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.
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Genmab/Abbvie’s Epcoritamab achieves a 100% response rate in patients with R/R follicular lymphoma (FL). Could safety issues be a concern?
1. Genmab/Abbvie’s Epcoritamab achieves a 100% response rate in
patients with R/R follicular lymphoma (FL). Could safety issues be a
concern?
Epcoritamab achieves a 100% response rate in patients with R/R follicular
lymphoma
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
2. 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.
KOL insights
“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.
Conclusion
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
3. 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.
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