Dr Fujiwara on the FDA Approval of Tisotumab Vedotin for Recurrent Cervical Cancer

Keiichi Fujiwara, MD, PhD, Saitama Medical University International Medical Center, discusses the significance of the FDA approval of tisotumab vedotin-tftv (Tivdak) for patients with recurrent or metastatic cervical cancer.

On April 29, 2024, the FDA granted full approval to tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer who have disease progression on or after treatment with chemotherapy. This regulatory decision was supported by findings from the phase 3 innovaTV 301 trial (NCT04697628), which demonstrated a median overall survival of 11.5 months (95% CI, 9.8-14.9) with tisotumab vedotin (n = 253) vs 9.5 months (95% CI, 7.9-10.7) with chemotherapy (n = 249; HR, 0.67; 95% CI, 0.54-0.89; P < .0038).

Furthermore, the median progression-free survival was 4.2 months (95% CI, 4.0-4.4) in the tisotumab vedotin arm compared with 2.9 months (95% CI, 2.6-3.1) in the chemotherapy arm (HR, 0.67; 95% CI, 0.54-0.82; P < .0001). The overall response rate (ORR) in the overall population was 17.8% (95% CI, 13.3%-23.1%) with the antibody-drug conjugate vs 5.2% (95% CI, 2.8%-8.8%) with chemotherapy (P < .0001).

Frontline therapy for patients with cervical cancer often consists of an immune-checkpoint inhibitors in combination with chemotherapy, Fujiwara says. Before immunotherapy agents were indicated in the frontline cervical cancer setting, investigators hypothesized that these agents would be most effective following recurrence on frontline chemotherapy alone, Fujiwara notes. However, now that checkpoint inhibitors are used in combination with chemotherapy in the frontline setting, subsequent tisotumab vedotin further improves outcomes for patients who recur on first-line therapy, Fujiwara explains.

A subgroup analysis of the innovaTV 301 trial showed an ORR benefit with tisotumab vedotin regardless of whether patients had received a checkpoint inhibitor in addition to frontline chemotherapy or frontline chemotherapy alone, Fujiwara emphasizes. The ORR was 16.9% in patients who had received prior checkpoint inhibition vs 18.1% in those who did not receive prior checkpoint inhibition. Therefore, tisotumab vedotin is a welcome addition to the second-line cervical cancer treatment paradigm, Fujiwara concludes.