Natera Inc. (NASDAQ:NTRA) on Wednesday revealed initial translational research results from the international randomized Phase 3 PALLAS study.
Data were presented at the San Antonio Breast Cancer Symposium (SABCS).
These first data, generated from a U.S. biomarker cohort of 420 patients, show that molecular residual disease (MRD) status, measured by the Signatera Genome test after surgery (and adjuvant chemotherapy +/- radiation if administered), is a highly prognostic biomarker for distant recurrence risk in stage II–III, HR+/HER2- breast cancer.
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MRD is the presence of a tiny number of cancer cells that remain in the body after treatment, which are undetectable by standard imaging or pathology tests
Data
At baseline, approximately 92% of patients were MRD-negative and had excellent outcomes, with a 5-year distant recurrence-free interval (DRFI) of 93%.
Measured starting at EOT, MRD-negative patients had a 5-year DRFI of 95%.
Baseline MRD positivity was observed in roughly 8% of this stage II–III HR+/HER2- population.
These patients had a 5-year DRFI of 28%.
At the end of protocol-directed therapy, MRD-positive patients had a 5-year DRFI of 32%, with hazard ratios exceeding 20 versus MRD-negative patients.
“The results from this preplanned analysis of the PALLAS trial support Natera’s vision for individualizing the management of early-stage HR+/HER2- breast cancer,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera.
NTRA Price Action: Natera shares were down 1.00% at $230.81 at the time of publication on Thursday, according to Benzinga Pro data.
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