Table 1.

Antitumor efficacy outcomes in the overall study population: tumor response, PFS, and OS.

	Group 1	Group 2	Group 3	Groups 2 and 3
Patients, n	34	33	35	68
ORR,an/N (%)	7/24 (29.2)	15/30 (50.0)	12/31 (38.7)	27/61 (44.3)
Median PFS,a months (95% CI)	5.7 (3.3–9.9)	9.4 (6.1–11.9)	7.3 (6.2–13.9)	9.0 (6.4–11.3)
HR (95% CI)	—	0.62 (0.3–1.2)	0.63 (0.3–1.2)	0.62 (0.4–1.1)
P value	—	0.2099	0.1816	0.1291
Median OS,b months (95% CI)	12.6 (6.3–15.6)	NR (10.2–NR)	17.8 (12.9–32.7)	19.8 (14.0–NR)
HR (95% CI)	—	0.31 (0.2–0.6)	0.40 (0.2–0.7)	0.37 (0.2–0.6)
P value	—	0.0016	0.0004	<0.0001

Note: Group 1, chemotherapy on days 1 and 8; group 2, trilaciclib prior to chemotherapy on days 1 and 8; group 3, trilaciclib alone on days 1 and 8 and prior to chemotherapy on days 2 and 9. HR and P values are for comparisons between group 2 and group 1, between group 3 and group 1, and between groups 2 and 3 combined and group 1.

Abbreviation: NR, not reached.

^aORR/PFS data are from the May 15, 2020 data cut-off.

^bOS data are from the final database lock, with a data cut-off of July 17, 2020.