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Tumore al seno metastatico, trastuzumab deruxtecan migliora significativamente sia la sopravvivenza libera da progressione che quella globale nelle pazienti con bassi livelli di HER2. I risultati dello studio DESTINY-Breast04

Ricerca

I primi risultati di fase 3 di trastuzumab deruxtecan sul carcinoma mammario metastatico con bassi livelli di HER2 (HER2 Low) indicano che la molecola di Daiichi Sankyo e AstraZeneca ha il potenziale di ridefinire il modo in cui la malattia 猫 trattata

Tokyo, Monaco e Basking Ridge, 22 febbraio 2022 鈥 L鈥檃nticorpo monoclonale farmaco-coniugato Trastuzumab deruxtecan di Daiichi Sankyo e AstraZeneca ha dimostrato un miglioramento statisticamente e clinicamente significativo sia della sopravvivenza libera da progressione (PFS) che della sopravvivenza globale (OS) rispetto alla chemioterapia a scelta del medico, ovvero l'attuale standard di cura nelle pazienti affette da carcinoma mammario non resecabile e/o metastatico con bassi livelli di HER2 (HER2low), a prescindere dallo status del recettore ormonale (HR). A dimostrarlo sono i primi risultati dello studio registrativo di Fase 3 DESTINY-Breast04, in cui tutte le pazienti arruolate sono state sottoposte a test HER2 e i risultati sono stati confermati a livello centrale. Uno status di HER2Low 猫 definito da un valore di immunoistochimica (IHC) 1+ o IHC2+ con test di ibridazione in situ (ISH) negativo.

L'espressione di HER2 猫 attualmente definita come positiva o negativa[i]. I tumori HER2 positivi sono definiti come IHC 3+ o IHC 2+/ISH+ e i tumori HER2 negativi come IHC 0, IHC 1+ o IHC 2+/ISH-.1 Fino al 55% di tutte le pazienti con cancro al seno hanno tumori con valore HER2 IHC 1+, o HER2 IHC 2+ in combinazione con un test ISH negativo, un livello di espressione di HER2 considerato al momento non idoneo alla terapia target anti-HER2.[ii],[iii] Una bassa espressione di HER2 si verifica sia nella malattia ormono-positiva (HR+) che in quella negativa.[iv]

Il test per HER2 猫 uno strumento ben consolidato per determinare una strategia di trattamento appropriata nel cancro al seno metastatico. Usare come bersaglio anche livelli pi霉 bassi di espressione di HER2 pu貌 offrire un altro approccio per ritardare la progressione della malattia e prolungare la sopravvivenza dei pazienti.[v]  Attualmente, la chemioterapia rimane l'unica opzione sia per pazienti con malattia HR-positiva in progressione di malattia a seguito della terapia endocrina sia per coloro che risultano HR-negativi. [vi]

Lo studio DESTINY-Breast04 ha raggiunto il suo endpoint primario con trastuzumab deruxtecan che ha dimostrato una PFS superiore rispetto allo standard di cura (chemioterapia), in pazienti precedentemente trattate per carcinoma mammario metastatico HR-positivo HER2 Low. Lo studio ha anche soddisfatto l'endpoint secondario di PFS in pazienti con carcinoma mammario metastatico HER Low, indipendentemente dallo stato di HR (HR positivo o HR negativo). Il trial ha inoltre raggiunto altri endpoint secondari quali la sopravvivenza globale (OS) nelle pazienti con malattia ormono-positiva e nelle pazienti indipendentemente dallo stato HR all'analisi ad interim.

Il profilo di sicurezza di trastuzumab deruxtecan 猫 risultato in linea con gli studi clinici precedenti, senza nuovi segnali di sicurezza identificati. I tassi complessivi di malattia polmonare interstiziale (ILD) sono stati coerenti con quelli osservati negli studi di trastuzumab deruxtecan sul carcinoma mammario HER2-positivo in fase avanzata, con un tasso inferiore di ILD di grado 5 osservato, come determinato da un comitato di aggiudicazione indipendente.

"Trastuzumab deruxtecan continua a ridefinire il trattamento dei tumori a bersaglio HER2. DESTINY-Breast04 猫 il primo studio di fase 3 di una terapia anti-HER2 che mostra un beneficio statisticamente e clinicamente significativo nella sopravvivenza libera da progressione e globale rispetto al trattamento standard in pazienti con carcinoma mammario metastatico con bassi livelli di espressione di HER2. - Ha dichiarato Ken Takeshita, MD, Capo globale del dipartimento R&D di Daiichi Sankyo. - Non vediamo l'ora di condividere nel dettaglio i risultati dello studio DESTINY-Breast04 con la comunit脿 medica e le agenzie regolatorie a livello globale, con il potenziale obiettivo di offrire trastuzumab deruxtecan a pazienti con tumore mammario metastatico finora considerato HER2-negativo".  

"I risultati dello studio DESTINY-Breast04 potrebbero ridefinire il modo in cui il tumore al seno 猫 classificato e trattato. - Ha affermato Susan Galbraith, MBBChir, PhD, Vice Presidente esecutivo dell鈥橰&D Oncologia di AstraZeneca. - Una terapia anti-HER2 non aveva mai mostrato prima un beneficio in pazienti con cancro al seno metastatico con bassi livelli di HER2. Questi risultati di trastuzumab deruxtecan rappresentano un enorme passo avanti e potrebbero potenzialmente espandere la nostra capacit脿 di colpire l'intero spettro di espressione di HER2, convalidando la necessit脿 di cambiare il modo di classificare e trattare il cancro al seno".

I dati dello studio DESTINY-Breast04 saranno presentati ad uno dei prossimi congressi di oncologia e condivisi con le autorit脿 regolatorie di tutto il mondo.

Contatti

Riferimenti

References:

[i] Iqbal N, et al. Mol Biol Int. 2014;852748.

[ii] Tarantino P, et al. J Clin Oncol. 2020;38(17):1951-1962

[iii] Ahn S, et al. J Pathol Transl Med. 2020; 54(1): 34鈥44.

[iv] Miglietta F, et al. NPJ Breast Cancer. 2021; 7:137.

[v] Eiger D, et al. Cancers. 2021; 10.3390/cancers13051015.

[vi] Matutino A, et al. Current Oncology. 2018; 25(S1):S131-S141.