Vibostolimab coformulated with pembrolizumab (vibo/pembro) for previously treated advanced mismatch repair–deficient (dMMR) endometrial cancer: Results from cohort B1 of the phase 2 KEYVIBE-005 study.
Notice bibliographique
Résumé
5502 Background: Treatment options for advanced endometrial cancer after failure of first-line chemotherapy are limited. In the KEYNOTE-158 study, pembro demonstrated durable antitumor activity (ORR, 48%; median DOR, not reached [NR]; median PFS, 13.1 mo; median OS, NR) and an acceptable safety profile in patients (pts) with previously treated advanced microsatellite instability-high/dMMR endometrial cancer. The immune checkpoints TIGIT and PD-L1 are upregulated in several tumor types, including endometrial cancer, and are heavily coexpressed in dMMR tumors, suggesting that dual TIGIT/PD-(L)1 blockade may be an effective therapeutic approach in advanced dMMR endometrial cancer. We present data from cohort B1 of the open-label phase 2 KEYVIBE-005 study (NCT05007106), which evaluated vibo/pembro (anti-TIGIT/anti–PD-1) in pts with previously treated advanced dMMR endometrial cancer. Methods: Eligible pts were aged ≥18 y with advanced dMMR endometrial cancer with progressive disease after 1 platinum-based chemotherapy regimen (or ≤2 lines if 1 was given in the [neo]adjuvant setting), no prior anti–PD-(L)1 therapy, and an ECOG PS of 0 or 1. Pts received vibo 200 mg coformulated with pembro 200 mg Q3W for ≤35 cycles (2 y). The primary end point was ORR per RECIST v1.1 by investigator assessment. Secondary end points included DOR and PFS per RECIST v1.1 by investigator assessment, OS, and safety. Results: A total of 40 pts were enrolled. Median age was 63 y and 60% of pts had ECOG PS 1; 31 pts had previously received 1 line of therapy in any setting and 9 pts had previously received ≥2 lines of therapy in any setting. The median time from first dose to data cutoff (Oct 24, 2023) was 17.2 mo (range, 7.7-23.4). At data cutoff, 23 pts had discontinued treatment and 17 were ongoing. The ORR was 65% (n = 26; 95% CI, 48-79); 5 pts (13%) had a complete response and 21 (53%) had a partial response. Median DOR was 13.7 mo (95% CI, 12.7-NR), and 75% of responders remained in response for ≥12 mo based on the Kaplan-Meier method for censored data. Median PFS was 15.0 mo (95% CI, 8.1-15.6) and the 12-mo PFS rate was 58%. Median OS was NR (95% CI, 16.1-NR) and the 12-mo OS rate was 82%. Treatment-related adverse events (AEs) occurred in 38 pts (95%). Grade 3 or 4 treatment-related AEs occurred in 14 pts (35%), of which the most common were arthritis (5%) and maculopapular rash (5%). Nine pts (23%) discontinued treatment due to a treatment-related AE. Any-grade immune-mediated AEs or infusion reactions occurred in 21 pts (53%) and grade 3 or 4 events occurred in 7 pts (18%). No deaths due to treatment-related AEs or immune-mediated AEs or infusion reactions occurred. Conclusions: Vibo/pembro demonstrated durable antitumor activity and a manageable safety profile in pts with previously treated advanced dMMR endometrial cancer. Clinical trial information: NCT05007106 .
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,001 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,001 | 0,002 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,003 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».