Natera Announces Successful Readout of Randomized, Phase III CALGB (Alliance) / SWOG 80702 Clinical Trial in Colorectal Cancer
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, Jan. 25, 2025 as a late-breaking oral presentation at the 2025 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA.
This first-of-its-kind study evaluated whether Signatera-positive patients benefit from an escalation in adjuvant treatment. In the trial, Signatera was used to evaluate the benefit of adding celecoxib, a non-steroidal anti-inflammatory drug (NSAID), to standard of care (SOC) adjuvant chemotherapy with FOLFOX in the management of stage III colorectal cancer (CRC). The pre-specified analysis included approximately 1,000 patients with available post-surgical plasma samples, who were randomized to receive FOLFOX (+/-) celecoxib.
Key findings included:
- Signatera-positivity after surgery was predictive of a disease-free survival (DFS) and overall survival (OS) benefit with the addition of celecoxib to adjuvant FOLFOX. The addition of celecoxib to SOC chemotherapy significantly improved DFS compared to placebo (HR 0.55, 95% CI 0.39-0.80; p=0.001) among Signatera-positive patients with a three-year DFS of 44.1% versus 26.6%. Similar results were seen for OS (HR 0.58, 95% CI 0.38-0.90; p=0.013). No survival benefit was seen by adding celecoxib to chemotherapy 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).
“The results from the CALGB (Alliance) / SWOG 80702 study mark an unprecedented moment in personalized medicine for patients with colorectal cancer,” said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology for Natera. “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. These data also offer compelling evidence to address an unmet need in adjuvant colorectal cancer treatment, where there has not been a new drug approval in over 20 years.”