Immunotherapy Nivolumab Receives FDA Approval for Second-Line Treatment of Esophageal Cancer

On 10 June 2020, the US Food and Drug Administration (FDA) approved the immunotherapy drug nivolumab (Opdivo) as a second-line treatment for squamous cell esophageal cancer.

To receive nivolumab for squamous cell esophageal cancer, a patient must have previously received fluoropyrimidine- and platinum-based chemotherapy and have a tumor that cannot be surgically removed, is recurrent, or is at a metastatic stage.

In the clinical trial called ATTRACTION-3, on which the approval was based;

• 210 patients received Opdivo, while 209 received chemotherapy (docetaxel or paclitaxel).
• Immunotherapy reduced the risk of death by 23% (hazard ratio [HR] 0.77; 95% confidence interval [CI]: 0.62 to 0.96; p = 0.0189).
• Median overall survival was 10.9 months with Opdivo and 8.4 months with chemotherapy. Opdivo is the first immunotherapy approved in this setting for esophageal cancer regardless of tumor PD-L1 positivity.

More than half of patients with esophageal cancer are diagnosed at an advanced / inoperable stage, and treatment options for advanced esophageal cancer are limited. The approval of the immunotherapy drug Opdivo, whose active ingredient is nivolumab, for second-line treatment of esophageal cancer regardless of PD-L1 levels has introduced an important treatment option for this group of our patients. Previously, in July 2019, another immunotherapy drug, pembrolizumab (Keytruda), was approved for second-line treatment of esophageal cancer in patients with PD-L1 >= 10% (see the related approval).

The most common (>10%) side effects in patients receiving nivolumab are rash, decreased appetite, diarrhea, constipation, musculoskeletal pain, upper respiratory tract infection, cough, pyrexia/fever, pneumonia, anemia, fatigue, itching, nausea and hypothyroidism.

The recommended nivolumab dose for squamous cell esophageal cancer is 240 mg every 2 weeks or 480 mg every 4 weeks.