Natera Highlights Positive Interim Futility Analysis from Allogene Therapeutics’ MRD-Guided ALPHA3 Trial in Large B-Cell Lymphoma

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today highlighted Allogene Therapeutics†(NASDAQ: ALLO) interim futility analysis from its registrational ALPHA3 trial for cemacabtagene ansegedleucel (cema-cel), an investigational allogeneic anti-CD19 CAR T therapy, in first-line (1L) consolidation large B-cell lymphoma (LBCL).

The ALPHA3 trial is enrolling patients with LBCL who test positive for molecular residual disease (MRD) following 1L therapy. These patients are then randomized either to cema-cel, an investigational allogeneic anti-CD19 CAR T therapy developed by Allogene, or observation. The interim analysis showed that 58.3% of MRD-positive patients treated with cema-cel achieved MRD clearance. In addition, at the Day-45 MRD assessment, plasma ctDNA levels decreased from baseline by a median of 97.7% in the cema-cel arm compared to a 26.6% median increase in the observation arm, suggesting molecular disease progression due to lack of intervention. These findings provide early evidence that cema-cel may help prevent or delay clinical relapse for LBCL patients with MRD.

While standard 1L chemoimmunotherapy (e.g., R-CHOP) is effective for most patients in achieving remission, approximately 30% will experience relapse. MRD assessment can identify such relapse before it shows up on imaging. ¹

ALPHA3 is the first MRD-guided randomized controlled trial in LBCL. The study is designed to assess whether treatment with an allogenic CAR T product can eliminate residual disease and potentially prevent recurrence. The study identifies high-risk patients using Nateraâ€s CLARITY ^TM MRD assay, which leverages Nateraâ€s patented phased variant MRD technology.

The interim analysis evaluated MRD clearance following treatment at a protocol-defined data cutoff. This represents another critical application for Nateraâ€s MRD technology, providing a meaningful interim endpoint for assessing drug efficacy.

“MRD status following frontline therapy has emerged as one of the strongest predictors of relapse in LBCL, and the ALPHA3 study and cema-cel could be transformative for patients with lymphoma,” said David Kurtz, M.D., Ph.D., senior vice president & chief scientific officer, Hematology Franchise at Natera. “Pairing our ultra-sensitive phased variant MRD technology with cema-cel, pending the outcome of ALPHA 3 study, creates an actionable solution for patients who test positive for MRD at the end of 1L treatment.”

Allogene will host a conference call and webcast today at 5:30 a.m. PT / 8:30 a.m. ET to discuss the interim futility analysis. The webcast will be made available at www.allogene.com under the Investors tab in the News and Events section.

References

1. Roschewski M, Kurtz D M, Westin J R, et al: Remission Assessment by Circulating Tumor DNA in Large B-Cell Lymphoma . J Clin Oncol 10.1200/JCO-25-01534.

About Natera

Nateraâ„¢ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, womenâ€s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Nateraâ€s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com .

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Nateraâ€s plans, estimates, or expectations will be achieved. These forward-looking statements represent Nateraâ€s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Nateraâ€s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov .

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Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

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