Transitional cell carcinoma

Infinity Pharmaceuticals Provides Update for Eganelisib in Patients with Metastatic Urothelial Cancer

Wednesday, January 6, 2021 - 2:11pm

Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today provided an update on MARIO-275, the Companys randomized, placebo controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab (Opdivo) in platinum-refractory, I/O nave patients with advanced, metastatic urothelial cancer (mUC) over nivolumab monotherapy which is approved in this setting.

Key Points: 
  • Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today provided an update on MARIO-275, the Companys randomized, placebo controlled Phase 2 study evaluating the benefit of adding eganelisib to nivolumab (Opdivo) in platinum-refractory, I/O nave patients with advanced, metastatic urothelial cancer (mUC) over nivolumab monotherapy which is approved in this setting.
  • The MARIO-275 study provided Infinity with important insights to shape the future of eganelisib in urothelial cancer, said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals.
  • We are leveraging the clinical and translational learnings from MARIO-275 in planning a new, registration-enabling study of eganelisib in patients with advanced urothelial cancer.
  • MARIO-275 is a global, randomized, placebo-controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.

UroGen Pharma Reports Third Quarter 2020 Financial Results and Recent Corporate Developments

Monday, November 9, 2020 - 1:00pm

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
  • Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S.
  • Our primary focus is on the health and well-being of patients, caregivers, and UroGen employees at this critical juncture.

Basilea reports interim results from phase 1/2 study FIDES-02 exploring derazantinib in patients with advanced urothelial cancer

Tuesday, October 13, 2020 - 6:15am

Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today interim results from the phase 1b part of the ongoing phase 1/2 study FIDES-02.

Key Points: 
  • Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today interim results from the phase 1b part of the ongoing phase 1/2 study FIDES-02.
  • The phase 2 substudies include patients with FGFR-positive advanced urothelial cancer receiving treatment with derazantinib alone or in combination with atezolizumab as first-line therapy or after progression on prior FGFR-inhibitor therapy.
  • This RP2D corresponds to the derazantinib monotherapy dose used in the phase 2 study FIDES-01 and the standard dose for atezolizumab as a single agent in urothelial cancer.
  • We have now moved to the next important step in the development of derazantinib, by exploring potential synergies of derazantinib and atezolizumab in our ongoing clinical study in patients with advanced urothelial cancer.

Urothelial Carcinoma Diagnostics Market Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (2020-2030)

Tuesday, October 6, 2020 - 2:12pm

According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).

Key Points: 
  • According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).
  • The reagent and kits segment, under product type, is expected to contribute more than 70% of revenue share in the urothelial carcinoma diagnostics market.
  • Based on end user, the hospitals segment accounts for a major revenue share in the urothelial carcinoma diagnostics market.
  • Leading players launching rapid diagnostic products with advances technology are expected to dominate the urothelial carcinoma diagnostics market space.

Urothelial Carcinoma Diagnostics Market Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (2020-2030)

Tuesday, October 6, 2020 - 2:09pm

According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).

Key Points: 
  • According to the latest report published by PMR, the Global Urothelial Carcinoma Diagnostics Market Was Valued At US$ 1 Bn In 2020, And Is Expected To Progress At A CAGR Of Over 11% During The Forecast Period (20202030).
  • The reagent and kits segment, under product type, is expected to contribute more than 70% of revenue share in the urothelial carcinoma diagnostics market.
  • Based on end user, the hospitals segment accounts for a major revenue share in the urothelial carcinoma diagnostics market.
  • Leading players launching rapid diagnostic products with advances technology are expected to dominate the urothelial carcinoma diagnostics market space.

Infinity Receives Fast Track Designation for Eganelisib in Combination with a Checkpoint Inhibitor and Chemotherapy for First-Line Treatment of Advanced TNBC

Tuesday, September 29, 2020 - 12:35pm

Earlier this year Infinity also received Fast Track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the companys global, randomized, controlled Phase 2 study in patients with advanced urothelial cancer.

Key Points: 
  • Earlier this year Infinity also received Fast Track designation for eganelisib in combination with the checkpoint inhibitor Opdivo for the treatment of advanced urothelial cancer which the company is studying in MARIO-275, the companys global, randomized, controlled Phase 2 study in patients with advanced urothelial cancer.
  • Fast Track designation is an exciting regulatory milestone that bolsters our momentum in TNBC, said Adelene Perkins, Chief Executive Officer and Chair of Infinity Pharmaceuticals.
  • MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq and Abraxane in front-line TNBC and in combination with Tecentriq and Avastin in front-line RCC.
  • In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus AB928 (dual adenosine receptor antagonist) plus Doxil in advanced TNBC patients.

JUPITER-02 Phase III Global Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival in Recurrent or Metastatic Nasopharyngeal Carcinoma

Tuesday, September 29, 2020 - 3:35am

Nasopharyngeal carcinoma (NPC), a subtype of head and neck cancer, is a malignant tumor that occurs in the nasopharynx.

Key Points: 
  • Nasopharyngeal carcinoma (NPC), a subtype of head and neck cancer, is a malignant tumor that occurs in the nasopharynx.
  • At the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the global study met its primary endpoint of progression free survival (PFS).
  • Compared with the placebo control, Toripalimab in combination with Gemcitabine/Cisplatin significantly prolonged the PFS as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.
  • In September 2020, Toripalimab for the treatment of nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the FDA.

RemeGen Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer

Friday, September 25, 2020 - 6:30pm

"An estimated 81,400 new cases of urothelial cancer and 17,980 deaths are predicted in the United States in 2020i," said Jianmin Fang, Ph.D., founder, CEO and CSO of RemeGen.

Key Points: 
  • "An estimated 81,400 new cases of urothelial cancer and 17,980 deaths are predicted in the United States in 2020i," said Jianmin Fang, Ph.D., founder, CEO and CSO of RemeGen.
  • "The high prevalence of metastatic urothelial cancer underscores the need for effective and accessible treatment methods for patients.
  • This Breakthrough Therapy designation will bring RemeGen one step closer to finding a safe and effective treatment for this devastating disease.
  • We look forward to working with the FDA to advance the clinical development of disitamab vedotin."

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

Friday, September 18, 2020 - 11:45am

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

Friday, July 17, 2020 - 1:00pm

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.