Updated results from studies of Yervoy + Opdivo to treat metastatic melanoma.

Bristol-Myers Squibb Company announced updated results from studies evaluating Opdivo (nivolumab) and Yervoy (ipilimumab), alone or in combination, in patients with advanced or metastatic melanoma. These analyses (Abstracts #9533, #9568 and #9551) were featured on Monday, June 3 from 1:15-4:15 PM CDT at the American Society of Clinical Oncology 2019 Annual Meeting in Chicago.

Five-Year Analysis from Phase 1 CA209-004 Study ; A five-year analysis of the Phase 1 CA209-004 study, the longest follow-up for the Opdivo plus Yervoy combination in patients with previously treated or untreated advanced melanoma to date, showed that with a median follow-up of 43.1 months (range: 0.9-76.7) in all patients, at four years or longer, overall survival (OS) rates were stable at 57% (95% Confidence Internal [CI]: 47, 67). The three-year OS rate following discontinuation of therapy was 56% (95% CI: 46, 66). The study also showed long-term survival outcomes with Opdivo plus Yervoy, regardless of BRAF or lactate dehydrogenase (LDH) status, with four-year OS rates of 62% (95% CI: 48, 74) versus 49% (95% CI: 32, 65) for patients with normal and elevated LDH, respectively, and four-year OS rates of 54% (95% CI: 41, 65) and 61% (95% CI: 38, 77) for patients with wild-type and mutant BRAF tumors, respectively. The overall safety of the combination was consistent with previously reported studies of these medicines in patients with advanced melanoma.

New Analyses from Phase III CheckMate -067 Study ;An analysis exploring long-term quality of life (QoL) and symptom burden in the Phase III CheckMate -067 study found that QoL was maintained during the treatment-free interval (TFI) – the period where a patient is off study treatment and free of subsequent therapy – in patients with previously untreated unresectable or metastatic melanoma following discontinuation of therapy with Opdivo or Opdivo plus Yervoy. Patient reported outcome (PRO) scores were maintained from last on-treatment visit to follow-up 1 (30 days after the last dose) or follow-up 2 (84 days after follow-up 1) for patients who discontinued treatment. PRO scores remained stable beyond follow-up for the EQ-5D-3L (measures of mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which were collected at survival follow-up visits every three months in the first year and then every six months.

Finally, a four-year analysis from the CheckMate -067 study of Opdivo and Yervoy, alone or in combination, in patients with previously untreated unresectable or metastatic melanoma, showed that patient-reported QoL and symptoms were maintained from baseline during extended treatment. Of 813 patients included in the PRO analysis population, QoL – including an assessment of functioning and symptom burden – was maintained for the duration of treatment and in follow-up, with no sustained clinically meaningful deterioration in any treatment arm.