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AbbVie and Genmab today jointly announced that the U.
S.
Food and Drug Administration (FDA) has accepted its investigational bispecific antibody epcoritamab for the treatment of relapsed/refractory large B-cell lymphoma (r/r).
LBCL), these patients have received at least 2 lines of systemic therapy
.
In addition, FDA has granted priority review to this application
.
If approved, epcoritamab would be the first subcutaneously administered bispecific antibody for the treatment of LBCL.
Large B-cell lymphoma, a type of non-Hodgkin lymphoma (NHL), is an aggressive blood cancer
that is difficult to treat.
Approximately 40% of patients develop relapsed or refractory disease
after the first treatment.
It is estimated that there are about 150 000 newly diagnosed LBCL patients
worldwide each year.
LBCL contains DLBCL, the most common type of NHL, accounting for about 30% of NHL cases
.
Epcoritamab is a subcutaneously administered CD20/CD3 bispecific antibody developed through Genmab's proprietary DuoBody platform
.
Epcoritamab can simultaneously target the CD3 protein on T cells and CD20 protein on B cells, thereby triggering T cell-mediated poisoning of CD20-positive cells
.
CD20 is an empirical target for many B-cell tumors including DLBCL, follicular lymphoma, mantle cell lymphoma
, etc.
The application submitted is based on the previously published EPCORE
Results of
the NHL-1 open-label, multicenter Phase 1/2 clinical trial.
The study cohort included 157 patients with relapsed or refractory LBCL who had previously received median third-line therapy, with an overall response rate (ORR) of 63% and a complete response rate (CR) of 39%.
Baseline characteristics of patients included resistance to the primary treatment, 20% had undergone autologous stem cell transplantation (ASCT), and 39% had received CAR-T cell therapy (of which 75% were resistant to CAR-T therapy).
Patients who participated in the study who did not receive CAR-T cell therapy achieved 69% ORR and 42% CR, while patients who received CAR-T cell therapy achieved 54% ORR and 34% CR.
After a median follow-up of 10.
7 months, the median duration of response (mDOR) was estimated to be 12 months
.
The safety profile of Epcoritamab is consistent
with previous findings.
Patients who participated in the study who did not receive CAR-T cell therapy achieved 69% ORR and 42% CR, while patients who received CAR-T cell therapy achieved 54% ORR and 34% CR.
In addition, the European Medicines Agency (EMA) has recently validated the marketing authorization application (MAA)
for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).
"We are committed to developing innovative therapies to provide important treatment options for patients with hematological cancers such as LBCL, who have only limited therapies for relapsed/refractory patients," said Mohamed, AbbVie's global head of oncology development and vice president
Dr.
Zaki said, "This milestone marks the first step
in our hopes of developing core therapies for patients with B cell tumors.
”