Foresight Diagnostics to Present New Data on Foresight CLARITY™ Ultra-Sensitive MRD Detection Across Multiple Studies at the 66th American Society of Hematology Annual Meeting

Foresight Diagnostics, a leader in ultrasensitive minimal residual disease (MRD) testing, today announced the presentation of multiple studies showcasing Foresight CLARITY™ MRD at the upcoming 66^th American Society of Hematology Annual Meeting and Exposition taking place December 7-10 in San Diego, California.

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. The studies include collaborations with multiple pharmaceutical companies and research institutions, including AstraZeneca, Bristol Myers Squibb (BMS), Daiichi Sankyo (DSI), Stanford University, Washington University, and others.

"These studies add to the growing body of evidence supporting ultra-sensitive MRD testing as a critical tool in lymphoma care and drug development," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "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."

Results utilizing Foresight CLARITY MRD technology are featured in six abstracts, including three that are co-authored by Foresight.

Presentation highlights include:

LBCL/DLBCL:

• ctDNA-MRD as a surrogate endpoint for 2L CAR T – Analysis of the Phase 3 TRANSFORM trial in second-line treatment for large B-cell lymphoma (LBCL) reinforced the potential of circulating tumor DNA (ctDNA) as an earlier endpoint for response assessment and assessment of clinical trial results. In the TRANSFORM study, patients receiving lisocabtagene maraleucel (liso-cel) had significantly improved event-free survival compared to standard of care. Consistent with this result, patients receiving liso-cel also demonstrated higher rates of MRD clearance, demonstrating CLARITY's ability to measure differential treatment responses.

• MRD Response with novel first-line therapy in high-risk DLBCL – Analysis of a Phase 1b trial CC-220-DLBCL-001 combining golcadomide with R-CHOP in previously untreated aggressive B-cell lymphoma showed promising MRD clearance rates. The data demonstrated that 90% of patients achieved MRD negativity at end of treatment with golcadomide 0.4mg + R-CHOP, with strong responses observed even in high-risk patients. These data further support the ongoing Phase 3 GOLSEEK-1 study investigating this novel combination therapy in high-risk 1L LBCL.

• Enhanced risk stratification by MRD vs. traditional methods – New research investigates the predictive value of the International Prognostic Index (IPI), currently the primary pre-treatment risk assessment tool for DLBCL. The study revealed that pre-treatment IPI scores did not significantly correlate with end-of-treatment MRD status, with MRD testing being a superior predictor of progression-free survival.

Follicular Lymphoma:

• MRD-based response assessment of novel FL therapies – Two studies demonstrated the value of MRD assessment in follicular lymphoma trials, with new treatment approaches showing early clearance. The CD19xCD3 bispecific antibody AZD0486 achieved 89% MRD negativity in relapsed or refractory FL patients by 12 weeks in complete responders. In the 1L setting, the chemotherapy-free combination of mosunetuzumab and polatuzumab vedotin showed similar early MRD clearance, with 7 of 8 complete responders achieving MRD negativity before cycle 3. These results highlight the potential for MRD as an early indicator of therapeutic response in FL clinical trials.

PTCL:

• ctDNA as a prognostic biomarker for T-cell lymphoma – Analysis from the VALENTINE-PTCL01 Phase 2 trial in relapsed/refractory peripheral T-cell lymphoma (PTCL) revealed that patients achieving early, deep ctDNA reduction (>5-fold decrease by Cycle 2 Day 1) experienced significantly longer progression-free survival, establishing ctDNA monitoring as a powerful tool for early response assessment.

Information on abstract presentation time and dates can be found below. To meet with Foresight Diagnostics, visit booth #3423 or contact us at BD@foresight-dx.com.

Oral Presentations:

Circulating Tumor DNA (ctDNA) as an Early Outcome Predictor in Patients with Second-Line Large B-Cell Lymphoma After Lisocabtagene Maraleucel Versus Standard of Care Treatment from the Phase 3, Randomized TRANSFORM Study

• Presenter: Ash Alizadeh, MD, PhD (Stanford University)
• Session 628
• Date/Time: Saturday, December 7, 2024, 10:45 a.m.
• Sponsor: Bristol Myers Squibb
• Co-authored by Foresight Diagnostics

Escalating Doses of AZD0486, a Novel CD19xCD3 T-Cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma

• Presenter: Jing-Zhou Hou, MD, PhD (UPMC Hillman Cancer Center)
• Session 623
• Date/Time: Saturday, December 7, 2024, 5 p.m.
• Sponsor: AstraZeneca

Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL)

• Presenter: Jason R. Westin, MD (MD Anderson)
• Session 627
• Date/Time: Sunday, December 8, 2024, 12:30 p.m.
• Sponsor: Bristol Myers Squibb

International prognostic index poorly predicts EOT ctDNA MRD status in DLBCL and has limited impact on its predictive value for outcomes

• Presenter: Jordan S. Goldstein, MD, MS (Stanford University)
• Session 626
• Date/Time: Sunday, December 8, 2024, 5 p.m.
• Co-authored by Foresight Diagnostics

Poster Presentations:

Prediction of Clinical Response by Phased Variants in Circulating Tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma

• Presenter: Neha Mehta-Shah, MD, MSCI (Washington University)
• Abstract #4342, Session 621
• Date/Time: Monday, December 9, 2024, 6-8 p.m.
• Sponsor: Daiichi Sankyo
• Co-authored by Foresight Diagnostics

Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma

• Presenter: David A Russler-Germain, MD, PhD (Washington University)
• Abstract #4414, Session 623
• Date/Time: Monday, December 9, 2024, 6-8 p.m.

About Foresight Diagnostics

Foresight Diagnostics is a privately-held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million^1. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

¹ Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

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