Ken Kato, MD, PhD: FDA Approval of Nivolumab for Esophageal Squamous Cell Carcinoma

The FDA recently approved nivolumab for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior fluoropyrimidine- and platinum-based chemotherapy. Ken Kato, MD, PhD, lead author on the study the approval was based on, spoke to i3 Health about the challenges of treating this patient population, in addition to the significance of this approval. What are the most challenging aspects of treating patients with advanced ESCC refra...
Continue reading

FDA Approves Nivolumab/Ipilimumab/Platinum-Doublet Chemotherapy: NSCLC

Nivolumab (Opdivo®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb) in combination with 2 cycles of platinum-doublet chemotherapy has been FDA approved for treatment-naive patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Approval was based on the randomized, open-label trial CHECKMATE-9LA (NCT03215706). A total of 719 patients with met...
Continue reading

Nivolumab/Ipilimumab Approved for Metastatic Non-Small Cell Lung Cancer

For patients with advanced non-small cell lung cancer (NSCLC) that test positive for programmed death-ligand 1 (PD-L1), the FDA just approved an effective treatment: nivolumab (Opdivo ®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb). A companion diagnostic, PD-L1 IHC 28.8 pharmDx (Agilent Technologies, Inc.), was also FDA approved for selecting patients with NSCLC for treatment with nivolumab/ipilimumab. Previously approved to treat advanced kidney cancer, advanced liver ...
Continue reading

Nivolumab/Ipilimumab Approved for Hepatocellular Carcinoma

​The FDA has granted accelerated approval to the combination of nivolumab (Opdivo®, Bristol-Myers Squibb) and ipilimumab (Yervoy®, Bristol-Myers Squibb) for the treatment of patients with hepatocellular carcinoma following treatment with sorafenib. Safety and efficacy were evaluated in Cohort 4 of the phase 1/2 CHECKMATE-040 trial (NCT01658878), in which patients previously treated with sorafenib were randomized to receive either nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every three weeks for fo...
Continue reading

Nivolumab Shows Long-Term Efficacy in Advanced RCC

In patients with previously treated advanced renal cell carcinoma (RCC), nivolumab significantly increases overall survival and response rates compared with everolimus, according to the final updated analysis of the phase 3 CheckMate 025 trial. A randomized, open-label trial, CheckMate 025 enrolled 821 patients with advanced RCC previously treated with antiangiogenic therapies. Patients were randomized in a 1:1 ratio to receive 3 mg/kg of nivolumab intravenously every two weeks or 10 mg of evero...
Continue reading

Copyright © 2020 i3 Health. All rights reserved.