Epcoritamab
- Generic Name
- Epcoritamab
- Brand Names
- Epkinly, Tepkinly
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 2134641-34-0
- Unique Ingredient Identifier
- D6OMY2L0WA
- Background
Epcoritamab is an IgG1-bispecific antibody that simultaneously binds to CD3 on T-cells and CD20 on B-cells. Epcoritamab promotes the activation and expansion of T-cells and, by being able to bind to both CD20 and CD3, it leads to the T-cell–mediated killing of CD20+ malignant B cells. Diffuse large B-cell lymphoma (DLBCL) is an aggressive type of cancer comm...
- Indication
Epcoritamab is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. This indication is approved under acc...
- Associated Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
- Associated Therapies
- -
ASH 2024: inMIND study results position Monjuvi as a promising therapy for R/R follicular lymphoma
The inMIND trial showed Monjuvi + Rituxan + Revlimid improved progression-free survival (PFS) to 22.4 months vs. 13.9 months for placebo in R/R follicular lymphoma. Key secondary endpoints also favored the experimental arm. Monjuvi aims to become a new standard-of-care option, with potential competition from other therapies.
Regeneron's Ordspono faces challenges, but positive results signal hope
Regeneron's Ordspono shows promise in treating r/r MZL with 77.1% ORR and CR rate, but faces challenges like low long-term adherence and regulatory delays. It received EU approval for r/r FL and DLBCL, but US market adoption is pending confirmatory trials. Competitors like AbbVie and Genmab's Epkinly pose threats with more convenient administration routes.
AstraZeneca set to take a BiTE out of follicular lymphoma market
AstraZeneca presented interim results of AZD0486, a CD19xCD3 BiTE, at ASH 2024, showing 96% ORR and 85% CR in r/r FL patients. AZD0486's CRS rate of 45% with all grade 1 events compares favorably to Epkinly and similarly to Lunsumio. A phase II trial is underway, with potential for first-in-class approval and $158 million in global sales by 2030.
Two Data Analyses From Clinical Trials Show Epcoritamab (DuoBody® CD3xCD20 ...
DLBCL, the most common NHL, affects 25-30% of NHL cases globally, with 25,000 new U.S. cases annually. DLBCL, a fast-growing NHL, often relapses or becomes refractory despite new therapies. Epcoritamab studies show promise in Phase 3 trials, with 91% MRD negativity in high-risk DLBCL patients and 59% ORR in R/R LBCL patients, highlighting potential for durable responses.
Related Clinical Trials:
Piecing Together the Proper BTK Usage in CLL
Nicole Lamanna discussed the progression in CLL patients with covalent BTK inhibitors and venetoclax, emphasizing the need for new treatments. She highlighted clinical trials and CAR T-cell therapy options, including the TRANSCEND CLL 004 trial with lisocabtagene ciloleucel, and the CaDAnCE-101 trial with BGB-16673. Lamanna also presented the EPCOR trial with epcoritamab-bysp, suggesting bispecific antibodies as potential next steps for CLL treatment.
Related Clinical Trials:
Nine Provinces Approve Accelerated Public Reimbursement of Diffuse Large B-Cell
AbbVie announced that nine provinces have accelerated public coverage of EPKINLY™, a treatment for adult patients with Relapsed or Refractory diffuse large B-cell lymphoma (R/R DLBCL). EPKINLY is indicated after two or more lines of systemic therapy in patients who have previously received or are unable to receive CAR-T cell therapy. The treatment is now publicly funded in almost all remaining provinces, including Nova Scotia, British Columbia, Saskatchewan, Manitoba, and Newfoundland & Labrador.
Global Bispecific Antibodies Clinical Trials Market Size
Bispecific antibodies market highlights include >30 development platforms, >USD 8B market size in 2023, and >800 clinical trials. Key approved antibodies like Blincyto and Hemlibra have seen significant sales. The market is driven by innovations in immuno-oncology, with ongoing trials by major pharma companies and research institutions globally.
Dr Mehta on FDA-Approved Treatment Options in Later-Line Hematologic Malignancies
Amitkumar Mehta discusses FDA-approved treatments for DLBCL and follicular lymphoma in later lines, highlighting glofitamab and epcoritamab for DLBCL, and epcoritamab and mosunetuzumab for follicular lymphoma. Both CAR T-cell therapies and bispecific antibodies have improved outcomes over conventional chemoimmunotherapy, though they differ in administration and cost.
Dr Danilov on Ongoing MCL Clinical Trials
Alexey Danilov discusses ongoing City of Hope trials improving MCL treatment, including chemotherapy-free approaches like glofitamab-gxbm, venetoclax, lenalidomide, and obinutuzumab for high-risk MCL, and nemtabrutinib with rituximab. Additional studies focus on CAR T-cell therapy, bispecific antibodies, and BTK degraders in CLL and Richter transformation. Danilov emphasizes the potential of these trials for better outcomes and encourages patient participation.
Drug Development Updates
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