Abbvie and Genmab Want Epkinly FDA Approved for Treating Follicular Lymphoma

After positive data in an early-stage trial, AbbVie and Genmab plan to ask the Food and Drug Administration to expand use of their dual-acting cancer immunotherapy Epkinly to benefit patients with a type of blood cancer called follicular lymphoma. 

AbbVie and Genmab hope Epkinly would compete with Lunsumio

AbbVie and Genmab reported that nearly two-thirds of patients taking Epkinly in EPCORE NHL-1 experienced CRS, but just 1.6% of those cases were graded as “severe” or higher, the level at which hospital intervention is necessary. Genmab and AbbVie didn’t release more details on the drug’s effectiveness, but stated that the response rate “exceeded the protocol prespecified threshold for efficacy.” 

AbbVie and Genmab hope Epkinly would compete with Lunsumio, which had an 80% response rate in a similar population, although comparing drugs across trials is difficult and the two medicines haven’t been tested head to head. Neither has been evaluated against a placebo or active treatment, either, meaning they are only eligible for an “accelerated” approval until the companies complete additional testing.

In April 2022, the two companies were talking about their intentions concerning epcoritamab. 

“Together with our partner, AbbVie, we will work with regulatory authorities to determine next steps and continue to evaluate epcoritamab in a variety of clinical trials as a potential treatment option for patients with various hematological malignancies,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to sharing the findings at a future medical meeting.”

LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL) – a cancer that develops in the lymphatic system – that affects B-cell lymphocytes, a type of white blood cell. There are an estimated 150,000 new LBCL cases each year globally. LBCL includes DLBCL, which is the most common type of NHL worldwide and accounts for approximately 31 percent of all NHL cases.

“We aim to leverage AbbVie’s strong blood cancer expertise to further develop epcoritamab, alongside Genmab, for certain blood cancer patients who have limited treatment options,” said Mohamed Zaki, M.D., Ph.D., Vice President and Head, Global Oncology Development, AbbVie.

In may, Epkinly was FDA approved for  the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma.

EPKINLY was approved under the FDA’s Accelerated Approval program 

Back in May of this year, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies. 

EPKINLY was approved under the FDA’s Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.

DLBCL is a type of aggressive, fast-growing non-Hodgkin’s lymphoma (NHL), a cancer that develops in the lymphatic system and affects B cells, a type of white blood cell. DLBCL is the most common type of NHL, with an estimated 30,400 U.S. cases in 2022 and 150,000 new cases each year globally. DLBCL patients are typically treated with chemoimmunotherapy-based regimens. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged. However, single agent and ready-available or off-the-shelf treatment options are limited.1,2,3,4,5

“DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of EPKINLY represents a new treatment mechanism of action for third line DLBCL patients. As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that EPKINLY can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. “The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignances.”

The third approved blood cancer treatment in AbbVie’s growing oncology portfolio

AbbVie is committed to transforming standards of care across blood cancers and advancing a dynamic cancer research and treatment pipeline. EPKINLY marks the third approved blood cancer treatment available as part of AbbVie’s growing oncology portfolio, as we strive to make a remarkable impact for people living with cancer.

“Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging,” said Tycel Phillips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation. “Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies.”

“The FDA approval of EPKINLY represents a new treatment for diffuse large B-cell lymphomas among patients who have relapsed or have refractory disease and are looking for a new medication,” said Meghan Gutierrez, chief executive officer, Lymphoma Research Foundation.

The preoccupation with developing treatments for cancer is not new for Abbvie. Back in 2018, the company said it was protecting itself from competition, while investing in new drugs in therapeutic areas like cancer and autoimmune diseases. Back then, AbbVie has granted Pfizer a non-exclusive license to market its Humira (adalimumab) biosimilar in the U.S., which will see Pfizer delay the launch of a copycat product to November 2023.

The deal was to end an intellectual rights dispute between the two companies, over a proposed similar Pfizer drug.  All litigation over Pfizer’s proposed product was also to be dropped. AbbVie was hoping that the new drugs it was developing were going to contribute 30 percent of sales by 2020 and offset lost Humira sales over the next decade.

Now, it remains to be seen what the FDA will decide, and whether Abbvie and Genmab’s drug will indeed become competition for Lunsumio. 

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.

Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.