On May 23, 2024 Invitae (OTC:NVTAQ), a leading medical genetics company, reported eight studies to be presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held in Chicago from May 31-June 4, 2024 (Press release, Invitae, MAY 23, 2024, View Source [SID1234643605]). The clinical data being presented demonstrate the importance of genetic testing for patients with various different types of cancers, including breast, gastric, prostate and lung, to better inform management and treatment decisions.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people.

Genetic testing guidelines need to be inclusive of more cancer types, with new data finding gastric, lung and prostate cancer patients with inherited genes linked to increased cancer risk

Gastric cancer is the fourth leading cause of cancer-related deaths worldwide, and the role of pathogenic (disease causing) variants in cancer predisposition genes is not well understood for this disease. One study looked at genetic testing results in 3,706 gastric cancer patients – the largest study of its kind – to better understand the prevalence of disease causing variants in cancer associated genes. The results found the percentage of patients with disease causing variants to be 13.4%, about 1 in 8 patients. This shows the value of genetic testing in all gastric cancer patients, as the prevalence of pathogenic variants is similar to other cancer types for which guidelines recommend universal genetic testing.

"Current guidelines haven’t met the needs for patients across cancer types, gastric cancer included," said Dr. Ophir Gilad, University of Chicago and a co-author of this study. "The prevalence of actionable gene variants found in this study of gastric cancer patients is on par with other cancer types for which guidelines recommend universal genetic testing. We’re increasingly seeing evidence for germline genetic testing to help guide treatment plans and familial testing for various cancer types."

Additionally, in a study of 14,317 patients with lung cancer, 12.6% had pathogenic germline variants — regardless of smoking history. The study results suggest these inherited genes are not only independently associated with lung cancer, but also additive to smoking risk for lung cancer. These data reinforce prior studies supporting consideration of germline genetic testing for all patients with lung cancer, independent of age or reported smoking history.

Genetic testing is similarly underutilized for prostate cancer. In a large study of 15,000 prostate cancer patients that received genetic testing, results showed that of the patients with genetic variants that increase risk of prostate cancer, 3 in 4 patients had no reported family history of prostate cancer and more than 1 in 3 patients had no reported family history of any cancer. The findings underscore the importance of genetic testing for all prostate cancer patients, regardless of age, stage or family history.

Breast cancer data in Rwanda demonstrates need for more genetic testing in underrepresented populations

Despite the observation that cancers are often diagnosed at young ages and take an aggressive course in Sub-Saharan Africa (SSA), genetic data that could inform treatment are limited for this population group.

In a recent study, patients undergoing cancer treatment in hospitals in Rwanda for female breast, male breast and prostate cancer underwent multigene panel testing (Invitae), and the results found a large proportion of the patients had inherited pathogenic variants that could help inform their treatment (18.3% of female breast cancer, 16.7% of male breast cancer, and 4.3% of prostate cancer patients). The findings suggest that genetic testing should be more routinely implemented into cancer care and prevention strategies in this population.

Underrepresented race, ethnicity, and ancestry (REA) groups face these challenges across geographies. In another recent study being presented at ASCO (Free ASCO Whitepaper) that included more than one million people over an eight-year period who underwent genetic testing for hereditary cancer syndromes, it was found that underrepresented REA groups are disproportionately impacted by variants of uncertain significance (VUS) in genetic testing, which are uncertain results that are not clinically actionable. With more representation of these groups in clinical studies, there will be more data that could uncover life-saving discoveries. Clinical evidence was the most significant source of information leading to VUS resolution, underscoring the importance of the clinician-lab partnership and communication.

"Germline genetic testing should be the standard of cancer care across many types of cancers. In underrepresented populations, this is especially crucial as more information needs to be collected to better inform care and improve population health overall," said Dr. Michael Korn, chief medical officer at Invitae. "Each year, ASCO (Free ASCO Whitepaper) presents us with an opportunity to share compelling research to help propel cancer treatment forward, and we’re proud of the clinical insights our tests are able to provide across cancer types."

Study offers reassurance that variants of uncertain significance in genetic testing results among patients with breast cancer do not lead to overuse of treatment or surveillance interventions, such as mastectomies

It’s common for patients with breast cancer undergoing germline genetic testing to have uncertain results, but it’s previously been unclear if these results impact clinical management. However, a recent study being presented at ASCO (Free ASCO Whitepaper) presents new evidence indicating that variants of uncertain significance (VUS) identified through germline genetic testing do not result in guideline-discordant management in real-world settings. Specifically, patients with breast cancer and VUS results demonstrated similar rates of treatment, prevention and surveillance interventions compared to those with negative results. This offers reassurance that VUS results do not lead to overuse of mastectomies or other interventions for patients with breast cancer.

2024 ASCO (Free ASCO Whitepaper) presentations and posters:

Oral presentation/Abstract 10513: Titled: Tracking uncertainty in germline genetic testing for hereditary cancer syndromes: Sources, attributes and resolution of variants of uncertain significance in over 1 million individuals. Presenter: Brian Reys, MS, CGC
Oral presentation/Abstract 10512: Titled: Real-world cancer care utilization among patients with breast cancer with germline variants of uncertain significance. Presenter: Allison W. Kurian, MD, MS, MSc, FASCO
Poster 374/Abstract 6058: Titled: The combination of patient-specific tumor and HPV sequencing to enable high-sensitivity detection of ctDNA in patients with HPV-associated oropharyngeal carcinoma. Presenter: Bill Diplas, MD, PhD
Poster 106/Abstract 10579: Titled: Uptake of risk-reduction, surveillance and therapeutic interventions among breast cancer patients with pathogenic germline variants. Presenter: Allison W. Kurian, MD, MS, MSc, FASCO
Poster 508/Abstract 5102: Titled: Germline gene-specific associations in a large prostate cancer cohort. Presenter: Hiba Khan, MD, MPH
Poster 105/Abstract 10578: Titled: Prevalence of pathogenic genetic variants in patients with gastric cancer ascertained through multi-gene panel testing. Presenter: Ophir Gilad, MD
Poster 118/Abstract 10591: Titled: Germline sequence variation in Rwandan patients with breast and prostate cancer. Presenter: Achille Manirakiza, MD, MMed
Poster 302/Abstract 8040: Titled: Smoking and pathogenic germline variants in patients with lung cancer. Presenter: Ed Esplin, FACMG, FACP, MD, PhD

On May 23, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported positive updated lead-in data from the company’s ongoing Phase 3 PEAK trial evaluating the selective and potent KIT mutant inhibitor, bezuclastinib, in combination with sunitinib, in patients with Gastrointestinal Stromal Tumors (GIST) (Press release, Cogent Biosciences, MAY 23, 2024, View Source [SID1234643621]). The data will be presented in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL on June 1. Cogent also announced today a new Phase 2 clinical trial of bezuclastinib plus sunitinib in later line GIST patients, sponsored by the Sarcoma Alliance for Research through Collaboration (SARC) and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute.

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"These data presented today reinforce our excitement that the combination of bezuclastinib and sunitinib has the potential to become a new standard of care for advanced GIST patients," said Andrew Robbins, President and Chief Executive Officer at Cogent Biosciences. "Coupled with the impressive clinical activity demonstrated by the combination, the addition of bezuclastinib to sunitinib continues to be generally well-tolerated with an encouraging safety profile. We are pleased to report that the pace of enrollment in PEAK is significantly ahead of schedule, and we now expect enrollment to complete in the third quarter of 2024."

"We are also excited today to announce a collaboration with SARC, The Life Raft Group and Dana-Farber on a new Phase 2 clinical trial assessing the potential benefit of bezuclastinib with sunitinib in later line GIST patients who are not eligible for the PEAK study and currently have very limited treatment options," continued Mr. Robbins.

"There is tremendous need for additional treatment options for GIST patients," said Andrew Wagner M.D., Ph.D., Senior Physician, Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. "Today’s updated lead-in data from the bezuclastinib combination are very promising, and I remain excited about the ongoing PEAK trial. Additionally, with the announcement of this new study today, we have a clinical trial which allows us to explore the use of bezuclastinib with sunitinib in patients who are not eligible for the PEAK study."

PEAK Trial Update
PEAK is a randomized, open-label, global, Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs sunitinib alone in GIST patients previously treated with imatinib. In the updated lead-in data being presented at ASCO (Free ASCO Whitepaper), as of the cutoff date, April 1, 2024, the 42 patients in Part 1 have been on study for a median of 15.3 months. The median progression-free survival (mPFS) during treatment with bezuclastinib and sunitinib was 10.2 months in all patients. In a subset of second-line GIST patients with only prior imatinib, which most closely resembles patients currently enrolling in Part 2 of PEAK, the data demonstrate a mPFS of 19.4 months. In addition, the objective response rate (ORR) in all patients treated with bezuclastinib and sunitinib was 27.5% and in the subset of second-line patients the ORR was 33.3%, per investigator assessment. Combination treatment resulted in a disease control rate of 80% in all patients and 100% in patients with prior imatinib only.

Safety Data
As of the data cutoff, the combination of bezuclastinib and sunitinib does not appear to add to the severity of adverse events known to be associated with sunitinib monotherapy and is well-tolerated. The majority of treatment-emergent adverse events (TEAEs) were low-grade and reversible. No additional serious adverse reactions or discontinuations due to TEAEs have been reported since the last presentation of data in November 2023.

ASCO Poster Details
Title: Peak part 1 summary: A phase 3, randomized, open-label multicenter clinical study of bezuclastinib (CGT9486) and sunitinib combination versus sunitinib in patients with gastrointestinal stromal tumors (GIST)
Session Type and Title: Poster Session – Sarcoma
Session Date and Time: June 1, 2024, 1:30 PM-4:30 PM CDT

The poster will be available in the Posters and Publications portion of the Cogent website at approximately 8:00 AM ET on June 1.

Phase 2 SARC Trial
The open label, single arm Phase 2 trial sponsored by SARC and in collaboration with The Life Raft Group and Dana-Farber Cancer Institute is designed to evaluate the mPFS as well as the safety and tolerability of bezuclastinib plus sunitinib in 40 patients with GIST who have previously progressed on sunitinib. This trial will focus on later line patients, where limited treatment options are available. Additional details can be found on clinicaltrials.gov; Identifier NCT06208748. For more information about SARC or The Life Raft Group, please visit www.sarctrials.org or www.liferaftgroup.org.

Bezuclastinib Clinical Development
Enrollment continues in the Phase 3 registration-enabling PEAK study, which will include approximately 388 second-line, post imatinib GIST patients. Due to rapid enrollment, the Company now expects PEAK enrollment to be completed in the third quarter of 2024 with top-line results still expected by the end of 2025. Cogent remains on-track to complete enrollment in APEX in patients with advanced systemic mastocytosis (AdvSM) by the end of 2024 and report top-line results mid-2025 and complete enrollment in SUMMIT Part 2 in the second quarter of 2025 and report top-line results by the end of 2025.

Upcoming Investor Conference
Cogent will participate in the Jefferies Global Healthcare Conference on Wednesday, June 5 at 2:30 p.m. ET. A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com/events. A replay will be available approximately two hours after completion of the event and will be archived for up to 30 days.

On May 23, 2024 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that clinical and biomarker data from its ST101 Phase 2 study in GBM will be delivered during an oral presentation on June 1, 2024 at the upcoming 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Sapience Therapeutics, MAY 23, 2024, View Source [SID1234643637]).

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ST101 is a first-in-class antagonist of C/EBPβ, currently being evaluated in patients with recurrent and newly diagnosed GBM in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279).

Sapience’s Chief Medical Officer, Abi Vainstein-Haras, MD, stated, "We are encouraged by ST101’s clinical and biomarker data for patients with glioblastoma. This novel therapy has the potential to be a new treatment opportunity for this devastating disease, and we are honored to be presenting these promising results in an oral presentation at ASCO (Free ASCO Whitepaper) 2024. We are committed to bringing new hope to patients battling glioblastoma and look forward to advancing ST101 through clinical development."

Dr. Fabio M. Iwamoto, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center, and Principal Investigator of the ST101-101 clinical study added, "Current treatments for recurrent glioblastoma offer limited hope for patients. I’m enthusiastic about the potential of ST101. It represents a novel approach with the potential to extend survival, both as a standalone therapy and in combination with existing treatments. Importantly, ST101’s safety profile suggests it could be well-tolerated, potentially offering a significant benefit for patients battling this aggressive disease."

Oral presentation details and abstract highlights include:

Abstract Title: "Efficacy and biomarker analysis of phase 2 (P2) and window-of-opportunity (WoO) cohorts of patients with glioblastoma (GBM) treated with ST101, an inhibitor of the transcription factor C/EBPβ"
Abstract Number for Publication: 2011
Session Type and Title: Clinical Science Symposium – Advancing Trial Design: Illuminating Tumor Evolution in Central Nervous System Cancer
Date and Time: 6/1/2024, 3:00 PM-4:30 PM CDT
Presenting Author: Fabio M. Iwamoto, MD, Division of Neuro-Oncology, New York-Presbyterian/Columbia University Irving Medical Center

ST101 has the potential to be a well-tolerated treatment option for patients with GBM

Outcome data to be presented from multiple cohorts of GBM patients
Main study: monotherapy in recurrent GBM
Window-of-Opportunity Study: mono/combination-therapy in GBM
Biomarker data to be presented from Window-of-Opportunity study cohorts
ST101 crosses the BBB and penetrates tumor tissue as shown by IHC
Target (C/EBPβ) engagement and degradation shown by IHC
Modulation of the tumor immune microenvironment to promote anti-tumor activity
Data supports continued clinical development of ST101 as a backbone treatment in combination with standard of care and immune-oncology agents.
The slide presentation described here will be made available on the Sapience Therapeutics website following the conference.

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in patients with newly diagnosed and recurrent GBM (ndGBM and rGBM) in the Phase 2 portion of an ongoing Phase 1-2 clinical study (NCT04478279). In an ongoing window-of-opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in ndGBM, with patients receiving ST101 before and after surgical resection. ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission.

On May 23, 2024 Novocure (NASDAQ: NVCR) reported topline efficacy and safety data from the TIGER study investigating the use of Tumor Treating Fields (TTFields) therapy in routine clinical care in the treatment of patients with newly diagnosed glioblastoma (GBM) in Germany (Press release, NovoCure, MAY 23, 2024, View Source [SID1234643652]). The TIGER study enrolled 429 patients who used TTFields therapy between August 2017 and November 2019 and is the largest prospective, non-interventional study of the use of TTFields therapy in routine clinical care completed to date.

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Median overall survival for patients treated with TTFields therapy was 19.6 months (95% CI, 17.9-22.4). Median progression-free survival was 10.2 months (95% CI, 9.4-11.4). TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated. The outcomes observed in the TIGER study are consistent with the survival and safety results from Novocure’s phase 3 EF-14 clinical trial.

Patients were followed for a median duration of 56.2 months. One-, two-, three-, and four- year survival rates were 79.2%, 42.4%, 31.5%, and 27.7%, respectively.

"As TTFields therapy use becomes more prevalent around the globe, it is exciting to see large, prospective studies like TIGER corroborate the survival benefits provided by using TTFields therapy to treat newly diagnosed GBM," said Oliver Bähr, MD, Department of Neurology, General Hospital Aschaffenburg-Alzenau. "The outcomes observed, particularly long-term survival rates, are promising and make a compelling case that TTFields therapy should be presented to all eligible GBM patients."

"TIGER is the largest prospective, non-interventional study analyzing TTFields therapy use in newly diagnosed GBM completed to date," said Nicolas Leupin, MD, Novocure’s Chief Medical Officer. "The observations from TIGER contribute to the multitude of data validating the use of TTFields therapy, and we are eager to continue exploring the benefits of our therapy in both the clinical and real-world settings."

The TIGER data (abstract #2036) will be presented at 9:00 a.m. CDT on Saturday, June 1, 2024 in Hall A during the Central Nervous System Tumors session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago.

About TIGER

TIGER (NCT03258021) is a prospective, non-interventional, multicenter, medical device post-authorization study designed to obtain real life data on the use of Tumor Treating Fields (TTFields) therapy in patients with newly diagnosed glioblastoma in routine clinical care in Germany. 710 patients with histologically confirmed newly diagnosed glioblastoma, who had clinical indication for TTFields therapy and were within the first 3 cycles of maintenance chemotherapy treatment were enrolled in the study from August 2017 to November 2019, across 81 participating centers in Germany. 583 patients opted to use TTFields therapy, and 429 received treatment. Endpoints of the study included overall survival, progression-free survival, safety and quality of life.

About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

On May 23, 2024 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, reported that the company, along with its collaborators, will present new data at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 – June 4, 2024 (Press release, Natera, MAY 23, 2024, View Source [SID1234643668]).

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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.

Minetta Liu, MD, chief medical officer of oncology at Natera, said, "We look forward to sharing new data across cancer types, reflecting Natera’s deep clinical pipeline in MRD with results from randomized trials as well as real-world studies. 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."

GALAXY is part of the CIRCULATE-Japan trial platform, which also includes ALTAIR, a first-of-its-kind, "treat on molecular recurrence" study evaluating the utility of Signatera in CRC. Natera expects to announce topline results for this phase III randomized trial in August 2024.

Below is the full list of presentations featuring Signatera and Empower at ASCO (Free ASCO Whitepaper):

Poster Presentation | Abstract # 3609 | Presenter: Yoshiaki Nakamura, MD, PhD | CRC
Prognostic and predictive value of ctDNA-based MRD and actionable biomarkers in patients with resectable CRC: CIRCULATE-Japan GALAXY
Oral Presentation | Abstract # LBA507 | Presenter: Sherene Loi, MD, PhD | Breast Cancer
Prognostic utility of ctDNA dynamics in the monarchE trial of adjuvant abemaciclib plus endocrine therapy (ET) in HR+, HER2-, node-positive, high-risk early breast cancer (EBC)
Poster Presentation | Abstract # 3586 | Presenter: Eric Lander, MD | CRC
Genomic alterations in early-onset versus average-onset stage IV CRC
Poster Presentation | Abstract # 5034 | Presenter: Rebecca Hassoun, MD | Testicular Cancer
Longitudinal Evaluation of ctDNA as a Prognostic Biomarker to Detect Minimal Residual Disease (MRD) in Testicular Cancer
Poster Presentation | Abstract # 4587 | Presenter: Adanma Ayanambakkam, MD | Urothelial Cancer
Longitudinal analysis of ctDNA in localised and metastatic urothelial cancer
Poster Presentation | Abstract # 4028 | Presenter: Aziz Zaanan, MD | Esophageal Cancer
Longitudinal ctDNA analysis during treatment (Tx) of locally advanced resectable (LAR) gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (ADENOCA): the PLAGAST prospective biomarker study
Poster Presentation | Abstract # 9564 | Presenter: Michael LaPelusa, MD | Melanoma
Association between ctDNA and Recurrence-Free Survival (RFS) in Patients (pts) with Resected Stage III Melanoma – an Exploratory Analysis of SWOG S1404
Poster Presentation | Abstract # 6056 | Presenter: Glenn Hanna, MD | Head and Neck Squamous Cell Carcinoma
Personalized ctDNA for monitoring disease status in HPV-negative head and neck squamous cell carcinoma
Poster Presentation | Abstract # TPS8659 | Presenter: Yasushi Goto, MD, PhD | Lung Cancer
Randomized phase III study comparing suspension or continuation of PD- 1 Pathway Blockade for patients with advanced non-small-cell lung cancer (SAVE study: JCOG1701)
Poster Presentation | Abstract # 569 | Presenter: Mridula George, MD | Breast Cancer
Predicting response to neoadjuvant therapy (NAT) in patients (pts) with early-stage breast cancer (BC) using ctDNA testing
Poster Presentation | Abstract # 549 | Presenter: Marla Lipsyc-Sharf, MD | Breast Cancer
Impact of ctDNA surveillance on clinical care for patients with stage I-III breast cancer: Findings from a multi-institutional study.
Poster Presentation | Abstract # 518 | Presenter: Yoichi Naito, MD | Breast Cancer
ctDNA monitoring for breast cancer at high risk of recurrence: Interim analysis of JCOG1204A1
Poster Presentation | Abstract # 10596 | Presenter: Sarah Lee, MD | Pan-Cancer (Empower)
A targeted panel of actionable high risk hereditary cancer predisposition genes can identify patients with pathogenic/likely pathogenic variants (PVs) irrespective of meeting established NCCN testing criteria
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, ovarian cancer 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 60 peer-reviewed papers.