Second-line avelumab treatment of patients (pts) with metastatic Merkel cell carcinoma (mMCC): Experience from a global expanded access program (EAP).
Notice bibliographique
Résumé
9537 Background: Avelumab is a human anti–PD-L1 IgG1 antibody that showed a favorable efficacy and toxicity profile in pts with mMCC and progressive disease (PD) on or after chemotherapy (CT) in the phase 2 JAVELIN Merkel 200 trial (JM 200; NCT02155647), leading to accelerated approval in the US and Europe. We describe real-world experience with avelumab in a global EAP for pts with mMCC. Methods: Pts participating in the EAP (NCT03089658) had stage IV mMCC and PD on or after CT or were ineligible for CT. In contrast to JM 200, pts in the EAP could have ECOG performance status of 2, treated brain metastases, or immunosuppressive conditions with sponsor medical approval. Pts received avelumab 10 mg/kg IV Q2W until PD or unacceptable toxicity. A 3-mo supply of avelumab for approved pts was provided to treating physicians; additional re-supply was allowed for pts who had complete response (CR), partial response (PR), stable disease (SD), or clinical benefit per treating physician assessment. No central imaging was obtained. Results: Between Jan 2016 and Jan 2018, 460 requests for avelumab were received from 37 countries: 395 were approved, 45 were medically rejected for various reasons (eg, incorrect diagnosis, lack of appropriate prior therapy, incomplete information), and 37 were withdrawn. Most requests were from France (n = 97), Italy (n = 69), and Australia (n = 46). Median age was 74 y (range, 28-95), and 65.7% of pts were male. Among 131 response-evaluable pts, the objective response rate was 51.1%, including CR in 22.1% (n = 29) and PR in 29.0% (n = 38; including 1 pt with HIV); 19.1% (n = 25) had SD and 29.8% (n = 39) had PD. Durable responses were observed in immune-competent and immunosuppressed pts. Updated data will be presented. The safety profile was similar to that of JM 200. The EAP is ongoing but will close in 2018 (US closed in April 2017) with regulatory approval in multiple countries. Conclusions: The avelumab EAP rapidly enrolled many pts with mMCC and answered an unmet, urgent medical need for pts ineligible for clinical trials or for whom no approved alternative treatments were available. In a real-world setting, avelumab demonstrated safety and efficacy consistent with JM 200. Clinical trial information: NCT03089658.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,001 | 0,000 |
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 tête enseignante, 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 ».