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. Author manuscript; available in PMC: 2022 Oct 5.
Published in final edited form as: Clin Cancer Res. 2020 Dec 7;27(9):2378–2382. doi: 10.1158/1078-0432.CCR-20-3901

Table 4:

Overall Response Rates and Duration of Response of Patients in SCLC Cohort in Study B-005

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)