Zai Lab Announces Positive Topline Results for TIVDAK in the China Subpopulation of the Global Phase 3 innovaTV 301 Trial in Patients with Recurrent or Metastatic Cervical Cancer
Zai Lab (NASDAQ: ZLAB) announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 trial for TIVDAK in recurrent or metastatic cervical cancer patients. The study demonstrated a 45% reduction in death risk compared to chemotherapy in Chinese patients, with median overall survival not reached versus 10.7 months for chemotherapy.
The results were consistent with the global population data, showing improved overall survival (OS), progression-free survival (PFS), and confirmed objective response rate (ORR). The safety profile was manageable and aligned with global findings. More than half of the Chinese study population had received prior anti-PD(L)1 therapy.
Following FDA's full approval of TIVDAK in April 2024, Zai Lab plans to submit a New Drug Application to China's NMPA in Q1 2025. With approximately 150,000 new cervical cancer cases annually in China, TIVDAK could provide a important treatment option for patients with alternatives after initial treatment failure.
Zai Lab (NASDAQ: ZLAB) ha annunciato risultati positivi dalle popolazioni sub-cinesi dello studio globale di Fase 3 innovaTV 301 per TIVDAK in pazienti con carcinoma cervicale ricorrente o metastatico. Lo studio ha dimostrato una riduzione del 45% del rischio di morte rispetto alla chemioterapia nei pazienti cinesi, con una sopravvivenza globale mediana non raggiunta rispetto ai 10,7 mesi della chemioterapia.
I risultati sono stati coerenti con i dati della popolazione globale, mostrando un miglioramento della sopravvivenza globale (OS), della sopravvivenza libera da progressione (PFS) e del tasso di risposta obiettiva confermata (ORR). Il profilo di sicurezza è stato gestibile e allineato con i risultati globali. Oltre la metà della popolazione di studio cinese aveva ricevuto precedentemente terapia anti-PD(L)1.
Dopo l'approvazione completa della FDA per TIVDAK nell'aprile del 2024, Zai Lab prevede di presentare una Nuova Domanda di Farmaco alla NMPA cinese nel primo trimestre del 2025. Con circa 150.000 nuovi casi di cancro cervicale all'anno in Cina, TIVDAK potrebbe offrire un'importante opzione terapeutica per i pazienti con opzioni alternative dopo il fallimento del trattamento iniziale.
Zai Lab (NASDAQ: ZLAB) anunció resultados positivos de la población subchina del ensayo clínico global de Fase 3 innovaTV 301 para TIVDAK en pacientes con cáncer cervical recidivante o metastásico. El estudio demostró una reducción del 45% en el riesgo de muerte en comparación con la quimioterapia en pacientes chinos, con una supervivencia global media no alcanzada frente a 10.7 meses para la quimioterapia.
Los resultados fueron consistentes con los datos de la población global, mostrando una mejoría en la supervivencia global (OS), supervivencia libre de progresión (PFS) y tasa de respuesta objetiva confirmada (ORR). El perfil de seguridad fue manejable y alineado con los hallazgos globales. Más de la mitad de la población de estudio china había recibido terapia anti-PD(L)1 previa.
Tras la aprobación total de la FDA de TIVDAK en abril de 2024, Zai Lab planea presentar una Solicitud de Nuevo Medicamento a la NMPA de China en el primer trimestre de 2025. Con aproximadamente 150,000 nuevos casos de cáncer cervical anualmente en China, TIVDAK podría ofrecer una opción de tratamiento importante para pacientes con alternativas tras el fracaso del tratamiento inicial.
Zai Lab (NASDAQ: ZLAB)는 재발성 또는 전이성 자궁경부암 환자를 위한 글로벌 3상 innovaTV 301 시험의 중국 하위 집단에서 긍정적인 주요 결과를 발표했습니다. 이 연구는 중국 환자에서 화학요법에 비해 45% 위험 감소를 나타냈으며, 화학요법의 10.7개월에 비해 중앙 전체 생존 기간은 도달하지 않았습니다.
결과는 글로벌 인구 데이터와 일치하며, 전체 생존률(OS), 무진행 생존률(PFS) 및 확인된 객관적 반응률(ORR)이 개선되었습니다. 안전성 프로필은 관리 가능하며 글로벌 결과와 일치했습니다. 중국 연구 인구의 절반 이상이 이전에 항-PD(L)1 치료를 받았습니다.
2024년 4월 TIVDAK에 대한 FDA의 전면 승인이 있은 후 Zai Lab은 2025년 1분기에 중국 NMPA에 신약 신청서를 제출할 계획입니다. 중국에서 매년 약 150,000건의 새로운 자궁경부암 사례가 발생함에 따라 TIVDAK은 초기 치료 실패 후 대안이 필요한 환자에게 중요한 치료 옵션을 제공할 수 있습니다.
Zai Lab (NASDAQ: ZLAB) a annoncé des résultats positifs provenant de la sous-population chinoise de l'essai clinique mondial de phase 3 innovaTV 301 pour TIVDAK chez des patients atteints de cancer du col de l'utérus récidivant ou métastatique. L'étude a démontré une réduction de 45% du risque de décès par rapport à la chimiothérapie chez les patients chinois, avec une survie globale médiane non atteinte contre 10,7 mois pour la chimiothérapie.
Les résultats étaient cohérents avec les données de la population mondiale, montrant une amélioration de la survie globale (OS), de la survie sans progression (PFS) et du taux de réponse objective confirmée (ORR). Le profil de sécurité était gérable et aligné avec les résultats globaux. Plus de la moitié de la population d'étude chinoise avait reçu une thérapie anti-PD(L)1 antérieure.
Après l'approbation complète de TIVDAK par la FDA en avril 2024, Zai Lab prévoit de soumettre une demande de nouveau médicament à la NMPA de Chine au premier trimestre de 2025. Avec environ 150 000 nouveaux cas de cancer du col de l'utérus chaque année en Chine, TIVDAK pourrait offrir une option de traitement importante pour les patients avec des alternatives après l'échec du traitement initial.
Zai Lab (NASDAQ: ZLAB) gab positive Gesamtergebnisse aus der chinesischen Subpopulation der globalen Phase-3-Studie innovaTV 301 für TIVDAK bei wiederkehrenden oder metastasierenden Zervixkarzinom-Patienten bekannt. Die Studie zeigte eine 45%ige Reduktion des Sterberisikos im Vergleich zur Chemotherapie bei chinesischen Patienten, wobei die mediane Gesamtüberlebenszeit im Vergleich zu 10,7 Monaten für Chemotherapie nicht erreicht wurde.
Die Ergebnisse entsprachen den globalen Bevölkerungsdaten und zeigen eine verbesserte Gesamtüberlebenszeit (OS), ein verbessertes progressionsfreies Überleben (PFS) und eine bestätigte objektive Ansprechrate (ORR). Das Sicherheitsprofil war handhabbar und stimmte mit globalen Ergebnissen überein. Mehr als die Hälfte der chinesischen Studienpopulation hatte zuvor eine anti-PD(L)1-Therapie erhalten.
Nach der vollumfänglichen Genehmigung von TIVDAK durch die FDA im April 2024 plant Zai Lab, im ersten Quartal 2025 einen Antrag auf ein neues Medikament bei der NMPA Chinas einzureichen. Mit etwa 150.000 neuen Fällen von Zervixkarzinom jährlich in China könnte TIVDAK eine wichtige Behandlungsoption für Patienten mit Alternativen nach dem initialen Behandlungsversagen bieten.
- 45% reduction in death risk compared to chemotherapy in Chinese population
- Superior overall survival with TIVDAK (not reached) vs chemotherapy (10.7 months)
- Improved progression-free survival and objective response rate vs chemotherapy
- FDA granted full approval for TIVDAK in April 2024
- None.
Insights
The Phase 3 innovaTV 301 trial results for TIVDAK in Chinese patients with recurrent/metastatic cervical cancer represent a significant therapeutic breakthrough. The data shows a remarkable 45% reduction in death risk compared to chemotherapy, with median overall survival not yet reached versus
The trial's strength lies in its patient population - over half had previously received anti-PD(L)1 therapy, reflecting real-world treatment patterns. The positive progression-free survival and objective response rate data further validate TIVDAK's clinical benefit profile. For context, in cervical cancer where second-line options are , these results could establish TIVDAK as a new standard of care.
With approximately 150,000 new cervical cancer cases annually in China, TIVDAK addresses a substantial market opportunity. The planned Q1 2025 NDA submission positions Zai Lab to potentially capture significant market share in this underserved segment. The company's existing ZEJULA commercial infrastructure in women's cancers provides a strategic advantage for TIVDAK's launch.
The full FDA approval in April 2024 strengthens TIVDAK's regulatory prospects in China. As the only antibody-drug conjugate (ADC) therapy in this setting, TIVDAK faces competition in the second-line space. This, combined with the strong efficacy data, could drive rapid market adoption and meaningful revenue contribution to Zai Lab's portfolio.
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Improved overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR) were observed in the
China subpopulation treated with TIVDAK compared to chemotherapy, consistent with those in the global population -
The safety profile of TIVDAK among the
China subpopulation was manageable and consistent with that observed in the global population - Zai Lab intends to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) in the first quarter of 2025
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Zai Lab will leverage its commercial footprint of ZEJULA in women’s cancer to bring the medicine to patients in
China if approved
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. Median OS for patients treated with TIVDAK was not reached versus chemotherapy 10.7 months [95% CI: 6.0-not reached] with a median follow-up of 11.5 months. - Secondary endpoints of PFS and confirmed ORR also favored treatment with TIVDAK compared to chemotherapy.
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The safety profile of TIVDAK in the
China subpopulation was manageable and consistent with the global profile.
“Recurrent or metastatic cervical cancer remains a significant challenge for patients, highlighting a critical unmet need for effective treatments that extend survival after relapse,” said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “The consistent and positive results in the
“There are approximately 150,000 new cases of cervical cancer annually in
In April 2024, the
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TIVDAK demonstrated a
30% reduction in the risk of death compared to chemotherapy (hazard ratio [HR]: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038)2. Median OS for patients treated with TIVDAK was 11.5 months [95% CI: 9.8-14.9] versus chemotherapy 9.5 months [95% CI: 7.9-10.7]. - PFS and confirmed ORR were also significantly improved compared to chemotherapy.
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The safety profile of TIVDAK was consistent with its known safety profile as presented in the
U.S. prescribing information, and no new safety signals were observed.
Based on these encouraging results, Zai Lab intends to submit an NDA for TIVDAK to China’s National Medical Products Administration (NMPA) in the first quarter of 2025. The full
About innovaTV 301 Trial Design
The innovaTV 301 trial (NCT04697628) is a global, 1:1 randomized, open-label Phase 3 trial evaluating TIVDAK® (tisotumab vedotin) versus investigator’s choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) with recurrent or metastatic cervical cancer who received chemotherapy.
Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate.
The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), as well as other global gynecological oncology cooperative groups.
For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.
About Cervical Cancer in
Cervical cancer remains one of the leading causes of cancer death in women in
About TIVDAK® (tisotumab vedotin)
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 accelerated approval from the FDA in September 2021 and full approval in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Please see full prescribing information, including BOXED WARNING for TIVDAK here.
Zai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland
About Zai Lab
Zai Lab (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 www.twitter.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.
Notes:
1 Bingfeng Han et al., "Cancer incidence and mortality in
2 The threshold for statistical significance is 0.0226 (2-sided).
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Investor Relations:
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+1 (917) 886-6929 / +86 136 8257 6943
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Source: Zai Lab Limited
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