Table 4.
Responses according to RECIST v1.1 produced by bireociclib combination therapy (part 2) – intention-to-treat population
|
Cohort A* (n = 35) |
Cohort B* (n = 28) |
Cohort C* (n = 67) |
|
|---|---|---|---|
| Best overall response, n (%) | |||
| CR | 1 (2.9) | 0 | 2 (3.0) |
| PR | 19 (54.3) | 16 (57.1) | 29 (43.3) |
| SD | 12 (34.3) | 9 (32.1) | 29 (43.3) |
| PD | 0 | 3 (10.7) | 7 (10.4) |
| Not evaluable | 3 (8.6) | 0 | 0 |
| ORR (%, 95% CI) | 57.1 (39.35–73.68) | 57.1 (37.18–75.54) | 46.3 (34.00–58.88) |
| DCR (%, 95% CI) | 91.4 (76.94–98.20) | 89.3 (71.77–97.73) | 89.6 (79.65–95.70) |
| CBR (%, 95% CI) | 71.4 (53.70–85.36) | 78.6 (59.05–91.70) | 71.6 (59.31–81.99) |
| Survival estimates | |||
| Median PFS (months, 95% CI) | NR (20.83–NR) | 26.3 (9.99–NR) | 20.1 (8.90–27.14) |
| Median DoR (months, 95% CI) | NR (NR–NR) | 24.5 (9.26–NR) | 21.8 (11.07–25.53) |
*Cohort A: bireociclib plus letrozole/anastrozole group; Cohort B: bireociclib plus FULV first-line; Cohort C: bireociclib plus FULV second-line. Cohorts A and B included patients who had not received prior systemic treatment in the metastatic setting. Among these patients, de novo metastatic cases represented only a minority, as the majority had previously received adjuvant therapy. CBR clinical benefit rate; CI confidence interval; CR complete response; DCR disease control rate; DoR duration of response; FULV fulvestrant; NR not reached; ORR objective response rate; PD progressive disease; PFS progression-free survival; PR partial response; RECIST Response Evaluation Criteria in Solid Tumors; SD stable disease