Tisotumab vedotin in 2L/3L recurrent or metastatic cervical cancer: Subsequent therapy data from ENGOT-cx12/GOG-3057/innovaTV 301.
Bibliographic record
Abstract
5531 Background: Tisotumab vedotin (TV) is an antibody-drug-conjugate directed to tissue factor with a microtubule-disrupting agent, MMAE, payload. The ENGOT-cx12/GOG-3057/innovaTV study 301 (NCT04697628) was the first to report OS benefit for TV vs chemotherapy in 2L/3L recurrent or metastatic cervical cancer (r/mCC), including in pts who have received prior anti-PD-(L)1 (HR 0.70; Vergote, Ann Oncol 2023). This abstract presents additional data on the use of subsequent therapies in this study. Methods: innovaTV 301 is a global, randomized, open-label phase 3 study. Eligible pts had r/mCC with disease progression on/after chemotherapy doublet ± bevacizumab and an anti-PD-(L)1 agent, if eligible and available. Pts were randomized 1:1 to TV monotherapy (2.0 mg/kg Q3W) or investigator’s choice of chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). Primary endpoint was OS. Descriptive analyses on type and time to first subsequent anticancer therapy are reported. Results: 502 pts were randomized (TV: 253; chemotherapy: 249). All pts received prior systemic therapy; 63.9% of pts had prior bevacizumab and 27.5% of pts had prior anti-PD-(L)1. Observed OS and PFS benefits for TV vs chemotherapy were generally consistent in prespecified subgroups, notably regardless of prior exposure to anti-PD-(L)1. In the ITT population, ORR was 17.8% (95% CI, 13.3-23.1) vs 5.2% (95% CI, 2.8-8.8) and DCR was 75.9% (95% CI, 70.1-81.0) vs 58.2% (95% CI, 51.8-64.4) in the TV vs chemotherapy arms, respectively. Median time-to-response was 1.58 mo and 1.74 mo in the TV and chemotherapy arms, respectively. Following discontinuation of study treatment, 127 (50.2%) pts on the TV arm and 108 (43.4%) on the chemotherapy arm received subsequent anticancer therapy, of which the majority received systemic therapy for progressive disease, including 112 (88.2%) pts on the TV arm and 91 (84.3%) pts on the chemotherapy arm. Median time from last dose of study treatment to first subsequent therapy was 6.7 weeks (range: 1-35) for pts treated with TV and 5.4 weeks (range: 1-51) for pts treated with chemotherapy. The most common types of subsequent systemic therapies were cytotoxic chemotherapy (82/112 [73.2%] vs 57/91 [62.2%] on the TV and chemotherapy arms, respectively) and immunotherapy (42/112 [37.5%] and 32/91 [35.2%] on the TV and chemotherapy arms, respectively). Conclusions: TV previously demonstrated a significant improvement in OS vs chemotherapy that was generally consistent across prespecified subgroups. Additionally, a meaningful proportion of pts received subsequent anticancer therapy in both treatment arms, with cytotoxic chemotherapy and immunotherapy as the most common choices. These data show that TV provides meaningful clinical benefit and does not prevent pts from receiving subsequent therapies, including immunotherapy. Clinical trial information: NCT04697628 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".