Table 4.

Summary of tumor responses stratified by both prior systemic anticancer therapy strata and PD-L1–expression status.

Eribulin +PD-L1+PD-L1PD-L1+PD-L1
pembrolizumabStratum 1Stratum 1Stratum 2Stratum 2
(n = 149)a(n = 29)(n = 31)(n = 45)(n = 44)
ORRb, %34.516.124.418.2
 95% CIb17.9–54.35.5–33.712.9–39.58.2–32.7
mOSc, months21.015.214.015.5
 95% CI8.3–29.012.8–19.411.0–19.412.4–18.7
mPFSc, months6.13.54.13.9
 95% CI4.1–10.22.0–4.22.1–4.82.3–6.3
mDORc,d months8.315.28.28.6
 95% CI3.2–NE6.5–22.25.1–25.13.5–13.2
  • Abbreviations: CI, confidence interval; CR, complete response; DOR, duration of response; m, median; NE, not estimable; ORR, objective response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response.

  • aExcludes 18 patients who had unknown tumor PD-L1 status.

  • bORR = CR + PR; 95% CIs were calculated by Clopper–Pearson method.

  • cMedians for PFS, OS, and DOR were estimated using the Kaplan–Meier method and their corresponding 95% CIs were calculated using a generalized Brookmeyer and Crowley method.

  • dIn patients with confirmed CR or PR.