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Updated results from CheckMate 238

Nivolumab demonstrated sustained efficacy benefit vs IPI in pts with resected stage III/IV melanoma at high risk of recurrence, regardless of disease stage, PD-L1 expression, or BRAF mutation status in the updated efficacy results form CheckMate 238 with an extended follow-up (abstract # 9502).

Background

In the initial report of data from CheckMate 238, at a minimum follow-up of 18 mo, NIVO demonstrated significantly longer recurrence-free survival (RFS) vs IPI in patients (pts) with resected stage III or IV melanoma. Here, Weber JS et al. report updated efficacy results from this phase III study with an additional 6 mo of follow-up.

Methods

Eligible pts included those ≥15 yrs of age who underwent complete resection of stage IIIB/C or IV melanoma. 906 pts were randomized 1:1 (stratified by disease stage and PD-L1 status at a 5% cutoff) to receive NIVO 3 mg/kg Q2W (N=453) or IPI 10 mg/kg Q3W for 4 doses, then Q12W (from week 24) (N=453) for up to 1 yr, or until disease recurrence or unacceptable toxicity. The primary endpoint was RFS; distant metastasis-free survival (DMFS) in pts with stage III disease was an exploratory endpoint.

Results

At a minimum follow-up of 24 mo, RFS continued to be significantly longer for NIVO vs IPI (hazard ratio 0.66, P<0.0001), with 171/453 and 221/453 events, respectively. The 24-mo RFS rates were higher for NIVO vs IPI in subgroups defined by disease stage, PD-L1 expression, and BRAF mutation status. DMFS also continued to be significantly longer for NIVO vs IPI, with 24-mo rates of 70.5% and 63.7%, respectively (hazard ratio 0.76, P=0.034). Subsequent therapies were received by 31.1% of pts in the NIVO group and 41.1% in the IPI group. Per protocol, there was no additional safety assessment for the current analysis given that all pts had been off study treatment >100 days at the time of the previous data cutoff.

Conclusions

With extended follow-up, NIVO demonstrated a sustained efficacy benefit vs IPI in pts with resected stage III/IV melanoma at high risk of recurrence, regardless of disease stage, PD-L1 expression, or BRAF mutation status. Clinical trial information: NCT02388906

Reference:
Weber JS et al. Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: Updated results from a phase III trial (CheckMate 238). abstract # 9502
Presented on Monday, June 4, 2018

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