FDA Approves Opdivo-Yervoy Combination For Treatment of Metastatic NSCLC

The Food and Drug Administration (FDA) has approved the combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adult patients with metastatic non—small cell lung cancer (NSCLC) whose tumors express the protein PD-L1 that is greater than or equal to 1%, as determined by an FDA approved test, and does not have EGFR or ALK genomic tumor aberrations.

The approval is based on findings from part 1a of the phase 3 CheckMate-227 trial, in which the combination of the two immunotherapies, both part of a family of drugs known as checkpoint inhibitors, demonstrated a significant improvement in overall survival (the length of life from the time study treatment began) compared with chemotherapy alone in previously untreated patients with metastatic NSCLC whose tumors express PD-L1 greater than or equal to 1%.

In the group of patients with a PD-L1 expression of greater than or equal to 1%, the median overall survival rate on the combination of Opdivo and Yervoy was 17.1 months compared with 14.9 months for patients on chemotherapy alone. Regardless of a patient’s PD-L1 expression, a significant improvement in overall survival remained across all patients in the study, with 17.1 months in the combination group and 13.9 months with chemotherapy alone.

Overall response rates (the proportion of patients who had a complete or partial response to therapy) were also better in the Opdivo and Yervoy group compared to the chemotherapy group with rates of 36% and 30%, respectively. Moreover, the duration of response for patients with NSCLC on the combination of Opdivo and Yervoy was 23.2 months compared with 6.2 months for patients on chemotherapy alone.

However, the immunotherapy combination did not improve the time until disease progression, which was 5.1 months with Opdivo plus Yervoy compared with 5.6 months in the chemotherapy arm.

No new safety findings were reported from part 1 of the trial. The most common side effects for Opdivo and Yervoy were fatigue, rash, decreased appetite, musculoskeletal pain, diarrhea/colitis, difficulty breathing, cough, severe itching, nausea and hepatitis.

Check back later for what you need to know about this approval.