Table 3.
Talazoparib | Chemotherapy | |||||
---|---|---|---|---|---|---|
gLOH (%) for clinical benefit—yes Median (range), n | gLOH (%) for clinical benefit—no Median (range), n | P value | gLOH (%) for clinical benefit—yes Median (range), n | gLOH (%) for clinical benefit—no Median (range), n | P value | |
Evaluable ITT | 21.3 (0.0–52.7), 100 | 22.5 (0.0–45.1), 40 | 0.9762 | 20.1 (0.3–35.9), 26 | 20.9 (0.2–40.5), 55 | 0.4917 |
No prior lines of chemotherapy | 22.0 (0.3–52.7), 44 | 26.4 (11.0–45.1), 10 | 0.1022 | 26.3 (0.3–35.9), 10 | 19.2 (0.2–40.5), 21 | 0.5771 |
1 prior line of chemotherapy | 20.4 (0.5–45.2), 33 | 18.7 (0.0–31.9), 16 | 0.1872 | Not shown (total n < 30) | ||
2 prior lines of chemotherapy | 23.1 (0.0–50.3), 21 | 22.7 (10.9–28.1), 11 | 0.5406 | Not shown (total n < 30) | ||
HR+ BC | 18.1 (0.0–50.3), 62 | 18.91 (6.33–31.9), 15 | 0.8171 | 19.1 (1.6–35.9), 21 | 17.5 (0.2–39.0), 24 | 0.2633 |
TNBC | 30.8 (0.3–52.7), 37 | 23.0 (0.0–45.1), 27 | 0.0456 | 23.6 (0.3–31.3), 5 | 26.7 (0.2–40.5), 32 | 0.3445 |
Note: Clinical benefit is based on target, nontarget, and new lesions per RECIST 1.1, and confirmation of CR, PR, and SD is not required. Clinical benefit is defined as best overall response of CR, PR, or SD lasting ≥24 weeks from randomization per RECIST 1.1 as determined by investigator. Subgroups shown are subgroups of the evaluable ITT population defined by previous lines of chemotherapy or cancer subtype. P value from two-tailed t test.
Abbreviation: HR+ BC, hormone receptor–positive breast cancer.