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Table 2 Efficacy analysis data from the BOLERO-2 trial and the SOLAR-1 study (cohort of PIK3CA-mutated cancer)

From: Everolimus versus alpelisib in advanced hormone receptor-positive HER2-negative breast cancer: targeting different nodes of the PI3K/AKT/mTORC1 pathway with different clinical implications

Clinical endpoint

Everolimus and exemestane group (N = 482)

Placebo and exemestane group (N = 238)

Alpelisib and fulvestrant group (N = 169)

Placebo and fulvestrant group (N = 172)

Best overall response (%)

 Complete response CR

0

0

0.6

1.2

 Partial response PR

12.6

2.1

26.0

11.6

 Stable disease SD

73.4

62.8

34.3

36.6

 Neither complete response nor progressive diseasea

/

/

22.5

14.5

 Progressive disease PD

5.8

23.4

9.5

30.8

 Unknown

8.2

11.7

7.1

5.2

Overall response (%)

12.6

2.1

26.6

12.8

Clinical benefit (%)

49.9

22.2

61.5

45.3

  1. “/,” not evaluated in this trial
  2. aIn this category, the best overall response was evaluated only in patients who had no measurable disease at baseline according to the Response Evaluation Criteria in Solid Tumors, version 1.1