Methods: In separate cohorts, IPI-N and IPI-R pts were randomized 1:1 to MK-3475 2 or 10 mg/kg every 3 wk (2 Q3W or 10 Q3W). IPI-N pts received ≤2 prior systemic therapies. IPI-R pts had any number of prior therapies and unequivocal or confirmed PD per immune-related response criteria (irRC) after ≥2 IPI doses; all BRAF-mutant pts were previously treated with BRAF inhibitors. Primary endpoint was ORR assessed by RECIST 1.1 every 12 wk by independent central review. Investigator-assessed response by irRC was also obtained.
Results: A total of 276 pts were randomized (103 IPI-N [2 Q3W, n = 51; 10 Q3W, n = 52] and 173 IPI-R [2 Q3W, n = 89; 10 Q3W, n = 84]. In both cohorts, treatment arms were well balanced for known prognostic factors. As of the 10/18/2013 cutoff, all IPI-N and 47% of IPI-T pts had ≥9 mo of follow-up. Among evaluable pts, no significant differences in ORR by RECIST were observed between doses in IPI-N (33% vs 40%) or IPI-R (26% vs 26%) pts. By RECIST, response duration ranged from 6+ wk to 39+ wk in both cohorts (median not reached), with ~90% of responses ongoing. PFS by RECIST was similar between doses. The safety profile was generally similar between pts treated with 2 Q3W and 10 Q3W. There were no drug-related deaths.
Conclusions: MK-3475 2 mg/kg Q3W and 10 mg/kg Q3W provided similar efficacy and safety in both IPI-N pts and IPI-R pts. Treatment was well tolerated with acceptable toxicity profile. The high ORR provided by MK-3475 comes with long durability in both IPI-N and IPI-R MEL. Clinical trial information: NCT01295827.
|Number of pages||1|
|Journal||Journal of Clinical Oncology|
|Publication status||Published - 20 May 2014|
|Event||50th Annual Meeting of the American-Society-of-Clinical-Oncology - Chicago, United States|
Duration: 30 May 2014 → 3 Jun 2014