TEST:

Foresight CLARITY™

P2, N=250, Recruiting, Allogene Therapeutics | Trial completion date: Aug 2031 --> Dec 2032 | Trial primary completion date: Aug 2027 --> Dec 2027

P2, N=38, Not yet recruiting, Michael Spinner, MD | Trial completion date: Apr 2033 --> Oct 2033 | Initiation date: Oct 2025 --> May 2026 | Trial primary completion date: Oct 2028 --> Mar 2029

P2, N=10, Not yet recruiting, M.D. Anderson Cancer Center

P2, N=38, Not yet recruiting, Michael Spinner, MD | Initiation date: Jul 2025 --> Oct 2025

P2, N=38, Not yet recruiting, Michael Spinner, MD

"The new collaborations with Tracer Biotechnologies and Foresight Diagnostics expand QIAGEN’s reach in MRD testing and cover solid tumors and hematological cancers."

"Foresight...announced new data from its ultra-sensitive Foresight CLARITY™ minimal residual disease (MRD) platform in early-stage breast cancer that will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS)...Foresight and Memorial Sloan Kettering (MSK) will present an analysis of 470 samples from 81 early-stage breast cancer patients demonstrating that ctDNA clearance following various perioperative treatments – including surgery, neoadjuvant chemotherapy, and adjuvant chemotherapy – is strongly associated with favorable survival outcomes."

"The presentations span various lymphoma types and treatment settings, demonstrating the broad applicability of the Foresight CLARITY MRD detection technology for monitoring treatment response and predicting patient outcomes....'We see in these studies that MRD measurement with Foresight CLARITY consistently enables earlier and more accurate treatment response assessment than conventional imaging-based methods. The ability to monitor disease status in real-time with ultra-sensitive MRD assays like Foresight CLARITY may help accelerate clinical trials and lead to more personalized decision-making for patient care'."

Median prior lines of therapy was 3 (range 2–12), 18 (38%) pts received prior lenalidomide–based therapy, 7 (15%) pts received prior chimeric antigen receptor T-cell therapy (CAR-T), and 4 (9%) received prior CD20 TCE therapy. The exposure-response analysis supports the target dose of 7.2 mg. Further studies of AZD0486 are planned as monotherapy and in combination regimens.

Ultrasensitive MRD analysis demonstrates that surgery also leads to a high rate of ctDNA clearance, suggesting the ability to measure and differentiate responses to both local and systemic therapies. Ultrasensitive ctDNA in EBC is likely to become an important biomarker of response to therapeutic interventions and warrants further study.

"Foresight Diagnostics founders Maximilian Diehn and Arash Ash Alizadeh, as individuals, said in a court document filed on Wednesday in the US District Court for the Northern District of California that the claims made by Roche in a lawsuit concerning trade secrets are meritless and untimely."

"Foresight Diagnostics...announced an upcoming presentation featuring its Foresight CLARITY MRD platform at the ESMO Congress 2024 on September 16 in Barcelona, Spain...In collaboration with Memorial Sloan Kettering Cancer Center (MSK) and Stanford University, the study will showcase the clinical performance of Foresight CLARITY for MRD-based recurrence detection in early-stage breast cancer patients from MSK’s Liquid Biopsy for INterception of Cancer (MSK-LINC) study...It is designed to assess the utility of MRD detection and monitoring during and after curative-intent therapy in enabling earlier treatment interventions and improving outcomes for patients with early-stage solid tumor cancers...The full data have been submitted for presentation at the ESMO Congress 2024."