Bristol-Myers Squibb has announced that its CheckMate-026 trial, a phase 3 study investigating the use of nivolumab (Opdivo) as monotherapy, did not meet its primary endpoint of progression-free survival (PFS) in patients with previously untreated advanced non–small-cell lung cancer (NSCLC) whose tumors expressed programmed death ligand-1 (PD-L1) at greater than or equal to 5%.

The open-label, randomized CheckMate-026 trial enrolled NSCLC patients who had received no prior systemic treatment for advanced disease and who tested positive for PD-L1 expression. The study randomly assigned 541 patients to receive either intravenous nivolumab 3 mg/kg every two weeks or the investigator’s choice of chemotherapy in a squamous cohort (gemcitabine with cisplatin/gemcitabine with carboplatin/paclitaxel with carboplatin) and a nonsquamous cohort (pemetrexed with cisplatin/pemetrexed with carboplatin) until disease progression, unacceptable toxicity, or the completion of six cycles. The study’s primary endpoint was PFS in patients with greater than or equal to 5% PD-L1 tumor expression.

Nivolumab is a PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells and that blocks the binding of PD-L1 and PD-L2, thereby preventing the PD-1 pathway’s suppressive signaling on the immune system, which includes interference with an antitumor immune response.

Nivolumab was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and it currently has regulatory approval in 54 countries, including the United States.

In the U.S., the drug is indicated for the treatment of:

  • Patients with BRAF V600 wild-type unresectable or metastatic melanoma (as a single agent)
  • Patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (as a single agent)
  • Patients with unresectable or metastatic melanoma (in combination with ipilimumab [Yervoy], Bristol-Myers Squibb)
  • Patients with metastatic NSCLC with progression on or after platinum-based chemotherapy
  • Patients with advanced renal-cell carcinoma who have received prior antiangiogenic therapy
  • Patients with classical Hodgkin’s lymphoma that has relapsed or progressed after autologous hematopoietic stem-cell transplantation and post-transplantation brentuximab vedotin.

Source: Bristol-Myers Squibb; August 5, 2016.

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