TEST:

MSK-ACCESS

P2, N=13, Recruiting, Memorial Sloan Kettering Cancer Center | Trial primary completion date: Nov 2025 --> Nov 2026 | N=25 --> 13 | Trial completion date: Nov 2025 --> Nov 2026

"Myriad Genetics...announced a strategic collaboration to develop and provide pharmaceutical companies with an innovative global liquid biopsy companion diagnostic (CDx) test. This partnership will leverage Myriad’s advanced laboratory capabilities in the U.S. to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment."

Active therapy at the time of ctDNA collection negatively affected the ability to detect primary and secondary KIT alterations in sequenced ctDNA from patients with advanced GIST. CtDNA responses may precede radiographic responses, and merits further investigation.

ctDNA is a promising tool in detection of somatic variants in PDAC. Concordance between ctDNA and tissue is high for patients with untreated metastatic disease, notably for detection of KRAS variants.

RB1 mosaicism should be considered when RB1 variants persist in cfDNA after treatment without evidence of disease; failure to do so may lead to false-positive results and overtreatment in patients with RB1 mosaicism. Identifying RB1 mosaicism may improve patient counseling, inform treatment decisions, and enhance surveillance efforts.

"SOPHiA GENETICS...today announced the expansion of its ongoing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to accelerate the deployment of MSK-ACCESS® powered with SOPHiA DDM™ globally. Building on the initial collaboration announced in October 2024, this new phase will extend the test's reach to a total of 30 clinical institutions worldwide in 2025."

"Precision for Medicine...today announced a strategic partnership with SOPHiA GENETICS to enhance its biomarker discovery and precision medicine services. As part of this collaboration, Precision for Medicine will integrate the SOPHiA DDM™ Platform for biomarker discovery, Clinical Trial Assays (CTAs), and advanced algorithms to expand clinical trial capabilities. This partnership will further enhance service offerings and provide biopharma companies with tools to accelerate clinical trial design, patient stratification, and data analysis."

"OncoHelix...to announce its partnership with AstraZeneca Canada to deliver cutting-edge liquid biopsy testing for men with metastatic castration-resistant prostate cancer (mCRPC) who meet appropriate clinical criteria and live in provinces which lack public funding for this type of diagnostic test. Utilizing advanced genomic profiling, this test provides critical insights to physicians to guide targeted treatments and is being made available for a limited time in Canada through OncoHelix's clinically accredited lab. The initiative is made possible with the support of a collaboration between AstraZeneca and Merck."

"SOPHiA GENETICS...announced a new milestone in the global adoption of its groundbreaking cancer testing applications MSK-ACCESS® powered with SOPHiA DDM™ and MSK-IMPACT® powered with SOPHiA DDM™. Thirty-seven prominent institutions, including top researchers and key opinion leaders worldwide, have already adopted the recently launched Liquid Biopsy and Solid Tumor applications."

Verification results of the decentralized MSK-ACCESS powered with SOPHiA DDM solution demonstrate a high concordance to the single-site test developed by MSK. This provides laboratories with a cfDNA solution that interrogates frequently mutated genomic regions in cancer and moderates the risk of incorrectly reporting germline and CH alterations through the inclusion of matched WBC testing.

These findings were consistent with those reported for SUMMIT hormone receptor-positive (HR+) HER2-mutant mBC cohorts, in which patients treated with N or N + fulvestrant (N+F) experienced promising clinical responses but shorter DOR. Although limited by small numbers, addition of T to N in patients with HER2-mutant mTNBC, despite deepening and prolonging response, did not appear to preclude eventual emergence of either on-pathway (ERBB3) or off-pathway (KRAS, TP53) mutations. In contrast to observations in N+F+T-treated patients with HR+, HER2-mutant disease, no additional HER2 alterations were detected upon progression in N+T-treated patients with mTNBC in this small dataset. Future investigations may evaluate clinical utility of sequencing therapies targeted to mutations acquired in response to N-based therapy in patients with HER2-mutant mTNBC.

Conclusion In this large cohort of MBC pts, ctDNA detection and levels emerged as strong prognostic indicators for OS, independently from disease burden. Our data suggest that ctDNA levels can provide valuable insight into tumor biology as well as disease burden and may be utilized for early prognostication in MBC.