Natera Announces Successful Readout of Randomized, Phase III CALGB (Svez) / SWOG 80702 Clinical Trial in Colorectal Cancer investicijom.com

Patient reading ~ 1K at ASCO GI 2025 shows signal™ Positive patients treated with both chemotherapy and celecoxib had a 40% improvement in overall survival compared to chemotherapy

ASCO GI Supplemental Poster Highlights Data from the Altair Clinical Trial, Showing Significant Clinical Benefit in Stage IV Colorectal Cancer Patients Treated with Trifluridine/Tipiracil (FTD/TPI)

Austin, Texas,-(Business Wire)-Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, announced new data from the randomized, phase III CALGB (Alliance) / SWOG 80702 study. The study will be presented today, January 25, 2025 as an oral presentation at the Late Breakthrough at the American Society of Clinical Oncology, Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA.

This first study evaluated whether signal-positive patients benefit from escalation in adjuvant treatment. In the trial, Signal was used to assess the benefit of adding celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), to standard of care (SOC) adjuvant chemotherapy with FOLFOX in the treatment of stage III colorectal cancer (CRC). The prespecified analysis included approximately 1,000 patients with available postsurgical plasma samples who were randomized to receive FOLFOX (+/-) CELECOXIB.

Key findings included:

• Postoperative signature-positivity was predictive of disease-free survival (DFS) and overall survival (OS) benefit of adding celecoxib to adjuvant FOLFOX. The addition of celecoxib to SOC chemotherapy significantly improved DFS compared with placebo (HR 0.55, 95% CI 0.39-0.80; p = 0.001) among signal-positive patients with a 3-year DFS of 44.1% in compared to 26.6%. Similar results were observed for OS (HR 0.58, 95% CI 0.38-0.90; P = 0.013). No survival benefit was reported by adding celecoxib to chemotherapy in signal-negative patients.
• Signal status after surgery and before starting adjuvant therapy was highly predictive of recurrence. Signal positivity was significantly associated with worse DFS (HR 7.14, 95% CI: 5.54-9.21; P

The results of the CALGB (Alliance) / SWOG 80702 study mark an unprecedented moment in personalized medicine for patients with colorectal cancer, said Alexey Aleshin, Ph.D. Med., Corporate Physician and CEO of Oncology for Natera (NASDAQ:). We demonstrated the ability of signal to predict benefit in both disease-free survival and overall survival in signal-positive patients from the addition of celecoxib, an extremely available, affordable and well-tolerated therapy. These data also offer compelling evidence to address an unmet need in the adjuvant treatment of colorectal cancer, where there has been no new drug approval in over 20 years.

Results from a randomized, double-blind clinical trial of Altair will also be presented at a poster today. Altair examined trifluridine/tipiracil (FTD/TPI) treatment escalation in patients with stage I-IV colorectal cancer. In the trial, 243 signal-positive patients were randomized to FTD/TPI or placebo over a six-month period. Results showed a trend in favor in the FTD/TPI group (median DFS of 9.3 months vs. 5.6 months in the placebo group), although it did not reach statistical significance (HR, 0.79; P = 0.107). There was a significant benefit for resected stage IV oligometastatic patients treated with FTD/TPI, showing a median DFS of 9.76 months compared with 3.96 months in the placebo group (HR, 0.53; P = 0.012). This represents an opportunity for clinical benefit in phase IV patients who test positive for MRD.

About the signal

Signatera is a personalized tumor-informed molecular residual disease test for patients previously diagnosed with cancer. Tailored to each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use, and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and bladder cancer, as well as for monitoring immunotherapy of any solid tumor. Signatera has been clinically validated in multiple cancer types and indications, with published evidence in over 100 peer-reviewed papers.

About Natera

Natera ™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health and organ health. Our goal is 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 longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485 certified and accredited Clinical Laboratory Improvement Amendments (CLIA) certified laboratories in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

Forward-looking statements

All statements that are not statements of historical fact contained in this press release are forward-looking statements and are not representations that Nater’s plans, estimates or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially, including whether the results of clinical or other studies will support the use of our product offerings, the impact of the results of such studies, our expectations of the reliability, accuracy and performance of our tests or the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in more detail in the “Risk Factors” in Natera’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.

See the original version on BusinessWire.com: https://www.businesswire.com/news/home/20250124878004/en/

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com
Media: Lesley Bogdanow, Vice President of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.