Zai Lab Announces Acceptance of Biologics License Application for TIVDAK for the Treatment of Patients with Recurrent or Metastatic Cervical Cancer
Zai Lab (NASDAQ: ZLAB) announced that China's NMPA has accepted the Biologics License Application (BLA) for TIVDAK to treat recurrent or metastatic cervical cancer patients whose disease progressed after systemic therapy.
The BLA is supported by the global Phase 3 innovaTV 301 trial and its China subpopulation results. In China, where approximately 150,000 new cervical cancer cases are diagnosed annually, TIVDAK demonstrated a 45% reduction in death risk compared to chemotherapy (HR: 0.55) in the China subpopulation. The median overall survival was not reached in the TIVDAK arm versus 10.7 months in the chemotherapy arm after 11.5 months median follow-up.
TIVDAK, the only antibody-drug conjugate therapy in cervical cancer, showed favorable results in secondary endpoints including progression-free survival and objective response rate, with manageable safety profile consistent with global data.
Zai Lab (NASDAQ: ZLAB) ha annunciato che la NMPA della Cina ha accettato la domanda di licenza biologica (BLA) per TIVDAK per trattare pazienti con cancro cervicale ricorrente o metastatico la cui malattia è progredita dopo terapia sistemica.
La BLA è supportata dallo studio globale di fase 3 innovaTV 301 e dai risultati della sua sottopopolazione in Cina. In Cina, dove vengono diagnosticati circa 150.000 nuovi casi di cancro cervicale ogni anno, TIVDAK ha dimostrato una riduzione del 45% del rischio di morte rispetto alla chemioterapia (HR: 0.55) nella sottopopolazione cinese. La sopravvivenza globale mediana non è stata raggiunta nel braccio TIVDAK rispetto ai 10,7 mesi nel braccio di chemioterapia dopo un follow-up mediano di 11,5 mesi.
TIVDAK, l'unica terapia con coniugato anticorpale-farmaco nel cancro cervicale, ha mostrato risultati favorevoli negli endpoint secondari, inclusa la sopravvivenza libera da progressione e il tasso di risposta obiettiva, con un profilo di sicurezza gestibile coerente con i dati globali.
Zai Lab (NASDAQ: ZLAB) anunció que la NMPA de China ha aceptado la Solicitud de Licencia Biológica (BLA) para TIVDAK para tratar a pacientes con cáncer cervical recurrente o metastásico cuya enfermedad ha progresado tras la terapia sistémica.
La BLA está respaldada por el ensayo global de fase 3 innovaTV 301 y sus resultados en la subpoblación de China. En China, donde se diagnostican aproximadamente 150,000 nuevos casos de cáncer cervical anualmente, TIVDAK demostró una reducción del 45% en el riesgo de muerte en comparación con la quimioterapia (HR: 0.55) en la subpoblación china. La supervivencia global media no se alcanzó en el grupo de TIVDAK en comparación con los 10.7 meses en el grupo de quimioterapia tras un seguimiento medio de 11.5 meses.
TIVDAK, la única terapia de conjugado anticuerpo-fármaco en cáncer cervical, mostró resultados favorables en los puntos finales secundarios, incluyendo la supervivencia libre de progresión y la tasa de respuesta objetiva, con un perfil de seguridad manejable consistente con los datos globales.
자이랩 (NASDAQ: ZLAB)은 중국 NMPA가 TIVDAK의 생물학적 제품 허가 신청(BLA)을 수락했다고 발표했습니다. 이는 전신 요법 후 질병이 진행된 재발성 또는 전이성 자궁경부암 환자를 치료하기 위한 것입니다.
BLA는 글로벌 3상 임상 시험인 innovaTV 301과 중국 하위 집단의 결과로 뒷받침됩니다. 중국에서는 매년 약 150,000건의 새로운 자궁경부암 사례가 진단되며, TIVDAK은 중국 하위 집단에서 화학요법에 비해 사망 위험을 45% 감소시킨 것으로 나타났습니다 (HR: 0.55). TIVDAK 그룹의 중앙 전체 생존 기간은 11.5개월의 중앙 추적 관찰 후 화학요법 그룹의 10.7개월과 비교하여 도달하지 못했습니다.
TIVDAK은 자궁경부암에서 유일한 항체-약물 접합 치료제로서, 무진행 생존 기간 및 객관적 반응률을 포함한 2차 평가 항목에서 유리한 결과를 보였으며, 글로벌 데이터와 일치하는 관리 가능한 안전성 프로필을 가지고 있습니다.
Zai Lab (NASDAQ: ZLAB) a annoncé que la NMPA de Chine a accepté la Demande de Licence Biologique (BLA) pour TIVDAK afin de traiter les patients atteints de cancer du col de l'utérus récidivant ou métastatique dont la maladie a progressé après une thérapie systémique.
La BLA est soutenue par l'essai clinique mondial de phase 3 innovaTV 301 et ses résultats dans la sous-population chinoise. En Chine, où environ 150 000 nouveaux cas de cancer du col de l'utérus sont diagnostiqués chaque année, TIVDAK a montré une réduction de 45 % du risque de décès par rapport à la chimiothérapie (HR : 0,55) dans la sous-population chinoise. La survie globale médiane n'a pas été atteinte dans le bras TIVDAK par rapport à 10,7 mois dans le bras chimiothérapie après un suivi médian de 11,5 mois.
TIVDAK, la seule thérapie de conjugaison anticorps-médicament dans le cancer du col de l'utérus, a montré des résultats favorables dans les critères d'évaluation secondaires, y compris la survie sans progression et le taux de réponse objective, avec un profil de sécurité gérable conforme aux données mondiales.
Zai Lab (NASDAQ: ZLAB) gab bekannt, dass die NMPA in China den Antrag auf Biologisches Lizenzverfahren (BLA) für TIVDAK zur Behandlung von Patienten mit rezidivierendem oder metastasierendem Zervixkarzinom, deren Erkrankung nach systemischer Therapie fortgeschritten ist, angenommen hat.
Die BLA wird durch die globale Phase-3-Studie innovaTV 301 und deren Ergebnisse in der chinesischen Unterpopulation unterstützt. In China, wo jährlich etwa 150.000 neue Fälle von Zervixkarzinom diagnostiziert werden, zeigte TIVDAK eine 45%ige Reduktion des Sterberisikos im Vergleich zur Chemotherapie (HR: 0.55) in der chinesischen Unterpopulation. Die mediane Gesamtüberlebenszeit wurde in der TIVDAK-Gruppe nicht erreicht, während sie in der Chemotherapie-Gruppe bei 10,7 Monaten nach einem medianen Follow-up von 11,5 Monaten lag.
TIVDAK, die einzige Antikörper-Wirkstoff-Konjugat-Therapie bei Zervixkarzinom, zeigte in sekundären Endpunkten wie progressionsfreier Überlebenszeit und objektiver Ansprechrate günstige Ergebnisse und wies ein handhabbares Sicherheitsprofil auf, das mit globalen Daten übereinstimmt.
- NMPA acceptance of BLA for TIVDAK represents significant regulatory progress
- Strong clinical data showing 45% reduction in death risk vs chemotherapy
- Potential market opportunity with 150,000 annual cervical cancer cases in China
- Synergy with existing ZEJULA commercial infrastructure
- Product not yet approved, facing regulatory uncertainty
- Will compete in market with existing treatment options
Insights
Zai Lab has reached a significant regulatory milestone with China's NMPA accepting the Biologics License Application for TIVDAK in recurrent or metastatic cervical cancer. This acceptance represents an important step in the approval process, though several regulatory hurdles remain before potential commercialization.
The clinical data supporting this application is compelling. In the China subpopulation of the global innovaTV 301 trial, TIVDAK demonstrated a
TIVDAK's antibody-drug conjugate (ADC) technology is particularly noteworthy. ADCs combine the targeting precision of antibodies with the cell-killing power of cytotoxic agents, potentially offering improved efficacy with manageable toxicity compared to traditional chemotherapy. As the only ADC approved for cervical cancer globally, TIVDAK represents an important therapeutic advance.
From a commercial perspective, this potential approval would strategically complement Zai Lab's existing women's cancer franchise. The company can leverage its established ZEJULA commercial infrastructure, creating operational efficiencies while addressing a significant market need among the approximately 150,000 annual cervical cancer patients in China. However, the addressable market is specifically patients with recurrent or metastatic disease who have progressed on prior therapy - a subset of the total incidence.
If approved, Zai Lab will face implementation challenges including physician education on managing TIVDAK's unique adverse event profile and navigating China's evolving reimbursement landscape to ensure patient access. Nevertheless, this regulatory advancement positions Zai Lab to potentially deliver a clinically meaningful therapy in an area of significant unmet need.
The NMPA's acceptance of the Biologics License Application for TIVDAK marks a significant regulatory advancement for Zai Lab in China's oncology market. This milestone typically indicates the application has passed preliminary review, positioning the company for potential approval within approximately 12-18 months, based on China's standard regulatory timeline for innovative biologics.
TIVDAK represents a differentiated asset in Zai Lab's portfolio. As an antibody-drug conjugate specifically developed for cervical cancer, it addresses a substantial unmet need in China, where treatment options for recurrent or metastatic disease are The clinical data from the China subpopulation is particularly compelling - showing a
From a strategic perspective, this potential approval aligns perfectly with Zai Lab's commercial infrastructure optimization. By expanding their women's cancer franchise beyond ZEJULA, the company can achieve significant operational leverage through their existing sales force, medical affairs, and market access teams. This expansion model reflects sound capital allocation by maximizing return on existing commercial investments.
The market opportunity for TIVDAK in China is substantial, though precisely defined. While cervical cancer affects approximately 150,000 new patients annually in China, TIVDAK specifically targets the subset with recurrent or metastatic disease who have progressed after systemic therapy - likely representing 15-25% of total cases. Even with this narrower focus, the addressable market remains significant.
Looking ahead, Zai Lab will need to navigate China's evolving National Reimbursement Drug List (NRDL) process to ensure optimal market access. The company's experience with ZEJULA provides valuable institutional knowledge for this pathway. This regulatory milestone strengthens Zai Lab's position as a growing oncology player in China with a strategically coherent commercial approach focused on areas of high unmet need.
“In China, cervical cancer is a serious health concern with approximately 150,000 new cases diagnosed annually1,” said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Treatment options for patients experiencing recurrence or metastasis after initial treatment are limited. TIVDAK, the only antibody-drug conjugate (ADC) therapy in cervical cancer, demonstrated promising benefits including a clinically meaningful improvement in overall survival (OS) in the pivotal global innovaTV 301 trial. If approved, TIVDAK will leverage our existing commercial infrastructure for ZEJULA, expanding our ability to offer treatment for women's cancer.”
The BLA submission is supported by the results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628) and the results from the
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TIVDAK demonstrated a
45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15] in theChina subpopulation who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. After a median follow-up of 11.5 months, the median OS was not reached in the TIVDAK arm versus 10.7 months in the chemotherapy arm. - Secondary endpoints of progression-free survival (PFS) and confirmed objective response rate (ORR) also favored treatment with TIVDAK.
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The safety of TIVDAK in the
China subpopulation was manageable and consistent with the global profile.
About TIVDAK® (tisotumab vedotin-tftv)
TIVDAK® (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity.
TIVDAK received full approval from
Please see full
Zai Lab has an exclusive license from Seagen Inc., acquired by Pfizer in 2023, to develop and commercialize TIVDAK in Greater China (mainland
About Cervical Cancer in
Cervical cancer remains one of the leading causes of cancer death in women in
Note:
1 Bingfeng Han et al., "Cancer incidence and mortality in
About Zai Lab
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing TIVDAK in
Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov.
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Investor Relations:
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Source: Zai Lab Limited
FAQ
What are the key clinical results of TIVDAK in the China subpopulation trial for ZLAB?
How many cervical cancer cases are diagnosed annually in China according to ZLAB's announcement?
What type of drug is TIVDAK and what makes it unique in cervical cancer treatment?
What regulatory milestone did ZLAB achieve for TIVDAK in China?
