innovaTV 301 / ENGOT-cx12 / GOG-3057
The first ADC to extend life in cervical cancer, for women whose disease has come back after chemotherapy.
OS 11.5 vs 9.5 months (HR 0.70) and PFS 4.2 vs 2.9 months (HR 0.67; NEJM 2024); ORR 17.8% vs 5.2%. Full FDA approval April 2024. Ocular events (~50%, mostly conjunctivitis), neuropathy, and bleeding require mitigation.
Setting
Recurrent or metastatic cervical cancer after 1-2 prior lines including platinum: tisotumab vedotin vs investigator's-choice chemotherapy
Phase
Phase 3
Sponsor
Genmab / Pfizer (Seagen)
Registry
Headline result
OS 11.5 vs 9.5 months (HR 0.70).
Reported
2023
Enrolled
502
In plain words
What these results mean for people, not percentages
Overall survivalprimarysurvival endpoint
- Median 11.5 vs 9.5 months with Tisotumab vedotin compared with Chemotherapy; about 2 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 30 percent lower chance of the event at any given time (hazard ratio 0.7, likely range 0.54 to 0.89).
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Progression-free survivalsurrogate endpoint
- Median 4.2 vs 2.9 months with Tisotumab vedotin compared with Chemotherapy; about 1.3 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Put another way, the treated group had about 33 percent lower chance of the event at any given time (hazard ratio 0.67, likely range 0.54 to 0.82).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Be careful
- These results apply to the people the trial enrolled: Recurrent or metastatic cervical cancer after 1-2 prior lines including platinum: tisotumab vedotin vs investigator's-choice chemotherapy. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
502 participants enrolled.
Pages like this
not linked directly; found by shared links- CompanySutro Biopharma
- Termmc-Val-Cit-PABC
- CompanyGenmab
Shares Tisotumab vedotin, Cervical cancer.
- TrialDESTINY-PanTumor02
- TermMMAE
- InstitutionStephenson Cancer Center, OU Health
- TermTubulin inhibitor payloads
- InstitutionGOG Foundation