Opdivo(nivolumab)

Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody. It is indicated for the treatment of adult patients with metastatic non-small cell lung cancer expressing PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, as first-line treatment in combination with ipilimumab. A new indication for Opdivo in combination with ipilimumab was approved for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test with no EGFR or ALK genomic tumor aberrations.

In an interim, non-comparative analysis of an ongoing, randomized (2:1), open-label study with 120 patients enrolled, the Overall Response Rate (ORR) was 31.7%, including 4 complete responses and 34 partial responses. 33 patients had ongoing responses, with 13 patients having ongoing responses for more than 6 months. The median progression-free survival was 3.5 months. The median overall survival was 15.7 months.

Notable safety findings include an immune-mediated pneumonitis incidence of 3.1% and 6%. 3.5% of patients experienced adverse events leading to discontinuation. Non-fatal Serious Adverse Events (SAEs) occurred in 15.5% of patients, with SAEs of pneumonitis at 1.7% and anemia at 1.7%. Anemia (all grades) was observed in 40% of patients. The application for this indication was a Supplemental BLA, received on November 15, 2019, and granted Priority review.