AJCC

Presentations at EADO Highlight Potential Impact of Castle Biosciences’ DecisionDx®-Melanoma and DecisionDx®-SCC Tests on the Management of Patients with Skin Cancer

Retrieved on: 
Thursday, April 4, 2024
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Sentinel lymph node, SCC, Congress, Castle, Risk, Patient, Neoplasm, Research, NCCN, AJCC, National Comprehensive Cancer Network, Risk assessment, Lymph node, Carcinoma, Melanoma, Trial of the century, Recurrence, Metastasis, SLN, Medical imaging

Summary: The DecisionDx-Melanoma test has been validated to predict individual risk of SLNB positivity and five-year risk of recurrence and metastasis for patients with CM.

Key Points: 
  • Summary: The DecisionDx-Melanoma test has been validated to predict individual risk of SLNB positivity and five-year risk of recurrence and metastasis for patients with CM.
  • This study explored the cost-savings impact of using the DecisionDx-Melanoma test to guide risk-aligned clinical decision-making versus using the current melanoma staging standard, a patient’s AJCC stage.
  • Summary: The DecisionDx-SCC test uses a patient’s tumor biology to independently predict risk of regional or distant metastasis in patients with high-risk SCC.
  • These data demonstrate that DecisionDx-SCC improves the accuracy of risk assessment based solely on clinicopathological risk factors, leading to more appropriate risk-aligned management plans for patients with high-risk SCC.

Provectus Biopharmaceuticals Provides Updated Data on Cancer Immunotherapy PV-10 for Advanced Cutaneous Melanoma

Retrieved on: 
Wednesday, November 15, 2023
AJCC, Safety, OTCQB, PRN, Progression-free survival, RECIST, Patient, PFS, Pembrolizumab, CRS, CB, ORR, Metastasis, Birth control, Pension fund

KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma ( NCT02557321 ).

Key Points: 
  • KNOXVILLE, TN, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided updated data from an ongoing Phase 1b/2 clinical trial of investigational cancer immunotherapy PV-10 (rose bengal sodium) in combination with standard of care immune checkpoint blockade (CB) for the treatment of advanced cutaneous melanoma ( NCT02557321 ).
  • Initial results from CB-naïve patients in the main study cohort illustrated potential clinical benefit across all stages of metastasis.
  • Longer-term follow-up of an expanded patient population has been assessed.
  • Participants must have had at least 1 injectable lesion and at least 1 measurable target lesion and been a candidate for pembrolizumab.

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.

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.”

Surgical Outcomes of Perioperative Durvalumab in AEGEAN Study to be Presented at IASLC 2023 World Conference on Lung Cancer

Retrieved on: 
Tuesday, September 12, 2023
CT, MPR, Arm, International Association, Lung cancer, Pneumonectomy, Research, NSCLC, Lung, PCR, AstraZeneca, Cardiothoracic surgery, HIV disease progression rates, MD, Patient, Physician, ECOG, Division, EGFR, AJCC, EFS, AEGEAN, Conference, Birth control, Medical imaging, Dentistry

SINGAPORE, Sept. 12, 2023 /PRNewswire-PRWeb/ -- Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.

Key Points: 
  • Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.
  • SINGAPORE, Sept. 12, 2023 /PRNewswire-PRWeb/ -- Adding perioperative durvalumab to neoadjuvant chemotherapy did not adversely impact surgery in patients with resectable NSCLC and was associated with a tolerable surgical safety profile, according to research presented today from the phase 3 AEGEAN trial at the International Association for the Study of Lung Cancer 2023 World Conference on Lung Cancer in Singapore.
  • The AEGEAN trial is a double-blind, placebo-controlled phase 3 study that evaluated the use of perioperative durvalumab in combination with neoadjuvant chemotherapy compared to neoadjuvant chemotherapy alone.
  • AEGEAN data from outcomes for patients with documented EGFR mutations are also being presented at IASLC 2023 World Conference on Lung Cancer.

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.

DecisionDx®-Melanoma Provides Improved Risk Stratification Over American Joint Committee on Cancer (AJCC) Staging Alone in Stage I Melanoma Patients

Retrieved on: 
Tuesday, April 25, 2023
Research, Genetics, Clinical Trials, Biometrics, Other Health, Biotechnology, Health, Science, Oncology, Other Science, Clifton Springs Hospital & Clinic, MSS, IB, RFS, American Joint Committee on Cancer, Congress, Death, CM, Patient, Risk, Melanoma, AJCC, Neoplasm, Mortality, European Association of Urology, Recurrence, Metastasis, Medical imaging, Silviculture

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data showing DecisionDx®-Melanoma can improve risk stratification over American Joint Committee on Cancer (AJCC) staging alone in patients with stage I cutaneous melanoma (CM).

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data showing DecisionDx®-Melanoma can improve risk stratification over American Joint Committee on Cancer (AJCC) staging alone in patients with stage I cutaneous melanoma (CM).
  • DecisionDx-Melanoma uses a patient’s tumor biology to provide the patient’s personalized risk of recurrence and metastasis, while AJCC staging is based on the clinical and pathologic risk factors of a patient’s melanoma tumor.
  • Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB RFS rates of 93.3% vs. 87.6%.
  • Risk-stratification according to AJCC staging provided low-risk stage IA vs. high-risk stage IB MSS rates of 97.6% vs. 97.9%.

FDA Approves KEYTRUDA® (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Friday, January 27, 2023
Biotechnology, Pharmaceutical, Surgery, Oncology, Health, FDA, Diabetes, Clinical Trials, MSD, Hematopoietic stem cell transplantation, Toxicity, American Joint Committee on Cancer, OS, II, Immunotherapy, PD-L1, CI, ALK, Pharmacology, III, Pemetrexed, Medicine, Patient, Arm, Carboplatin, T2A, NYSE, RECIST, AJCC, Hypothyroidism, Hepatitis, Hyperthyroidism, HIV disease progression rates, EGFR, Colitis, TPS, Recurrence, Merck & Co., Food, Yale Cancer Center, Risk, Death, Survival, Myocarditis, Lung cancer, Disease, Neoplasm, DFS, Yale School of Medicine, MRK, PEARLS, Pneumonitis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Platinum, Paclitaxel, NSCLC, Nephritis, History, Metastasis, Pharmaceutical industry, Vaccine, Merck

In patients who received adjuvant platinum-based chemotherapy following surgical resection, KEYTRUDA reduced the risk of disease recurrence or death by 27% (hazard ratio [HR]=0.73 [95% CI, 0.60-0.89]) versus placebo regardless of PD-L1 expression.

Key Points: 
  • In patients who received adjuvant platinum-based chemotherapy following surgical resection, KEYTRUDA reduced the risk of disease recurrence or death by 27% (hazard ratio [HR]=0.73 [95% CI, 0.60-0.89]) versus placebo regardless of PD-L1 expression.
  • In an exploratory subgroup analysis of the 167 patients (14%) who did not receive adjuvant chemotherapy, the DFS HR was 1.25 (95% CI, 0.76-2.05).
  • “While there have been many advances for patients with metastatic disease, surgery remains the typical treatment for people with stage IB, II and IIIA non-small cell lung cancer.
  • “Today’s approval for KEYTRUDA offers a new, important immunotherapy treatment option for stage IB (T2a ≥4 cm), II, or IIIA patients with non-small cell lung cancer following surgery and adjuvant chemotherapy.

Provectus Biopharmaceuticals Releases 2023 Stockholder Letter

Retrieved on: 
Monday, January 9, 2023
Disease, OS, RECIST, Knowledge, SOC, CR, CRS, Melanoma, Cancer, University, Dermatology, Particle-size distribution, Orphan Drug Act of 1983, H. Lee Moffitt Cancer Center & Research Institute, RCT, RBS, Cumming School of Medicine, Metastasis, Combination therapy, CB, SEER, Research, ITM, ORR, Hematology, III, Incidence, Progression-free survival, Classification, PFS, Neoplasm, Rockefeller University, AJCC, Infection, Prevalence, Lymph, Meta-analysis, Clinical trial, PV-10, Cell death, Standard of care, Safety, Vaccine, Diagnosis, PRN, Survival, Patient, Pembrolizumab, Medical device, Pharmaceutical industry, Medical imaging, Television, Veterinary medicine, Epidemiology, Medicine

This effort has been utilizing Provectus’ clinical efficacy data from approximately 180 in-transit melanoma (ITM) patients treated with single-agent PV-10, as well as safety data from more than 300 melanoma patients.

Key Points: 
  • This effort has been utilizing Provectus’ clinical efficacy data from approximately 180 in-transit melanoma (ITM) patients treated with single-agent PV-10, as well as safety data from more than 300 melanoma patients.
  • ITM diagnosis is specifically associated with an overall poor prognosis and has the potential to be seriously debilitating and life threatening.
  • Furthermore, we encourage collaboration between our various researchers to assist Provectus in building the Company’s medical science platform and associated drug pipeline.
  • Provectus’ capital raising efforts will continue in 2023.