Novocure Announces Positive Topline Results from Phase 3 PANOVA-3 Clinical Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer
Novocure (NVCR) announced positive results from its Phase 3 PANOVA-3 trial, showing significant improvement in overall survival for pancreatic cancer patients. The study evaluated Tumor Treating Fields (TTFields) therapy combined with gemcitabine and nab-paclitaxel as first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. Patients treated with TTFields showed median overall survival of 16.20 months versus 14.16 months in the control group, representing a 2.0-month improvement. The treatment demonstrated a 13% improvement in survival rate at 12 months and 33% at 24 months. The company plans to file for regulatory approval in the US, EU, Japan, and other markets.
Novocure (NVCR) ha annunciato risultati positivi dal suo studio di Fase 3 PANOVA-3, mostrando un significativo miglioramento nella sopravvivenza globale per i pazienti affetti da cancro al pancreas. Lo studio ha valutato la terapia con Campi di Trattamento Tumorale (TTFields) combinata con gemcitabina e nab-paclitaxel come trattamento di prima linea per l'adenocarcinoma pancreatico localmente avanzato e non reseccabile. I pazienti trattati con TTFields hanno mostrato una sopravvivenza globale mediana di 16,20 mesi rispetto ai 14,16 mesi del gruppo di controllo, rappresentando un miglioramento di 2,0 mesi. Il trattamento ha dimostrato un miglioramento del 13% del tasso di sopravvivenza a 12 mesi e del 33% a 24 mesi. L'azienda prevede di richiedere l'approvazione normativa negli Stati Uniti, Unione Europea, Giappone e altri mercati.
Novocure (NVCR) anunció resultados positivos de su ensayo de Fase 3 PANOVA-3, mostrando una mejora significativa en la supervivencia general para pacientes con cáncer de páncreas. El estudio evaluó la terapia con Campos de Tratamiento Tumoral (TTFields) combinada con gemcitabina y nab-paclitaxel como tratamiento de primera línea para el adenocarcinoma pancreático localmente avanzado y no resecable. Los pacientes tratados con TTFields mostraron una supervivencia general mediana de 16,20 meses en comparación con 14,16 meses en el grupo de control, lo que representa una mejora de 2,0 meses. El tratamiento mostró una mejora del 13% en la tasa de supervivencia a 12 meses y del 33% a 24 meses. La empresa planea presentar una solicitud para la aprobación regulatoria en EE. UU., UE, Japón y otros mercados.
Novocure (NVCR)는 3상 PANOVA-3 시험에서 긍정적인 결과를 발표하며 췌장암 환자의 전체 생존율이 크게 향상되었음을 보여주었습니다. 이 연구는 종양 치료 필드(TTFields) 요법을 지방구성 전이성이 없는 췌장 선암의 1차 치료로서 gemcitabine 및 nab-paclitaxel과 결합하여 평가하였습니다. TTFields로 치료를 받은 환자는 대조군의 14.16개월에 비해 16.20개월의 중앙 전체 생존 기간을 보였으며, 이는 2.0개월의 개선을 나타냅니다. 이 치료는 12개월 시점에서 13%의 생존율 개선과 24개월 차에서는 33%의 생존율 개선을 보였습니다. 이 회사는 미국, 유럽연합, 일본 및 기타 시장에서 규제 승인을 신청할 계획입니다.
Novocure (NVCR) a annoncé des résultats positifs de son essai de Phase 3 PANOVA-3, montrant une amélioration significative de la survie globale des patients atteints de cancer du pancréas. L'étude a évalué la thérapie des Champs de Traitement Tumoral (TTFields) combinée avec la gemcitabine et le nab-paclitaxel comme traitement de première intention pour l'adénocarcinome pancréatique localement avancé et non résécable. Les patients traités avec TTFields ont montré une survie globale médiane de 16,20 mois contre 14,16 mois dans le groupe témoin, représentant une amélioration de 2,0 mois. Le traitement a montré une amélioration de 13% du taux de survie à 12 mois et de 33% à 24 mois. La société prévoit de demander l'approbation réglementaire aux États-Unis, en UE, au Japon et sur d'autres marchés.
Novocure (NVCR) gab positive Ergebnisse aus der Phase-3-Studie PANOVA-3 bekannt, die eine signifikante Verbesserung der Gesamtüberlebensrate bei Pankreaskrebspatienten zeigen. Die Studie bewertete die Tumor Treating Fields (TTFields)-Therapie in Kombination mit Gemcitabin und Nab-Paclitaxel als Erstlinientherapie für nicht resektables, lokal fortgeschrittenes Pankreasadenokarzinom. Patienten, die mit TTFields behandelt wurden, zeigten ein medianes Gesamtüberleben von 16,20 Monaten im Vergleich zu 14,16 Monaten in der Kontrollgruppe, was eine Verbesserung von 2,0 Monaten darstellt. Die Behandlung zeigte eine Verbesserung der Überlebensrate um 13% nach 12 Monaten und 33% nach 24 Monaten. Das Unternehmen plant, eine Zulassung in den USA, der EU, Japan und anderen Märkten zu beantragen.
- Phase 3 PANOVA-3 trial met primary endpoint with statistically significant results
- 2.0-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
- Company advancing toward regulatory submissions in major markets
- Modest 2-month survival benefit might impact market adoption
- Regulatory approvals still pending in all markets
Insights
The PANOVA-3 Phase 3 trial results represent a significant breakthrough in pancreatic cancer treatment. A 2.0-month improvement in median overall survival (from 14.16 to 16.20 months) with TTFields therapy is clinically meaningful for this aggressive cancer type. The 33% improvement in 24-month survival rate is particularly noteworthy, suggesting durable benefits for longer-term survivors.
The positive safety profile and statistical significance (P=0.039) strengthen the therapy's clinical value. This advancement is especially important given pancreatic cancer's historically poor treatment outcomes and therapeutic options. The trial's success in locally advanced, unresectable disease addresses a critical unmet need in oncology.
This pivotal trial success significantly expands Novocure's market opportunity. Pancreatic cancer represents a substantial addressable market with approximately 60,000 new cases annually in the U.S. alone. With plans to file for regulatory approval in major markets (U.S., EU, Japan), TTFields could become a standard first-line treatment option.
The positive data from PANOVA-3, following two other successful Phase 3 trials in the past two years, validates Novocure's technology platform and strengthens its competitive position. The ongoing PANOVA-4 trial investigating combination with immunotherapy could further expand market potential. Expect increased institutional interest and potential strategic partnerships given these results.
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
ROOT,
“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.”
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.
Novocure continues to follow patients in its Phase 2 PANOVA-4 trial, exploring the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. PANOVA-4 has completed enrollment with data anticipated in 2026.
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 PANOVA-4
PANOVA-4 is an international, multi-center Phase 2 clinical trial designed to test the safety and efficacy of Tumor Treating Fields (TTFields) therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treating of metastatic pancreatic cancer. The primary endpoint is disease control rate. Secondary endpoints include overall survival, progression-free survival, one-year survival rate, objective response rate, progression-free survival at six months, duration of response and toxicity. The study is designed to enroll 76 patients.
About Pancreatic Cancer
Pancreatic cancer is one of the most lethal cancers and is the third most frequent cause of death from cancer in the
Physicians use different combinations of surgery, radiation and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy with or without radiation. Unfortunately, most locally advanced cases are diagnosed once the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.
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 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
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “could” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2024, and subsequent filings with the
1 American Cancer Society. Cancer Facts & Figures 2024.
2 https://pmc.ncbi.nlm.nih.gov/articles/PMC9476884/#B4
3 American Cancer Society. Cancer Facts & Figures 2024.
4 American Cancer Society. Cancer Facts & Figures 2024.
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Source: Novocure
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