American Joint Committee on Cancer

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as Single Agent After Surgery Reduced Risk of Death by 28% Versus Pre-Operative Chemotherapy in Resectable Stage II, IIIA or IIIB Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Friday, October 20, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Survival, Neoplasm, FDA, Pemetrexed, PD-L1, McGill University Health Centre, SCLC, NSCLC, Aes, NYSE, ESMO, Food, Trae tha Truth, Lung cancer, Cisplatin, American Joint Committee on Cancer, Congress, Head, MRK, European Society for Medical Oncology, PCR, Carcinoma, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Treatment of lung cancer, Research, Neoadjuvant therapy, Disease, Merck & Co., Risk, MPR, EFS, RECIST, Safety, AJCC, Cancer, European Society of Gynaecological Oncology, Patient, OS, Death, Associate, Pharmaceutical industry, Merck

The 36-month OS rates were 71.3% for patients who received the KEYTRUDA-based regimen versus 64.0% for patients who received the chemotherapy-placebo regimen.

Key Points: 
  • The 36-month OS rates were 71.3% for patients who received the KEYTRUDA-based regimen versus 64.0% for patients who received the chemotherapy-placebo regimen.
  • The 36-month EFS rates were 54.3% for patients who received the KEYTRUDA-based regimen versus 35.4% for patients who received the chemotherapy-placebo regimen.
  • “The results of KEYNOTE-671 represent an important milestone in our fight to improve treatment outcomes for patients with surgically resectable non-small cell lung cancer.
  • “Non-small cell lung cancer is the leading cause of cancer-related death worldwide and this new regimen applies to a wide range of surgically resectable patients.

Next-Generation Cologuard® Test Demonstrates High Sensitivity and Specificity in Pivotal BLUE-C Study, Significantly Outperforming Fecal Immunochemical Testing (FIT) for Cancer and Precancer Detection

Retrieved on: 
Sunday, October 22, 2023
Colorectal cancer, FDA, American College, Exact sciences, ACG, American Joint Committee on Cancer, Research, American College of Gastroenterology, NYU, Large intestine, Indiana University School of Medicine, Colonoscopy, Exact Sciences (company), FIT, New York University Grossman School of Medicine, Conditional sentence, Patient, Medical device, Pharmaceutical industry, MD, Medicine, Yeah! Yeah! Die! Die! Death Metal Symphony in Deep C

MADISON, Wis., Oct. 22, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced late-breaking data from the pivotal BLUE-C trial showing the next-generation Cologuard® test met all study endpoints, demonstrating 94 percent sensitivity for colorectal cancer (CRC) at 91% specificity, during the American College of Gastroenterology (ACG) Annual Meeting 2023.[1] Additionally, results show the next-generation Cologuard test was significantly more likely to detect cancer or precancer than fecal immunochemical testing (FIT)* (94% vs 67% and 43% vs 23%, respectively).[1]  Finally, the next-generation Cologuard test demonstrated higher sensitivity for the most clinically significant form of advanced precancerous lesions (high-grade dysplasia at 75%) than FIT (47%).[1]    

Key Points: 
  • In addition to superiority over FIT in sensitivity for both colorectal cancer and advanced precancerous lesions, the next-generation Cologuard test demonstrated 91% specificity.1 The specificity for FIT was 95%.
  • [1,3] For patients with a negative or non-neoplastic  findings on colonoscopy, specificity for the next-generation Cologuard test reached 93%.
  • "The findings indicate that the next-generation mt-sDNA test demonstrates even higher sensitivity for colorectal cancer screening (94%) and high-grade dysplasia (75%), compared with the current Cologuard test.
  • These findings suggest that, if FDA approved, the mt-sDNA test will be a valuable option in providing non-invasive colorectal cancer screening."

Improving Global Patient Care: CAP Partners with the IARC-WHO to Streamline Updates to Cancer Protocols

Retrieved on: 
Tuesday, October 17, 2023
Research, General Health, Professional Services, Oncology, Hospitals, University, Education, Data Analytics, Science, Biotechnology, Nursing, Health, Partnership, MOU, International Agency for Research on Cancer, Classification, College, American Joint Committee on Cancer, IARC, WHO classification of tumours of the central nervous system, CAP, International, Marie Cassidy, Laboratory, WHO, World Health Organization, Pathology, Medical imaging, Neoplasm, MD, Cancer

Under the renewed memorandum of understanding (MOU), the CAP will collaborate with the IARC-WHO to support harmonized cancer protocols to better align with stakeholders across the world.

Key Points: 
  • Under the renewed memorandum of understanding (MOU), the CAP will collaborate with the IARC-WHO to support harmonized cancer protocols to better align with stakeholders across the world.
  • “Through CAP Cancer Protocols, we play a critical role in bridging pathology cancer reporting with the WHO classification, thus empowering many aspects of the fight against cancer.”
    The CAP Cancer Protocols provide guidelines for collecting the essential pathology and biomarker data elements for complete reporting of malignant tumors.
  • “The WHO Classification of Tumors is the standard adopted by CAP for Cancer Protocols,” explains Dr. Khoury.
  • “This MOU strengthens and facilitates the exchange of information between the CAP and IARC-WHO and aligns the publication of the most recent releases of the WHO blue books with updates to the CAP Cancer Protocols.”

FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With Resectable (T≥4 cm or N+) NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as a Single Agent as Adjuvant Treatment After Surgery

Retrieved on: 
Tuesday, October 17, 2023
Oncology, Health, FDA, Surgery, Clinical Trials, Pharmaceutical, Biotechnology, MSD, Congress, III, Hepatitis, HIV disease progression rates, Immunosuppression, MRK, NYSE, Lung cancer, Food, Platinum, American Joint Committee on Cancer, Pembrolizumab, The New England Journal of Medicine, AJCC, OS, PD-L1, Colitis, EGFR, Stanford University, Medicine, Pemetrexed, Patient, ESMO, Merck & Co., Steroid, EFS, II, Carboplatin, TPS, Pneumonitis, Paclitaxel, History, Head, International Association, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, European Society for Medical Oncology, Neoplasm, Hematopoietic stem cell transplantation, European Society of Gynaecological Oncology, T2A, ALK, Nephritis, Pharmaceutical industry, Vaccine, NSCLC, Merck

With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.

Key Points: 
  • With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.
  • The EFS results, which were from the first interim analysis, were published in June 2023 in the New England Journal of Medicine.
  • Adverse reactions occurring in patients with resectable NSCLC receiving KEYTRUDA in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single agent adjuvant treatment, were generally similar to those occurring in patients across tumor types receiving KEYTRUDA in combination with chemotherapy.
  • Eighty-one percent of patients in the KEYTRUDA in combination with platinum-containing chemotherapy arm had definitive surgery compared to 76% of patients in the placebo in combination with platinum-containing chemotherapy arm.

European Commission Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adults With Non-Small Cell Lung Cancer at High Risk of Recurrence Following Complete Resection and Platinum-Based Chemotherapy

Retrieved on: 
Monday, October 16, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, DFS, MRK, NYSE, Lung cancer, American Joint Committee on Cancer, European Directive on Traditional Herbal Medicinal Products, Death, NSCLC, Rated R, AJCC, Committee for Medicinal Products for Human Use, Risk, European Commission, Recurrence, Disease, Merck & Co., Immunotherapy, EC, II, Marketing, Committee, Civil service commission, Face, Patient, Pharmaceutical industry, Merck, EU

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
  • This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in September 2023 and was based on results from the Phase 3 KEYNOTE-091 trial.
  • At a median follow up time of 46.7 months, KEYTRUDA demonstrated a clinically meaningful improvement in disease-free survival (DFS) in patients who received adjuvant chemotherapy, reducing the risk of disease recurrence or death by 24% (HR=0.76 [95% CI, 0.64-0.91]).
  • “We are proud that in Europe, KEYTRUDA now has five approved indications in non-small cell lung cancer, in both earlier and advanced stages of disease.”

DecisionDx®-Melanoma Outperforms Memorial Sloan Kettering Cancer Center (MSKCC) Nomogram in Predicting Sentinel Lymph Node Positivity in Patients with Cutaneous Melanoma

Retrieved on: 
Thursday, October 5, 2023
Managed Care, Research, Other Health, General Health, Radiology, Oncology, Medical Devices, Genetics, Clinical Trials, Science, Biotechnology, Health, Other Science, Algorithm, American Joint Committee on Cancer, Memorial Sloan Kettering Cancer Center, Risk, Recurrence, MSKCC, Lymph node, Melanoma, Anticancer Research, Patient, National Comprehensive Cancer Network, SLN, Sentinel lymph node, Metastasis, CM, NCCN, Medical imaging

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a new study demonstrating DecisionDx®-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM).

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced a new study demonstrating DecisionDx®-Melanoma outperforms a nomogram developed at the Memorial Sloan Kettering Cancer Center (MSKCC) in predicting the risk of sentinel lymph node (SLN) positivity in patients with cutaneous melanoma (CM).
  • The MSKCC nomogram, which uses logistic regression and only clinical and pathologic factors to predict a patient’s SLN positivity risk.
  • Patients from previously published multicenter cohorts with T1-T2 tumors who had undergone the SLNB procedure (n=465) were analyzed using both DecisionDx-Melanoma and the MSKCC nomogram.
  • DecisionDx-Melanoma also demonstrated better accuracy in predicting SLN positivity, including higher sensitivity (95% vs. 81%) and negative predictive value (97% vs. 90%) than the MSKCC nomogram.

United States Squamous-Cell Carcinoma of the Head and Neck Epidemiology Report 2022-2042 - ResearchAndMarkets.com

Retrieved on: 
Thursday, August 3, 2023
Health, Oncology, IV, Squamous-cell carcinoma, Table, Head, Clinical trial, Cancer, Risk, II, NCCN, Incidence, American Joint Committee on Cancer, AJCC, III, Disease, Mobile phone, Dietary supplement, Vaccine

The "Squamous-Cell Carcinoma of the Head and Neck in the United States, 2022-2042: Cancer Populations USA Report and Data Dashboard" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Squamous-Cell Carcinoma of the Head and Neck in the United States, 2022-2042: Cancer Populations USA Report and Data Dashboard" report has been added to ResearchAndMarkets.com's offering.
  • All estimates in this report are based on nationally representative datasets, such as population-based cancer registries, large epidemiological studies and published national population forecasts.
  • We provide estimates for the year 2022 and forecast estimates to 2032 and 2042 in the main body of this report.
  • In this report on squamous-cell carcinoma of the head and neck (SCC-HN), we provide forecast estimates of incident cases by stage, age and gender, race-ethnicity, anatomical subsite, and PD-L1 status.

Castle Biosciences Reports Second Quarter 2023 Results

Retrieved on: 
Wednesday, August 2, 2023
Oncology, Mental Health, Health, Other Health, Pharmaceutical, Biotechnology, ECRI, Table, Neoplasm, GAAP, NCCN, Medicare, Acquisition, CM, Patient, Risk, Carcinoma, Artificial intelligence, News, Cohort (statistics), National Cancer Institute, ART, National Comprehensive Cancer Network, Net, Registry, Esophageal cancer, Medtech, Metastasis, Safety, Abstract, Depression, Overalls, ID, Sentinel lymph node, The Arizona Republic, Webcast, Depreciation, Mortality, Adjustment, Workforce, SCC, American Joint Committee on Cancer, BE, EBITDA, Guideline, Melanoma, Recurrence, Pharmaceutical industry, Medical imaging, Video game, Vaccine, Film industry, Cryptocurrency, Clothing, Rare-earth element, Real estate, Brigham

“Castle delivered an outstanding second quarter, with strength across our entire test portfolio,” said Derek Maetzold, president and chief executive officer of Castle Biosciences.

Key Points: 
  • “Castle delivered an outstanding second quarter, with strength across our entire test portfolio,” said Derek Maetzold, president and chief executive officer of Castle Biosciences.
  • Delivered 16,820 total test reports in the second quarter of 2023, an increase of 52% compared to 11,034 in the same period of 2022:
    DecisionDx-Melanoma test reports delivered in the quarter were 8,597, compared to 7,125 in the second quarter of 2022, an increase of 21%.
  • MyPath® Melanoma test reports delivered in the quarter were 953, compared to 955 MyPath Melanoma and DiffDx®-Melanoma aggregate test reports in the second quarter of 2022.
  • Castle Biosciences will hold a conference call on Wednesday, August 2, 2023, at 4:30 p.m. Eastern time to discuss its second quarter 2023 results and provide a corporate update.

Castle Biosciences to Present New DecisionDx®-SCC and DecisionDx®-Melanoma Data at the American Head & Neck Society’s (AHNS) 11th International Conference on Head and Neck Cancer

Retrieved on: 
Friday, July 7, 2023
Research, Genetics, Biotechnology, Other Health, Health, General Health, Other Science, Science, Oncology, SCC, Cone Health Women's Hospital, GEP, Cancer, Head, American Head, American Joint Committee on Cancer, CM, Patient, BWH, Hospital, Conference, Metastasis, Pharmaceutical industry, Medical imaging, QC, Brigham

Details are as follows:

Key Points: 
  • Details are as follows:
    “Traditional staging methods rely on a limited set of clinicopathologic risk factors to categorize cancer patients into different stages,” said Newman.
  • “While these factors provide important information, they may not fully capture the underlying biological heterogeneity and variability in tumor behavior.
  • Additionally, the metastatic risk predictions provided by AJCC8 and BWH staging were significantly improved when DecisionDx-SCC test results were included.
  • Overall, the data demonstrated that combining the test’s results with AJCC8 staging significantly improved risk prediction over use of either alone, providing actionable information that can enable risk-aligned patient care.

Study Data from Castle Biosciences’ Collaboration with the National Cancer Institute’s SEER Program Registries Published in JCO Precision Oncology

Retrieved on: 
Friday, June 30, 2023
Oncology, Health, Genetics, Other Health, Research, Science, Biotechnology, Registry, University Challenge 2013–14, Public, Overalls, Survival, Cohort (statistics), Risk, JCO, American Joint Committee on Cancer, Patient, CM, Melanoma, SEER, Mortality, Lymph node, NCI, Metastasis, Medical imaging, Pharmaceutical industry

Additionally, data from the study shows that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients.

Key Points: 
  • Additionally, data from the study shows that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients.
  • This large study of real-world, unselected, clinically tested patients who received our test as part of their ongoing melanoma care further supports these findings.
  • Key findings of the study include:
    DecisionDx-Melanoma independently risk-stratified patients according to their risk of dying from melanoma, consistent with previously published retrospective and prospective studies.
  • “We are looking forward to continuing our collaboration with the NCI SEER Program’s Registries to provide DecisionDx Melanoma data to the SEER registries as part of public health reporting to further advance research and patient care.”