Transitional cell carcinoma

Aravive Announces Initiation of Investigator-Sponsored Phase 1/2 Study of AVB-500 in Combination with Avelumab in Patients with Advanced Urothelial Carcinoma (COAXIN)

Retrieved on: 
Tuesday, March 24, 2020

Locally advanced or metastatic urothelial carcinoma is an aggressive cancer with poor long-term survival, said Dr. Tripathi.

Key Points: 
  • Locally advanced or metastatic urothelial carcinoma is an aggressive cancer with poor long-term survival, said Dr. Tripathi.
  • Although immunotherapy results in durable responses in some patients, only a small proportion of patients respond and most eventually progress.
  • The COAXIN study is a multi-center, single arm, Phase 1/2 trial evaluating safety and preliminary antitumor efficacy of avelumab in combination with AVB-500 in patients with advanced UC.
  • An investigator-sponsored Phase 1/2 trial of AVB-500, in combination with durvalumab in patients with platinum-resistant recurrent epithelial ovarian cancer, is also ongoing.

BridgeBio Pharma’s QED Therapeutics Announces Dosing of First Patients in Phase 3 and Phase 2 Clinical Trials of Infigratinib in Tumors with FGFR Genetic Alterations

Retrieved on: 
Thursday, March 12, 2020

The Phase 3 PROOF 302 trial sponsored by QED is studying infigratinib for the adjuvant (post-surgery) treatment of invasive urothelial carcinoma.

Key Points: 
  • The Phase 3 PROOF 302 trial sponsored by QED is studying infigratinib for the adjuvant (post-surgery) treatment of invasive urothelial carcinoma.
  • The primary outcome is disease-free survival, and secondary outcomes include metastasis-free survival, overall survival, and safety and tolerability measures.
  • There appear to be multiple FGFR alterations that can drive cancer growthand we hope to see these patients benefit too.
  • Moreover, QED Therapeutics operates in a very competitive and rapidly changing environment in which new risks emerge from time to time.

Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Pembrolizumab in First-Line Advanced Bladder Cancer

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Wednesday, February 19, 2020

This is an important step in our investigation of PADCEV in combination with pembrolizumab as a first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy, said Roger Dansey, M.D., Chief Medical Officer, Seattle Genetics.

Key Points: 
  • This is an important step in our investigation of PADCEV in combination with pembrolizumab as a first-line therapy for patients with advanced urothelial cancer who are unable to receive cisplatin-based chemotherapy, said Roger Dansey, M.D., Chief Medical Officer, Seattle Genetics.
  • Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those with and without pre-existing diabetes mellitus.
  • Seattle Genetics and Astellas are co-developing PADCEV (enfortumab vedotin-ejfv) under a collaboration that was entered into in 2007 and expanded in 2009.
  • Seattle Genetics and Astellas entered a clinical collaboration agreement with Merck to evaluate the combination of Seattle Genetics and Astellas PADCEV (enfortumab vedotin-ejfv) and Mercks KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer.

Seattle Genetics and Astellas Announce Updated Results from Phase 1b/2 Trial of PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as Investigational First-Line Treatment for Advanced Bladder Cancer

Retrieved on: 
Tuesday, February 11, 2020

Forty-five patients were treated with the combination of PADCEV (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy.

Key Points: 
  • Forty-five patients were treated with the combination of PADCEV (enfortumab vedotin-ejfv) and pembrolizumab and were evaluated for safety and efficacy.
  • EV-103 is an ongoing, multi-cohort, open-label, multicenter phase 1b/2 trial of PADCEV alone or in combination, evaluating safety, tolerability and efficacy in muscle invasive, locally advanced and first- and second-line metastatic urothelial cancer.
  • The dose-escalation cohort and expansion cohort A include locally advanced or metastatic urothelial cancer patients who are ineligible for cisplatin-based chemotherapy.
  • Dry eye symptoms occurred in 36% of patients, and blurred vision occurred in 14% of patients, during treatment with PADCEV.

Genentech Provides an Update on Phase III Study of Tecentriq in People With Muscle-invasive Urothelial Cancer

Retrieved on: 
Friday, January 24, 2020

Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.

Key Points: 
  • Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
  • In addition to ongoing Phase III studies in early and advanced bladder cancer, Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.
  • Urothelial cancer is the most common type of bladder cancer, accounting for about 90-95% of all cases.
  • Tecentriq is a prescription medicine used to treat adults with:
    A type of bladder and urinary tract cancer called urothelial carcinoma.

Seattle Genetics to Host Conference Call and Webcast Discussion of Fourth Quarter and Full Year 2019 Financial Results on February 6, 2020

Retrieved on: 
Tuesday, January 21, 2020

Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it will report its fourth quarter and full year 2019 financial results on Thursday, February 6, 2020 after the close of financial markets.

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it will report its fourth quarter and full year 2019 financial results on Thursday, February 6, 2020 after the close of financial markets.
  • Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update.
  • ADCETRIS is approved for the treatment of several types of CD30-expressing lymphomas, and PADCEV is approved to treat adults with metastatic urothelial cancer.
  • The company is headquartered in Bothell, Washington, and has offices in California, Switzerland and the European Union.

FDA approves new type of therapy to treat advanced urothelial cancer

Retrieved on: 
Wednesday, December 18, 2019

Platinum-containing chemotherapy, PD-1 and PD-L1 inhibitors are standard treatments for patients with bladder cancer, the sixth most common cancer in the U.S. Urothelial cancer, accounting for more than 90% of bladder cancers, begins in cells that line the bladder and nearby organs.

Key Points: 
  • Platinum-containing chemotherapy, PD-1 and PD-L1 inhibitors are standard treatments for patients with bladder cancer, the sixth most common cancer in the U.S. Urothelial cancer, accounting for more than 90% of bladder cancers, begins in cells that line the bladder and nearby organs.
  • Padcev represents a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.
  • "Antibody-drug conjugates are strategic tools in the targeted treatment of cancer.
  • The FDA granted the approval of Padcevto Astellas Pharma US Inc.

Global Bladder Cancer Drugs Market Report 2020: Focus on Non-Muscle-Invasive Bladder Cancer & Muscle-Invasive Bladder Cancer - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 11, 2019

Global Bladder Cancer Drugs Market Report 2020 provides strategists, marketers and senior management with the critical information they need to assess the global bladder cancer drugs market.

Key Points: 
  • Global Bladder Cancer Drugs Market Report 2020 provides strategists, marketers and senior management with the critical information they need to assess the global bladder cancer drugs market.
  • The bladder cancer drugs market consists of sales of bladder cancer drugs.
  • The bladder cancer market consists of treatments of bladder cancer types such as urothelial carcinoma, squamous cell bladder cancer, adenocarcinoma and others.
  • This increased incidence of bladder cancer increases the demand for bladder cancer drugs, contributing to the growth of the market.

Seattle Genetics and Astellas Announce Clinical Trial Collaboration with Merck to Evaluate Enfortumab Vedotin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Metastatic Urothelial Cancer

Retrieved on: 
Monday, December 2, 2019

The trial will be designed to evaluate the efficacy of the combination of enfortumab vedotin and pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer.

Key Points: 
  • The trial will be designed to evaluate the efficacy of the combination of enfortumab vedotin and pembrolizumab in patients with previously untreated locally advanced or metastatic urothelial cancer.
  • We look forward to initiating a randomized phase 3 trial in patients with previously untreated locally advanced or metastatic urothelial cancer, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.
  • Recent data from a phase 1b trial of enfortumab vedotin in combination with pembrolizumab showed evidence of clinical activity leading to the development of this phase 3 trial.
  • KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Agilent Companion Diagnostic Expands CE-IVD mark in Europe to include Head and Neck Squamous Cell Carcinoma (HNSCC)

Retrieved on: 
Friday, November 22, 2019

PD-L1 IHC 22C3 pharmDx is now CE-IVDmarked as a companion diagnostic to KEYTRUDA in three tumor indications NSCLC, urothelial carcinoma, and HNSCC.

Key Points: 
  • PD-L1 IHC 22C3 pharmDx is now CE-IVDmarked as a companion diagnostic to KEYTRUDA in three tumor indications NSCLC, urothelial carcinoma, and HNSCC.
  • PD-L1 IHC 22C3 pharmDx also helps physicians identify non-small cell lung cancer (NSCLC) and urothelial carcinoma patients for treatment with KEYTRUDA.
  • Safety and Clinical Activity of Pembrolizumab for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of The Head and Neck (KEYNOTE-012): An Open-label, Multicenter, Phase 1b Trial.
  • 2014 Review of Cancer Medicines on the WHO List of Essential Medicines: Locally Advanced Squamous Carcinoma of the Head and Neck.