In non-small cell lung cancer (NSCLC), Opdivo is prescribed when a tumor has spread or grown, and chemotherapy that contains platinum did not work or is no longer working. It is also given in cases where the tumor has a mutation in the EGFR and ALK genes, and treatment with other drugs approved by the U.S. Food and Drug Administration (FDA) has failed .
In 2015, the FDA expanded the approved use for advanced squamous NSCLC following earlier therapy. That lung cancer is named after the squamous cells found in the tissue that forms the lining of the respiratory tract.
How Opdivo works
Opdivo works with the immune system, meaning that it blocks the PD-1 (programmed death-1) pathway through the PD-L1 (programmed death cell ligand-1) that is overexpressed in NSCLC. That activates T-cells — a type of white blood cells — and other immune system cells to kill cancer cells. While it helps the immune system kill cancer cells, it can also cause it to attack healthy organs and tissues in other parts of the body, affecting their normal functioning.
The FDA based its 2015 approval of Opdivo for patients with advanced metastatic squamous NSCLC on the results of a randomized trial, in which 135 participants received Opdivo and 137 received docetaxel, another anti-cancer drug. Patients on Opdivo lived an average 3.2 months longer than those on docetaxel.
Later that year, it received expanded approval to treat patients with advanced non-squamous NSCLC whose disease progressed during or after platinum-based chemotherapy. A study of 582 patients with advanced NSCLC whose disease progressed during or after treatment with platinum-based chemotherapy and appropriate biologic therapy demonstrated its safety and effectiveness. Patients who received Opdivo had a 27 percent lower risk of dying than those on docetaxel.
The results of another study showed that Opdivo was a safe and viable option to pre-treat patients with early-stage lung cancer before surgery. This neoadjuvant therapy is used to shrink the tumor before surgery. Prior to treatment, tissue samples from the tumor were collected from 20 participants for analysis. Doctors then gave them Opdivo four weeks and again two weeks before surgery. This attracted cytotoxic T-cells to the tumor that were not present in the pre-treatment tissue samples, results showed.
A Phase 1 multi-arm study (NCT01454102, known as CheckMate-012) to assess safety and tolerability of Opdivo alone or in combination with other cancer therapies such as Yervoy (ipilimumab) is still ongoing, but not currently recruiting participants.
Data from a pooled analysis of the Opdivo-plus-Yervoy combination cohorts showed that after 16 months of follow-up, patients with PD-L1 expression of 1 percent or more had a median progression-free survival of 12.7 months. Importantly, the one-year overall survival rate for patients with 50 percent or higher PD-L1 expression was 100 percent, and 87 percent in the 1 percent or higher PD-L1 expression group. In addition, the objective response rate was 43 percent in all treated patients, which was nearly double the 23 percent observed in the Opdivo monotherapy group. The study will likely end in November 2017.
Patients enrolled in the CheckMate-012 study may participate in a Phase 1 cohort trial (NCT03138161) to study escalating doses of Yondelis (trabectedin) every three weeks. Two weeks after the first dose of Yondelis, all patients will be treated with Yervoy and Opdivo.
A Phase 1 dose escalation study (NCT02637531) is now recruiting participants to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-459 alone or in combination with Opdivo. The dose escalation arm of IPI-549 combined with Opdivo will examine the combo treatment’s potential to drive improved, sustained efficacy and tolerability, compared with current standard of care, by targeting the immunosuppressive cells in the tumor microenvironment.
A multicenter, open-label, Phase 2 study (NCT02823990) is also recruiting participants to evaluate the safety and efficacy of Opdivo with the therapeutic vaccine TG4010 in patients with metastatic non-squamous NSCLC whose platinum-based chemotherapy has not worked. TG4010 is an immunotherapy drug to induce immune response to MUC1-positive tumors, such as non-squamous NSCLC. The study expects to enroll up to 33 participants, with final data being released at the end of 2018.
In April 2017, Bristol-Myers Squibb reported data from a Phase 1 study (NCT00730639) at the American Association for Cancer Research (AACR) 2017 Annual Meeting. In this study, three different doses of Opdivo (1, 3, or 10 mg/kg) were administered every two weeks in eight-week cycles, for up to 96 weeks. Patients were enrolled regardless of the PD-L1 status of their tumor. Results showed that Opdivo more than tripled five-year survival rates in NSCLC.
It is an intravenous infusion administered through a vein in the arm or hand. Depending on the treatment, Opdivo is given every two weeks for 60 minutes. The doctor decides the number of treatment cycles. Common side effects include tiredness, diarrhea and coughing as well as muscle, bone and joint pain.
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