NEJM Highlights PredicineCARE™ Liquid Biopsy Role in Roche's Itovebi Breast Cancer Trial
Key Insights
PredicineCARE™ liquid biopsy assay was pivotal in Roche's INAVO120 Phase 3 trial, identifying PIK3CA-mutated metastatic breast cancer (search) patients.
The assay's use contributed to the FDA approval of Inavolisib (Itovebi) as a first-line treatment for HR+, HER2-negative breast cancer (search) with PIK3CA mutations.
PredicineCARE™ demonstrated a 98.7% testing success rate and a rapid turnaround time of five business days in the study.
The New England Journal of Medicine (NEJM) has featured a study highlighting the clinical utility of PredicineCARE™ liquid biopsy assay in Roche’s pivotal INAVO120 Phase 3 clinical trial of Inavolisib (Itovebi). The assay played a crucial role in identifying and enrolling patients with PIK3CA-mutated, hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer (search) (mBC) in China.
The U.S. FDA recently approved the Itovebi-based regimen as a first-line treatment for people with HR+, Her2-negative breast cancer (search) with PIK3CA mutations. The PredicineCARE™ blood ctDNA assay was instrumental in the accurate identification and enrollment of PIK3CA-positive mBC patients in China.
Clinical Impact of Itovebi
According to Dr. Huiping Li, Chair of the Department of Breast Oncology at Peking University Cancer Hospital & Institute, the Itovebi-based regimen demonstrated a doubling of progression-free survival with consistent benefit across all pre-specified patient subgroups. "With the essential support of biomarker testing, this new first-line standard of care brings significant hope to breast cancer (search) patients with PIK3CA mutations," said Dr. Li.
PredicineCARE™ Assay Details
PredicineCARE™ is a next-generation sequencing (NGS) assay that facilitates accurate blood ctDNA-based testing to detect genomic alterations among trial participants. The assay achieved a 98.7% testing success rate and a rapid turnaround time (TAT) of just five business days in the INAVO120 study.
Predicine's Commitment
"The publication of the INAVO120 study in the New England Journal of Medicine demonstrates the clinical utility of harmonized PredicineCARE™ liquid biopsy assay in global clinical trials and personalized cancer care," said Dr. Shidong Jia, Founder & CEO of Predicine (search). He emphasized Predicine's commitment to robust, efficient, and cost-effective early biomarker testing, helping identify patients who may benefit from targeted therapy such as Itovebi. PredicineCARE™ has received both FDA breakthrough device designation and New York State approval.