Recurrence

Medicare Extends Coverage of Natera’s Signatera™ MRD Test to Ovarian Cancer and Neoadjuvant Breast Cancer

Retrieved on: 
Monday, February 26, 2024

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.

Key Points: 
  • 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.
  • The MolDX coverage decision applies to patients with ovarian cancer, in both the adjuvant and surveillance settings.
  • This MolDx coverage decision applies to patients with breast cancer in the neoadjuvant setting across all subtypes of the disease, including hormone receptor (HR)-positive, HER2-positive, and triple negative breast cancers.
  • We are incredibly proud of this milestone, and look forward to continuing to work with Medicare to make Signatera more widely accessible for people affected by cancer.”

Study Finds DecisionDx®-Melanoma Significantly Improves the Risk Stratification of Patients with Stage I Melanoma Compared to American Joint Committee on Cancer 8th Edition Staging

Retrieved on: 
Monday, February 26, 2024

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced the publication of a study in Cancers 1 demonstrating that DecisionDx-Melanoma provided significantly better risk stratification than American Joint Committee on Cancer 8th Edition (AJCC8) staging 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 the publication of a study in Cancers 1 demonstrating that DecisionDx-Melanoma provided significantly better risk stratification than American Joint Committee on Cancer 8th Edition (AJCC8) staging in patients with stage I cutaneous melanoma (CM).
  • Stage I CM tumors are considered low risk; however, since stage I encompasses a large group of patients diagnosed, many melanoma-specific deaths are seen in patients initially diagnosed with stage I disease.
  • Thus, there is a clinical gap in the low-risk treatment pathway for stage I patients.
  • The new study in Cancers provides further information that DecisionDx-Melanoma testing could enable more precise risk stratification in stage I melanomas than provided by traditional staging to better inform risk-appropriate clinical management.

Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Monotherapy as Adjuvant Treatment, for the Treatment of Resectable NSCLC at High Risk of Recurrence

Retrieved on: 
Friday, February 23, 2024

The recommendation is based on results from the Phase 3 KEYNOTE-671 trial, in which neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as a single agent after surgical resection demonstrated statistically significant and clinically meaningful improvements in overall survival and event-free survival, the study’s dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients.

Key Points: 
  • The recommendation is based on results from the Phase 3 KEYNOTE-671 trial, in which neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as a single agent after surgical resection demonstrated statistically significant and clinically meaningful improvements in overall survival and event-free survival, the study’s dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients.
  • Key eligibility criteria for KEYNOTE-671 included: patients with previously untreated and resectable NSCLC at high risk of recurrence (stage II, IIIA, or IIIB [N2] by American Joint Committee on Cancer eighth edition), regardless of tumor PD-L1 expression.
  • The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union (EU), and a final decision is expected in the first half of 2024.
  • “The CHMP’s positive opinion puts us another step closer to helping certain patients in Europe with earlier stages of non-small cell lung cancer, regardless of PD-L1 expression,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.

DermBiont Announces 2024 Development Pipeline Update for its First-in-Class Targeted Topical Therapeutics for Seborrheic Keratoses, Basal Cell Carcinomas, and Melasma

Retrieved on: 
Thursday, February 22, 2024

DermBiont currently anticipates that data will be available in Q3 2024.

Key Points: 
  • DermBiont currently anticipates that data will be available in Q3 2024.
  • SKs: DermBiont expects to report data from its CT-213 Phase 2b clinical trial of SM-020 gel 1.0% in Q3 2024.
  • BCCs and SCCISs: DermBiont expects to initiate its CT-217 Phase 2a clinical trial in Q1 2024 and report data in Q3 2024.
  • Melasma: DermBiont anticipates enrolling the first patient in its randomized, observer-blinded, vehicle-controlled CT-214 Phase 2b trial of SM-030 in 138 subjects with melasma in Q2 2024.

Global Microbiome Research Report 2023: Market Booming with Breakthrough Treatments for Recurrent C. Difficile Infection, Fecal Microbial Transplantation (FMT) Emerges as a Game-Changer - ResearchAndMarkets.com

Retrieved on: 
Wednesday, February 21, 2024

The microbiome therapeutics market is successfully commercializing Seres Therapeutics' SER-109 and Rebiotix's RBX-2660 for recurrent Clostridium difficile infection (Recurrent C. difficile).

Key Points: 
  • The microbiome therapeutics market is successfully commercializing Seres Therapeutics' SER-109 and Rebiotix's RBX-2660 for recurrent Clostridium difficile infection (Recurrent C. difficile).
  • While integrated omics-based projects are underway, researchers focus more on differences in gut microbiota between individuals that may be associated with disease expression.
  • This report covers the efforts of companies involved in the microbiome market.
  • Trends in the global microbiome market are also summarized by country (and some areas), and the current market size, competitive landscape, and challenges are analyzed and forecasted for the future.

U.S. Food and Drug Administration Approves Opdivo® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, March 7, 2024

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer.1,2 This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy (n=304), compared to cisplatin-gemcitabine alone (n=304), for patients with previously untreated unresectable or metastatic UC.1,3 The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR).1
    In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63, 0.96; p=0.0171).1,4 Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone (HR 0.72; 95% CI: 0.59, 0.88; p=0.0012).1
    Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% (n=175) (95% CI: 51.8, 63.2) versus 43.1% (n=131) (95% CI: 37.5, 48.9) with cisplatin-gemcitabine alone.1,4 The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% (n=66) and 36% (n=109), respectively, versus 12% (n=36) and 31% (n=95) with cisplatin-gemcitabine alone.1
    “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients a chance to live longer,”5 said Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology and the Phase I Clinical Research Unit and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, Orlando, Florida.
  • “Based on outcomes and the safety profile seen in the CheckMate -901 clinical trial, the approval of Opdivo in combination with cisplatin and gemcitabine has the potential to change how metastatic or unresectable UC is treated for certain patients and offers them new hope.”1
    Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.
  • Please see Important Safety Information below.1
    “Bringing Opdivo to the first-line setting in UC with chemotherapy is the latest realization of our history of research and progress in immunotherapy, which has helped transform the treatment landscape for many cancers, including bladder cancer,”1,6 said Wendy Short Bartie, senior vice president and general manager, U.S. Hematology and Oncology at Bristol Myers Squibb.
  • “This milestone adds a meaningful expansion to our portfolio of Opdivo-based treatments in genitourinary cancers, where we now have offerings in UC spanning three indications across stages of disease and treatment needs.”1
    The FDA previously approved Opdivo for the adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC; it also previously approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC who have had disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.1
    Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) leading to today’s approval was granted Priority Review status by the FDA, and was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.7 The review was also conducted under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in several other countries where the application remains under review.

DiaCarta Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024

Retrieved on: 
Monday, March 4, 2024

PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.

Key Points: 
  • PLEASANTON, Calif., March 4, 2024 /PRNewswire/ -- DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.
  • Oncuria-Monitor: Enables the monitoring of bladder cancer recurrence, offering physicians valuable insights for disease management and surveillance.
  • Oncuria-Predict: Revolutionizes the prediction of BCG therapy response for non-muscle invasive bladder cancer (NMIBC) patients, empowering clinicians with personalized treatment strategies.
  • By securing Medicare reimbursement for Oncuria®, DiaCarta continues to facilitate access to innovative diagnostic solutions for patients and healthcare providers nationwide.

DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test

Retrieved on: 
Monday, February 26, 2024

The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.

Key Points: 
  • The collaboration aims to leverage DiaCarta's expertise in customizable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.
  • This partnership will expedite the validation process and pave the way for commercialization of the OncoAssure Prostate LDT test, benefiting healthcare providers and patients alike."
  • Dr. Adam (Aiguo) Zhang, CEO and President of DiaCarta, added, "We are very pleased to collaborate with OncoAssure to bring the best-in-class highly accurate OncoAssure Prostate LDT test to commercialization in DiaCarta's CAP/CLIA laboratory.
  • The unique OncoAssure Prostate prognostic test addresses an unmet need in prostate cancer management and is a valued addition to DiaCarta's portfolio of molecular diagnostic tests for cancer that includes tests for bladder and colorectal cancer."

GC Cell and BioCentriq® Execute Process Transfer Agreement in Anticipation of the U.S. entry of Immuncell-LC Inj.

Retrieved on: 
Monday, February 26, 2024

(Link)

Key Points: 
  • (Link)
    Through this agreement with BioCentriq, GC Cell is accelerating the transfer of Immuncell-LC Inj.
  • YONGIN, South Korea and NEWARK, N.J., Feb. 26, 2024 /PRNewswire/ -- GC Cell , a fully integrated cell therapy pioneer has announced a strategic partnership with BioCentriq , a cell therapy contract development and manufacturing organization (CDMO) and US affiliate of GC Cell.
  • "The Process Transfer Agreement between GC Cell and BioCentriq initiates the groundwork for introducing Immuncell-LC to the U.S. market" said James Park, CEO of GC Cell.
  • "We are thrilled to partner with GC Cell to bring Immuncell-LC, a proven autologous cell therapy to the U.S. Market.