Opdivo (nivolumab) is a promising therapy for patients with advanced head and neck cancers who fail to respond to chemotherapy or whose cancers have metastasized, according to data from a Phase 3 clinical trial.
The data, recently presented at the European Society for Medical Oncology (ESMO) Congress Oct. 7-11 in Denmark, shows that Opdivo more than doubled patient survival with fewer side effects than currently available options.
“Nivolumab could be a real game-changer for patients with advanced head and neck cancer. This trial found that it can greatly extend life among a group of patients who have no existing treatment options, without worsening quality of life,” lead reseacher Kevin Harrington, professor of biological cancer therapies at The Institute of Cancer Research in London and a consultant at The Royal Marsden NHS Foundation Trust, said in a press release.
Currently, patients with metastatic head and neck cancers who do not respond following platinum-based chemotherapy have no other therapeutic approaches to prolong their survival.
“Once it has relapsed or spread, head and neck cancer is extremely difficult to treat,” Harrington said. “So it’s great news that these results indicate we now have a new treatment that can significantly extend life, and I’m keen to see it enter the clinic as soon as possible.”
To assess whether Opdivo could improve outcomes, Harrington collaborated with 20 other research organizations worldwide in the open-label CheckMate 141 Phase 3 study (NCT02105636).
The study enrolled 361 patients with relapsed or metastatic head and neck cancer who were randomized to receive either Opdivo (240 patients) or one of three different chemotherapies: Taxotere (docetaxel), Erbitux (cetuximab), or Rasuvo (methotrexate).
Results revealed that the one-year survival rate in the Opdivo group was 36 percent compared to the chemotherapy group’s 17 percent. Median survival rates were also higher in the Opdivo group (7.5 months vs. 5.1 months).
For patients with human papilloma virus (HPV), the survival benefit was more pronounced in patients whose tumors were positive for HPV (9.1 months vs. 4.4 months).
Opdivo treatment resulted in fewer side effects than those observed in the chemotherapy group (13 percent vs. 35 percent). Regarding physical, social, and emotional status, patients who received chemotherapy reported a deterioration while those taking Opdivo remained stable.
“Nivolumab is one of a new wave of immunotherapies that are beginning to have an impact across cancer treatment. This Phase 3 clinical trial expands the repertoire of nivolumab even further, showing that it is the first treatment to have significant benefits in relapsed head and neck cancer,” said Paul Workman, chief executive of The Institute of Cancer Research in London.