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What is the success rate of Epkinly?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on July 10, 2024.

Official Answer by Drugs.com

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.

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.

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.

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).

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

Related questions

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.

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:

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:

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:

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:

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

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