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Table 2 Five-year iDFS events in patients treated with neratinib and placebo relative to PIK3CA status

From: PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial

Population Neratinib Placebo   
n iDFS events, n n iDFS events, n HR (95% CI) Two-sided P valuea
ITT 1420 116 1420 163 0.73 (0.57–0.92)b 0.008b
Correlative cohort 593 45 608 70 0.67 (0.45–0.96) 0.032
PIK3CA mutation positive 104 7 106 17 0.43 (0.17–1.01) 0.056
PIK3CA mutation negative 385 27 396 42 0.66 (0.40–1.06) 0.089
PIK3CA amplified 33 1 28 4 0.20 (0.01–1.33) 0.106
PIK3CA non-amplified 316 29 325 36 0.85 (0.52–1.39) 0.521
PIK3CA alteredc 130 8 132 20 0.41 (0.17–0.90) 0.028
  1. A total of nine patients (seven patients in the neratinib arm and two patients in the placebo arm) had tumors harboring both a mutation and amplification
  2. aLog-rank test
  3. bStratified analysis
  4. cTumors harboring either a PIK3CA mutation or PIK3CA amplification