2024 SABCS｜Results Unveiled for the Phase III Study of Disitamab Vedotin in Treating HER2-Positive Advanced Breast Cancer with Liver Metastasis
RemeGen presented groundbreaking results from its Phase III study of Disitamab Vedotin (DV) for HER2-positive advanced breast cancer with liver metastasis at the 47th San Antonio Breast Cancer Symposium. The study, involving 104 patients, compared DV against Lapatinib plus Capecitabine in patients previously treated with Trastuzumab and Taxanes.
Key findings showed DV significantly improved progression-free survival (9.9 months vs. 4.9 months), with a hazard ratio of 0.56. The overall survival data, while not yet mature, showed a positive trend favoring DV. This marks the first global prospective randomized Phase III study demonstrating significant efficacy of a HER2-targeting ADC in this patient population, where the 5-year survival rate is typically only 8% to 12%.
The Biologics License Application for DV has been accepted by China's National Medical Products Administration with priority review status.
RemeGen ha presentato risultati innovativi del suo studio di Fase III su Disitamab Vedotin (DV) per il cancro al seno avanzato HER2-positivo con metastasi epatiche al 47° Simposio di San Antonio sul Cancro al Seno. Lo studio, che ha coinvolto 104 pazienti, ha confrontato DV con Lapatinib più Capecitabina in pazienti precedentemente trattati con Trastuzumab e Taxani.
I risultati chiave hanno mostrato che DV ha migliorato significativamente la sopravvivenza libera da progressione (9,9 mesi contro 4,9 mesi), con un rapporto di rischio di 0,56. I dati sulla sopravvivenza complessiva, sebbene non ancora maturi, hanno mostrato una tendenza positiva a favore di DV. Questo segna il primo studio prospettico randomizzato globale di Fase III che dimostra l'efficacia significativa di un ADC mirato a HER2 in questa popolazione di pazienti, dove il tasso di sopravvivenza a 5 anni è tipicamente solo dell'8% al 12%.
La domanda di licenza biologica per DV è stata accettata dall'Amministrazione Nazionale dei Prodotti Medici della Cina con stato di revisione prioritaria.
RemeGen presentó resultados innovadores de su estudio de Fase III sobre Disitamab Vedotin (DV) para el cáncer de mama avanzado HER2 positivo con metástasis hepáticas en el 47° Simposio de Cáncer de Mama de San Antonio. El estudio, que involucró a 104 pacientes, comparó DV contra Lapatinib más Capecitabina en pacientes previamente tratados con Trastuzumab y Taxanos.
Los hallazgos clave mostraron que DV mejoró significativamente la
La solicitud de licencia biológica para DV ha sido aceptada por la Administración Nacional de Productos Médicos de China con estado de revisión prioritaria.
RemeGen은 47회 샌안토니오 유방암 심포지엄에서 간 전이가 있는 HER2 양성 진행성 유방암에 대한 Disitamab Vedotin (DV)의 3상 연구에서 혁신적인 결과를 발표했습니다. 104명의 환자가 참여한 이 연구는 Trastuzumab 및 Taxanes로 치료한 후 Lapatinib와 Capecitabine에 대해 DV를 비교했습니다.
주요 발견은 DV가 무진행 생존 기간을 유의미하게 개선했다는 것(9.9개월 대 4.9개월)이며, 위험 비율은 0.56이었습니다. 전체 생존 데이터는 아직 성숙되지 않았지만 DV에 유리한 긍정적인 경향을 보였습니다. 이는 이 환자 집단에서 HER2를 표적한 ADC의 유의적인 효능을 입증하는 최초의 글로벌 전향적 무작위 3상 연구입니다. 이 집단에서 5년 생존율은 일반적으로 8%에서 12%에 불과합니다.
DV의 생물학적 라이센스 신청이 중국 국가약품감독관리국에 의해 우선 검토 상태로 승인되었습니다.
RemeGen a présenté des résultats révolutionnaires de son étude de Phase III sur Disitamab Vedotin (DV) pour le cancer du sein avancé HER2 positif avec métastases hépatiques lors du 47e Symposium de San Antonio sur le cancer du sein. L'étude, impliquant 104 patients, a comparé DV à Lapatinib plus Capecitabine chez des patients déjà traités par Trastuzumab et Taxanes.
Les résultats clés ont montré que DV améliorait significativement la survie sans progression (9,9 mois contre 4,9 mois), avec un rapport de risque de 0,56. Les données sur la survie globale, bien que pas encore matures, ont montré une tendance positive en faveur de DV. Cela marque la première étude randomisée prospective de Phase III à démontrer l'efficacité significative d'un ADC ciblant HER2 dans cette population de patients, où le taux de survie à 5 ans est typiquement seulement de 8 % à 12 %.
La demande de licence biologique pour DV a été acceptée par l'Administration nationale des produits médicaux de Chine avec un statut de révision prioritaire.
RemeGen präsentierte bahnbrechende Ergebnisse seiner Phase-III-Studie zu Disitamab Vedotin (DV) bei HER2-positivem, fortgeschrittenem Brustkrebs mit Lebermetastasen auf dem 47. San Antonio Breast Cancer Symposium. Die Studie, an der 104 Patienten teilnahmen, verglich DV mit Lapatinib plus Capecitabin bei zuvor mit Trastuzumab und Taxanen behandelten Patienten.
Wichtige Ergebnisse zeigten, dass DV die progressionsfreie Überlebenszeit signifikant verbesserte (9,9 Monate gegenüber 4,9 Monaten) mit einem Hazard Ratio von 0,56. Die Überlebensdaten insgesamt, obwohl noch nicht ausgereift, zeigten einen positiven Trend zugunsten von DV. Dies ist die erste globale prospektive randomisierte Phase-III-Studie, die die signifikante Wirksamkeit eines HER2-targeting ADC in dieser Patientengruppe demonstriert, wobei die 5-Jahres-Überlebensrate typischerweise nur 8 % bis 12 % beträgt.
Der Antrag auf biotechnologische Zulassung für DV wurde von der Nationalen Medizinischen Aufsichtsbehörde Chinas mit Prioritätsprüfungsstatus akzeptiert.
- Significant improvement in progression-free survival (9.9 vs 4.9 months)
- First successful Phase III study for HER2-targeting ADC in liver metastasis
- BLA filing accepted with priority review status in China
- Positive trend in overall survival data
- Manageable safety profile with no new safety signals
- Overall survival data still immature
- to patients previously treated with Trastuzumab and Taxanes
Data shows that about
This is a randomized, open-label, multicenter phase III study comparing the efficacy and safety of DV versus Lapatinib plus Capecitabine in patients with HER2-positive advanced BCLM. A total of 104 patients were enrolled, of whom 53 received DV and 50 received Lapatinib plus Capecitabine. All patients had previously been treated with Trastuzumab and Taxanes.
As of data cutoff date (December 31, 2023), according to the assessment by the Independent Review Committee (IRC), DV significantly improved progression-free survival (PFS) versus Lapatinib plus Capecitabine (median: 9.9 months vs. 4.9 months; hazard ratio [HR]: 0.56 [
"This is the first confirmatory phase III study that demonstrated promising efficacy of an HER2-targeting ADC in patients with HER2-positive advanced BCLM," observed Professor Jiayu Wang. DV demonstrated clinically meaningful benefit compared with Lapatinib plus Capecitabine and a manageable safety profile, potentially offering a promising new treatment option for patients with HER2-positive advanced BCLM previously treated with Trastuzumab and Taxanes. The Biologics License Application (BLA) filing for this indication of DV has been accepted by the Center for Drug Evaluation (CDE) of
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SOURCE RemeGen Co., Ltd
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