. The trial included 46 evaluable patients, all of whom exhibited a response, with 87% achieving a complete response after a median follow-up of 27.4 months. This combination is presently being evaluated in a Phase 3 trial for first-line treatment. Allam Fakhoury, AbbVie's head of hematology oncology, mentioned that the trial is fully enrolled, and the company is in the process of determining the timing for data readout.

For FL, the trial combined Epkinly with rituximab and lenalidomide, marketed as Rituxan and Revlimid, respectively. This combination achieved a 96% overall response rate among 111 previously treated patients, with an 87% complete response rate at a median follow-up of just over two years. AbbVie's therapeutic area head for hematology, Mariana Cota Stirner, referred to these results as "encouraging." A Phase 3 trial is now testing this Epkinly combination in FL patients who have received at least one prior therapy.

Epkinly has already demonstrated efficacy in third-line settings, securing accelerated approvals as a monotherapy for both FL and DLBCL. AbbVie initially partnered with Genmab in 2020, providing $750 million upfront for collaborative cancer treatment endeavors, including Epkinly. The drug has shown a successful launch, generating $43 million in sales during the third quarter reported in October.

Epkinly was featured in over 20 abstracts at the ASH meeting, including findings in chronic lymphocytic leukemia (CLL). In this context, 23 patients were treated within an expansion cohort of the Phase 1b/2 trial, with 61% responding to the treatment and 39% achieving complete response. The median progression-free survival for this group was 12.8 months, while the median overall survival had not been reached.

Moreover, AbbVie and Genmab noted improvements in immune-related toxicities in a separate "optimization" cohort that included an extra step-up dose. Brian Elliott, Genmab's clinical development lead for Epkinly, commented that the regimen seems more tolerable, causing only low-grade cases of cytokine release syndrome, which is an immune system overreaction to treatment. Elliott expressed optimism about the findings, despite the small group of patients involved at this stage.

In summary, the continued investigation and combination trials of Epkinly suggest promising advancements in the treatment of non-Hodgkin lymphoma. The encouraging response rates and improvements in tolerability highlight Epkinly's potential as a significant therapeutic option in these cancer types.