Table 2.

Efficacy for single-agent breast cancer cohort, overall and by HR and HER2 status

EndpointBreast cancer overalla (N = 47)HR-positive(N = 36)HR-negative (N = 9)HR-positive, HER2-positive (N = 11)HR-positive, HER2-negative(N = 25)
Best overall response
 CR00000
 PR11 (23%)b11 (31%)04 (36%)7 (28%)
 SD22 (47%)18 (50%)3 (33%)7 (64%)11 (44%)
  ≥24 weeks12 (26%)11 (31%)1 (11%)2 (18%)9 (36%)
  <24 weeks10 (21%)7 (19%)2 (22%)5 (45%)2 (8%)
 Progressive disease11 (23%)5 (14%)6 (67%)05 (20%)
 Not evaluable3 (6%)2 (6%)002 (8%)
Response rate (CR + PR), (95% CI)23% (12.3–38.0)31% (16.3–48.1)0% (0–33·6)36% (10.9–69.2)28% (12.1–49.4)
Clinical benefit rate (CR + PR + SD ≥ 24 weeks), (95% CI)49% (34.1–63.9)61.1% (43.5–76.9)11.1% (0.3–48.2)54.5% (23.4–83.3)64% (42.5–82.0)
Disease control rate (CR + PR + SD), (95% CI)70% (55.1–82.7)81% (64.0–91.8)33% (7.5–70.1)100% (71.5–100.0)72% (50.6–87.9)
Median duration of response, c months13.4 (9.0–13.4) (11 patients)13.4 (3.7–13.4)NAd4.6, 10.0, 9.2, 5.3 (4 patients)13.4 (3.7–13.4)
Median PFS (95% CI), months5.8 (2.9–10.9)8.8 (4.2–16.0)1.1 (0.6–4.0)7.2 (2.8–12.0)8.8 (2.9–18.0)
  • NOTE: Data are represented as n (%), unless otherwise specified.

  • Abbreviations: CI, confidence interval; NA, not available.

  • aTwo patients had unknown HR status.

  • bAll 11 patients with breast cancer who had a partial response were HR-positive.

  • cMedian duration of response is reported if ≥5 patients had a response in each category. If <5 patients had a response, individual values are presented.

  • dDuration of response was not available for patients with HR-negative breast cancer as none of these patients had a partial response.