New Hope for Follicular Lymphoma: AbbVie’s Epcoritamab Gains Positive Review in Europe

Epcoritamab Gains Positive Recommendation in Europe

AbbVie has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its drug epcoritamab, also known as TEPKINLY®. This medication is notable for being the first T-cell engaging bispecific antibody administered under the skin for treating relapsed or refractory follicular lymphoma (R/R FL) in adults who have undergone at least two prior therapies.

This favorable review signals a significant advancement for patients with R/R FL, a group that often faces ongoing disease recurrences and diminishing responses to standard treatments.

Understanding Follicular Lymphoma

Follicular lymphoma (FL) is a slow-growing type of non-Hodgkin's lymphoma that originates from B-lymphocytes. It is the second most common form of non-Hodgkin's lymphoma, making up 20-30% of all cases. In 2023, an estimated 13,000 cases of FL were diagnosed in Western Europe alone. Unfortunately, current treatments are unable to cure FL, and many patients experience repeated relapses.

The nature of FL means that each relapse typically results in shorter periods of remission and more aggressive disease progression, making new treatment options like epcoritamab crucial for improving patient outcomes.

Details of the EPCORE® NHL-1 Clinical Trial

The CHMP’s opinion is backed by data from the Phase 1/2 EPCORE® NHL-1 clinical trial, which included 128 patients with relapsed or refractory FL. This study found significant response rates to epcoritamab, with many patients showing both overall and complete responses. The treatment's safety profile was comparable to previous studies involving patients with diffuse large B-cell lymphoma (DLBCL).

An additional subgroup of the trial, consisting of 86 patients, tested a 3-step-up dosing schedule aimed at reducing the risk of cytokine release syndrome (CRS), a potential side effect of immune-engaging cancer treatments. The initial results of this regimen were encouraging, showing reduced incidence and severity of CRS.

Mechanism and Development of Epcoritamab

Epcoritamab is a bispecific antibody that targets both CD3 on T cells and CD20 on B cells. By binding to these proteins, it activates T cells to kill the cancerous B cells. This innovative mechanism is made possible through Genmab’s proprietary DuoBody® technology.

Developed jointly by AbbVie and Genmab, epcoritamab is also being tested for other types of lymphoma. AbbVie will be responsible for global commercialization activities, with both companies seeking additional regulatory approvals worldwide.

Safety and Efficacy of Epcoritamab

The safety profile of epcoritamab includes risks such as CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), infections, tumor lysis syndrome (TLS), and possible tumor flare. Patients undergoing treatment need careful monitoring, especially during the initial dosages, to manage these potential side effects effectively.

Patients should be educated on recognizing symptoms of CRS and ICANS, as timely medical intervention is crucial for managing these side effects. Additionally, precautions should be taken to avoid infections, and prophylactic antimicrobials may be necessary.

Next Steps and Future Directions

The positive recommendation from the CHMP represents an essential step in making epcoritamab available to patients who need new treatment options for R/R FL. The European Commission's final decision is expected later this year, and approval could pave the way for broader use of this promising therapy.

Further clinical trials are ongoing to evaluate the efficacy of epcoritamab in other subtypes of lymphoma and in combination with other therapies, potentially expanding its use in treating different hematologic malignancies.

Conclusion

Epcoritamab offers a ray of hope for individuals battling relapsed or refractory follicular lymphoma. The advancement in treatment options underscores the continuous efforts in the medical community to provide better outcomes for cancer patients. As research progresses, it may soon offer transformative results not only in FL but in various other blood cancers.