ESMO 2019: Initial Results of EV-103, A phase 1b Study Evaluating the Safety and Activity of Enfortumab Vedotin Plus Pembrolizumab – A Medical Oncologist’s Perspective

Barcelona, Spain (UroToday.com) Platinum-based chemotherapy is the standard of care in patients with locally advanced or metastatic urothelial carcinoma, but this therapy is often toxic with overall response rates of 50% or less. These tumors highly and consistently express the type I transmembrane cellular adhesion protein, Nectin-4. Enfortumab vedotin (EV) is an antibody-drug conjugate against […]

ESMO 2019: Phase 2 TROPHY-U-01 Open-Label Study of Patients Receiving Sacituzumab Govitecan with Metastatic Urothelial Cancer After Failure of Platinum-Based Regimens or Immunotherapy

Barcelona, Spain (UroToday.com) Platinum-based chemotherapy has been the standard first-line therapy for patients with metastatic urothelial cancer (mUC). Historically, response to standard of care second-line chemotherapy regimens is < 15%. Although immune checkpoint inhibitors (ICIs) now provide another option for patients with platinum-refractory mUC, response rates are similarly low, highlighting a critical need for novel therapeutic agents […]

ESMO 2019: The Effect of Telaglenastat with Everolimus on Progression Free Survival in Patients with Advanced Renal Cell Carcinoma – Results from the Phase 2 ENTRATA Study

Barcelona, Spain (UroToday.com) Cancer cells, including renal cell carcinoma cells, have long been known to preferentially utilize glycolysis rather than aerobic oxidative phosphorylation to produce intracellular ATP, a phenomenon known as the Warburg effect. In the relative absence of pyruvate created by the Warburg effect, cancer cells take up excess glutamine, which is converted to […]

Data From Randomized Phase 2 ENTRATA Study Demonstrate Telaglenastat with Everolimus Improves Progression-Free Survival in Renal Cell Carcinoma

San Francisco, CA (UroToday.com) — Calithera Biosciences, Inc., a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, presented supporting data for its previously reported positive results from its randomized placebo-controlled Phase 2 ENTRATA study of telaglenastat (CB-839) in combination with everolimus […]

ESMO 2019: Invited Discussant: The Search for New Treatment Strategies in Genitourinary Cancer, Discussion of the ENTRATA and TROPHY-U-01 Trials

Barcelona, Spain (UroToday.com) Professor Ignacio Durán provided a discussion of the recently presented ENTRATA and TROPHY-U-01 trials at the 2019 European Society for Medical Oncology annual meeting (ESMO) proffered paper session. ENTRATA was a randomized phase II study of telaglenastat + everolimus vs. placebo + everolimus in heavily pre-treated metastatic renal cell carcinoma (mRCC) patients, reporting a median […]

ESMO 2019: Initial Results From TROPHY-U-01: A Phase 2 Open-Label Study of Sacituzumab Govitecan in Patients with Metastatic Urothelial Cancer After Failure of Platinum-Based Regimens or Immunotherapy

Barcelona, Spain (UroToday.com) Patients with metastatic urothelial carcinoma have limited options after disease progression on platinum-based chemotherapy and/or checkpoint inhibitors. Sacituzumab govitecan is an antibody-drug conjugate comprising a humanized anti-Trop-2 monoclonal antibody coupled to SN-38 via a unique hydrolysable linker. In the prior phase I/II IMMU-132-01 study, Sacituzumab govitecan showed significant clinical activity and manageable […]

ESMO 2019: EV-103: Initial Results of Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

Barcelona, Spain (UroToday.com) Platinum-based chemotherapy remains the standard of care for patients with locally advanced or metastatic urothelial carcinoma. Despite the use of first-line PD-1/PD-1L inhibitors, 71–76% of patients who are cisplatin-ineligible do not respond to treatment. Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4, which is highly expressed in metastatic urothelial carcinoma. Enfortumab vedotin […]

ESMO 2019: ENTRATA: Randomized, Double-Blind, Phase 2 Study of Telaglenastat + Everolimus vs. Placebo + Everolimus in Patients with Advanced/Metastatic Renal Cell Carcinoma

Barcelona, Spain (UroToday.com) Altered glucose and glutamine metabolism is a hallmark of renal cell carcinoma (RCC). Abnormal glucose metabolism, known as the Warburg effect, deprives the citric acid cycle (TCA cycle) of critical metabolites. Cancer cells compensate for the Warburg effect by increasing glutamine metabolism to sustain the TCA cycle for growth and proliferation. Glutaminase […]

ESMO 2019: BISCAY: An Adaptive, Biomarker Directed Platform Study in Metastatic Urothelial Cancer with Durvalumab in Combination with Targeted Therapies

Barcelona, Spain (UroToday.com) Durvalumab is a PD-L1 inhibitor with efficacy in platinum-refractory advanced urothelial cancer and approved by the FDA after a reported response rate of 18%.1 FGFR targeted therapy (ie. erdafitinib) also has FDA approval in biomarker-selected patients with urothelial cancer based on a response rate of 40%.2 At the ESMO 2019 non-prostate cancer session, […]

A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors Condition: Renal Cell Carcinoma Intervention: Biological: Nivolumab Biological: Ipilimumab Other: Ipilimumab placebo Purpose: The purpose of this study is to test the effectiveness and safety of nivolumab […]

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