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

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

January 27, 2025 Catherine Williams - Chief Editor Business

Natera’s Signatera Shows Promise in Predicting Colorectal Cancer Recurrence, Treatment Response

In a significant breakthrough for personalized cancer care, Natera, Inc. (NASDAQ: NTRA) announced compelling data from two clinical trials at the 2025 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium. The trials, CALGB (Alliance) / SWOG 80702 and ALTAIR, shed light on the potential of Natera’s Signatera test to predict colorectal cancer recurrence and guide treatment decisions.

The randomized, Phase III CALGB (Alliance) / SWOG 80702 study evaluated whether Signatera-positive patients could benefit from an escalation in adjuvant treatment. The test was used to assess the addition of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), to the standard of care (SOC) adjuvant chemotherapy with FOLFOX in managing stage III colorectal cancer (CRC).

Key findings from the study include:

  • Signatera-positivity after surgery predicted a significant disease-free survival (DFS) and overall survival (OS) benefit with the addition of celecoxib to adjuvant FOLFOX. The three-year DFS rate was 44.1% versus 26.6% in Signatera-positive patients who received celecoxib, with a hazard ratio (HR) of 0.55 (95% CI 0.39-0.80; p=0.001). Similar results were seen for OS (HR 0.58, 95% CI 0.38-0.90; p=0.013). No survival benefit was observed in Signatera-negative patients.

  • Signatera status after surgery and prior to starting adjuvant therapy was highly predictive of recurrence. Signatera-positivity was significantly associated with worse DFS (HR 7.14, 95% CI: 5.54-9.21; p<0.0001) and OS (HR 6.72, 95% CI: 4.91-9.18; p<0.0001).

Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera, hailed the results as "an unprecedented moment in personalized medicine for patients with colorectal cancer." He noted, "We demonstrated Signatera’s ability to predict a benefit in both disease-free survival and overall survival for Signatera-positive patients from the addition of celecoxib, an extremely accessible, affordable, and well-tolerated therapy."

In the ALTAIR clinical trial, treatment escalation with Trifluridine/Tipiracil (FTD/TPI) in patients with stage I-IV colorectal cancer showed a trend toward benefit 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). However, there was a significant benefit for resected oligometastatic stage IV patients treated with FTD/TPI, with a median DFS of 9.76 months as compared to 3.96 months in the placebo group (HR, 0.53; P = 0.012).

Signatera, a personalized, tumor-informed, molecular residual disease test, 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 muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor.