Abstract CT188: 5-year survival and other long-term outcomes from KEYNOTE-006 study of pembrolizumab (pembro) for ipilimumab (ipi)-naive advanced melanoma
Notice bibliographique
Résumé
Abstract Introduction: Pembro significantly improved OS vs ipi in advanced melanoma in the KEYNOTE-006 study (NCT01866319). We present outcomes from the 5-year follow-up of this study−the longest to date in a randomized phase 3 trial of pembro in advanced cancer. Long-term follow-up for pts completing 2 years of pembro and data for pts treated with a second course (2nd course) of pembro are also reported. Methods: Eligible pts (N=834) were randomly assigned (1:1:1) to pembro 10 mg/kg Q2W or Q3W for up to 2 years or ipi 3 mg/kg Q3W for 4 doses. Eligible pts who completed pembro or stopped for CR and then progressed could receive an additional 12 mo of pembro if they met inclusion criteria. End points included OS and ORR per irRC by investigator review. Pembro completion was defined as discontinuation with CR, PR, or SD after ≥94 weeks of pembro. Results were pooled from the 2 pembro arms. Results: At data cutoff (Dec 3, 2018), median follow-up of surviving pts was 57.7 mo (range, 0.03-62.1). Median OS (95% CI) was 32.7 mo (24.5-41.6) in the combined pembro arms (n=556) and 15.9 mo (13.3-22.0) in the ipi arm (n=278) (HR, 0.73). Five-year OS rates (95% CI) were estimated to be 38.7% (34.2-43.1) and 31.0% (25.3-36.9), respectively. For pts receiving first-line pembro, median OS (95% CI) was 38.7 mo (27.3-50.7) in the combined pembro arms (n=368) and 17.1 mo (13.8-26.2) in the ipi arm (n=181) (HR, 0.73); 5-year OS rates (95% CI) were estimated to be 43.2% (38.0-48.3) and 33.0% (25.8-40.3), respectively. A total of 103 (18.5%) pts completed 2 years of pembro; median survival follow-up from pembro completion was 34.5 mo; OS rate at 36 mo was 93.8%. Of the 103 pts, 76 were progression-free and 27 had PD. Median time from pembro end to progression was 16.8 mo (range, 0.99-33.9). Thirteen pts received 2nd course pembro; best overall response (BOR) in 1st course was 6 CR, 6 PR, and 1 SD. Median duration of 2nd-course pembro was 9.7 mo; BOR on 2nd course was 3 CR, 4 PR, 3 SD, and 1 PD (response assessment was pending for 2 pts). All 3 pts with 2nd-course CR and 2 of 4 with PR had ongoing response; the remaining 2 pts who had 2nd-course PR subsequently progressed. Four pts discontinued 2nd-course treatment before 12 mo (2 due to PD, 1 due to G2 interstitial pneumonia, and 1 due to physician decision). Six pts had grade1/2 TRAEs during 2nd-course pembro; there were no grade 3/4 TRAEs or deaths. Conclusions: Pembro continued to show improved OS vs ipi in 5-year follow-up of pts with advanced melanoma with 43.2% estimated to be alive at 5 years versus 33.0% with ipi. Almost one-fifth of pts completed 2 years of pembro, and 93.8% are estimated to be alive 3 years after pembro completion. Second-course pembro treatment was generally well tolerated and provided additional antitumor activity. These results confirm that 2-year pembro is an effective treatment for pts with advanced melanoma. Citation Format: Caroline Robert, Jacob Schachter, Georgina V. Long, Ana Arance, Jean-Jacques Grob, Laurent Mortier, Adil Daud, Matteo S. Carlino, Catriona McNeil, Michal Lotem, James Larkin, Paul Lorigan, Bart Neyns, Christian U. Blank, Omid Hamid, Teresa M. Petrella, James Anderson, Clemens Krepler, Scott J. Diede, Antoni Ribas. 5-year survival and other long-term outcomes from KEYNOTE-006 study of pembrolizumab (pembro) for ipilimumab (ipi)-naive advanced melanoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT188.
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 | 0,002 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,002 |
| Bibliométrie | 0,000 | 0,001 |
| 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) | 0,008 | 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 ».