Tisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/ENGOT-cx8/GOG-3024 study

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064211%3A_____%2F26%3AW0000104" target="_blank" >RIV/00064211:_____/26:W0000104 - isvavai.cz</a>

Výsledek na webu

<a href="https://oadoi.org/10.1016/j.ygyno.2026.02.008" target="_blank" >https://oadoi.org/10.1016/j.ygyno.2026.02.008</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.ygyno.2026.02.008" target="_blank" >10.1016/j.ygyno.2026.02.008</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Tisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/ENGOT-cx8/GOG-3024 study

Popis výsledku v původním jazyce

Objective Treatment options for recurrent or metastatic cervical cancer (r/mCC) remain limited. We evaluated the efficacy and safety of tisotumab vedotin (TV)-based combinations with standard agents in first-line (1L) and previously treated (second-line or later [2L+]) settings in r/mCC. Methods innovaTV 205/ENGOT-cx8/GOG-3024 (NCT03786081) was a multicenter, open-label phase 1b/2 study, which included dose-expansion arms of 1L TV + carboplatin (arm D), 1L/2L+ TV + pembrolizumab (arms E/F), and 1L TV + carboplatin + pembrolizumab +/- bevacizumab (arm H). The primary endpoint was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Results As of October 15, 2025, 139 patients were enrolled in dose-expansion arms D (n = 33), E (n = 33), F (n = 35), and H (n = 38). Confirmed ORR (median DOR) was 54.5% (8.6 months), 40.6% (not reached), 35.3% (18.2 months), and 65.8% (13.3 months) in arms D-F and H, respectively. Median PFS was 6.9, 5.3, 5.6, and 10.6 months; median OS was 25.5, 30.7, 15.3, and 28.0 months. Grade >= 3 AEs related to any treatment component occurred in 72.7%, 45.5%, 48.6%, and 86.8% of patients; AEs leading to TV discontinuation occurred in 24.2%, 24.2%, 34.3%, and 55.3% of patients in arms D-F and H, respectively. Conclusion With >= 5 years of follow-up, TV doublet combinations demonstrated durable activity consistent with previous findings and encouraging long-term OS in 1L and 2L+ r/mCC, with no new safety signals. The 1L TV-based triplet/quadruplet regimen showed meaningful antitumor activity with expected toxicity. (c) 2026 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

Název v anglickém jazyce

Tisotumab vedotin plus carboplatin or pembrolizumab in recurrent or metastatic cervical cancer: 5-year results from the innovaTV 205/ENGOT-cx8/GOG-3024 study

Popis výsledku anglicky

Objective Treatment options for recurrent or metastatic cervical cancer (r/mCC) remain limited. We evaluated the efficacy and safety of tisotumab vedotin (TV)-based combinations with standard agents in first-line (1L) and previously treated (second-line or later [2L+]) settings in r/mCC. Methods innovaTV 205/ENGOT-cx8/GOG-3024 (NCT03786081) was a multicenter, open-label phase 1b/2 study, which included dose-expansion arms of 1L TV + carboplatin (arm D), 1L/2L+ TV + pembrolizumab (arms E/F), and 1L TV + carboplatin + pembrolizumab +/- bevacizumab (arm H). The primary endpoint was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors v1.1. Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Results As of October 15, 2025, 139 patients were enrolled in dose-expansion arms D (n = 33), E (n = 33), F (n = 35), and H (n = 38). Confirmed ORR (median DOR) was 54.5% (8.6 months), 40.6% (not reached), 35.3% (18.2 months), and 65.8% (13.3 months) in arms D-F and H, respectively. Median PFS was 6.9, 5.3, 5.6, and 10.6 months; median OS was 25.5, 30.7, 15.3, and 28.0 months. Grade >= 3 AEs related to any treatment component occurred in 72.7%, 45.5%, 48.6%, and 86.8% of patients; AEs leading to TV discontinuation occurred in 24.2%, 24.2%, 34.3%, and 55.3% of patients in arms D-F and H, respectively. Conclusion With >= 5 years of follow-up, TV doublet combinations demonstrated durable activity consistent with previous findings and encouraging long-term OS in 1L and 2L+ r/mCC, with no new safety signals. The 1L TV-based triplet/quadruplet regimen showed meaningful antitumor activity with expected toxicity. (c) 2026 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2026

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

GYNECOLOGIC ONCOLOGY

ISSN

0090-8258

e-ISSN

1095-6859

Svazek periodika

207

Číslo periodika v rámci svazku

APR 2026

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

3-13

Kód UT WoS článku

001750314700001

EID výsledku v databázi Scopus

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