<div id="readability-page-1"><div><p>Natera, Inc. together with Alliance Foundation Trials, LLC (AFT) and the Austrian Breast and Colorectal Cancer Study Group (ABCSG), announced initial translational research results from the international randomized Phase III PALLAS study. 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. The findings support Natera's strategy to integrate MRD testing into routine post-surgical risk assessment, enabling a more personalized approach to managing early-stage HR+ breast cancer.</p><p>Data from a parallel ex-US cohort will be presented in conjunction with a treatment subgroup analysis at a later date. In PALLAS, patients with stage II-III HR+/HER2- Breast cancer were randomized to receive two years of palbociclib, a CDK4/6 inhibitor, in combination with endocrine therapy. Signatera MRD assessments were performed after surgery at three key postoperative timepoints: on the first day of protocol-directed experimental therapy (baseline), on-treatment at approximately 6 months (C6D1), and at the end of the 2-year interventional treatment period (EOT).</p><p>Key findings from this initial analysis include: Signatera correctly identified patients with low risk of recurrence. At baseline, approximately 92% of patients were MRD-negative and had excellent outcomes, with 5-year distant recurrence-free interval (DRFI) of 93%. Measured starting at EOT, MRD-negative patients had a 5-year DRFI of 95%.</p><p>This underscored that MRD-negativity after surgery and adjuvant endocrine therapy is associated with an exceptionally low risk of distant recurrence. Palbociclib is not approved in EBC.</p></div></div>

NTRA

<p>Natera, Inc. 和 Alliance Foundation Trials, LLC 在 SABCS 上公布了 III 期 PALLAS 研究的初步结果。研究表明，通过 Signatera 测量的微小残留病（MRD）状态是 II-III 期 HR+/HER2- 乳腺癌复发风险的预后生物标志物。研究结果支持将 MRD 检测纳入术后风险评估，以实现个性化管理。主要结果包括 MRD 阴性患者的高无复发生存期（DRFI），表明复发风险低。Palbociclib 在早期乳腺癌（EBC）中尚未获得批准</p>

Natera, Inc. and Alliance Foundation Trials, LLC Announces Initial Translational Research Results from the International Randomized Phase III PALLAS Study

Natera 公司和 Alliance Foundation Trials, LLC 宣布国际随机 III 期 PALLAS 研究的初步转化研究结果