Tisotumab Vedotin Improved Efficacy Among Patients With Recurrent or Metastatic Cervical Cancer

According to results from the phase 3 innovaTV 301 trial, tisotumab vedotin significantly improved efficacy outcomes compared to chemotherapy in the second-or third-line setting among patients with recurrent or metastatic cervical cancer. 

Despite current advances, “the prognosis for patients with cervical cancer is poor, with 5-year overall survival less than 19% among patients with distant disease,” stated Ignace Vergote, MD, PhD, Universitaire Ziekenhuizen Leuven, Belgium, and coauthors. “Tisotumab vedotin is an investigational antibody-drug conjugate that was shown to produce encouraging and durable responses as a second-line and third-line treatment in patients with recurrent or metastatic cervical cancer in a phase 2 trial.”

This multi-national, open-label study enrolled 502 patients with recurrent or metastatic cervical cancer after previous therapy. Patients were randomized on a 1-to-1 basis to receive either 2 mg/kg of tisotumab vedotin every 3 weeks (n = 253) or investigator’s choice chemotherapy (n = 249). The primary end point was overall survival (OS). Key secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.

At the time of this prespecified interim analysis, with a median follow-up duration of 10.8 months, the median OS was 11.5 months in the tisotumab vedotin arm and 9.5 months in the chemotherapy arm (hazard ratio [HR] 0.70; 95% confidence interval [CI], 0.54 to 0.89; P = .004). Median PFS was 4.2 months and 2.9 months, respectively (HR 0.67; 95% CI, 0.54 to 0.82; P < .001). The confirmed ORR was 17.8% in the tisotumab vedotin arm and 5.2% in the chemotherapy arm (95% CI, 2.1 to 7.6; P < .001). 

Grade ≥3 adverse events occurred among 52% of patients treated with tisotumab vedotin and 62.3% of patients treated with chemotherapy. Treatment discontinuation due to toxicity occurred among 14.8% of patients treated with tisotumab vedotin. 

“These data suggest that tisotumab vedotin may be a preferred second-line or third-line treatment option over chemotherapy for patients with recurrent cervical cancer,” concluded Dr Vergote et al.  

Source: 

Vergote I, González-Martín A, Fujiwara K, et al. Tisotumab vedotin as second- or third-line therapy for recurrent cervical cancer. N Engl J Med. Published online: July 9, 2024. doi: 10.1056/NEJMoa2313811