Table 3.
Efficacy outcomes for patients with dose reductions or interruptions (brain metastasis-negative population).
| Outcome | Overall BMNeg population | Dose reductions | No dose reductions | Dose interruptions | No dose interruptions | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| SG (n = 235) | TPC (n = 233) | SG (n = 62) | TPC (n = 52) | SG (n = 173) | TPC (n = 181) | SG (n = 144) | TPC (n = 78) | SG (n = 91) | TPC (n = 155) | |
| ORR (BICR), n (%) | 82 (35) | 11 (5) | 29 (47) | 7 (13) | 53 (31) | 4 (2) | 56 (39) | 5 (6) | 26 (29) | 6 (4) |
| CBR (BICR), n (%) | 105 (45) | 20 (9) | 37 (60) | 11 (21) | 68 (39) | 9 (5) | 71 (49) | 12 (15) | 34 (37) | 8 (5) |
| Best overall response, n (%) | ||||||||||
| CR | 10 (4) | 2 (1) | 5 (8) | 1 (2) | 5 (3) | 1 (1) | 7 (5) | 0 | 3 (3) | 2 (1) |
| PR | 72 (31) | 9 (4) | 24 (39) | 6 (12) | 48 (28) | 3 (2) | 49 (34) | 5 (6) | 23 (25) | 4 (3) |
| Median PFS (BICR), mo (95% CI) | 5.6 (4.3–6.3) | 1.7 (1.5–2.6) | 8.3 (5.4–10.3) | 2.9 (2.7–4.3) | 4.6 (3.5–5.7) | 1.5 (1.4–1.7) | 5.7 (4.3–7.0) | 2.7 (1.7–3.0) | 4.2 (2.9–6.8) | 1.6 (1.5–2.2) |
Assessed in brain metastases-negative population (SG, n = 235; TPC, n = 233).
BICR blind independent central review, BMNeg brain metastases-negative, CBR clinical benefit rate, CR complete response, ORR objective response rate, PFS progression-free survival, PR partial response, SG sacituzumab govitecan, TPC treatment of physician’s choice.