Table 4:
Investigator Assessed Response | All SCLC N=105 | Sensitive CTFI ≥ 90 days N=60 | Resistant CTFI < 90 days N=45 |
---|---|---|---|
Overall Response Rate (95% CI) | 35% (26, 45) | 45% (32, 58) | 22% (11, 37) |
Complete response, n (%) | 0 (0) | 0 (0) | 0 (0) |
Partial response, n (%) | 37 (35) | 27 (45) | 10 (22) |
Median DOR months (95% CI) | 5.3 (4.1, 6.4) | 6.2 (3.5, 7.3) | 4.7 (2.6, 5.6) |
≥ 6 months DOR, n (%) | 13 (35) | 12 (44) | 1 (10) |
| |||
IRC Assessed Response | |||
| |||
Overall Response Rate (95% CI) | 30.5% (22 40) | 43% (31, 57) | 13% (5, 27) |
Complete response, n (%) | 0 (0) | 0 (0) | 0 (0) |
Partial response, n (%) | 32 (30) | 26 (43) | 6 (13) |
Median DOR months (95% CI) | 5.1 (4.9, 6.4) | 5.3 (4.9, 7.0) | 4.8 (2.4, 5.3) |
≥ 6 months DOR, n (%) | 8 (25) | 8 (31) | 0 (0) |
Abbreviations: CI: confidence interval; CTFI: chemotherapy-free interval; DOR: duration of response; IRC: independent review committee; SCLC: small cell lung cancer.
Source: ZEPZELCA (lurbinectedin) [package insert] (Ref. 11)