Table 20. Overall response rates in patients from P001 (18 October 2013 cut off). BRAF 2 mg/kg 10 mg/kg 10 mg/kg status Q3W Q3W Q2W Mutant 8 out of 38 9 out of 45 7 out of 14 24 out of 97 (21%) (20%) (50%) (25%) Mutant, use of BRAFi/MEKi 13 out of 66 (20%) Mutant, no use of BRAFi/MEKi 11 out of 31 (35%) Wild-type 39 out of 46 out of 19 out of 39 104 out of 124 (31%) 147 (31%) (49%) 310 (34%) In the 18 April 2014 cut off analysis of B1+B2+B3+D, there were 308 IPI naïve subjects and 342 IPI exposed subjects (many of whom were included in the above analysis). In Table 21 is presented the analysis of ORRs is by BRAF status and ipilimumab exposure. Table 21. Analysis of overall response rates is by BRAF status and ipilimumab exposure BRAF status IPI-naive IPI-exposed total Mutant n=91 n=64 n=155 ORR = 27.5% ORR = 17% ORR = 23% - Mutant, use n=45 n=56 n=101 of ORR = 24% ORR = 18% ORR = 21% BRAFi/MEKi - Mutant, no n=46 n=8 n=54 use of ORR = 30% ORR = 12.5% ORR = 28% BRAFi/MEKi Wild-type n=217 n=277 n=494 ORR = 40% ORR = 28.5% ORR = 34% Total n=308 n=342 n=650 ORR = 36% ORR = 27% ORR = 31% Safety results Exposure Exposure to pembrolizumab in 411 subjects with advanced melanoma within sub-studies B1, B2 and D was as follows, based on the 18 October 2013 cut off (values from the 18 April 2014 cut off follow, in bold and parentheses)
Table 20. Overall response rates in patients from P001 (18 October 2013 cut off). BRAF status 2 mg/kg Q3W 10 mg/kg Q3W 10 mg/kg Q2W Mutant 8 out of 38 (21%) 9 out of 45 (20%) 7 out of 14 (50%) 24 out of 97 (25%) Mutant, use of BRAFi/MEKi 13 out of 66 (20%) Mutant, no use of BRAFi/MEKi 11 out of 31 (35%) Wild-type 39 out of 124 (31%) 46 out of 147 (31%) 19 out of 39 (49%) 104 out of 310 (34%) In the 18 April 2014 cut off analysis of B1+B2+B3+D, there were 308 IPI naïve subjects and 342 IPI exposed subjects (many of whom were included in the above analysis). In Table 21 is presented the analysis of ORRs is by BRAF status and ipilimumab exposure. Table 21. Analysis of overall response rates is by BRAF status and ipilimumab exposure BRAF status IPI-naive IPI-exposed total Mutant n=91 ORR = 27.5% n=64 ORR = 17% n=155 ORR = 23% - Mutant, use of BRAFi/MEKi n=45 ORR = 24% n=56 ORR = 18% n=101 ORR = 21% - Mutant, no use of BRAFi/MEKi n=46 ORR = 30% n=8 ORR = 12.5% n=54 ORR = 28% Wild-type n=217 ORR = 40% n=277 ORR = 28.5% n=494 ORR = 34% Total n=308 ORR = 36% n=342 ORR = 27% n=650 ORR = 31% Safety results Exposure Exposure to pembrolizumab in 411 subjects with advanced melanoma within sub-studies B1, B2 and D was as follows, based on the 18 October 2013 cut off (values from the 18 April 2014 cut off follow, in bold and parentheses)
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