FDA Approves Opdivo-Chemotherapy Regimen for Pre-Surgical Treatment of Non-Small Cell Lung Cancer

The Food and Drug Administration (FDA) approved the use of Opdivo (nivolumab) plus a platinum-doublet chemotherapy regimen as a pre-surgical treatment option for adults with resectable — defined as tumors greater than or equal to 4 centimeters in size or node positive — non-small cell lung cancer.

The FDA’s decision, according to Opdivo’s manufacturer Bristol Myers Squibb, marks the agency’s first-and-only approval of an immunotherapy-based regimen to be administered before surgical resection.

“Given the rates of disease recurrence in patients with resectable (non-small cell lung cancer), additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning,” Dr. Mark Awad, clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute in Boston, said in a news release announcing the approval. “The approval of (Opdivo) with platinum-doublet chemotherapy marks a turning point in how we treat resectable (non-small cell lung cancer) and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery.”

The FDA based its authorization of the combination using data from the phase 3 CheckMate-816 trial, of which Awad was the lead investigator.

The findings of the study demonstrated that treatment with Opdivo plus the chemotherapy-doublet regimen (179 patients) induced a significant improvement in event-free survival (time after treatment ends when a patient remains free of certain complications or events) with a 37% reduction in the risk of disease progression, recurrence or death compared with chemotherapy alone (179 patients).

Moreover, the use of the Opdivo-based regimen resulted in a median event-free survival of 31.6 months compared 20.8 months for those who received just the chemotherapy-doublet regimen. Partial complete responses to treatment were also higher in the Opdivo-based treatment group (24% versus 2.2%).

Ten percent of the patients receiving the Opdivo plus platinum-doublet chemotherapy regimen experience side effects that ultimately led to treatment discontinuation. Additionally, 30% of patients had at least one treatment withheld because of a side effect.

The results also showed that serious side effects occurred in 30% of patients receiving the study drug combination. Some of the serious side effects to occur in more than 2% of patients included vomiting and pneumonia. There were, however, no fatal events attributed to side effects in those who were treated with the Opdivo-based regimen.

The most common side effects (defined as those to occur in more than 20% of the patient population) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%) and rash (20%).

A full report of the event-free survival data, according to Bristol Myers Squibb, will be presented at an upcoming medical conference in April.

In response to the news of the FDA approval, the main Twitter account for Johns Hopkins Thoracic Oncology tweeted: “Great news for patients newly diagnosed with stage 2-3a non-small cell lung cancer. (Three) treatments of chemotherapy with immunotherapy prior to surgery reduces the risk of cancer progression, recurrent cancer or death by 37% compared to chemo alone. Now FDA approved!”

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