Zai Lab and Novocure Announce Positive Topline Results from Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer
Zai Lab (ZLAB) and Novocure announced positive results from their Phase 3 PANOVA-3 trial, evaluating Tumor Treating Fields (TTFields) therapy combined with gemcitabine and nab-paclitaxel for pancreatic cancer. The trial met its primary endpoint, showing a statistically significant improvement in median overall survival of 16.20 months compared to 14.16 months in the control group (hazard ratio=0.819; P=0.039). The treatment demonstrated increasing survival benefits over time, with a 13% improvement at 12 months and 33% at 24 months. Both companies plan to seek regulatory approvals in their respective markets.
Zai Lab (ZLAB) e Novocure hanno annunciato risultati positivi dal loro studio di fase 3 PANOVA-3, che valuta la terapia con Campi Tumorali (TTFields) combinata con gemcitabina e nab-paclitaxel per il trattamento del cancro pancreatico. Lo studio ha raggiunto il suo obiettivo primario, mostrando un miglioramento statisticamente significativo nella sopravvivenza globale mediana di 16,20 mesi rispetto a 14,16 mesi nel gruppo di controllo (hazard ratio=0,819; P=0,039). Il trattamento ha dimostrato increasing benefici nella sopravvivenza nel tempo, con un miglioramento del 13% a 12 mesi e del 33% a 24 mesi. Entrambe le aziende pianificano di richiedere approvazioni normative nei loro rispettivi mercati.
Zai Lab (ZLAB) y Novocure anunciaron resultados positivos de su ensayo de fase 3 PANOVA-3, que evalúa la terapia de Campos Tumorales (TTFields) combinada con gemcitabina y nab-paclitaxel para el cáncer de páncreas. El ensayo cumplió con su objetivo primario, mostrando una mejora estadísticamente significativa en la supervivencia general mediana de 16,20 meses en comparación con 14,16 meses en el grupo de control (ratio de riesgo=0,819; P=0,039). El tratamiento demostró beneficios de supervivencia crecientes con el tiempo, con una mejora del 13% a los 12 meses y del 33% a los 24 meses. Ambas empresas planean solicitar aprobaciones regulatorias en sus respectivos mercados.
Zai Lab (ZLAB)와 Novocure는 췌장암에 대한 종양 치료 필드(TTFields) 요법과 gemcitabine 및 nab-paclitaxel을 결합한 3상 PANOVA-3 시험에서 긍정적인 결과를 발표했습니다. 이 시험은 주요 목표를 달성했으며, 대조군의 14.16개월에 비해 중앙 전체 생존 기간이 16.20개월로 통계적으로 유의미한 개선을 보여주었습니다(위험비=0.819; P=0.039). 치료법은 시간이 지남에 따라 생존 혜택이 증가하는 것으로 나타났으며, 12개월에서 13% 증가하고 24개월에서 33% 증가했습니다. 두 회사 모두 각자의 시장에서 규제 승인을 요청할 계획입니다.
Zai Lab (ZLAB) et Novocure ont annoncé des résultats positifs de leur essai de phase 3 PANOVA-3, évaluant la thérapie par Champs Tumoraux (TTFields) combinée à la gemcitabine et au nab-paclitaxel pour le cancer du pancréas. L'essai a atteint son objectif principal, montrant une amélioration statistiquement significative de la survie globale médiane de 16,20 mois par rapport à 14,16 mois dans le groupe témoin (rapport de risque=0,819; P=0,039). Le traitement a montré des bénéfices de survie qui augmentent avec le temps, avec une amélioration de 13% à 12 mois et de 33% à 24 mois. Les deux entreprises prévoient de demander des approbations réglementaires sur leurs marchés respectifs.
Zai Lab (ZLAB) und Novocure haben positive Ergebnisse aus ihrer Phase-3-Studie PANOVA-3 bekannt gegeben, die die Tumorbehandlungsfelder (TTFields)-Therapie in Kombination mit Gemcitabin und Nab-Paclitaxel bei Pankreaskrebs bewertet. Die Studie erreichte ihr primäres Ziel und zeigte eine statistisch signifikante Verbesserung der medianen Gesamtüberlebenszeit von 16,20 Monaten im Vergleich zu 14,16 Monaten in der Kontrollgruppe (Hazard Ratio=0,819; P=0,039). Die Behandlung zeigte im Laufe der Zeit zunehmende Überlebensvorteile, mit einer Verbesserung von 13% nach 12 Monaten und 33% nach 24 Monaten. Beide Unternehmen planen, regulatorische Genehmigungen in ihren jeweiligen Märkten zu beantragen.
- Phase 3 PANOVA-3 trial met primary endpoint with statistical significance
- 2.04-month improvement in median overall survival (16.20 vs 14.16 months)
- 33% improvement in survival rate at 24 months
- Treatment was well-tolerated with consistent safety profile
- Plans for regulatory submissions in multiple markets including US, EU, Japan, and China
- Modest 2.04-month survival benefit in absolute terms
Insights
The PANOVA-3 Phase 3 trial results represent a significant breakthrough in pancreatic cancer treatment. A
The positive safety profile and statistical significance (P=0.039) in the intent-to-treat population of 571 patients provide robust evidence for regulatory submissions. This advancement is especially notable as it targets unresectable, locally advanced disease, where treatment options are With approximately 134,000 new cases annually in China alone, this therapy could address a substantial unmet medical need.
This breakthrough positions Zai Lab and Novocure for significant market expansion in the pancreatic cancer space. The positive Phase 3 results mark Novocure's third successful late-stage trial in two years, building strong momentum for their TTFields platform technology. Regulatory submissions planned across major markets - US, EU, Japan and China - could unlock substantial revenue potential.
The addressable market is considerable, particularly in China where Zai Lab holds regional rights. The therapy's demonstrated efficacy in combination with standard chemotherapy (gemcitabine and nab-paclitaxel) suggests strong commercial potential as a first-line treatment option. The robust survival benefit and favorable safety profile should support reimbursement discussions and market adoption.
PANOVA-3 met its primary endpoint with a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic adenocarcinoma treated in the first-line with TTFields concomitant with gemcitabine and nab-paclitaxel
Novocure plans to file for regulatory approval in the
Full results from the PANOVA-3 trial will be presented at an upcoming medical congress
“As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary endpoint of overall survival, a landmark outcome for this field,” said Vincent Picozzi, M.D., medical oncologist and investigator in the PANOVA-3 trial. “These data for Tumor Treating Fields are very promising, especially in this difficult to treat patient population.”
In the intent-to-treat population, patients treated with TTFields therapy concomitant with gemcitabine and nab-paclitaxel had an mOS of 16.20 months compared to 14.16 months in patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement (hazard ratio=0.819; P=0.039) (N=571). The survival rate benefit for patients treated with TTFields therapy increased over time with a
“PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive Phase 3 clinical trial in the last two years,” said Nicolas Leupin, M.D., PhD, Chief Medical Officer, Novocure. “We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference.”
“There are approximately 134,000 new cases of pancreatic cancer diagnosed annually in
Novocure plans to file for regulatory approval of TTFields in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 and plans to submit the PANOVA-3 results for presentation at an upcoming medical congress. Zai Lab plans to file for regulatory approval in
About PANOVA-3
PANOVA-3 is a prospective, randomized open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment of locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.
The primary endpoint is overall survival. Secondary endpoints include progression free survival, local progression free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.
A total of 571 patients were enrolled in the study, randomized 1:1 and followed for a minimum of 18 months.
About Pancreatic Cancer in
Pancreatic cancer is one of the most common and deadliest cancers globally. In
1 Xia C, Dong X, Li H et al. Cancer statistics in
2 Hu JX, Zhao CF, Chen WB et al. Pancreatic cancer: A review of epidemiology, trend, and risk factors. World J Gastroenterol 2021; 27: 4298-4321.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.
To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.
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 www.twitter.com/ZaiLab_Global.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.
Novocure’s global headquarters is located in Root Switzerland, with
Zai Lab Forward-Looking Statements
This press release contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding the prospects of and plans for developing and commercializing TTFields therapy, the potential benefits of TTFields therapy, and the potential treatment of pancreatic cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business initiatives, (3) the results of clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business 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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For more information, please contact:
Zai Lab Investor Relations:
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Source: Zai Lab
FAQ
What were the key results of Zai Lab's PANOVA-3 trial for pancreatic cancer?
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When will Zai Lab (ZLAB) submit for regulatory approval of TTFields therapy?
