Table 1 Best overall response

From: MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer

Best overall responsea Abemaciclib plus nonsteroidal AI Placebo plus nonsteroidal AI p value
n (%) 95% CI n (%) 95% CI
All patients, n 328 165  
CR 9 (2.7) 1.0, 4.5 1 (0.6) -0.6, 1.8  
PR 154 (47.0) 41.6, 52.4 60 (36.4) 29.0, 43.7  
SD 128 (39.0) 33.7, 44.3 82 (49.7) 42.1, 57.3  
SD ≥ 6 months 93 (28.4) 23.5, 33.2 57 (34.5) 27.3, 41.8  
Progressive disease 12 (3.7) 1.6, 5.7 12 (7.3) 3.3, 11.2  
Not evaluable 25 (7.6) 4.8, 10.5 10 (6.1) 2.4, 9.7  
Objective response rate (CR/PR)b 163 (49.7) 44.3, 55.1 61 (37.0) 29.6, 44.3 0.005
Disease control rate (CR/PR/SD) 291 (88.7) 85.3, 92.1 143 (86.7) 81.5, 91.9 0.501
Clinical benefit rate (CR/PR/SD ≥ 6 months) 256 (78.0) 73.6, 82.5 118 (71.5) 64.6, 78.4 0.101
Patients with measurable disease at baseline, n 267 132  
CR 9 (3.4) 1.2, 5.5 0 N/A  
PR 154 (57.7) 51.8, 63.6 60 (45.5) 37.0, 53.9  
SD 76 (28.5) 23.1, 33.9 54 (40.9) 32.5, 49.3  
SD ≥ 6 months 48 (18.0) 13.4, 22.6 32 (24.2) 16.9, 31.6  
Progressive disease 10 (3.7) 1.5, 6.0 12 (9.1) 4.2, 14.0  
Not evaluable 18 (6.7) 3.7, 9.7 6 (4.5) 1.0, 8.1  
Objective response rate (CR/PR)c 163 (61.0) 55.2, 66.9 60 (45.5) 37.0, 53.9 0.003
Disease control rate (CR/PR/SD) 239 (89.5) 85.8, 93.2 114 (86.4) 80.5, 92.2 0.310
Clinical benefit rate (CR/PR/SD ≥ 6 months) 211 (79.0) 74.1, 83.9 92 (69.7) 61.9, 77.5 0.037
  1. N/A, not applicable
  2. aUsing RECIST v1.1
  3. bConfirmed ORR for all patients: 45.1% in the abemaciclib arm, 32.7% in the placebo arm
  4. cConfirmed ORR for patients with measurable disease: 55.4% in the abemaciclib arm, 40.2% in the placebo arm