NeraCare Announces Publication of Abstract on Clinical Validation of a Prognostic 7-Biomarker Assay for Prediction of Relapse in Patients with Early-Stage Cutaneous Melanoma at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting
May 23 2024 - 5:00PM
Business Wire
- Assay identified 98% of relapses and 100% of cutaneous
melanoma-related deaths in stage IB/IIA patients
- Patients with stage IB/IIA melanoma identified as high-risk had
a relapse rate comparable to later-stage patients for whom adjuvant
therapy is already approved
- The prognostic assay may be useful in selecting early-stage
melanoma patients for adjuvant trials
- Assay is being transferred to the Akoya Biosciences’
PhenoImager® HT multiplex platform to enable automation and tissue
preservation
NeraCare, a leading developer of laboratory tests for
personalized survival prediction of melanoma patients, today
announced publication of an abstract describing the clinical
validation of a prognostic seven biomarker immunohistochemistry
(7-IHC; Immunoprint) risk categorization assay that stratifies
patients with early-stage (IB/IIA) cutaneous melanoma into
high-risk or low-risk groups for recurrence and melanoma-specific
survival, on the American Society of Clinical Oncology (ASCO)
website.
Results of the Melarisk-001 study demonstrated that use of 7-IHC
identified 98% of relapses and 100% of cutaneous melanoma-related
deaths in stage IB/IIA patients. Patients with 7-IHC high-risk had
a relapse rate comparable to stage IIB-IV patients for whom
adjuvant therapy is approved. Results of the study suggest its
utility in selecting early-stage melanoma patients for adjuvant
trials.
“Anti-PD-1 therapy is a standard of care adjuvant therapy for
cutaneous melanoma patients with resected AJCC stages IIB-IV
disease.” said Jeffrey Weber, MD, PhD, co-author of the poster and
Deputy Director of the Perlmutter Cancer Center and Co-Director of
the Melanoma Research Center at NYU Langone Health. “Nonetheless, a
smaller subgroup of earlier-stage patients with IB or IIA disease
is at high risk of relapse and death, and remains without access to
adjuvant therapy. This subgroup accounts for a significant share of
overall melanoma-related mortality. While adjuvant clinical trials
for these earlier-stage patients that will be destined to relapse
may be merited, this subgroup is not detectable via current AJCC
staging alone. The ability to identify these patients using 7-IHC
may be useful in selecting such high-risk participants for adjuvant
trials.”
The multicenter MELARISK-001 archival study enrolled 382
patients diagnosed with stage IB/IIA cutaneous melanoma with
available formalin-fixed paraffin-embedded primary melanoma tissue
sections; 247 (65%) patients were categorized as stage IB and 135
(35%) were stage IIA, all sentinel node-negative. Tissue specimens
were analyzed by the 7-IHC assay and patients classified as either
high-risk or low-risk. The assay measures the expression of five
risk markers (Bax, Bcl-X, CD20, COX-2, PTEN) and two protective
markers (MTAP, β-Catenin). Median follow-up for recurrence-free
survival (RFS) was 90 months and for melanoma-specific survival
(MSS), 98 months.
- 7-IHC classified 212 patients (55%) as high-risk and 170 (45%)
as low-risk
- 7-IHC high-risk patients had significantly worse survival
outcomes than 7-IHC low-risk patients
“As the majority of melanoma patients are diagnosed with
early-stage disease, there is a critical unmet medical need to
identify those at-risk patients to potentially enable earlier
access to life-saving therapeutic agents,” said Daniel von
Janowski, Co-Founder of NeraCare.
“With clinical validation of 7-IHC and the potential for tens of
thousands of early-stage melanoma patients to benefit from the
test, we are already in the process of transferring the assay from
IHC to the Akoya Biosciences’ PhenoImager HT multiplex platform. In
doing so, the assay can be fully automated and will require a much
smaller tissue sample than is needed for IHC.” said Friedrich
Ackermann, Co-Founder of NeraCare.
Poster Presentation Details: Title: Clinical
validation of a prognostic 7-marker IHC assay (7-IHC) in 382
patients (pts) with stage IB/IIA cutaneous melanoma (CM;
MELARISK-001) Presenter: Teresa Amaral, MD, PhD, Skin Cancer
Center, Department of Dermatology, Eberhard Karls University of
Tübingen Abstract: 9572 Poster Board: 356 Session
Title: Melanoma/Skin Cancers Session Location, Date, and
Time: Hall A, Saturday, June 1 - 1:30pm CDT
ABOUT NERACARE
NeraCare is a developer of laboratory tests for individualized
survival with offices in Frankfurt and New York. In addition to
Immunoprint®, the company markets the gene expression-based assay
MelaGenix®, which was used in the phase III NivoMela trial, the
first clinical trial in melanoma to select patients for adjuvant
treatment based on individualized risk for relapse. The company has
raised more than $20 million in venture capital funding led by MIG
Capital AG, also a founding investor of German biotech giant
BioNTech.
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