stage IIA non-small cell lung cancer

FOSTER CITY, Calif., April 28, 2025 /PRNewswire/ -- Adela, Inc., an innovator in blood testing for molecular residual disease (MRD) monitoring and early cancer detection through a proprietary genome-wide methylome enrichment technology, presented initial results demonstrating the ability of its MRD test to predict recurrence in early-stage non-small cell lung cancer, at the American Association for Cancer Research (AACR) Annual Meeting from April 25-30, 2025. Adela's MRD test is a blood-only, tissue-free approach for detecting recurrence prior to clinical exam and imaging, eliminating the need for tumor tissue samples and enabling broader access to MRD testing. A blood-only approach is especially important in lung cancer, where nearly 40% of patients do not have sufficient tumor tissue for tissue-informed MRD tests.1 The ability of Adela's test to quantify cfDNA cancer signal and predict recurrence was evaluated in 136 samples from 24 patients diagnosed with stage I-II non-small cell lung cancer treated at New York University Langone Medical Center. Blood draws occurred prior to surgery, after surgery and at intervals before recurrence or last clinical follow-up. Adela's test demonstrated the ability to identify recurrences up to 35.9 months before standard of care clinical exam and imaging, with a mean lead time of 16.6 months. Significant differences in recurrence-free survival (RFS) were observed when patients were stratified by MRD positivity (hazard ratio of 3.58, P=0.038). "We are greatly encouraged by these results which highlight the ability of Adela's tissue-free MRD test to detect recurrence in lung cancer well in advance of standard of care," said Dr. Anne-Renee Hartman, Chief Medical Officer of Adela. "Adela's MRD test has been clinically validated for head & neck cancer. These results further validate the strong performance of Adela's genome-wide methylome enrichment platform and demonstrate its applicability across multiple cancer types." Adela's MRD test based on its genome-wide methylome enrichment platform is currently available to biopharmaceutical companies and other investigators for Research Use Only (RUO), including for biomarker discovery and drug development. Adela plans to commercialize the test in 2025 for use in patients who have received curative intent treatment for head & neck cancer, regardless of HPV status, to detect recurrence earlier and help guide treatment decision-making. Presentation Details Abstract #: 3249: The Development of a Tissue-Agnostic Genome-Wide Methylome Enrichment Assay for Lung Cancer Harvey I. Pass2 Monday Apr 28, 2025 2:00 PM - 5:00 PM Poster Section 29, Poster Board Number: 14 About Adela Adela is developing best-in-class technology to accelerate the diagnosis and improve the management of cancer through blood tests for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Adela's blood-based, tissue-free product ensures universal accessibility to MRD testing for patients with cancer, eliminating any dependency on tumor tissue availability. Adela's approach efficiently captures extensive, biologically-relevant genomic information from the methylome, providing greater opportunity to detect cancer signals in the blood compared to platforms that target a smaller set of genomic regions. Adela's first product utilizing this genome-wide methylome enrichment platform was recently clinically validated for predicting and surveilling for recurrence in patients with head & neck cancer and published in Annals of Oncology. Adela's investors are F-Prime Capital, OrbiMed, Deerfield Management, Decheng Capital, RA Capital Management and Labcorp. Find more information at adelabio.com. 1 Sam Khan et al. ctDNA-Lung-DETECT: ctDNA outcomes for resected early stage non-small cell lung cancers at 12 months.. JCO 42, 8018-8018(2024). DOI:10.1200/JCO.2024.42.16_suppl.8018 2 Department of Cardiothoracic Surgery, NYU Langone Medical Center New York, NY SOURCE Adela WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Merck & Co. said Thursday that it is discontinuing two Phase III studies investigating the anti-PD-1 therapy Keytruda (pembrolizumab) in earlier lines of treatment – one in patients with stage I or II non-small-cell lung cancer (NSCLC) and another in cutaneous squamous cell carcinoma (cSCC) – after coming up short at interim analyses.The first trial, dubbed KEYNOTE-867, explored Keytruda in combination with stereotactic body radiotherapy (SBRT) for the treatment of around 436 patients with stage I or II NSCLC, including those who are medically inoperable or have refused surgery. The company noted that at a pre-specified interim analysis, the Keytruda arm did not demonstrate an improvement in event-free survival or overall survival (OS), the study’s primary and key secondary endpoints, respectively.Higher rate of AEs, deathMerck added that in the trial, Keytruda in combination with SBRT was also associated with higher rates of adverse events (AEs), including AEs leading to death, compared with SBRT and placebo. Meanwhile, the KEYNOTE-630 trial was evaluating Keytruda for the adjuvant treatment of about 430 patients with high-risk locally advanced cSCC following surgery and radiation. The study's data monitoring committee recommended halting the trial for futility after a pre-planned analysis showed that Keytruda did not cross the boundary for statistical significance in recurrence-free survival, the primary endpoint.Merck added that although the trial's key secondary goal of OS was not formally tested, at the time of the analysis, the results did not favour Keytruda compared to placebo. Analyses of both studies are ongoing with results expected to be shared at a future date.The company recently reported that quarterly sales of Keytruda crossed $7 billion for the first time, with growth being driven by both the breadth of the product's label and continued adoption as an earlier-stage therapy (for related analysis, see Spotlight On: Lilly’s tirzepatide emerging as 2024's fastest growing drug amidst +$30B industry boom). However, not all efforts to move Keytruda up the treatment ladder have been successful, with the failure in May of the Phase III KEYNOTE-B21 study in certain newly diagnosed patients with endometrial cancer marking a rare blot on the drug's copybook.

Clinical management was altered in 100% of patients with a Signatera positive result AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in The Journal of Thoracic and Cardiovascular Surgery demonstrating the ability of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to risk stratify and detect recurrence early in patients with resected stage I-II non-small cell lung cancer (NSCLC). The full study can be found here. Worldwide, lung cancer is the second most commonly diagnosed cancer. In the U.S., NSCLC accounts for 81% of all lung cancer diagnoses.1 About 25-30% of NSCLC patients are diagnosed with stage I-II disease.2,3 These patients typically undergo curative-intent complete surgical resection and may be treated with adjuvant systemic therapy. However, 30–55% of patients develop disease recurrence within the first five years after surgery, and five-year overall survival ranges from 68-92% for stage I and 53-60% for stage II NSCLC patients respectively.4,5,6 Given the significant risk of recurrence and death in NSCLC, it is critical to accurately risk-stratify patients to identify who may derive benefit from additional treatment after surgery. In addition, there is a need for sensitive and specific biomarkers to support early detection of recurrence before the onset of disease-related symptoms at a time when therapy might provide greater clinical benefit. This study investigated the association of circulating tumor DNA (ctDNA) status with recurrence-free survival (RFS), as well as changes in clinical practice after a positive ctDNA result in patients with resected stage I-II NSCLC. A total of 378 serial plasma samples from 108 NSCLC patients were analyzed after surgical resection, with a median clinical followup of 16 months. Key findings include: Patients who were ctDNA-positive within 6 months post-resection and prior to adjuvant treatment were 53-times more likely to recur (p<0.0001) as compared to ctDNA-negative patients. ctDNA detection demonstrated a median lead time of 5.5 months when compared to confirmation of recurrence by radiographic imaging. Post-operative surveillance strategies were altered in 100% of ctDNA-positive patients (earlier radiographic imaging), and patients with PET scans positive for malignant features received early referrals for treatment. “This study demonstrates that serial monitoring with Signatera can identify patients who are most likely to benefit from adjuvant systemic therapy and/or more intensified imaging,” said Minetta Liu, MD, chief medical officer of oncology at Natera. “With measurable clinical impact in 100% of Signatera MRD-positive cases, this study supports the utility of Signatera in the management of non-metastatic, resected NSCLC.” The study builds on previous Signatera data across early- and late-stage NSCLC. This includes a 2023 publication in Frontiers in Oncology, demonstrating Signatera’s ability to risk stratify and detect progression early in unresectable NSCLC,7 as well as the EMPower Lung-1 trial presented at the 2023 ASCO annual meeting, which showed Signatera’s ability to monitor response to immunotherapy and predict clinical outcomes in advanced NSCLC patients.8 This recent work also builds upon the 2017 TRACERx Nature publication that first reported Signatera’s ability to detect relapse early with high sensitivity and specificity in patients with resected NSCLC.9 About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for 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 (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA testing, 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 validated by more than 180 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit . 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 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 and . References Cancer.Net. Lung Cancer (Non-Small Cell) - Statistics. . 2023. Cancer of the Lung and Bronchus (Invasive). In: Howlader N, Noone AM, Krapcho M, et al. editors. SEER Cancer Statistics Review, 1975-2014. Bethesda, MD: National Cancer Institute, 2017. Kocher F, Hilbe W, Seeber A, et al. Longitudinal analysis of 2293 NSCLC patients: A comprehensive study from the TYROL registry. Lung Cancer. 2015;87(2):193-200. doi:10.1016/j.lungcan.2014.12.006 Uramoto H, Tanaka F. Recurrence after surgery in patients with NSCLC. Transl Lung Cancer Res. 2014;3(4):242-249. doi:10.3978/j.issn.2218-6751.2013.12.05 Lou F, Sima CS, Rusch VW, Jones DR, Huang J. Differences in patterns of recurrence in early-stage versus locally advanced non-small cell lung cancer. Annals of Thoracic Surgery. 2014;98(5):1755-1761. doi:10.1016/j.athoracsur.2014.05.070 Journal of Thoracic Oncology 2016 1139-51DOI: (10.1016/j.jtho.2015.09.009) Lebow et al. ctDNA-based detection of molecular residual disease in stage I-III non-small cell lung cancer patients treated with definitive radiotherapy. Front. Oncol. 2023,13:1253629. Vokes N, Gandara D, et al. Circulating Tumor DNA (ctDNA) Dynamics and Survival Outcomes in Patients with Advanced NSCLC and High (>50%) PD-L1 Expression, Randomized to Cemiplimab vs Chemotherapy. Presented at ASCO Annual Meeting, Chicago, IL, June 2023. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446-451.