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innovaTV 301

Tisotumab vedotin versus investigator's choice chemotherapy as second- or third-line therapy for recurrent or metastatic cervical cancer (innovaTV 301/ENGOT-cx12/GOG-3057)

Phase 3N = 502NCT04697628

Population
Recurrent or metastatic cervical cancer, second- or third-line therapy after progression following first-line combination therapy
Design
Multinational, open-label phase 3 trial; 1:1 randomisation to tisotumab vedotin monotherapy 2.0 mg per kilogram every 3 weeks or investigator's choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed). Primary endpoint: overall survival.
Primary endpoint
OS
Arms
  • Tisotumab vedotin (experimental, n = 253): Tisotumab vedotin monotherapy 2.0 mg per kilogram every 3 weeks
  • Investigator's choice chemotherapy (control, n = 249): Topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed
People
Vergote I, senior author innovaTV 301/ENGOT-cx12/GOG-3057 Collaborators, innovaTV 301/ENGOT-cx12/GOG-3057 Collaborators
OSHR 0.70 (95% CI 0.54–0.89)Δ median OS+2 monthsPFSHR 0.67 (95% CI 0.54–0.82)Δ median PFS+1.3 monthsΔ ORR+12.6 points
Show the numbers
Results reported for innovaTV 301
EndpointAnalysisTisotumab vedotinInvestigator's choice chemotherapyEffect
OSRandomised patients (N = 502)primaryVergote 2024median 11.5 months (9.8–14.9)median 9.5 months (7.9–10.7)HR 0.70 (95% CI 0.54–0.89)P=0.004
PFSRandomised patients (N = 502)primaryVergote 2024median 4.2 months (4.0–4.4)median 2.9 months (2.6–3.1)HR 0.67 (95% CI 0.54–0.82)P<0.001Key secondary endpoint.
ORRRandomised patients (N = 502)primaryVergote 202417.8%5.2%P<0.001Confirmed objective response rate; odds ratio 4.0 (95% CI 2.1 to 7.6).
Results reported for innovaTV 301
EndpointAnalysisTisotumab vedotinInvestigator's choice chemotherapyEffect
OSRandomised patients (N = 502)primaryVergote 2024median 11.5 months (9.8–14.9)median 9.5 months (7.9–10.7)HR 0.70 (95% CI 0.54–0.89)P=0.004
PFSRandomised patients (N = 502)primaryVergote 2024median 4.2 months (4.0–4.4)median 2.9 months (2.6–3.1)HR 0.67 (95% CI 0.54–0.82)P<0.001Key secondary endpoint.
ORRRandomised patients (N = 502)primaryVergote 202417.8%5.2%P<0.001Confirmed objective response rate; odds ratio 4.0 (95% CI 2.1 to 7.6).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.70.54–0.89
PFS0.670.54–0.82
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Tisotumab vedotin (experimental)
  • Investigator's choice chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTisotumab vedotinInvestigator's choice chemotherapy
0100.0%100.0%
765.6%60.0%
1443.0%36.0%
2226.6%20.1%
2917.4%12.1%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%0246810Months (modelled)
  • Tisotumab vedotin (experimental)
  • Investigator's choice chemotherapy (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTisotumab vedotinInvestigator's choice chemotherapy
0100.0%100.0%
361.0%48.8%
543.8%30.3%
826.7%14.8%
1116.3%7.2%
Primary publication: Vergote I, González-Martín A, Fujiwara K, Kalbacher E, Bagaméri A, Ghamande S, et al. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med. 2024;391(1):44-55. PubMedDOI

Appears in

Sources

  1. Vergote I, González-Martín A, Fujiwara K, Kalbacher E, Bagaméri A, Ghamande S, et al. Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer. N Engl J Med. 2024;391(1):44-55.

    PubMedDOI