COMPANY:

Natera

"Natera, Inc... issued the following statement regarding its ongoing patent infringement litigation with NeoGenomics in response to inquiries...the District Court for the Middle District of North Carolina entered a permanent injunction against NeoGenomics’ accused RaDaR assay, which was preliminarily enjoined in December 2023. Natera continues to prosecute its claim against a modified version of RaDaR for infringement of Natera’s ‘454 patent. Natera seeks full remedies, including injunctive relief, after the Patent Office denied NeoGenomics’ petition for ‘inter partes’ review challenging the validity of the ‘454 patent."

"Natera, Inc...announced the simultaneous publication of three peer-reviewed papers, crossing a milestone of more than 85 peer-reviewed publications on Signatera...CRC Data from GALAXY ( Nature Medicine & ESMO Poster)...CRC Data from GALAXY ( Annals of Oncology & ESMO Poster)."

P=Obs | N=6,300 | GALAXY (UMIN000039205) | "Natera...announced that new data from the GALAXY arm of the ongoing CIRCULATE-Japan trial was released today at the 2024 Congress of the European Society for Medical Oncology (ESMO)....Signatera-positivity in the post-op MRD window was found to be significantly associated with worse OS compared to Signatera-negative patients (HR: 9.68, p-value < 0.01) with a 36-month OS of 71.80% vs. 96.0%, respectively....High-risk stage II and stage III-IV patients who were Signatera-positive after surgery and received ACT demonstrated superior OS (adjusted HR: 0.53, p-value = 0.05), corresponding to a 50% reduction in the risk of death when treated with ACT....Signatera-positivity after surgery was the single most significant prognostic factor associated with inferior DFS (HR 12.08, p-value <0.01) and OS (HR 9.87, p-value <0.01) in a multivariate analysis that included all clinicopathologic risk factors currently in use."

P=Obs | N=6,000 | GALAXY (UMIN000039205) | "Natera...announced it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2024 European Society for Medical Oncology (ESMO) Congress....The GALAXY data includes an updated analysis of more than 2,100 patients with stage I-IV CRC, reporting 36-month disease-free survival (DFS), and, for the first time, overall survival (OS). Key highlights include: Signatera-positive patients had significantly shorter OS compared to those who were Signatera-negative (hazard ratio of ~10), suggesting that Signatera-negative patients had an almost 10-fold advantage in OS. This compares favorably to all known guideline recommended biomarkers that typically have hazard ratios for overall survival in the 1-4 range. Overall survival stratified by adjuvant chemotherapy (ACT) will also be presented."

P=NA | N=NA | "Natera, Inc...announced a new study published in the Journal of Clinical Oncology highlighting the utility of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, for surveillance in Merkel cell carcinoma (MCC)....Signatera showed a test sensitivity of approximately 95% for detecting clinically evident disease at time of enrollment. ctDNA positivity during surveillance was associated with up to 20 times higher risk of recurrence than persistently ctDNA-negative patients. At 12 months of surveillance, the recurrence-free probability was 9% among patients with a positive ctDNA result at any time, compared with 91% for patients who remained ctDNA-negative."

"Natera...announced a new gastroesophageal cancer trial, DECIPHER, that will utilize the company’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, to guide patient selection and assess the rate of MRD clearance in patients being treated for gastroesophageal cancer."

"Natera...announced that enrollment has begun in the CIRCULATE-Japan and BESPOKE CRC trials, with both studies experiencing strong interest from centers across Japan and the U.S. The studies will measure clinical outcomes of Signatera molecular residual disease (MRD) testing in resectable Stages II-IV colorectal cancer (CRC)."

"Natera, Inc...today announced that the company, along with its collaborators, will present new data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, 2024...The presentations feature data across a variety of indications, including breast cancer, colorectal cancer (CRC), lung cancer, melanoma, esophageal cancer, and urothelial cancer, with one oral presentation and 12 poster presentations on Signatera, Natera’s personalized and tumor-informed molecular residual disease test, as well as one poster with data on Empower, Natera’s test for hereditary cancer...'This includes promising new findings from the CIRCULATE-Japan GALAXY study demonstrating the prognostic and predictive utility of Signatera and actionable biomarkers in colorectal cancer.'....Natera expects to announce topline results for this phase III randomized trial in August 2024."

P=NA | N=156 | "Natera, Inc...announced a new publication in JCO Precision Oncology reporting on the ability of its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to detect recurrence early in patients with early-stage breast cancer....Patients were followed for up to 12 years after surgery and adjuvant chemotherapy, with blood samples collected semi-annually and then analyzed using Signatera. Key findings include: Signatera detected relapse up to 38 months earlier than imaging (median lead time 10.5 months), with an overall sensitivity of 88.2% (30/34). Relapse-free survival (RFS) and overall survival (OS) were significantly worse in patients who were ctDNA-positive, regardless of hormone receptor and HER2 subtype (HR 52.98 and 53.69, respectively). In a multivariate analysis, ctDNA status was the most significant factor associated with RFS and OS."

P3 | N=520 | IMvigor011 (NCT04660344) | Sponsor: Hoffmann-La Roche | "The analysis presented at the EAU Congress evaluated clinical outcomes in 171 high-risk MIBC patients who entered screening for IMvigor011 and remained MRD-negative during the surveillance window. Key takeaways from the presentation include: Overall survival (OS) rates of 100% at 12 months and 98% at 18 months, in patients who remained serially MRD-negative; Disease-free survival (DFS) rates of 92% at 12 months and 88% at 18 months, in patients who remained serially MRD-negative."

"Natera, Inc...today announced the launch of Alliance A032103 (MODERN), a randomized, phase II/III, biomarker-integrated trial. Alliance A032103 (MODERN) will utilize Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to help guide personalized treatment based on molecular status in patients diagnosed with muscle-invasive urothelial cancer (MIUC) after radical cystectomy....In the Alliance A032103 (MODERN) trial, approximately 1,000 patients will be enrolled at more than 300 sites in North America. Patients will be divided into two cohorts based on an initial assessment of MRD status. Patients who are Signatera MRD-positive will have treatment randomized to either nivolumab, a PD-1 antibody, or escalation with nivolumab, a PD-1 antibody plus relatlimab, a LAG-3 antibody; LAG-3 and PD-1 are distinct inhibitory immune checkpoints."

"Natera, Inc...announced a collaboration with the Fédération Francophone de Cancérologie Digestive and CHU Dijon Bourgogne on the CIRCULATE-PRODIGE-70 study, a randomized, multicenter, prospective phase III clinical trial in France investigating molecular residual disease (MRD)-guided adjuvant treatment in stage II colorectal cancer (CRC) patients....The initial readout is expected in 2025."

"Natera, Inc...announced new data being presented on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, and hereditary cancer test, Empower, at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer taking place March 16-18, 2024. A total of seven abstracts will be presented, including two oral presentations and five poster presentations. The presentations will feature new data highlighting Signatera’s predictive and prognostic utility in ovarian cancer and other gynecologic malignancies."

"Natera, Inc...announced that its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, has met coverage requirements from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) in two new indications: ovarian cancer in the adjuvant and surveillance settings, and breast cancer in the neoadjuvant setting. These determinations add to a growing list of covered indications for Signatera, including adjuvant and recurrence monitoring coverage in colorectal cancer, muscle-invasive bladder cancer, and breast cancer; and pan-cancer immunotherapy response monitoring."

"Natera, Inc...today announced a new study published in Gynecologic Oncology validating its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, in endometrial cancer....This real-world study analyzed 267 plasma samples drawn after surgery from 101 patients with EC. The patient cohort was composed of multiple histological subtypes, with patients stratified based on clinicopathological risk factors into high-risk (52%), high-intermediate (22%), low-risk (15%), and other (12%). Key findings include: Patients who tested Signatera MRD-positive at either a single time point or longitudinally experienced significantly higher rates of recurrence than those who remained Signatera-negative (58% and 52%, vs. 6% and 0%, respectively), regardless of mismatch repair (MMR) or p53 status."

"Natera...announced that a jury in the U.S. District Court for the District of Delaware has reached a unanimous verdict in favor of Natera in its patent infringement case against CareDx, Inc."

"Natera, Inc...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)....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."

"Natera...announced the publication of two new studies in Nature Medicine evaluating Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera™."

P=Obs | N=6300 | GALAXY (UMIN000039205) | "This latest analysis from GALAXY included close to 3,000 stage I-IV CRC patients. Key findings include: ctDNA dynamics at the six-month time point post-surgery showed that patients who remained ctDNA-positive were >6 times more likely to recur compared to those who cleared their ctDNA; ctDNA-positive patients with sustained clearance in subsequent time points as a result of adjuvant chemotherapy (ACT) had remarkably better outcomes compared to those with transient ctDNA clearance (24-month DFS rate; 90.1% vs 2.3%) or no clearance (24-month DFS rate; 90.1% vs 2%)."

"NeoGenomics, Inc...announced that NeoGenomics Laboratories, Inc., a subsidiary of NeoGenomics Inc., will appeal the preliminary injunction issued by the United States District Court for the Middle District of North Carolina."

"Natera, Inc...announced that the federal District Court for the Middle District of North Carolina has issued a preliminary injunction, effective immediately, enjoining the RaDaR assay from NeoGenomics Labs, Inc."

P=NA | N=NA | "Natera, Inc...today announced a new study published in Molecular Oncology comparing the performance of mean tumor molecules per milliliter (MTM/mL) against mean variant allele frequency (mVAF) for measuring circulating tumor DNA (ctDNA), using Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test...Among the 18,426 patients with longitudinal ctDNA measurements, 13.3% had discordant ctDNA trajectories (increase/decrease) when calculated using MTM/mL versus mVAF...In a case study of a patient with metastatic triple-negative breast cancer, disease progression during systemic therapy was reflected in increasing MTM/mL values, while mVAF levels remained stable."

"The US District Court for the District of Delaware on Friday ordered that ArcherDx and Invitae permanently stop using products containing material patented by Natera, with certain exceptions."

P3 | N=5,637 | monarchE (NCT03155997) | Sponsor: Eli Lilly and Compan | "This study investigated the technical feasibility of ctDNA testing beginning prior to adjuvant CDK4/6i therapy and examined rates of ctDNA persistence and clearance in a highly selected cohort of 178 patients from the phase 3 monarchE trial, which excluded any recurrences in the first 24 months after surgery. Persistent ctDNA positivity during two years of treatment was found to be associated with a 100% risk of relapse. Additionally, none of the patients developed recurrence if they were initially ctDNA-positive and later became ctDNA-negative during treatment (ctDNA clearance). An analysis of an expanded cohort is ongoing, which will be more reflective of the intent-to-treat population and will include additional time points and recurrent cases within the 2-year treatment period."

"Natera, Inc...today announced that it has entered into an agreement with Merck, known as MSD outside the United States and Canada, under which Merck will utilize Natera’s real-world database (RWD) to advance oncology research....Natera’s oncology RWD contains de-identified clinical and genomic data from more than 100,000 early- and late-stage patients with cancer who have been tested with Signatera™, the company’s personalized and tumor-informed molecular residual disease (MRD) test. Longitudinal monitoring data is available for the majority of patients, providing an objective measure of molecular response to treatment and connected to a multi-modal database that includes clinical outcomes, genomic profiling, and imaging. Pharmaceutical companies can use Natera’s RWD to strategically advance drug development programs across early-stage and metastatic settings."

"Natera, Inc...announced its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, will be used in a new breast cancer study called TREAT ctDNA (EORTC 2129-BCG). This international, multi-center, randomized, phase III clinical trial is being conducted by the European Organisation for Research and Treatment of Cancer (EORTC) Breast Cancer Group in collaboration with Natera and Menarini Group (Menarini), a leading international pharmaceutical and diagnostics company....The study will screen approximately 1,900 patients across more than 120 sites in 12 countries throughout Europe and is expected to launch before the end of the year."

"Natera, Inc...announced updated data from the GALAXY arm of the CIRCULATE-Japan trial further showcasing the ability of the Signatera molecular residual disease (MRD) test to help identify patients with resectable colorectal cancer (CRC) who are at an increased risk of recurrence and predict who are most likely to benefit from adjuvant chemotherapy."

"Natera, Inc...today announced it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2023 European Society for Medical Oncology (ESMO) Congress, taking place Oct. 20-24 in Madrid, Spain....Natera and its collaborators will present MRD data in a total of seven abstracts, including a mini-oral and several poster presentations. The mini-oral presentation will feature an updated analysis of more than 2,000 patients from the GALAXY observational arm of the CIRCULATE-Japan trial, one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC). Other presentations will highlight new Signatera data in rectal cancer, appendiceal adenocarcinoma, hepatocellular carcinoma, renal cell carcinoma, and other solid tumors."

"Foundation Medicine, Inc., and Natera, Inc., today announced the broad clinical launch of FoundationOne^®Tracker, a personalized tissue-informed circulating tumor DNA (ctDNA) test to monitor cancer patients’ response to therapy. FoundationOne Tracker is now available to all U.S. healthcare providers for treatment response monitoring (TRM). Additionally, the Centers for Medicare & Medicaid Services’ (CMS) Palmetto GBA Molecular Diagnostics Program (MolDX) has determined, effective June 17, 2023, that FoundationOne Tracker is covered for monitoring of response to immune-checkpoint inhibitor (ICI) therapy, for qualifying Medicare beneficiaries with all solid tumors. FoundationOne Tracker is also approved by the Clinical Laboratory Evaluation Program (CLEP) of New York, which is the only U.S. state that requires an independent regulatory review process for laboratory developed tests."

"Natera, Inc...announced a new study published in Frontiers in Oncology demonstrating the ability of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to detect progression early, with high sensitivity and specificity, and risk stratify patients with unresectable stage I-III non-small cell lung cancer (NSCLC) treated with definitive radiotherapy."

"Natera, Inc...announced the submission of the first module of its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, as a companion diagnostic (CDx) assay for patients with muscle-invasive bladder cancer (MIBC). This module, submitted on September 28, included the required documentation regarding Natera’s manufacturing and quality control systems, which the Company expects will support all future indications for Signatera as well as other Natera products. The remaining modules for the Signatera MIBC indication, including software, analytical and clinical validation data, are expected to be submitted through 2025 upon completion of the ongoing registrational trial."

"Natera, Inc...today announced a new study as part of the I-SPY 2 trial, sponsored and operated by Quantum Leap Healthcare Collaborative, that will use Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test, to monitor response to neoadjuvant therapy in breast cancer patients across all subtypes...This prospective study, in which 600 patients will be monitored in real time, will support efforts to establish circulating tumor DNA (ctDNA) as a composite endpoint and generate additional data on post-surgical ctDNA status in patients treated with neoadjuvant therapy."

"Natera, Inc...announced that it has filed a lawsuit in the North Carolina Federal District Court against NeoGenomics Labs, Inc. ('NeoGenomics') for infringement of Natera’s U.S. Patent Nos. 11,519,035 and 11,530,454 by NeoGenomics’ RaDaR molecular residual disease assay."

"Natera, Inc...today announced the completion of enrollment to the randomized, double-blind phase III ALTAIR clinical trial...ALTAIR is the circulating tumor DNA (ctDNA)-guided treatment escalation arm of the CIRCULATE-Japan adaptive trial platform evaluating the utility of the Signatera molecular residual disease (MRD) test in patients with stage II-IV resectable colorectal cancer (CRC). CIRCULATE-Japan also includes the observational GALAXY study and the randomized phase III VEGA trial for ctDNA-guided treatment de-escalation. The company expects to share primary results from ALTAIR in mid-2024....The ALTAIR investigators have met their goal to enroll >240 patients who tested ctDNA-positive at any time within 2 years after surgery, but with no clinical or radiographic evidence of disease."

"Natera, Inc...announced that new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera™, will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2 – 6, 2023....Results will be presented from the Phase 3 EMPOWER-Lung 1 study of 175 NSCLC patients randomized to chemotherapy vs cemiplimab."

"Natera, Inc...announced that a jury in the U.S. District Court for the District of Delaware has reached a unanimous verdict in favor of Natera in the patent infringement suit it filed against ArcherDX/Invitae Corp. The jury found that all accused ArcherDX/Invitae products infringe three of Natera’s patents."

"Invitae...announced that it intends to appeal the verdict delivered by a jury at the United States District Court for the District of Delaware. The jury found that Invitae's products using Anchored Multiplex PCR ('AMP') chemistry infringe certain Natera, Inc. patents. The jury awarded Natera a total of $19.35 million, based on lost profits and a royalty rate of 10% on certain products. Invitae will vigorously defend itself in future proceedings regarding Natera's request for injunctive relief."

P2 | N=5,000 | I-SPY (NCT01042379) | "Natera, Inc...announced the publication of a new paper in Cancer Cell from the I-SPY2 trial, highlighting the prognostic and predictive utility of Natera’s personalized and tumor-informed, molecular residual disease (MRD) test, Signatera, in locally advanced breast cancer patients receiving neoadjuvant chemotherapy (NAC, treatment before surgery)....ctDNA-positivity before, during, and after NAC was significantly associated with inferior distant recurrence-free survival (DRFS) in both subtypes (p=0.02 to p<0.0001); and in the 9% of TNBC patients who tested ctDNA-negative pretreatment, zero DRFS events were observed with a median follow-up of 3.12 years. Early ctDNA clearance at 3 weeks of NAC was a significant predictor of response, as determined by pathologic complete response (pCR) or residual cancer burden (RCB) in TNBC (p=0.0002)."

"Natera, Inc...announced new data on its Signatera molecular residual disease (MRD) test being presented at the annual meeting of the American Association for Cancer Research (AACR) taking place April 14 – 19, 2023. Natera and its collaborators will present findings from five studies on Signatera in esophago-gastric adenocarcinoma, muscle-invasive bladder cancer (MIBC), colorectal cancer (CRC) and hepatocellular carcinoma (HCC)."

"Natera, Inc...announced a new study published in Cancer showing the prognostic and predictive utility of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to inform adjuvant treatment decisions and monitor for recurrence and therapy response in patients with stages III-IV melanoma....Current guidelines recommend periodic imaging and clinical assessment to determine therapeutic efficacy; however, imaging-based surveillance has limitations."

"Natera, Inc...announced the Company’s first commercial coverage policies for its molecular residual disease test, Signatera, including its first pan-cancer coverage policy for adjuvant, recurrence monitoring, and treatment monitoring. Effective March 1, 2023, Blue Shield of California now provides commercial coverage of Signatera for plan members diagnosed with any solid tumors....In addition, effective January 1, 2023, Blue Cross and Blue Shield of Louisiana is providing coverage of serial testing with Signatera for plan members diagnosed with colorectal and muscle invasive bladder cancer and for pan-cancer immunotherapy monitoring."

"Natera, Inc...announced that it has received written confirmation from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) that Natera’s Signatera molecular residual disease (MRD) test has met coverage requirements for adjuvant and recurrence monitoring in patients with stage IIb or higher breast cancer. The coverage applies across all subtypes of the disease, including hormone receptor (HR)-positive, HER2-positive, and triple negative breast cancers. This decision adds to Medicare’s prior coverage of Signatera in colorectal cancer, muscle-invasive bladder cancer, and pan-cancer immunotherapy monitoring."