Review of emerging biological therapies for recurrent and advanced metastatic cervical cancer

Figures & data

Figure 1. Schema for innova tisotumab vedotin trials.

Table 1. Progression of pharmacologic management for recurrent and metastatic cervical cancer.

Trial, Drug	GOG-240, Bevacizumab (n = 452)	Keynote-158, Pembrolizumab (n = 107)	Keynote-826, Pembrolizumab (n = 617)	EMPOWER, Cemiplimab (n = 608)	InnovaTV-204, Tisotumab Vedotin (n = 101)	InnovaTV-205, Tisotumab Vedotin (n = 159)	Keynote-A18, Pembrolizumab (n = 980)	InnovaTV-301, Tisotumab Vedotin (n = 502)
Phase	III	II	III	II	II	Ib/II	?	III
Population	Persistent or rmCC	Advanced solid tumors that progressed following prior treatment	Persistent or rmCC	rmCC following prior treatment with platinum therapy	rmCC following prior treatment with platinum therapy	rmCC previously untreated or following prior treatment with platinum therapy	Previously untreated locally advanced cervical cancer	rmCC following prior treatment with platinum therapy
Treatment Arms	A. Control: Cisplatin + paclitaxel + placebo B. Experimental: cisplatin + paclitaxel + bevacizumab C. Topotecan + paclitaxel + placebo bevacizumab D. Topotecan + paclitaxel + bevacizumab	A. Pembrolizumab monotherapy	A. Experimental: Chemotherapy + pembrolizumab B. Control: Chemotherapy + Placebo	A. Experimental: Cemiplimab monotherapy B. Active comparator: Investigator’s choice chemotherapy	A. TV monotherapy	A. TV+ bevacizumab B. TV + pembrolizumab C. TV + carboplatin D. 1 L TV + carboplatin E. 1 L TV + pembrolizumab F. 2 L/3 L TV + pembrolizumab G. TV monotherapy H. TV + pembrolizumab ± bevacizumab	A. Experimental: CRT + pembrolizumab B. Control: CRT + placebo	A. Experimental: TV monotherapy B. Active comparator: investigator’s choice chemotherapy
Primary Endpoint	OS	ORR	PFS, OS	OS	ORR	ORR for arm D,E,F	PFS	OS
HR	0.77	30.8%	PFS: 0.62; OS: 0.64	0.75	24%	D: 54.5%; E:40.6%; F:35.3%	0.54	0.70
95% CI	0.62–0.95	25.8–36.2	PFS: 0.50–0.77; OS: 0.50–0.81	0.63–0.89	15.9–33.3	D: 36.4–71.9; E: 23.7–59.4; F: 19.7–53.5	0.41–0.71	0.54–0.89
P value	<0.007	-	PFS, OS: 0.0001	0.0005	0.0002	-	<0.001	0.004

Abbreviations: rmCC: recurrent/metastatic cervical cancer, HR: hazard ratio, 95% CI: 95% confidence interval, OS: overall survival, ORR: objective response rate, PFS: progression free survival, TV: Tisotumab vedotin, 1 L: first line, 2 L: second line, 3 L: third line, CRT: chemoradiotherapy.