Transitional cell carcinoma

Seattle Genetics and Astellas Announce PADCEV® (enfortumab vedotin-ejfv) Significantly Improved Overall Survival in Phase 3 Trial in Previously Treated Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Friday, September 18, 2020
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical trials, Clinical medicine, Health, Medicine, Breakthrough therapy, Monoclonal antibodies, Cancer treatments, Cancer immunotherapy, Orphan drugs, Enfortumab vedotin, Clinical endpoint, Transitional cell carcinoma, Chemotherapy, the EV-301 Trial, PADCEV® (enfortumab vedotin-ejfv), Seattle Genetics, Astellas, the Seattle Genetics and Astellas Collaboration

The global EV-301 clinical trial compared PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

Key Points: 
  • The global EV-301 clinical trial compared PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
  • We continue to explore PADCEVs activity across the spectrum of urothelial cancer including its potential for use in earlier lines of therapy.
  • The primary endpoint is overall survival of participants treated with PADCEV compared to those treated with chemotherapy.
  • Secondary endpoints include progression-free survival, duration of response, and overall response rate, as well as assessment of safety/tolerability and quality-of-life parameters.

Nucleix Presents Two Bladder EpiCheck® Studies at EAU20 Virtual Congress, Including Interim Data in Patients with Upper Tract Urothelial Cancer

Retrieved on: 
Friday, July 17, 2020
Research, Surgery, Genetics, Clinical trials, Biotechnology, Health, General Health, Science, Oncology, Urology, Neoplasms, Cancer, Bladder cancer, RTT, Transitional cell carcinoma, Transitional epithelium, Urinary bladder, Ureteroscopy, Papillary urothelial neoplasm of low malignant potential, Urine cytology, Bladder EpiCheck®, Nucleix

The first presentation, titled Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial, evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018.

Key Points: 
  • The first presentation, titled Feasibility of the EpiCheck test in upper tract tumor: interim analysis of a prospective trial, evaluated 47 patients who underwent an ureteroscopy for primary or recurrent upper tract urothelial cancer (UTUC) since June 1, 2018.
  • This interim analysis reported a significantly higher overall sensitivity of Bladder EpiCheck compared to cytology in voided urine (75% vs 39%, p=0.03).
  • We are encouraged that these data demonstrate the promise of Bladder EpiChecks ability to accurately rule-out high-grade upper tract urothelial cancer with a simple voided urine test.
  • We are building an EpiCheck franchise, beginning with our Bladder EpiCheck testing kit marketed in Europe for bladder cancer recurrence.

FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Tuesday, June 30, 2020
Clinical medicine, Neoplasms, Health, Breakthrough therapy, Merck, Carcinoma, Avelumab, Transitional cell carcinoma, Monoclonal antibodies, Merkel-cell carcinoma, Transitional epithelium, Cancer immunotherapy

For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.

Key Points: 
  • For patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity.
  • BAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
  • In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
  • A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIOplus best supportive care (BSC) as first-line maintenance treatment.

Merck Provides Update on Phase 3 KEYNOTE-361 Trial Evaluating KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy in Patients with Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Tuesday, June 9, 2020
Other Health, Research, General Health, Pharmaceutical, Oncology, Infectious diseases, Clinical trials, Science, Biotechnology, AIDS, Other Science, Health, Clinical medicine, Cancer treatments, Cancer, Lung cancer, Antineoplastic drugs, Breakthrough therapy, Carcinoma, Merck, Pembrolizumab, Merkel-cell carcinoma, Transitional cell carcinoma, Non-small-cell lung carcinoma, KEYNOTE-361, Bladder Cancer, Merck

KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.

Key Points: 
  • KEYNOTE-361 (ClinicalTrials.gov, NCT02853305 ) is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA as monotherapy and in combination with chemotherapy versus chemotherapy alone, the current standard of care, for the first-line treatment of advanced or metastatic urothelial carcinoma.
  • KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma.

BridgeBio Pharma’s QED Therapeutics Presents Data on Infigratinib in Cholangiocarcinoma and Urothelial Carcinoma at the American Society of Clinical Oncology 2020 Virtual Scientific Program

Retrieved on: 
Friday, May 29, 2020
Cancer, Neoplasms, Clinical medicine, Cholangiocarcinoma, Hepatology, RTT, Transitional epithelium, Transitional cell carcinoma, Fibroblast growth factor receptor 1

SAN FRANCISCO, May 29, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) affiliate QED Therapeutics announced today that it will present data at the American Society of Clinical Oncology 2020 Virtual Scientific Program showing clinical advancement for infigratinib, QEDs oral FGFR1-3 inhibitor, in both urothelial carcinoma and cholangiocarcinoma (CCA).

Key Points: 
  • SAN FRANCISCO, May 29, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) affiliate QED Therapeutics announced today that it will present data at the American Society of Clinical Oncology 2020 Virtual Scientific Program showing clinical advancement for infigratinib, QEDs oral FGFR1-3 inhibitor, in both urothelial carcinoma and cholangiocarcinoma (CCA).
  • An analysis of response rates in patients with advanced/unresectable or metastatic urothelial carcinoma based on the amount of prior lines of treatment showed consistent response to infigratinib.
  • All eight patients in the study with upper tract urothelial carcinoma (UTUC) received infigratinib as second-line or later therapy.
  • Moreover, QED Therapeutics operates in a very competitive and rapidly changing environment in which new risks emerge from time to time.

UroGen Announces Positive Data from Pivotal OLYMPUS Trial Evaluating Jelmyto™ in Patients with Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Friday, May 15, 2020
Research, FDA, Public relations, Investor relations, Clinical trials, Communications, General Health, Pharmaceutical, Health, Science, Oncology, Organic compounds, Chemical compounds, Neoplasms, Carcinoma, Transitional cell carcinoma, Aziridines, Carbamates, Enones, Quinones, Transitional epithelium, Mitomycins, Urinary bladder, the Phase 3 OLYMPUS Trial, Jelmyto™ (mitomycin) for pyelocalyceal solution, UroGen Pharma Ltd.

UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC).
  • OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of Jelmyto (mitomycin) for pyelocalyceal solution to evaluate the safety, tolerability and tumor ablative effect of Jelmyto in patients with low-grade upper tract urothelial cancer.
  • Jelmyto (mitomycin) for pyelocalyceal solution is a drug formulation of mitomycin for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Genentech to Present First Clinical Data on Novel Anti-TIGIT Cancer Immunotherapy Tiragolumab at ASCO

Retrieved on: 
Wednesday, May 13, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Branches of biology, Medical specialties, Organ systems, TIGIT, Atezolizumab, Immune system, CD155, Poliovirus, PD-L1, Transitional epithelium, Transitional cell carcinoma, Urinary bladder

By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the bodys immune response.

Key Points: 
  • By binding to TIGIT, tiragolumab blocks its interaction with a protein called poliovirus receptor (PVR, or CD155) that can suppress the bodys immune response.
  • Blockade of TIGIT and PD-L1 may synergistically enable the re-activation of T cells and enhance NK cell antitumor activity.
  • Tecentriq is a prescription medicine used to treat adults with:
    A type of bladder and urinary tract cancer called urothelial carcinoma.
  • The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response.

Exelixis Announces Results From COSMIC-021 Trial of Cabozantinib in Combination With Atezolizumab in Multiple Advanced Solid Tumor Types

Retrieved on: 
Wednesday, May 13, 2020
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Infectious diseases, Clinical trials, Clinical medicine, Medicine, Cancer, Cancer treatments, Genentech, Lung cancer, Atezolizumab, Carcinoma, Tyrosine kinase inhibitors, Exelixis, Checkpoint inhibitor, Transitional cell carcinoma, the COSMIC-021 Study, NSCLC, UC, CRPC, CABOMETYX® (cabozantinib)

Exelixis, Inc. (NASDAQ: EXEL) today announced phase 1b clinical trial results for the combination of cabozantinib (CABOMETYX) and atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic solid tumors.

Key Points: 
  • Exelixis, Inc. (NASDAQ: EXEL) today announced phase 1b clinical trial results for the combination of cabozantinib (CABOMETYX) and atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic solid tumors.
  • Fifty percent of patients received the cabozantinib and atezolizumab combination as their second line of therapy and 50% as their third line of therapy.
  • Further evaluation of cabozantinib and atezolizumab in patients with advanced tumor types, including immune checkpoint inhibitor-pretreated NSCLC, and forms of prostate and urothelial cancers, is warranted.
  • The efficacy data and favorable safety profiles seen in the three cohorts suggest the combination of cabozantinib and atezolizumab offers promise for patients with advanced, difficult-to-treat tumor types.

New Data from 18 Approved and Investigational Pfizer Medicines to be Showcased at ASCO20 Virtual Scientific Program

Retrieved on: 
Tuesday, May 12, 2020
Biotechnology, Pharmaceutical, Medical Supplies, Oncology, Health, Infectious diseases, Clinical trials, Other Health, Cancer, Health, Neoplasms, Infectious causes of cancer, RTT, Avelumab, Breakthrough therapy, Merck, Pfizer, Transitional cell carcinoma, Prostate cancer, Transitional epithelium

Pfizer Inc. (NYSE: PFE) today announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO20 Virtual Scientific Program, from May 29-May 31.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that new data from clinical trials of 18 approved and investigational medicines will be presented virtually at the ASCO20 Virtual Scientific Program, from May 29-May 31.
  • These data will support our rapidly expanding efforts in bladder cancer and add to the growing body of clinical evidence generated with XTANDI in prostate cancer.
  • Key presentations featuring Pfizer medicines in the ASCO20 Virtual Scientific Program include:
    Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase 3 interim analysis.
  • At Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients.

Junshi Biosciences Announces Acceptance of a Supplemental NDA in China for Toripalimab in Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Thursday, May 7, 2020
RTT, Cancer, Neoplasms, Clinical medicine, Carcinoma, Transitional cell carcinoma, Transitional epithelium, Bladder cancer, Neprilysin, Atezolizumab, Durvalumab

Urothelial carcinoma is the most common (more than 90%) histologic type of bladder cancer in China.

Key Points: 
  • Urothelial carcinoma is the most common (more than 90%) histologic type of bladder cancer in China.
  • It ranked ninth for all cancer deaths in China, accounting for about 14% of bladder cancer deaths worldwide.
  • In China, patients with advanced urothelial carcinoma after failure of standard chemotherapy have limited treatment options.
  • Toripalimab received its first approval for 2nd line treatment of metastatic melanoma on December 17, 2018 in China and was commercially launched in February 2019.