(Head and Neck Cancer) Opdivo/Nivolumab Clinical Trial

The following information about Opdivo (nivolumab) is excerpted from an Ono Pharmaceutical press release issued on February 2.

The press release states that the Phase III clinical trial for squamous cell carcinoma of the head and neck (SCCHN) showed favorable results and was terminated early. The independent Data Monitoring Committee (DMC) evaluated the overall survival (OS) to be higher compared to the control group.

In the United States, starting December 2014, Opdivo rapidly received approval for unresectable or metastatic melanoma after treatment with Yervoy and for BRAF V600 wild-type and positive mutation cases, and in March 2015, approval was expanded to include use during and after platinum-based chemotherapy. Internationally, clinical trials are currently being conducted for head and neck cancer, hematologic tumors, colorectal cancer, and other conditions. Related clinical trials are also underway in Japan.

The CheckMate 141 clinical trial enrolled 361 volunteers who were randomized in a 2:1 ratio to receive either Opdivo or chemotherapy. Related data on OS, ORR, and PFS will be presented at academic conferences.

Head and neck cancer is currently the seventh most common cancer worldwide, with approximately 400,000-600,000 new diagnoses each year, and approximately 223,000-300,000 deaths annually. Squamous cell carcinoma of the head and neck (SCCHN) accounts for 90% of cases, primarily caused by alcohol consumption or smoking.

For the complete press release, please refer to: https://www.ono.co.jp/jpnw/PDF/n16_0202_02.pdf

BMS continues its research into immunomolecular therapies targeting CTLA-4, CD-137, KIR, SLAMF7, PD-1, GITR, IDO, and LAG-3.

Dosing information provided by clinic director Morisaki: Approximately 1 in 20 patients shows a significant effect, and approximately 1 in 1,000 experiences severe life-threatening complications. Calculated based on patient body weight at 2mg/kg. For a patient weighing 60kg, the estimated dose per administration is 120mg, with drug costs of approximately 360,000 yen per treatment (excluding consumption tax, import handling fees, and medical fees). This information is for reference only; actual costs should be confirmed with the hospital's medical cost estimate.

Medical Supporter was formerly certified as an international medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

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Related Cancer Information

• Colorectal cancer
• Melanoma