Durvalumab

AUSTIN, Texas--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced it will present new data in genitourinary malignancies at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026. Across four oral presentations in muscle-invasive bladder cancer (MIBC), these data reinforce Signatera’s role in identifying patients who benefit from adjuvant immunotherapy, supporting response-adaptive bladder preservation strategies, and refining molecular residual disease (MRD) detection with plasma circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA). Bladder Preservation: INDIBLADE and RETAIN The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate Signatera’s consistent performance in treatment response monitoring across diverse neoadjuvant regimens in MIBC, with 73-77% of patients demonstrating clearance of ctDNA following therapy and Signatera-negativity showing strong associations with positive outcomes, even with the bladder preserved. INDIBLADE, the findings of which will be published today in Nature Medicine, investigated induction with combination immune checkpoint inhibitors (ICI) followed by chemoradiotherapy as a bladder-sparing strategy in stage II/III MIBC patients. The results show that Signatera status post-ICI was associated with bladder-intact event-free survival (BI-EFS). Specifically, Signatera-negativity at baseline and post-neoadjuvant therapy was linked to an 88.6% and 91% estimated two-year BI-EFS, respectively. RETAIN evaluated a clinical response-adapted approach to identify patients for potential bladder-preservation following neoadjuvant therapy. The findings showed that post-treatment ctDNA clearance or negativity was associated with improved metastasis-free survival (MFS), and that Signatera-negative patients with no clinical or radiographic evidence of disease managed with active surveillance achieved MFS comparable to Signatera-negative patients undergoing cystectomy. In contrast, persistent Signatera-positivity was associated with poor outcomes. Perioperative Care: NIAGARA This phase 3 randomized perioperative study includes the first-ever presentation of utDNA data with clinical correlation. The combination of utDNA and ctDNA status post-neoadjuvant therapy and pre-cystectomy identified the group with the highest 24-month EFS. utDNA-positivity pre-cystectomy was more strongly associated with residual non-invasive disease vs ctDNA-positivity was more strongly associated with residual invasive disease. These data suggest that the combined assessment of utDNA and ctDNA can provide complementary risk stratification benchmarked against pathologic staging, enabling comprehensive identification of residual disease. “As treatment options expand in perioperative and bladder preservation settings, we need tools that help us determine who truly requires additional therapy and who may safely avoid it,” said Michiel van der Heijden, M.D., Ph.D., Netherlands Cancer Institute, principal investigator of INDIBLADE and presenting author of the NIAGARA study. “The data presented at ASCO GU demonstrate that MRD assessment with Signatera has strong correlations with outcomes and the potential to inform these critical treatment decisions.” “Following our milestone PMA submission to the FDA based on IMvigor011, these compelling data presentations reflect our commitment to transforming care across the spectrum of genitourinary malignancies,” said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. “The new data suggests a particularly important opportunity for Signatera to optimize clinical decisions around bladder preservation, a major opening to improve patient quality of life.” The full list of presentations at ASCO GU includes: February 27, 8:10 AM PT | Abstract #633 (Oral Presentation) Presenter: Joaquim Bellmunt, M.D. Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial February 27, 8:10 AM PT | Abstract #632 (Oral Presentation) Presenter: Pooja Ghatalia, M.D. Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials February 27, 11:30 AM PT | Abstract #797 Presenter: Can Aydogdu, M.D. Integrating genomic profiling and circulating tumor DNA monitoring to optimize surveillance strategies in muscle-invasive bladder cancer February 27, 11:30 AM PT | Abstract #831 Presenter: Can Aydogdu, M.D. Association of ctDNA status with upstaging, pathologic outcomes, and genomic alterations in high-risk NMIBC February 27, 2:30 PM PT | Abstract #637 (Oral Presentation) Presenter: Jan-Jaap J. Mellema, M.D. Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 INDIBLADE trial February 27, 4:00 PM PT | Abstract #636 (Oral Presentation) Presenter: Michiel van der Heijden, M.D., Ph.D. Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA February 28, 7:00 AM PT | Abstract #532 Presenter: Shuchi Gulati, M.D., M.Sc. Association of pre-operative circulating tumor DNA (ctDNA) status with clinicopathologic characteristics in patients (pts) with localized renal cell carcinoma (RCC) February 28, 7:00 AM PT | Abstract #620 Presenter: Dalia Kaakour, M.D., MPH Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer February 27, 11:30 AM PT | Abstract #860 Presenter: Lingbin Meng, M.D., Ph.D. Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer February 27, 11:30 AM PT | Abstract #800 Presenter: Tanya Jindal, BS, BA Predictive value of early circulating tumor DNA (ctDNA) response in advanced urothelial carcinoma (aUC) treated with enfortumab vedotin plus pembrolizumab (EVP). February 28, 7:00 AM PT | Abstract #541 Presenter: David F. McDermott, M.D. Circulating tumor DNA (ctDNA) analysis in participants (pts) with advanced clear cell renal cell carcinoma (ccRCC) treated with first-line pembrolizumab (pembro) monotherapy from the phase 2 KEYNOTE-427 study. About Natera Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’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. Natera’s tests are supported by more than 350 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 Natera’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 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 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.