Phase III study of Opdivo (nivolumab) in squamous cell carcinoma of the head and neck shows improved quality of life data- BMS

Bristol-Myers Squibb has announced new patient-reported quality-of-life data from an exploratory endpoint in the pivotal Phase III CheckMate -141 trial evaluating Opdivo (nivolumab) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel or cetuximab). Outcome assessments showed Opdivo stabilized patients’ symptoms and functioning, including physical, role and social functioning across three separate instruments. Both PD-L1 expressors and non-expressors treated with investigator’s choice of therapy experienced statistically significant worsening of patient-reported outcomes from baseline to week 15 versus Opdivo.

In addition, Opdivo more than doubled the time to deterioration for most functional domains measured and significantly delayed the time to worsening symptoms of fatigue, dyspnea and insomnia, compared to investigator’s choice of therapy. Responses to the QLQ-H&N35 questionnaire showed while patients treated with Opdivo reported stable Patient-reported outcomes (PROs) relative to baseline, those treated with investigator’s choice of therapy had significant worsening in pain as well as significant and clinically meaningful worsening in sensory problems and social contact problems. Compared with investigator’s choice of therapy, Opdivo reduced the rate of clinically meaningful deterioration in pain by 74%, sensory problems by 62% and opening mouth problems by 51%. Patients treated with Opdivo experienced stable health status, as measured by the EQ-5D VAS, whereas those in the investigator’s choice arm experienced worsening of health status, with a statistically significant difference at 15 weeks. Median time to deterioration of health status was nearly triple with 9.1 months for patients receiving Opdivo versus 3.3 months for those in the investigator’s choice arm. These findings will be presented during a Presidential Symposium at the 2016 European Society for Medical Oncology Congress.