Not really news here. Guess what drug does better and in whom??? Nivo or ipi???? (But, spoiler alert!!!! As I've been saying, even patients with minimal PD-L1 expression can still gain a response!!!)
Methods: Eligible pts included those greater than/= to15 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, 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 (Table). DMFS also continued to be significantly longer for NIVO vs IPI, with 24-mo rates of 70.5% and 63.7%, respectively. 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 for 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
|Sorry about the sad pic. Best I could do. ASCO doesn't make this easy.|
Okay. There you go. Happy Friday!!! - c