AbbVie ABBV and partner Genmab GMAB announced that the FDA has granted accelerated approval to their T-cell engaging bispecific antibody epcoritamab for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The new drug will be marketed by the trade name of Epkinly. Continued approval for this indication will be based on data from some confirmatory studies.
Epkinly is approved for treating relapsed/refractory DLBCL not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma, after two or more lines of systemic therapies. DLBCL is a common, aggressive and fast-growing form of non-Hodgkin's lymphoma (NHL).
At present, DLBCL is being treated with chemoimmunotherapy-based regimens while several targeted therapies including T-cell mediated treatments are there for relapsed/refractory DLBCL patients. Epcoritamab offers a non-chemotherapy, single-agent treatment for the third-line DLBCL patient population in need of additional therapy following failure to respond to currently available therapies.
Epkinly is the third approved blood cancer drug in AbbVie’s portfolio, the other two being Imbruvica and Venclexta. However, Epkinly’s label contains a boxed warning for serious or life-threatening cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.
The approval was based on the response rate and durability of response data from the expansion cohort of phase I/II study, EPCORE NHL-1. In the study, epcoritamab demonstrated a confirmed overall response rate of 61%, a complete response rate of 38%, while the median duration of response was 15.6 months patients with CD20+ DLBCL.
AbbVie’s stock has declined 2% in the past year against an increase of 9.6% for the industry.
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AbbVie and Genmab announced an oncology collaboration deal in 2020 to jointly develop and market three of the latter’s early-stage investigational bispecific antibody product candidates, which included epcoritamab. AbbVie and Genmab share commercial responsibilities for epcoritamab in the United States and Japan. AbbVie is responsible for further global commercialization. Genmab had filed the BLA for epcoritamab, a subcutaneous bispecific antibody, in October 2022. In the EU too, a marketing authorization application was validated by the European Medicines Agency in October.
AbbVie and Genmab are evaluating epcoritamab both as a monotherapy and as a combination regimen across lines of therapy in a range of hematologic malignancies. Some ongoing studies are a phase III study on epcoritamab as a monotherapy in patients with relapsed/refractory DLBCL and two other evaluating epcoritamab in combination in patients with newly diagnosed DLBCL and relapsed/refractory follicular lymphoma.
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked large drugmakers are Novo Nordisk NVO and Novartis NVS. While Novo Nordisk has a Zacks Rank of 1 (Strong Buy), Novartis has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.43 to $4.95 over the past 30 days. Estimates for 2024 have jumped from $5.19 per share to $5.74 in the same timeframe. Novo Nordisk’s stock has surged 58.2% in the past year.
Novo Nordisk beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.35%, on average.
Estimates for Novartis’ earnings per share have increased from $6.55 to $6.67 over the past 60 days, while those for 2024 have gone up from $7.04 per share to $7.22 per share. Novartis’ stock has risen 11.2% in the past year.
Novartis beat earnings expectations in each of the trailing four quarters. The company delivered a four-quarter earnings surprise of 5.15%, on average.
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