Bristol-Myers Squibb has reported that Opdivo (nivolumab), its immuno-oncology anti-cancer drug, did not meet its primary endpoint in a trial investigating the use of the drug as a monotherapy in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at ≥ 5%. The company will complete an evaluation of the trial's data and work with investigators on the future presentation of the results.

BMS' Opdivo is a human antibody designed to alleviate immune suppression. It is indicated for the treatment of patients with NSCLC with progression on or after platinum-based chemotherapy. In the US, Opdivo is approved as a single agent for treating BRAF V600 wild-type unresectable or metastatic melanoma and as a single agent for treating BRAF V600 mutation-positive unresectable or metastatic melanoma. It is also approved in combination with Yervoy (ipilimumab) for treating unresectable or metastatic melanoma and for treating advanced renal cell carcinoma that has received prior anti-angiogenic therapy. It is also approved for treating patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin.

Opdivo is projected to be a blockbuster drug by some analysts. In 2015, it had global sales of $942 million, and a recent Thomson Reuters analysis
projects that 2019 sales will reach nearly $8.9 billion.

Source: Bristol-Myers Squibb