Genmab A/S GMAB and AbbVie ABBV announced top-line data from the first cohort of a phase I/II study — EPCORE NHL-1 — evaluating its subcutaneous bispecific antibody candidate, epcoritamab (DuoBody-CD3xCD20), as a potential treatment for relapsed/refractory (r/r) large B-cell lymphoma (LBCL).
The phase I/II study evaluated epcoritamab in r/r LBCL patients who have received at least two prior lines of systemic therapy, including chimeric antigen receptor (CAR) T-cell therapy. Data from the first cohort of the study demonstrated that treatment with the candidate achieved a confirmed overall response rate (ORR) of 63.1%, as assessed by an independent review committee. The candidate achieved a mean duration of response of 12 months.
This cohort of the study included patients who have received 2 to 11 prior therapies. Based on the data from this cohort, AbbVie and Genmab are planning to engage with global regulatory authorities.
Shares of Genmab have declined 6.3% so far this year compared with the industry’s decrease of 14%.
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AbbVie and Genmab are developing epcoritamab as part of their broad oncology collaboration signed in 2020. The companies are evaluating the candidate as monotherapy or in combination regimens for treating hematologic malignancies including non-Hodgkin’s lymphoma, in patients who have received multiple prior lines of therapy.
Per the terms of the collaboration agreement, AbbVie should pay $750 million in upfront payments along with potential milestone payments of up to $3.15 billion.
We note that epcoritamab has been developed using Genmab’s proprietary DuoBody technology platform. Apart from AbbVie, the company’s technology platform has also attracted J&J JNJ to sign an agreement. In 2012, J&J and Genmab entered into a partnership for developing bispecific antibodies using the latter’s proprietary DuoBody technology platform. In May 2021, J&J received FDA approval for Rybrevant, developed using Genmab’s DuoBody technology platform, for treating adult patients with non-small cell lung cancer with EGFR mutations. J&J’s Darzalex and Darzalex Faspro have also been developed in partnership with Genmab.
Last year, Genmab’s partner Seagen SGEN announced that the FDA had granted accelerated approval to their investigational antibody-drug conjugate, Tivdak (tisotumab vedotin-tftv). Seagen received approval for Tivdak for recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy. Seagen and Genmab continue to evaluate Tivdak as a potential treatment for cervical cancer and other solid tumors in different clinical studies.
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Genmab currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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