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Melanoma: Durable CRs with NIVO+IPI

Combination treatment with two anti-PD-1 antibodies (Nivolumab, NIVO and Ipilimumab, IPI) resulted in higher response rates, longer progression-free survival (PFS), and improved overall survival (OS) vs. IPI alone. The following study analysed CRs among patients who received NIVO or IPI or a combination of the two.

The post hoc analysis used data from the phase 2 CheckMate 069, phase 3 CheckMate 066, and phase 3 CheckMate 067 studies in patients with advanced Melanoma. The minimum duration of follow-up was two years.

In the pooled analysis, the CR rate was 18% for NIVO+IPI, 16 % for NIVO, and 4% for IPI, with partial responses (RRs) in 41 %, 28 %, and 14 % of pts, respectively. Among the 75 CR pts in the NIVO+IPI cohort, the majority (77 %) are off treatment and 8 % received a subsequent systemic therapy; 15 % had elevated LDH levels and 32 % had M1c disease.
Median duration of CR has not been reached, with 63/75 pts (84 %) remaining in response.

After an additional follow-up of 12 months (from one year follow-up) 24/166 pts (14 %) with a PR converted to a CR. For the 75 CR pts in the NIVO+IPI group, 2-year PFS and OS rates were 86% and 92 % respectively.
Treatment-related AEs of grade 3/4 occurred in 60% of NIVO+IPI treated pts with a CR, 65% with a PR, and in 60% with stable disease; 31 %, 36 % and 35 %, respectively, led to discontinuation (not treatment related deaths).
Updated analyses based on 3-year data will be presented at the ESMO 2017 in Madrid.

Robert C et al., abstract 12130: Characterization of complete responses (CRs) in patients with advanced melanoma (MEL) who received the combination of nivolumab (NIVO) and Ipilimumab (IPI), NIVO, or IPI alone



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