BioSpace News Archive

Exelixis, Inc. announced detailed results from CABINET, a phase 3 pivotal trial evaluating cabozantinib compared with placebo in two cohorts of patients with previously treated neuroendocrine tumors: one cohort of patients with advanced pancreatic neuroendocrine tumors and a second cohort of patients with advanced extra-pancreatic NET.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the first results from an open-label, multicenter Phase 1 study evaluating the safety and efficacy of TAR-210, an intravesical delivery system designed to provide sustained, local release of erdafitinib into the bladder in patients with non-muscle-invasive bladder cancer with select fibroblast growth factor receptor alterations.

Updated results from the BEGONIA Phase Ib/II trial for the cohort of patients treated with datopotamab deruxtecan plus IMFINZI® showed that the combination demonstrated durable tumor responses and no new safety signals in patients with previously untreated advanced or metastatic triple-negative breast cancer with six months additional follow-up from the previous data cut-off.

Merck, known as MSD outside of the United States and Canada, announced results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate, compared to chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Natera, Inc. announced updated data from the GALAXY arm of the CIRCULATE-Japan trial further showcasing the ability of the Signatera™ molecular residual disease test to help identify patients with resectable colorectal cancer who are at an increased risk of recurrence and predict who are most likely to benefit from adjuvant chemotherapy.

Regeneron Pharmaceuticals, Inc. and Sanofi announced that positive results from a Phase 3 trial evaluating the investigational use of Dupixent® showed consistent efficacy and safety for up to one year in children aged 1 to 11 years with eosinophilic esophagitis.

Exact Sciences Corp. announced late-breaking data from the pivotal BLUE-C trial showing the next-generation Cologuard® test met all study endpoints, demonstrating 94 percent sensitivity for colorectal cancer at 91% specificity, during the American College of Gastroenterology Annual Meeting 2023.

Adiso Therapeutics, Inc. announced positive topline data from its Phase 1b multiple ascending dose clinical trial evaluating ADS051 in patients with moderate-to-severe ulcerative colitis.

Celltrion USA announced that the U.S. Food and Drug Administration has approved ZYMFENTRA® for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an infliximab product administered intravenously.

Revolution Medicines, Inc. announced promising anti-tumor and safety data for RMC-6236, its RASMULTI Inhibitor, in patients with previously treated non-small cell lung cancer and pancreatic ductal adenocarcinoma across several dose levels and KRASG12X genotypes, including common KRAS-mutant genotypes G12D and G12V.