The European Medicines Agency (EMA) could soon change the face of cancer treatment with its potential approval of two novel bispecific antibodies, epcoritamab and talquetamab. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting conditional marketing authorization for two novel cancer therapies — AbbVie’s epcoritamab and Janssen’s talquetamab.
Epcoritamab for relapsed/refractory diffuse large B-cell lymphoma
Epcoritamab is an investigational bispecific antibody for adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. CHMP made the decision after reviewing data from the pivotal EPCORE NHL-1 phase 1/2 trial showing an overall response rate of 63.1% with epcoritamab monotherapy in DLBCL patients. If approved, epcoritamab would be the first subcutaneous bispecific antibody for relapsed/refractory DLBCL.
In May, FDA approved epcoritamab (Epkinly, AbbVie and GenMab) to treat adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) following at least two lines of systemic therapy. This indication includes DLBCL stemming from indolent lymphoma and high-grade B-cell lymphoma.
Talquetamab for relapsed/refractory multiple myeloma
Conversely, talquetamab is a bispecific antibody targeting GPRC5D, a novel target on multiple myeloma cells, and CD3 on T-cells. The CHMP recommendation is based on data from the phase 1/2 MonumenTAL-1 study focused on evaluating talquetamab in relapsed/refractory multiple myeloma patients. Talquetamab would provide a new treatment option for multiple myeloma patients who have exhausted current treatment options.
The CHMP also recommended approval of a biweekly dosing schedule for Janssen’s teclistamab, the first bispecific BCMA-targeting antibody approved in Europe for relapsed/refractory multiple myeloma.
Both epcoritamab and talquetamab have won PRIME designation and accelerated assessment by the EMA. If approved, these novel bispecific antibodies would address unmet needs for patients with blood cancers like DLBCL and multiple myeloma who have limited treatment options after relapse or refractory disease. AbbVie and Janssen expect the final European Commission decisions on the conditional marketing authorizations later this year.
In late 2022, Genmab submitted a Biologics License Application (BLA) to the FDA for epcoritamab for adults with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
AbbVie and Genmab are co-developing epcoritamab as part of their oncology collaboration.
Filed Under: Biologics, Drug Discovery, Hematology, Oncology