Long-term survival in advanced melanoma for patients treated with nivolumab plus ipilimumab in CheckMate 067.

• DOI: 10.1200/jco.2022.40.16_suppl.9522
• Publication Date: 2022-06-06T17:22:06Z
• Authors: F. Stephen Hodi; Vanna Chiarion -S...; Karl D. Lewis; Jean-Jacques Grob; Piotr Rutkowski; Christopher D. Lao; Charles Lance Cowey; Dirk Schadendorf; John Wagstaff; Reinhard Dummer; Paola Queirolo; Michael Smylie; Marcus O. Butler; Andrew Graham Hill; Ivan Marquez-Rodas; John B. A. G. Haanen; Piyush Durani; Peter Wang; Jedd D. Wolchok; James Larkin
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

9522 Background: Durable clinical benefit has been achieved with nivolumab (NIVO) + ipilimumab (IPI), including an overall survival (OS) of 49% and a melanoma-specific (MSS) 56%, median MSS not reached (NR) at 6.5-y minimum follow-up. Here we report sustained efficacy outcomes 7.5 y. Methods: Patients (pts) previously untreated, unresectable stage III/IV melanoma were randomly assigned 1:1:1 stratified by PD-L1 status, BRAF mutation metastasis to receive NIVO 1 mg/kg IPI 3 for 4 doses Q3W, followed Q2W (n = 314); placebo 316); or Q3W 315) until progression unacceptable toxicity. Co-primary endpoints progression-free (PFS) OS alone versus IPI. Results: With follow-up y, remained stable 72.1 mo (NIVO IPI), 36.9 (NIVO), 19.9 (IPI); was NR, 49.4 mo, 21.9 respectively (Table). While the objective response rate 58% 45% 19% duration had now 90.8 remains NR 19.2 IPI, respectively. Subsequent systemic therapy received 36%, 49%, 66% IPI-, NIVO-, IPI-treated patients, respectively, time that (95% CI, 45.9–NR), 24.7 (16.0–38.7), 8.0 (6.5–8.7). Of patients alive 106/138 (77%, 80/115 (70%, NIVO), 27/60 (45%, IPI) off treatment never subsequent therapy. No change safety summary observed additional follow-up; updated health-related quality life data will be reported. 10 new deaths since (ie, 5 IPI; NIVO; 2 none treatment-related; due progression; unknown cause; other causes, but associated COVID diagnosis. Conclusions: The 7.5-y continues demonstrate durability responses ongoing plateau. A substantial difference in between treated descriptive analyses. Clinical trial information: NCT04540705. [Table: see text]