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special territories; also total price for VAT-free export deliveries to third countries) Benefit-risk Assessment of Nivolumab 240 Mg Flat Dose Relative to 3 mg/kg Q2W Regimen in Japanese Patients With Advanced Cancers. PMID: 31773815 PMCID: PMC7004547 DOI: 10.1111/cas.14252 Free PMC article. Benefit-risk Assessment of Nivolumab 240 Mg Flat Dose Relative to 3 mg/kg Q2W Regimen in Japanese Patients With Advanced Cancers. PMID: 31773815 PMCID: PMC7004547 DOI: 10.1111/cas.14252. Nivolumab 3 mg/kg every 2 weeks (Q2W) has been approved in Japan for various cancers; however, use of a flat dose is expected to simplify dosing and administration. A quantitative clinical pharmacology approach was used to assess the benefit-risk profile of nivolumab 240 mg Q2W relative to the approved dose of nivolumab 3 mg/kg Q2W in Japanese patients. Three exposure-response safety analyses were performed for adverse events that led to discontinuation/death, were grade 3 or higher, and were immune-mediated and grade 2 or higher for Japanese patients diagnosed with one of multiple tumor types. Exposure-response analyses of efficacy were evaluated for overall survival and objective response rate. Exposures of nivolumab 240 mg Q2W were 37% higher than those of nivolumab 3 mg/kg Q2W in Japanese patients across the tumor types analyzed. Predicted safety profiles at the two doses differed by less than 2% across tumor types for adverse events leading to discontinuation/death, adverse events of grade 3 or higher, or immune-mediated adverse events of grade 2 or higher. In addition, the predicted 1-year and 2-year overall survival rates, the mean overall survival and the objective response rates were comparable between the doses regardless of the tumor type analyzed. Overall, these results demonstrated that the benefit-risk of nivolumab 240 mg Q2W was comparable to that of the previously approved 3 mg/kg Q2W dosing regimen, and was the basis for the approval of the 240 mg Q2W as an alternative dosing regimen for treatment in Japanese patients across multiple tumor types. Keywords: Japanese patients; cancer immunotherapy; clinical pharmacology; flat dosing; nivolumab. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. Shinji Uemura and Tomoya Ohno are employees of ONO Pharmaceutical. Di Bei and Amit Roy are employees of Bristol‐Myers Squibb and Mayu Osawa is employee of Bristol‐Myers Squibb KK. Mayumi Hasegawa was employed by Bristol‐Myers Squibb KK at the time this work was completed. This study was designed and funded by Bristol‐Myers Squibb and ONO Pharmaceutical. Nivolumab supply and support to collect and analyze the data were provided by Bristol‐Myers Squibb. All authors had access to the complete data, significantly contributed to development of the manuscript and had final responsibility for the decision to submit the manuscript for publication. At The Oil Works we pride ourselves on providing every customer with outstanding, professional service. We have been proudly servicing the area for the past 22 years. So whether you're looking for a full service oil change using our leading premium synthetic or conventional oils or one of our other automotive services, we'll help keep your car running smoothly for years to come. Full Service Oil Change Tire Rotation/Inflation Engine Flush Service Headlight & Bulb Fuel System Maintenance Cabin Air Filter Service Battery Service Wiper Blade. COOKIES THIS WEBSITE USES COOKIES FOR A BETTER USER EXPERIENCE.

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