Bristol-Myers reports quality-of-life data from CheckMate-141 trial
Bristol-Myers Squibb announced new patient-reported quality-of-life data from an exploratory endpoint in the pivotal Phase 3 CheckMate -141 trial evaluating Opdivo 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. Specifically, patient-reported outcomes were collected using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC Head and Neck Cancer-Specific Module and the 3-level EQ-5D questionnaire. Both the EORTC QLQ-C30 and EORTC QLQ-H&N35 questionnaires showed there were significant differences in PROs between patients treated with Opdivo and those treated with investigator's choice of therapy at 15 weeks. In the EORTC QLQ-C30, while patients treated with Opdivo had stable PROs relative to baseline, those treated with investigator's choice of therapy had significant and clinically meaningful worsening of physical, role and social functioning, fatigue, dyspnea and appetite loss. Opdivo more than doubled the median time to deterioration for global health status, at 7.7 versus 3.0 months; physical functioning, at 7.8 versus 3.6 months; role functioning, at 8.6 versus 3.8 months; cognitive functioning, at 7.8 versus 3.3 months; and social functioning, at 7.7 versus 3.0 months compared with investigator's choice of therapy. In emotional functioning, Opdivo demonstrated a median time to deterioration of 6.7 months versus 4.7 months for investigator's choice of therapy. Opdivo also reduced the rate of clinically meaningful deterioration in fatigue, insomnia and dypsnea by 50%. While patients treated with Opdivo reported stable 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.