Ignace B. Vergote, MD, Ph.D., Head of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven speaks about ESMO 2021 Abstract – 723MO – Tisotumab vedotin (TV) + carboplatin (Carbo) in first-line (1L) or + pembrolizumab (Pembro) in previously treated (2L/3L) recurrent or metastatic cervical cancer (r/mCC): Interim results of ENGOT-Cx8/GOG-3024/innovaTV 205 study.
Abstract 723MO
Background:
In previously treated r/mCC, TV exhibited persistent activity (objective response rate [ORR]=24 percent; median duration of response [mDOR]=8.3 mo) with manageable safety (Lancet Oncol. 2021; 22:609-619). The results of the 2-part, multi-cohort phase Ib/II study ENGOT-cx8/GOG-3024/innovaTV 205 in r/mCC are shown here for the 1L TV + carbo and 2L/3L TV + pembro cohorts.
Methods:
Pts in the 1L TV + carbo cohort received TV 2.0 mg/kg + carbo AUC 5 IV every 3 weeks with no prior systemic treatment (except chemoradiation) for r/mCC (Q3W). Pts with r/mCC who had disease progression on/after 1"“2 previous systemic treatments received TV 2.0 mg/kg + pembro 200 mg IV Q3W in the 2L/3L TV + pembro group. ORR, as defined by RECIST v1.1, was the main goal.
Results:
There were 33 people who were given 1 liter of TV and carbohydrate (median 5 cycles). The ORR was confirmed to be 55%. (Table). Regardless of causation, all treated patients had adverse events (AEs), with 76 percent experiencing grade 3 AEs. Ocular (55 percent /3 percent ), peripheral neuropathy (27 percent /12 percent ), and bleeding events (48 percent /6 percent ) were among the prespecified AEs of concern (gr 1-2/ gr 3). There were 35 patients treated with 2L/3L TV + pembro (median 6 cycles), the majority of whom had previously had one systemic therapy for r/mCC (57%) and prior bevacizumab (57 percent ). The ORR was confirmed to be 35%. (Table). AEs occurred in 74% of all treated patients, with 74 percent reporting grade 3 AEs regardless of causation. Ocular (51 percent /3 percent ), peripheral neuropathy (37 percent /3 percent ), and bleeding events (54 percent /9% ) were among the AEs of interest (gr 1-2/ gr 3) In neither group, there were any treatment-related fatalities.
Conclusions:
In patients with r/mCC, both 1L TV + carbo and 2L/3L TV + pembro showed promising anticancer efficacy with acceptable safety profiles.
Clinical trial identification
NCT03786081.