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Printemps Hematologie VF.Pdf UN REGARD TRANSVERSAL SUR L’ACTUALITÉ EN ONCO-HÉMATOLOGIE À L’OCCASION DES CONGRÈS DE Association Américaine pour Société Américaine Association Européenne Conférence Internationale la Recherche sur le Cancer d’Oncologie Clinique d’Hématologie sur les lymphomes malins Atlanta / 29 mars - 03 avril 2019 Chicago / 31 mai - 5 juin 2019 Amsterdam / 13-16 juin 2019 Lugano / 18-22 juin 2019 ÉDITÉ PAR SOUS L’ÉGIDE DE AVEC LE SOUTIEN INSTITUTIONNEL Attention, ceci est un compte-rendu de congrès et/ou un recueil de résumés de communications dont l’objectif est de fournir des informations sur l’état actuel de la recherche ; ainsi, les données présentées sont susceptibles de ne pas être validées par les autorités de santé françaises et ne doivent donc pas être mises en pratique. Le contenu est sous la seule responsabilité du coordonnateur, des auteurs et du Directeur de la Publication qui sont garants de son objectivité. Comité éditorial des Printemps de l’Hématologie Olivier HERMINE, Hôpital Necker, Paris Guillaume CARTRON, CHU de Montpellier Jacques-Olivier BAY, CHU de Clermont-Ferrand Nicolas BOISSEL, Hôpital Saint-Louis, Paris Roch HOUOT, CHU de Rennes Philippe MOREAU, CHU de Nantes Karin TARTE , CHU de Rennes Loïc YSEBAERT, IUCT-Oncopôle, Toulouse Comité de rédaction des Printemps de l’Hématologie Réda BOUABDALLAH, Institut Paoli-Calmettes, Marseille Bénédicte DEAU-FISCHER, Hôpital Cochin, Paris Guillemette FOUQUET, Hôpital Necker, Paris Maël HEIBLIG, Gustave Roussy, Villejuif Lucie OBÉRIC, IUCT-Oncopôle, Toulouse Sommaire CHAPITRE 1 : NOUVELLES STRATÉGIES DE TRAITEMENT (1/2) Stratégies Chemo-free… ▪ Dans la LLC ▪ Dans les lymphomes indolents Nouvelles stratégies dans les LDGCB Nouvelles stratégies dans les lymphomes du manteau Nouvelles stratégies dans les lymphomes T Nouvelles stratégies dans le lymphome de Hodgkin Sommaire CHAPITRE 1 : NOUVELLES STRATÉGIES DE TRAITEMENT (2/2) Nouvelles stratégies dans le myélome multiple Les thérapies ciblées dans les leucémies Le concept de l'arrêt de traitement… Nouvelles stratégies dans l’allogreffe Sommaire CHAPITRE 2 : LES CAR T-CELLS Car T-cells : le « revers de la médaille » Étiologie, sémiologie et prise en charge du CRS et des neurotoxicités Dans la leucémie aiguë lymphoblastique Dans le myélome multiple Dans la LLC Dans les lymphomes Sommaire CHAPITRE 3 : LES NOUVELLES GENERATIONS D’ANTICORPS Le 1er anticorps anti-CD47 Anticorps anti-CD19 Les anticorps conjugués Les anticorps bispécifiques Sommaire CHAPITRE 4 : L’APPORT DE L’IMAGERIE Impact du volume tumoral métabolique sur la réponse à l’axicabtagene ciloleucel dans les LDGCB refractaires Impact de la surveillance par imagerie sur la survie après 1ère rémission d’un lymphome folliculaire Valeur pronostique du TEP au diagnostic dans le lymphome folliculaire Analyse ancillaire de l’étude REMARC : le volume métabolique tumoral est prédictif de la survie Valeur pronostique du TMTV au diagnostic dans les LDGCB : analyse de l’étude GOYA Sommaire CHAPITRE 5 : L’APPORT DES NOUVELLES TECHNOLOGIES Médecine connectée : la nouvelle télémédecine ? ▪ Suivi des patients à l'aide d'objets connectés ▪ Une application pour prendre en charge la douleur liée au cancer Intelligence artificielle ▪ Utiliser le machine learning pour prédire la mortalité chez les patients âgés atteints de cancer Sommaire POUR ALLER PLUS LOIN - QUELQUES SESSIONS ÉDUCATIONNELLES THÉMATIQUES… Les nouvelles approches dans les leucémies aigües ▪ BCL2 comme cible universelle dans la LAM ▪ Approches innovantes pour traiter les patients âgés ▪ Est-il nécessaire d’identifier les LAL Ph like ? Maladie résiduelle : place et perspectives Chapitre 1 Nouvelles stratégies de traitement Stratégies Chemo-free… …dans la LLC… ÉTUDE CLL 14 : IMPACT DU TRAITEMENT À DURÉE FIXE VÉNÉTOCLAX PLUS OBINUTUZUMAB (VENG) SUR LA SURVIE SANS PROGRESSION (PFS) ET LA NÉGATIVITÉ DE LA MALADIE RÉSIDUELLE (MRD-) CHEZ LES PATIENTS ATTEINTS DE LLC NON TRAITÉS PRÉCÉDEMMENT (PTS) D'après la communication de Fischer K et al. Abstract #7502 Congrès de la Société Américaine d’Oncologie Clinique 2019 Rédigé par le Dr Guillemette Fouquet Étude CLL 14 Principe de l’étude : thérapie ciblée par vénétoclax et obinutuzumab de durée fixe dans la LLC Durée fixe ▪ Car un traitement continu est associé à des toxicités, des problèmes d’observance, un coût, l’apparition potentielle de mutations de résistance Combinaison vénétoclax + obinutuzumab ▪ Les monothérapies permettent rarement d’obtenir des maladies résiduelles négatives, et la durée de réponse est relativement courte notamment chez les patients à haut risque (Soumerai J et al. Lancet Haem 2019) ▪ vénétoclax + obinutuzumab = effets additifs dans des modèles précliniques (Flinn IW et al., Blood 2019) Étude CLL 14 – Design Chlorambucil Phase « safety run-in »* vénétoclax-obinutuzumab ▪ Per SG, 0.5 mg/kg à J1 et J15 des N = 216 cycles 1 à 12, en cycles de 28 jours vénétoclax vénétoclax- Phase de suivi vénétoclax Patients atteints obinutuzumab 6 cycles ▪ Per SG, début J22 du cycle 1 de LLC avec des 6 cycles Critères primaires: et escalade de dose sur 5 semaines pathologies co- Survie sans progression [20, 50, 100, 200, 400 mg/jour], puis existantes non R 420 mg/jour jusqu’à la fin précédemment traités 1:1 Critères secondaires : du cycle 12 CIRS > 6 et/ou CrCI Chlorambucil- Chlorambucil Réponse minimale, < 70 mL/mn obinutuzumab 6 cycles maladie résiduelle, Obinutuzumab 6 cycles Survie globale ▪ IV, 1000 mg à J1 (ou 100 mg J1 + 900 mg J2), J8 et J15 du cycle 1, puis 1000 mg à J1 des cycles 2 à 6, en cycles de 28 jours *Fischer K et al., vénétoclax and Ombinutuzumab in chronic lymphotic leukemia, Blood 11 May 2017 Étude CLL 14 – Tolérance Profil de tolérance similaire entre les 2 bras Très peu de syndromes de lyse tumorale Incidence un peu plus élevée de neutropénies dans le bras vénétoclax (53 % versus 48 % dans le bras chlorambucil) ▪ Pas d’augmentation des neutropénies fébriles Plus de décès après la fin du traitement dans le bras vénétoclax notamment dus à des infections : 11 versus 4 dans le bras chlorambucil ▪ Non significatif et non liés au traitement Étude CLL 14 – Réponse vénétoclax-Obinutuzumab versus Chlorambucil-Obinutuzumab ▪ Réponse globale : 85 % versus 51 % (p = 0,0007) ▪ Réponse complète : 50 % versus 23 % ▪ Maladie résiduelle négative sang/moelle : 76 %/56 % versus 35 %/17 % (p < 0,001) Evolution de la maladie résiduelle au cours du temps ▪ Se négative plus rapidement et persiste plus longtemps dans le bras vénétoclax Chlorambucil- vénétoclax- 1 obinutuzumab obinutuzumab 0,1 0,01 0,001 0,0001 0,00001 Niveau de(fraction) MRD Étude CLL 14 – Survie sans progression 100 vénétoclax-obinutuzumab Survie sans progression 80 à 24 mois ▪ 88 % dans le bras vénétoclax- 60 obinutuzumab Chlorambucil-obinutuzumab 40 ▪ 64 % dans le bras chlorambucil- obinutuzumab l’investigateur (%) l’investigateur 20 HR = 0,35 (IC 95 % 0,23-0,53), p < 0,0001 Survie sans progression selon progression sansSurvie 0 Suivi médian à 28 mois 0 6 12 18 24 30 36 Temps (mois) Étude CLL 14 – Survie sans progression Survie sans progression Survie sans progression selon le profil IGHV selon le profil TP53 100 100 80 80 60 60 HR = 0,35 (IC 95 % 0,23-0,53), 40 p < 0,0001 40 Suivi médian à 28 mois 20 20 l’investigateur(%) l’investigateur(%) 0 0 Survie sans progression selon selon progression sans Survie Survie sans progression selon selon progression sans Survie 0 6 12 18 24 30 36 0 6 12 18 24 30 36 Temps (mois) Temps (mois) vénétoclax-obinutuzumab IGVH Chlorambucil-obinutuzumab IGVH vénétoclax-obinutuzumab TP53 délété ou muté non muté non muté vénétoclax-obinutuzumab TP53 WT vénétoclax-obinutuzumab IGVH Chlorambucil-obinutuzumab IGVH Chlorambucil-obinutuzumab TP53 délété ou muté non muté muté Chlorambucil-obinutuzumab TP53 WT Étude CLL 14 – Survie globale 100 80 60 vénétoclax-obinutuzumab 40 Chlorambucil-obinutuzumab Survie globale (%) 20 HR = 1,24 (IC 95 % 0,64-2,40), p = 0,52 vénétoclax-obinutuzumab, 9 % patients avec évènement 0 Chlorambucil-obinutuzumab, 8 % patients avec évènement 0 6 12 18 24 30 36 Temps (mois) Pas de différence en survie globale – Suivi médian de 28 mois Conclusion / Avis d’expert Le profil de tolérance est cTRGect Les taux de maladie résiduelle sont prometteurs, notamment dans un contexte de LLC en rechute/réfractaire et semblent prolongés dans le bras vénétoclax Limite : bras comparateur chlorambucil + obinutuzumab, utilisé en pratique chez un faible nombre de patients vénétoclax + obinutuzumab est un traitement très prometteur, qui pourrait changer les pratiques en 1ère ligne et être évalué en rechute ▪ En attente d’un suivi à plus long terme ACALABRUTINIB VS RITUXIMAB PLUS IDELALISIB (IDR) OU BENDAMUSTINE (BR) SELON LE CHOIX DE L’INVESTIGATEUR CHEZ LES PATIENTS ATTEINTS DE LLC EN RECHUTE/RÉFRACTAIRE : RÉSULTATS DE L’ÉTUDE DE PHASE 3 ASCEND D’après la présentation de Ghia P. et al. Abstract LB2606 Congrès de l’Association Européenne d’Hématologie 2019 Rédigé par le Dr Maël Heiblig Design de l’étude ASCEND (ACE-CL-309) Objectif primaire : Acalabrutinib • SSP (évaluée par un IRC) LLC R/R (N = 310) 100 mg per SG 2 x / jour Principaux objectifs Stratification : secondaires : Statut del(17p) (y vs n) R 1:1 Idelalisib plus rituximab (IdR) • ORR (évaluée par un IRC et par l’investigateur) Idelalisib 150 mg per SG 2 x / jour + rituximab ECOG PS 0-1 vs 2 • Durée de réponse 1-3 vs ≥ 4 lignes de OU • SSP (évaluée par traitement antérieures Bendamustine plus rituximab (BR) l’investigateur) Bendamustine 70 mg/m² IV + rituximab • SG Crossover entre les bras IdR et BR autorisé en cas de progression
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