Transitional cell carcinoma

Sorrento Announces That Its Subsidiary Levena and Its Partner Escugen Have Received Clearance to Begin Clinical Trials With Anti-TROP-2 Antibody Drug Conjugate For Multiple Solid Tumors

Retrieved on: 
Wednesday, July 21, 2021

Anti-TROP-2 coupled to SN38 (a DNA polymerase inhibitor) (ESG-401) has received approval to begin clinical trials.

Key Points: 
  • Anti-TROP-2 coupled to SN38 (a DNA polymerase inhibitor) (ESG-401) has received approval to begin clinical trials.
  • ESG-401 addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.
  • ESG-401 potentially addresses a highly unmet need for the treatment of multiple solid tumors, including triple-negative breast cancer and urothelial carcinoma.
  • Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19.

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Friday, July 9, 2021

The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

Key Points: 
  • The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
  • PADCEV is the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer who have received immunotherapy and cannot receive cisplatin, said Roger Dansey, M.D., Chief Medical Officer, Seagen.
  • In clinical trials, 14% of the 680 patients treated with PADCEV developed hyperglycemia; 7% of patients developed Grade 3-4 hyperglycemia.
  • Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicenter, single-arm, phase 2 trial.

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Friday, July 9, 2021

In 2019, the FDA granted accelerated approval for PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.

Key Points: 
  • In 2019, the FDA granted accelerated approval for PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.
  • The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
  • "PADCEV is the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer who have received immunotherapy and cannot receive cisplatin," said Roger Dansey, M.D., Chief Medical Officer, Seagen.
  • Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicenter, single-arm, phase 2 trial.

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC)

Retrieved on: 
Tuesday, July 6, 2021

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Key Points: 
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.
  • KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation.
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma.

CicloMed Announces Initiation of Phase 1B Trial of Fosciclopirox in Newly Diagnosed and Recurrent Urothelial Cancer Patients

Retrieved on: 
Tuesday, June 29, 2021

We are excited to have initiated this Phase 1B trial of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors, said Tammy Ham, CEO of CicloMed.

Key Points: 
  • We are excited to have initiated this Phase 1B trial of fosciclopirox in newly diagnosed and recurrent urothelial cancer patients scheduled for transurethral resection of bladder tumors, said Tammy Ham, CEO of CicloMed.
  • We believe that fosciclopirox provides strong potential to improve treatment outcomes for patients with bladder cancer.
  • In September 2020, CicloMed was awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI), enabling the Phase 1B trial.
  • The initiation of this Phase 1B trial enables us to characterize the pharmacologic activity and mechanisms of fosciclopirox action following treatment in urothelial cancer patients, Weir added.

First Patient Dosed in Clinical Study of TLX250-CDx in Bladder Cancer

Retrieved on: 
Wednesday, June 23, 2021

The objective of the ZiP-UP (Zirconium-girentuximab PET in Urothelial Cancer Patients) study is to evaluate the feasibility of using TLX250-CDx PET/CT1 in the detection of localised and metastatic urothelial carcinoma or bladder cancer.

Key Points: 
  • The objective of the ZiP-UP (Zirconium-girentuximab PET in Urothelial Cancer Patients) study is to evaluate the feasibility of using TLX250-CDx PET/CT1 in the detection of localised and metastatic urothelial carcinoma or bladder cancer.
  • The trial will recruit 20 patients over 12 months: ten patients with known metastatic urothelial carcinoma or bladder cancer; and ten patients that require primary staging of localised urothelial carcinoma or bladder cancer.
  • Telix CEO, Dr Christian Behrenbruch added, We are pleased that a first patient has been dosed in this study exploring the clinical utility of TLX250-CDx to image other cancers, beyond renal cancer, and in indications where conventional imaging has limitations.
  • Bladder cancer is the sixth most commonly occurring cancer in men, and the tenth most common cancer overall worldwide.2 In 2020, 573,278 people worldwide were diagnosed with bladder cancer and 212,536 people died from their disease.3 Urothelial carcinoma (or UCC) accounts for ~90% of all bladder cancers.

Yale Cancer Center Study Shows Novel Test Can Detect New and Recurrent Bladder Cancer

Retrieved on: 
Friday, June 4, 2021

According to the American Cancer Society, an estimated 81,000 cases of bladder cancer will be diagnosed in the United States this year.

Key Points: 
  • According to the American Cancer Society, an estimated 81,000 cases of bladder cancer will be diagnosed in the United States this year.
  • Accurate detection of bladder cancer, or urothelial carcinoma (UC), is often difficult and expensive, requiring invasive camera-based testing methodology.
  • Yale Cancer Center (YCC) is one of only 51 National Cancer Institute-designated comprehensive cancer centers in the nation and the only such center in Connecticut.
  • The URO17 bladder cancer test developed by KDx may prove to be the most sensitive and specific for bladder cancer developed to date.

Infinity to Present at the 7th Annual Truist Securities Life Sciences Summit

Retrieved on: 
Tuesday, April 27, 2021

MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.

Key Points: 
  • MARIO-275 is a randomized, controlled combination study of eganelisib combined with Opdivo\xc2\xae in I/O na\xc3\xafve urothelial cancer.
  • MARIO-3 is the first eganelisib combination study in front-line advanced cancer patients and is evaluating eganelisib in combination with Tecentriq\xc2\xae and Abraxane\xc2\xae in front-line TNBC and in combination with Tecentriq and Avastin\xc2\xae in front-line RCC.
  • In collaboration with Arcus Biosciences, Infinity is evaluating a checkpoint inhibitor-free, novel combination regimen of eganelisib plus etrumadenant (AB928, a dual adenosine receptor antagonist) plus Doxil\xc2\xae in advanced TNBC patients.
  • With these studies Infinity is evaluating eganelisib in the anti-PD-1 refractory, I/O-na\xc3\xafve, and front-line settings.

Cancer Immunotherapy Market: Current Analysis and Forecast 2021-2027

Retrieved on: 
Monday, April 26, 2021

The Cancer Immunotherapy Market report has been aggregated by collecting informative data of various dynamics such as market drivers, restraints, and opportunities.

Key Points: 
  • The Cancer Immunotherapy Market report has been aggregated by collecting informative data of various dynamics such as market drivers, restraints, and opportunities.
  • This innovative report makes use of several analyses to get a closer outlook on the Cancer Immunotherapy market.
  • The Cancer Immunotherapy market report offers a detailed analysis of the latest industry developments and trending factors in the market that are influencing the market growth.
  • Immunotherapy is becoming a key treatment option in conditions like melanoma, lung cancer, urothelial cancer, renal cancer, and head and neck cancer.

Cancer Immunotherapy Market: Current Analysis and Forecast 2021-2027

Retrieved on: 
Monday, April 26, 2021

The Cancer Immunotherapy Market report has been aggregated by collecting informative data of various dynamics such as market drivers, restraints, and opportunities.

Key Points: 
  • The Cancer Immunotherapy Market report has been aggregated by collecting informative data of various dynamics such as market drivers, restraints, and opportunities.
  • This innovative report makes use of several analyses to get a closer outlook on the Cancer Immunotherapy market.
  • The Cancer Immunotherapy market report offers a detailed analysis of the latest industry developments and trending factors in the market that are influencing the market growth.
  • Immunotherapy is becoming a key treatment option in conditions like melanoma, lung cancer, urothelial cancer, renal cancer, and head and neck cancer.