In the EPCORE NHL-1 trial, Epkinly delivered an overall response rate (ORR) of 61% with a median duration of response of 15.6 months in adults treated for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). In adults with R/R follicular lymphoma (FL), Epkinly demonstrated an 82% ORR, with more than 50% of patients still responsive at 14.8 months.

• In a clinical study, the overall response rate (ORR) is the percent of people that have a partial or complete response to a treatment in a certain amount of time.
• Partial response means there is a decrease in the amount of cancer in the body, while a complete response is a disappearance of all signs of cancer. A complete response does not always mean the cancer is cured.
• Measuring the ORR is one way researchers can determine how well a treatment works.

Epkinly is used to treat adults with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL) or follicular lymphoma (FL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more cancer treatments.

Epkinley is not an intravenous (IV) infusion, chemotherapy, or stem cell therapy. It is given by subcutaneous (under the skin) injection but is still associated with possible serious or fatal side effects. It is an off-the-shelf treatment that is ready-to-use and can be administered when needed at your doctor’s office or an outpatient clinic.

Epkinly received accelerated approval from the FDA. Approval is based on patient response data for both DLBCL and FL. Additional studies are ongoing to confirm the clinical benefit of Epkinly.

EPCORE NHL-1 trials for Epkinly

Diffuse Large B-cell lymphoma (DLBCL)

The efficacy of Epkinly for diffuse large B-cell lymphoma (DLBCL) and was evaluated in the EPCORE NHL-1 trial, a study in 148 adult patients with relapsed or refractory large B-cell lymphoma (LBCL). Patients had received 2 or more previous treatments (median of 3) but were no longer responding.

• Epkinly delivered an overall response rate of 61% (the primary endpoint), a complete response rate of 38%, a partial response rate of 23% and median duration of response of 15.6 months. Complete responses were achieved as late as 10.2 months.
• The median time to a response was 1.4 months.
• Patients continued to receive treatment until the disease worsened or they had unacceptable side effects.

Follicular lymphoma (FL)

EPCORE NHL-1 trial also evaluated 127 adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). Patients had received 2 or more previous treatments (median of 3) but were no longer responsive.

• Epkinly demonstrated an 82% overall response rate (the primary endpoint), with a 60% complete response rate and a 22% partial response rate. The median time to first response was 1.4 months (range: 1 to 3 months).
• More than 50% of patients who responded to treatment remained responsive at a median of 14.8 months. A median duration of response had not been reached at 14.8 months.
• Patients continued to receive treatment until the disease worsened or they had unacceptable side effects.

What is lymphoma?

In general, lymphoma is a type of blood cancer that affects the immune (lymphatic) system and white blood cells called lymphocytes.

Lymphoma occurs when the lymphocytes grow uncontrollably and accumulate in the lymph nodes. The lymphatic system and white blood cells help to kill bacteria, viruses, and abnormal cells to defend the body from infection and other diseases.

There are two main types of lymphoma, Hodgkins’s lymphoma and the more common non-Hodgkin’s lymphoma. These can be further classified into many different subtypes and may have different treatments and outcomes.

Symptoms of lymphoma can include swelling of the lymph nodes (for example, in the neck or under the arm), unexplained fever, swollen stomach area, loss of appetite, night sweats, frequent infections, and weight loss.

Diffuse large B-cell lymphoma (DLBCL) is a type of aggressive, fast-growing non-Hodgkin's lymphoma (NHL).

• DLBCL is the most common type of NHL and comprises almost 30% of all cases of non-Hodgkin’s lymphoma. There were an estimated 30,400 U.S. cases in 2022 and 150,000 new cases each year globally.
• DLBCL can be cured in about 60% of all patients, but the stage of the disease can affect this. Patients who fail initial therapy often have poor outcomes and need novel treatments.

Follicular lymphoma (FL) is a slow growing (indolent) form of NHL that arises from B-cell lymphocytes.

• FL is the second most common form of NHL overall, after DLBCL, is responsible for 20% to 30% of all NHL cases. About 15,000 people develop FL each year in the U.S.
• Early in diagnosis, FL may not need to be treated right away, or treated at all, especially if the swollen lymph nodes do not cause symptoms for the patient. However, FL is considered incurable and can return many years after treatment.

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How does Epkliny work in lymphoma?

Epkinly works in lymphoma cancer by attaching to T cells and B cells found in your immune system. Some B-cells can become cancerous and grow out of control. T-cells are also immune cells that fight against infection and cancerous cells. Epkinly brings these cells together so that the T cells can attack the cancerous B cells, leading to cancer cell death.

• Epkinly contains the active ingredient epcoritamab-bysp, known as a bispecific CD20-directed CD3 T-cell engager.
• It is called "bispecific" because it works by binding to 2 proteins - CD3 on T-cells and CD20 on B-cells - which helps the T-cells to kill the cancerous B cells. CD20 is a protein found on B-cells, a type of white blood cell in the immune system that helps to fight infections. CD20 is an important treatment target in many B-cell cancers like DLBCL.
• Epkinly helps to direct T-cells to the CD20 cancer site to kill the lymphoma B cells.

As of July 2024, Epkinly was the first bispecific antibody approved to treat both diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma.

What side effects were seen in Epkinly studies?

Epkinly can cause common and serious side effects. Your doctor will monitor you for side effects during treatment and treat them if needed. Ask your doctor how to recognize side effects with Epkinly and when you should contact them

In people being treated for diffuse large B-cell lymphoma (DLBCL), side effects that occurred in at least 20% of (20 out of every 100) patients were:

• Cytokine release syndrome
• Feeling tired (fatigue)
• Muscle or joint pain
• Injection site reactions
• Fever
• Stomach area pain
• Nausea
• Diarrhea

More serious laboratory test changes (Grade 3-4) also occurred including decreases in red and white blood cell counts and decreases in platelets (cells that help your blood to clot).

In people being treated for FL, side effects that occurred at least 20% of (20 out of every 100) patients were:

• Injection site reactions
• Cytokine release syndrome
• COVID-19
• Feeling tired (fatigue)
• Upper respiratory tract infection
• Muscle or joint pain
• Rash
• Diarrhea
• Fever
• Cough
• Headache

More serious laboratory test changes (Grade 3-4) also occurred including decreases in red and white blood cell counts.

Warnings and precautions include infections, low levels of blood cells, and harm in an unborn baby (embryo-fetal toxicity).

Boxed Warnings for Epkinly

The prescribing information for Epkinly contains a Boxed Warning, the FDA’s most stringent safety warning, for serious or life-threatening Cytokine Release Syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

CRS is a common, serious or life-threatening side effect that can occur during Epkinly treatment. CRS may occur when T cells in the body release chemicals (cytokines) that ramp up the immune system. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:

• Fever of 100.4°F (38°C) or higher
• Dizziness or light-headedness
• Trouble breathing
• Chills
• Fast heartbeat
• Feeling anxious
• Headache
• Confusion
• Shaking (tremors)
• Problems with balance and movement, such as trouble walking

Due to the risk of CRS, you will receive Epkinly treatment on a “step-up dosing schedule”, receiving 2 or 3 smaller “step-up” doses during your first cycle of treatment. You may also receive other medicines to help reduce your risk of CRS.

Immune effector cell-associated neurotoxicity syndrome (ICANS) is a group of brain and nervous system problems that can be life-threatening and lead to death. These problems can happen days or weeks after you receive Epkinly treatment. Tell your healthcare provider right away if you develop any signs or symptoms of nervous system problems, including:

• Trouble speaking or writing
• Confusion and disorientation
• Drowsiness
• Tiredness or lack of energy
• Muscle weakness
• Shaking (tremors)
• Seizures
• Memory loss

Related: Warnings, Precautions and Side Effects with Epkinly (in more detail)

This is not all the information you need to know about Epkinly for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

• FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma. US Food and Drug Administration (FDA). May 19, 2023. Accessed July 10, 2024 at https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-diffuse-large-b-cell
• Epkinly [package insert]. Plainsboro, NJ: Genmab US, Inc. and North Chicago, IL: AbbVie Inc. 2024. Accessed July 10, 2024 at https://www.genmab-pi.com/prescribing-information/epkinly-pi.pdf
• FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma. US Food and Drug Administration (FDA). June 26, 2024. Accessed July 10, 2024 at https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma
• Epkinly (epcoritamab-bysp) approved by US FDA as the first and only bispecific antibody to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). News release. AbbVie. May 19, 2023. Accessed July 10, 2024 at https://news.abbvie.com/article_display.cfm?article_id=12584
• Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. 
• Treating B-Cell Non-Hodgkin Lymphoma. American Cancer Society. Accessed July 10, 2024 at https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/treating/b-cell-lymphoma.html
• U.S. Food and Drug Administration Grants Second Approval for Epkinly (epcoritamab-bysp) to Treat Patients with Relapsed or Refractory Follicular Lymphoma. News Center. AbbVie. Accessed July 10, 2024 at https://news.abbvie.com/2024-06-26-U-S-Food-and-Drug-Administration-Grants-Second-Approval-for-EPKINLY-R-epcoritamab-bysp-to-Treat-Patients-with-Relapsed-or-Refractory-Follicular-Lymphoma
• New pivotal data for bispecific antibody epcoritamab (DuoBody CD3xCD20) demonstrates high overall and complete responses in patients with hard-to-treat relapsed/refractory follicular lymphoma (FL). News release. Genmab and AbbVie. December 9, 2023. Accessed July 10, 2024 at https://ir.genmab.com/news-releases/news-release-details/new-pivotal-data-bispecific-antibody-epcoritamab-duobodyr
• First-in-human (FIH) trial in patients with relapsed, progressive or refractory B-cell lymphoma (EPCORE NHL-1). ClinicalTrials.gov. Updated February 16, 2024. Accessed July 10, 2024 at https://classic.clinicaltrials.gov/ct2/show/NCT03625037
• Sehn LH, Salles G. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021 Mar 4;384(9):842-858. doi: 10.1056/NEJMra2027612. 

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Drug information

• Epkinly Information for Consumers
• Epkinly prescribing info & package insert (for Health Professionals)
• Side Effects of Epkinly (detailed)

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