Genmab/Abbvie presented spectacular findings from arm 2 of the EPCORE NHL-2 (Phase Ib/II) trial in the patients with R/R Follicular Lymphoma.
Epcoritamab Mechanism of Action: Antibody-dependent cell cytotoxicity; B cell inhibitors; CD20 antigen inhibitors; CD3 antigen inhibitors; CD4-positive T-lymphocyte inhibitors; CD8 positive T lymphocyte stimulants
Epcoritamab (AbbVie) is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology, which is currently being evaluated as a treatment option for patients with Follicular Lymphoma in several clinical trials. In March 2022, Genmab announced that the US FDA granted Orphan Drug Designation to epcoritamab Genmab AbbVie to treat Follicular Lymphoma. The company presented the encouraging findings from its ongoing Phase Ib/II (NCT04663347) open-label study at the ASCO 2022 conference. At the cutoff date of March 25, 2022, a total of 28 patients were evaluable in the cohort, with a median follow-up of 2.2 months in arm 2b. Moreover, the overall response rate in arm 2b was 93%, with complete metabolic response achieved was 61%, and the partial metabolic response rate was 32%. Based on these astonishing response rates, patients in arm 2b achieved encouraging efficacy. In arm 2a, the evaluable patients achieved a 96% metabolic response rate, with the remaining patients achieving a partial metabolic response. In addition to that, around 93% of patients maintained response at 6 weeks, and the other 7% had stable disease.
In terms of Safety, in arm 2a, Treatment-emergent adverse events (TEAEs) resulted in epcoritamab follicular lymphoma dose reduction in 43% of patients and discontinuation in 7%, but no fatal TEAEs have been documented. Injection-site responses accounted for 53% of all TEAEs in arm 2a, followed by CRS (50%) and others. Most importantly, low-grade cytokine release syndrome (CRS) was a low incidence in patients with relapsed/refractory follicular lymphoma in an overall patient pool.
“Epcoritamab (AbbVie) with R2 (Revlimid) showed encouraging results with all patients in arm 2a achieving a response, and most a complete response.” –Expert Opinion.
“Based on response rates at 6 weeks, patients in arm 2b also achieved encouraging efficacy.”– Expert Opinion.
Looking at the encouraging findings of the triplet combination from the EPCORE NHL-2 trial, we can anticipate a change in treatment patterns for the patients who are suffering from Follicular Lymphoma. As most patients with Follicular Lymphoma experience frequent relapses, and with each successive therapy, the duration of remission and survival shortens. In hematologic malignancies, this can bring new hope for treatment options to the people living with this disease. The impact of a 100% response rate from the EPCORE NHL-2 trial sets the bar for other rival competitors, including Roche’s Mosunetuzumab. Although, Mosunetuzumab has the first-mover advantage, as the company has completed the filing process in Europe, and CHMP has already validated its MAA application. Recent findings of the Epcoritamab clinical trials from Epcoritamab ASCO 2022 also indicate the possibility that this drug can change the standard of care for follicular lymphoma. Therefore, it will be very interesting to watch the approval of these upcoming bispecific antibody for Follicular Lymphoma treatment.
Companies- Abbvie, Genmab, Boehringer Ingelheim GmbH, CTI BioPharma Corp., Celldex Therapeutics, Bristol-Myers Squibb Company, Coherus BioSciences, Celgene Corporation, Dynavax Technologies Corporation, Cellular Biomedicine Group, Celltrion, Curis, Gilead Sciences, Immune Design Corp., Eisai, GlaxoSmithKline, Genentech, EpiZyme, Hutchison MediPharma Limited, ImmunoGen, and others.