Sacituzumab govitecan in Chinese patients with recurrent/metastatic cervical cancer: Results from the phase 2 EVER-132-003 basket study (NCT05119907)

Abstract

Background

Standard treatment for metastatic cervical cancer is chemotherapy plus immunotherapy in first line and antibody-drug conjugates in second line. Limited treatment options exist after progression on first-line therapy, particularly after immunotherapy.

Methods

In the cervical cancer cohort of open-label, phase 2 EVER-132-003 (NCT05119907) study, Chinese patients with previously treated recurrent/metastatic cervical cancer received sacituzumab govitecan (SG) 10 mg/kg intravenously on days 1 and 8 of 21-day cycles. Primary endpoint was investigator-assessed objective response rate (ORR). Secondary endpoints included investigator-assessed duration of response (DOR) and progression-free survival (PFS) as well as overall survival and safety.

Results

For the 40 patients enrolled, median age was 54 years. Patients received median two (range, 1–5) prior systemic treatments for recurrent/metastatic disease; 68 % received prior immunotherapy. In the full analysis set, at 9.6 months' median follow-up, ORR was 43 % (95 % CI, 27–59) and median DOR 9.2 (95 % CI, 4.6–11.7) months. Median PFS was 7.1 (95 % CI, 4.2–8.4) months. Similar efficacy was observed in patients previously treated with immunotherapy (ORR 48 %, median DOR 9.5 months). Exploratory analysis of Trop-2 expression showed limited correlation with SG efficacy. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 25 (63 %) patients, most frequently neutropenia (17 [43 %]), leukopenia (15 [38 %]), and anemia (8 [20 %]). Overall, 3 (8 %) patients discontinued SG due to TEAEs. No TEAEs led to death.

Conclusions

Single-agent SG demonstrated promising antitumor activity in pretreated Chinese patients with recurrent/metastatic cervical cancer and in patients previously treated with immunotherapy. AEs were manageable and consistent with known SG safety profile.