Last month, the FDA approved Nivolumab (Opdivo), an immunotherapy drug, combined with chemotherapy for the treatment of patients with early-stage non-small cell lung cancer (NSCLC), before undergoing surgical resection (i.e. neoadjuvant treatment).

This represents the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

The approval was based on results from a clinical trial in which 358 patients with early-stage NSCLC were randomly assigned to receive either Nivolumab plus chemotherapy every three weeks for up to three cycles, or chemotherapy alone administered on the same schedule.

The study results point towards a significant lower risk of disease recurrence among those receiving Nivolumab plus chemotherapy, compared to those receiving chemotherapy alone.

Regarding the surgical pathologic results, 24% of the patients receiving Nivolumab plus chemotherapy had complete response (i.e. no evidence of residual disease), compared to only about 2% receiving chemotherapy alone.

Treatment related adverse events were similar with the Nivolumab-chemotherapy combination versus chemotherapy alone, as well as all surgery-related adverse events.

Based on the promising study results, the researchers believe that this changing approach in treating patients with early stage NSCLC, increases the potential for better long-term outcomes with Nivolumab in combination with chemotherapy among these patients.