Table 2.

Progression-free survival and overall response rate by biomarker status based on archival tissue and ctDNA analyses

PFSORR% (95% CI)
BiomarkeraSampleBuparlisib + paclitaxel (PFS in months)Placebo + paclitaxel (PFS in months)HR (95% CI)Buparlisib + paclitaxelPlacebo + paclitaxel
HPV statusArchival tumor
 Positive4.995.131.06 (0.40–2.79)35.3 (14.2–61.7)27.3 (6.0–61.0)
 Negative3.712.330.58 (0.38–0.89)39.6 (26.5–54.0)11.3 (4.7–21.9)
HPV statusctDNA
 Positive3.663.681.23 (0.44–3.41)25.0 (5.5–57.2)18.2 (2.3–51.8)
 Negative4.633.610.62 (0.37–1.02)43.9 (28.5–60.3)18.8 (8.9–32.6)
TP53 alterationArchival tumor
TP53 altered5.032.170.45 (0.23–0.89)38.5 (20.2–59.4)7.7 (0.9–25.1)
TP53 nonaltered3.783.610.74 (0.33–1.64)42.1 (20.3–66.5)23.1 (5.0–53.8)
TP53 alterationctDNA
TP53 altered3.482.170.76 (0.37–1.53)33.3 (13.3–59.0)8.0 (1.0–26.0)
TP53 nonaltered5.033.710.81 (0.46–1.43)42.9 (26.3–60.6)26.5 (12.9–44.4)
Mutational loadctDNA
 Low mutational load (<13 variants)4.903.610.63 (0.37–1.08)43.6 (27.8–60.4)19.1 (9.1–33.3)
 High mutational load (≥13 variants)2.943.711.23 (0.51–2.97)28.6 (8.4–58.1)16.7 (2.1–48.4)
PI3K pathway activation statusArchival tumor
 Activated5.323.730.67 (0.21–2.14)50.0 (15.7–84.3)10.0 (0.3–44.5)
 Nonactivated4.93.450.63 (0.4–0.99)38.0 (24.7–52.8)13.5 (5.6–25.8)
PD-L1 expression statusArchival tumor
 <13.683.940.64 (0.24–1.68)77.8 (40.0–97.2)13.3 (1.7–40.5)
 ≥14.903.450.77 (0.34–1.77)39.1 (19.7–61.5)15.4 (1.9–45.4)
Intratumoral TILsArchival tumor
 <10%3.713.520.81 (0.51–1.29)39.0 (24.2–55.5)15.4 (6.9–28.1)
 ≥10%4.992.200.53 (0.26–1.07)41.4 (23.5–61.1)9.5 (1.2–30.4)
Stromal TILsArchival tumor
 <15%3.713.550.91 (0.47–1.74)33.3 (14.6–57.0)16.1 (5.5–33.7)
 ≥15%4.902.200.51 (0.31–0.84)43.8 (29.5–58.8)9.8 (2.7–23.1)
Intratumoral CD8 expressionArchival tumor
 <5%3.523.520.78 (0.46–1.31)30.6 (16.3–48.1)14.6 (5.6–29.2)
 ≥5%5.322.200.42 (0.21–0.86)50.0 (29.9–70.1)14.3 (3.0–36.3)
Stromal CD8 expressionArchival tumor
 <10%3.042.370.72 (0.35–1.46)31.6 (12.6–56.6)11.5 (2.4–30.2)
 ≥10%5.322.370.46 (0.27–0.80)42.9 (27.7–59.0)14.3 (4.8–30.3)
CD8 expression in invasive marginsArchival tumor
 ≤25%3.612.330.63 (0.38–1.05)39.5 (24.0–56.6)7.9 (1.7–21.4)
>25%a7.825.540.42 (0.14–1.24)41.2 (18.4–67.1)12.5 (0.3–52.7)
  • Abbreviations: CD8, cluster of differentiation 8; ctDNA, circulating tumor DNA; HPV, human papilloma virus; PD-L1, programmed death ligand 1; TILs, tumor infiltrating lymphocytes.

  • aRefer to Table 1 for the number of patients (n) included in each biomarker/treatment subgroup.