Metastatic Urothelial Carcinoma (mUC) Archives

BMS, Synairgen regroup after trials miss primary endpoints

Blockbusters, Bristol Myers Squibb, Business, Clinical Trials, COVID-19 Therapeutic, COVID-19 therapeutic candidates, COVID-19 Therapeutics, COVID-19 Therapies, Metastatic Urothelial Carcinoma (mUC), R&D, R&D, Therapeutics

Bristol Myers Squibb shared the news that the company’s Phase III clinical trial investigating the safety and efficacy of Opdivo and Yervoy combination therapy (NCT03036098) in patients with metastatic urothelial carcinoma failed to meet the predetermined primary endpoint. A posthoc analysis was shared by Synairgen suggesting that, despite SNG001 failing to meet the primary endpoint of patient recovery and subsequent hospital discharge in a Phase III study for patients hospitalized with COVID-19 who required supplemental oxygen treatment, they may benefit from receiving the treatment.

May 16, 2022/by BioSpace

Nektar stops clinical trials for key cancer drug, shares tumble

Bladder Cancer, Blockbusters, Bristol Myers Squibb, Business, Clinical Trials, Melanoma, Metastatic Urothelial Carcinoma (mUC), Partnerships, R&D, Renal Cell Carcinoma (RCC), Shares, Therapeutics

Nektar Therapeutics said on April 14 the company had stopped all clinical trials involving the drug developer’s key cancer drug bempegaldesleukin following its failure in multiple studies, dragging Nektar shares down 23% in after-market trading.

April 14, 2022/by Andrew Humphreys

FDA Issues CRL to Merck

Acquisitions, Agreements, Blockbusters, Business, Chemotherapy, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency (EMA), FDA, Keytruda, Merck, Metastatic Urothelial Carcinoma (mUC), PD-1/PD-L1 inhibitors, Spin-offs, Therapeutics, Triple Negative Breast Cancer (TNBC)

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.

March 30, 2021/by Andrew Humphreys

Roche Pulls Checkpoint Inhibitor in Bladder Cancer

AstraZeneca, Blockbusters, Checkpoint Inhibitors, Clinical Trial Endpoints, FDA, Metastatic Urothelial Carcinoma (mUC), Monoclonal Antibodies, PD-1/PD-L1 inhibitors, Postmarket Studies, Roche, Therapeutics, Voluntary Indication Withdrawal

Two weeks after AstraZeneca announced the company was withdrawing the use of Imfinzi as a treatment for bladder cancer in the United States, Swiss pharma giant Roche followed suit with the checkpoint inhibitor Tecentriq (atezolizumab).

March 8, 2021/by Andrew Humphreys

Opdivo Significantly Improves DFS vs. Placebo as Adjuvant Therapy for Patients with High-Risk, Muscle-Invasive Urothelial Carcinoma

Blockbusters, Clinical Trials, Disease-Free Survival (DFS), Immunotherapies, Metastatic Urothelial Carcinoma (mUC), PD-1/PD-L1 inhibitors, Placebo, Primary Endpoints, R&D, Solid Tumors, Therapeutics, Tumors

Bristol Myers Squibb announced that CheckMate -274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after surgery in patients with high-risk, muscle-invasive urothelial carcinoma, met primary endpoints of improving disease-free survival (DFS) versus placebo in both all randomized patients and in patients whose tumor cells express PD-L1 ≥1% (programmed death-ligand 1).

September 24, 2020/by Andrew Humphreys

FDA Gives Bavencio Thumbs-Up for UC

Approvals, Checkpoint Inhibitors, FDA, FDA/Regulatory, Metastatic Urothelial Carcinoma (mUC), New Indications, PD-1/PD-L1 inhibitors

The U.S. Food and Drug Administration approved Bavencio (avelumab) for maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-containing chemotherapy.

July 1, 2020/by BioSpace

Keytruda Fails to Hit Mark in First-Line Bladder Cancer Treatment Trial

Blockbusters, Checkpoint Inhibitors, Chemotherapy, Clinical Trials, Metastatic Urothelial Carcinoma (mUC), Primary Endpoints, R&D, Therapeutics

Merck’s checkpoint inhibitor Keytruda (pembrolizumab) did not meet the pre-specified dual primary endpoints in a study of the drug in combination with chemotherapy for the first-line treatment of advanced or metastatic urothelial carcinoma.

June 10, 2020/by BioSpace

Pfizer and Merck KGaA’s Checkpoint Inhibitor Prolongs Survival in Urothelial Carcinoma

Checkpoint Inhibitors, Clinical Trials, Metastatic Urothelial Carcinoma (mUC), R&D

Pfizer and EMD Serono – the biopharmaceutical unit of Darmstadt, Germany-based Merck KGaA – announced that the companies’ Phase III JAVELIN Bladder 100 trial hits the primary endpoint of overall survival (OS) at a planned interim analysis.

January 6, 2020/by BioSpace

Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.

August 11, 2019/by Andrew Humphreys

Seattle Genetics & Astellas Report Positive Urothelial Cancer Study

Checkpoint Inhibitors, Chemotherapy, Metastatic Urothelial Carcinoma (mUC)

Seattle Genetics and Tokyo-based Astellas Pharma announced positive top-line data from the first cohort of the Phase II EV-201 trial evaluating enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who had previously received both platinum-based chemotherapy and a checkpoint inhibitor.

March 28, 2019/by BioSpace