IN PREVIOUSLY UNTREATED METASTATIC OR
UNRESECTABLE STAGE III OR IV MELANOMA
BICR: Blinded Independent Central Review; CI: confidence interval; HR: hazard ratio; PFS: progression-free survival.
* RELATIVITY-047 is a phase 2/3, randomized, double-blinded trial in 714 patients with previously untreated metastatic or unresectable Stage III or IV melanoma. Patients received OPDUALAG (nivolumab 480 mg and relatlimab 160 mg, n=355) or nivolumab 480 mg (n=359) by IV infusion every 4 weeks until disease progression or unacceptable toxicity. Patients were allowed to have received prior adjuvant or neoadjuvant melanoma therapy: anti-PD-1 therapy, anti-CTLA-4 therapy, or BRAF+/- MEK inhibitors were allowed if there was at least 6 months between the last dose of therapy and date of recurrence; interferon therapy was allowed if the last dose was at least 6 weeks prior to randomization.
† Kaplan-Meier estimate.
‡ Based on stratified log-rank test.
§ Final PFS analysis, with a median follow-up of 13.2 months.
CI: confidence interval; HR: hazard ratio; OS: overall survival..
* RELATIVITY-047 is a phase 2/3, randomized, double-blinded trial in 714 patients with previously untreated metastatic or unresectable Stage III or IV melanoma. Patients received OPDUALAG (nivolumab 480 mg and relatlimab 160 mg, n=355) or nivolumab 480 mg (n=359) by IV infusion every 4 weeks until disease progression or unacceptable toxicity. Patients were allowed to have received prior adjuvant or neoadjuvant melanoma therapy: anti-PD-1 therapy, anti-CTLA-4 therapy, or BRAF+/- MEK inhibitors were allowed if there was at least 6 months between the last dose of therapy and date of recurrence; interferon therapy was allowed if the last dose was at least 6 weeks prior to randomization.
† Kaplan-Meier estimate.
‡ Based on stratified log-rank test.
§ Not significant at alpha level 0.04302.
CI: confidence interval; CR: complete response; ORR: objective response rate; OS: overall survival; PR: partial response.
* RELATIVITY-047 is a phase 2/3, randomized, double-blinded trial in 714 patients with previously untreated metastatic or unresectable Stage III or IV melanoma. Patients received OPDUALAG (nivolumab 480 mg and relatlimab 160 mg, n=355) or nivolumab 480 mg (n=359) by IV infusion every 4 weeks until disease progression or unacceptable toxicity. Patients were allowed to have received prior adjuvant or neoadjuvant melanoma therapy: anti-PD-1 therapy, anti-CTLA-4 therapy, or BRAF+/- MEK inhibitors were allowed if there was at least 6 months between the last dose of therapy and date of recurrence; interferon therapy was allowed if the last dose was at least 6 weeks prior to randomization.
† At the time of the final OS analysis, which was event-driven and occurred after the final PFS analysis, with a median follow-up of 19.9 months.