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Carcinoma mammario: Seagen annuncia i risultati a lungo termine dello studio registrativo di tucatinib

Seagen Inc. ha annunciato oggi che i miglioramenti nella sopravvivenza globale (Overall Survival, OS) e nella sopravvivenza libera da progressione (Progression-Free Survival, PFS) sono stati mantenuti con un follow-up a lungo termine dello studio registrativo HER2CLIMB, che ha valutato l’aggiunta di  tucatinib a trastuzumab e capecitabina in pazienti con carcinoma mammario metastatico HER2-positivo con e senza metastasi cerebrali. I dati dell’analisi esplorativa prespecificata (Abstract n. 1043) saranno presentati nell’ambito del programma scientifico virtuale della conferenza annuale della Società Americana di Oncologia Clinica (ASCO) 2021.

Il beneficio in termini di sopravvivenza globale osservato con tucatinib al momento dell’analisi primaria è stato mantenuto dopo 15,6 mesi aggiuntivi di follow-up (totale di 29,6 mesi), dimostrando un miglioramento di 5,5 mesi nella OS mediana (24,7 mesi (intervallo di confidenza [IC] al 95%: 21,6, 28,9) per il regime con tucatinib rispetto a 19,2 mesi (IC al 95%: 16,4, 21,4) per capecitabina e trastuzumab da soli). Questo beneficio ha continuato a essere generalmente consistente nei sottogruppi di pazienti prespecificati.

“Il carcinoma metastatico HER2-positivo in stadio avanzato si è dimostrato difficile da trattare”, ha affermato il Prof. Giuseppe Curigliano, responsabile della Divisione Sviluppo Nuovi Farmaci presso l’Istituto Europeo di Oncologia, IRCCS, e professore associato di oncologia medica, Università di Milano. “Questi dati supportano ulteriormente il fatto che il trattamento con il regime con tucatinib aiuta i pazienti a vivere più a lungo rispetto a trastuzumab e capecitabina da soli. Questi benefici sono stati osservati in tutti i sottogruppi prespecificati di pazienti nella sperimentazione, inclusi quelli con o senza metastasi cerebrali.”

“Questi risultati supportano l’impatto significativo che un regime con tucatinib può avere sui pazienti con carcinoma mammario metastatico HER2-positivo”, ha affermato il Dott. Roger D. Dansey, responsabile medico di Seagen. “I dati a lungo termine dello studio HER2CLIMB hanno dimostrato che il beneficio in termini di sopravvivenza è stato sostenuto con la sopravvivenza globale mediana più prolungata rispetto a quella osservata nell’analisi primaria.”

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