Latest news with #TTFields
Yahoo
a day ago
- Business
- Yahoo
NovoCure's Tumor Treating Fields Boost One-Year And Pain-Free Survival In Pancreatic Cancer Trial
Zai Lab Limited (NASDAQ:ZLAB) and NovoCure Limited (NASDAQ:NVCR) revealed additional data on Saturday from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer. The data were presented at the 2025 American Society of Clinical Oncology Annual Meeting. The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields. In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints, including one-year and pain-free survival rates. The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group, 68.1%, compared to 60.2% for those who received gemcitabine and nab-paclitaxel alone. Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months compared to a median of 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until patients reported an increase of 20 or more points on a visual scale for pain or until death. There was no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival, or tumor resectability rate between the TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms. TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. Price Action: NVCR stock is trading lower by 8.63% to $17.46 at last check Monday. Read Next:Photo by Aunt Spray via Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? This article NovoCure's Tumor Treating Fields Boost One-Year And Pain-Free Survival In Pancreatic Cancer Trial originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
2 days ago
- Health
- Business Insider
Novocure announces results from Phase 3 PANOVA-3 trial
Novocure (NVCR) announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields therapy for pancreatic cancer will be presented at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate and pain-free survival. The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group with compared to those who received gemcitabine and nab-paclitaxel alone. Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months compared to a median 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual scale for pain or until death.
Medscape
2 days ago
- Business
- Medscape
Tumor Treating Fields Boost Pancreatic Cancer Survival
The addition of low-intensity electric tumor treating fields (TTFields) therapy to first-line standard chemotherapy was associated with significantly improved overall survival in a phase 3 trial for patients with unresectable, locally advanced, pancreatic adenocarcinoma (LA-PAC). The PANOVA-3 trial 'establishes tumor treating fields with gemcitabine/nab-paclitaxel as a potential new standard treatment paradigm for unresectable, locally advanced pancreatic cancer,' reported Vincent J. Picozzi, MD, first author of the new research, at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The new study, which was simultaneously published in the Journal of Clinical Oncology , is the first phase 3 trial to show an overall survival (OS) benefit for any treatment added to standard chemotherapy in this patient population, where the current 5-year OS rate is less than 8%, said Picozzi in his presentation. TTFields is a non-invasive therapy that delivers electricity to the tumor site via a wearable device and transducer arrays placed on the skin. The electric fields 'disrupt processes critical for cancer cell division and may do a variety of other things, such as trigger an enhanced anti-tumor response,' he explained. The therapy has already been approved in the United States and Europe for use in various cancers, including glioblastomas, metastatic pleural mesothelioma, and metastatic non-small cell lung cancer (NSCLC). Study Methods The open-label study, conducted across 20 countries and 196 sites, included 571 patients with unresectable, locally advanced, biopsy-confirmed, and previously untreated pancreatic adenocarcinoma. Participants had a life expectancy of at least 3 months and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2. The patients (median age 67 years, 47.6% male) were randomly assigned to receive only gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 by intravenous infusion once a day on days 1, 8, and 15 of a 28-day cycle (n = 286), or the same chemotherapy plus TTFields (n = 285). Patients wore the devices about 15 hours per day for about 28 weeks on average. Notably, almost 30% of the patients were non-White, almost 4% were ECOG PS 2, 'and perhaps most importantly, almost 30% had CA 19-9 levels greater than 1000, suggesting a high incidence of occult, unrecognized metastatic disease,' said Picozzi, a hematologist-oncologist and director of the Pancreaticobiliary Program at Virginia Mason Medical Center, Seattle, Washington. Follow-up visits were every 4 weeks, with chest, abdomen, and brain CT or MRI performed every 8 weeks to assess disease progression. Study Results After a median follow-up of about 13 months, the primary endpoint of OS was statistically improved in the TTFields arm compared with controls (16.2 vs 14.2 months, hazard ratio [HR] 0.82, P = .039), and the 1-year survival rate was similarly better (68.1% vs 60.2%; P = .029). There was no significant difference between groups in median progression-free survival (PFS), at 10.6 vs 9.3 months, respectively. However, the 1-year PFS rate was higher in the TTFields arm (43.9% vs 34.1%, P = .026). 'Perhaps somewhat surprisingly,' a post-hoc analysis showed a statistically significant benefit to TTFields in distant PFS, Picozzi said. Importantly, TTFields showed benefit in quality of life. 'In pain-free survival, another secondary endpoint — which really is freedom from progression of pain over time — we see a very distinct difference' (median 15.2 vs 9.1 months, 1-year pain-free survival rate 54.1% vs 45.1%), he reported. 'Pain is a common and debilitating morbidity in patients with advanced pancreatic adenocarcinoma and a predictor of survival. Thus, by mitigating cancer pain, TTFields may preserve the quality of life of patients with LA-PAC, further supporting TTFields' utility as first-line treatment of this disease,' the authors write in the paper. Patients also performed quality-of-life analyses using the EORTC QLQ-C30 questionnaire, along with the pancreatic cancer–specific PAN26 addendum, 'and using these tools, there was an improvement in deterioration of global health status, pain, and digestive problems,' said Picozzi. Most serious adverse events (SAEs), occurring in 53.6% of the TTFields arm and 48% of controls, were related to chemotherapy or the underlying disease, and were not device-related, the authors wrote. The most common SAEs, which were relatively balanced between arms, were sepsis (6.9% TTFields vs 9.5% controls), cholangitis (5.8% vs 3.7%), bile duct obstruction (5.5% vs 3.3%), and pneumonia (5.1% vs 3.3%), which is a toxicity profile expected for gemcitabine/nab-paclitaxel, Picozzi said. Most device-related AEs were mild-to-moderate skin reactions, consistent with previous trials of TTFields, and could be managed with topical steroids and calcineurin cream. In total, 23 patients (8.4%) had device-related AEs leading to TTFields discontinuation, while discontinuation of chemotherapy due to chemotherapy-related AEs occurred in 17.2% in the TTFields group and 15.8% of controls. Pros and Cons of the Device Study discussant Brian M. Wolpin, MD, a medical oncologist and director of the Gastrointestinal Cancer Center at the Dana-Farber Cancer Institute, Boston, Massachusetts, said, 'Assuming appropriate regulatory approvals, I think the combination of the survival increase and quality-of-life benefits suggests this could be an approach that we could use in patients with locally advanced pancreatic cancer.' But 'there are some lifestyle constraints of wearing the device 18 hours a day continuously for months,' he noted. Wolpin's comments also raised the question of whether TTFields could be combined with other first-line choices for LA-PAC, and pointed out that some oncologists treat locally advanced disease with chemotherapy other than gemcitabine/nab-paclitaxel. 'Many of the newer trials have now started to use multi-agent chemotherapy, many different chemotherapy programs, and different lengths of of these trials have used radiation, some have not,' he said. Indeed, the addition of radiation to first-line chemotherapy for LA-PAC is 'very, very routine' in the United States, Michael Chuong, MD, told Medscape Medical News . Nevertheless, Chuong, a professor of radiation oncology at Florida International University in Miami and medical director of radiation oncology at Miami Cancer Institute, called PANOVA-3's results exciting. 'The use of chemotherapy, plus any other non-chemo treatment, has never before shown a survival difference,' he said. 'For example, randomized trials of chemotherapy, plus or minus definitive radiation therapy, showed only differences in local control. I would say [this trial] definitely is going to lead to this becoming a standard-of-care option now. Whether all patients with locally advanced pancreatic cancer should be getting this remains to be seen.' He said the trial's ad hoc finding of statistically significant benefit for TTFields in distant PFS — but not local PFS — suggests that TTFields may be most effective at delaying metastasis. 'If it's delaying onset of liver and peritoneal disease, which almost every one of these patients will ultimately develop, that's huge,' he said, adding that the trial's high number of participants with CA 19-9 levels greater than 1000 suggested a certain amount of metastatic disease in the cohort. Other TTFields Research Is Ongoing Chuong is conducting a single-arm, phase 2 study in the same type of population. In his study, TTFields is being combined with stereotactic ablative body radiation (SABR) in the first-line setting, and he has hypothesized that this will delay metastasis. 'From a mechanistic standpoint, this is a treatment that's applied to the entirety of the abdomen. These low electrical fields are delivered to the peritoneum, into the liver, and that's where the predominant site of distant metastatic disease is in these patients.' The study was funded by Novocure GmbH. Picozzi disclosed stock and other ownership interests in Amgen, Cigna, Iovance Biotherapeutics, Johnson & Johnson, Lilly, McKesson, and Thermo Fisher; a scientific consulting or advisory role with Revolution Medicines, TriSalus Life Sciences; and research funding from AbbVie, Amal Therapeutics, Astellas Pharma, FibroGen, Ipsen, and NovoCureBrian. Wolpin disclosed a consulting or advisory role with Agenus, BeiGene, EcoR1 Capital, Harbinger Health, Ipsen, Mirati Therapeutics, Revolution Medicines, Tango Therapeutics, and Third Rock Ventures; and research funding from Amgen (Inst), AstraZeneca (Inst), Harbinger Health (Inst), Lilly (Inst), Novartis (Inst), and Revolution Medicines (Inst). Chuong disclosed funding from Novocure, Viewray, and Stratpharma.
Yahoo
3 days ago
- Business
- Yahoo
Zai Lab and Novocure Announce Results From the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer to be Presented at 2025 ASCO Annual Meeting
TTFields therapy concomitant with gemcitabine and nab-paclitaxel is the first treatment to show a clinically meaningful and statistically significant improvement in overall survival (OS) for patients with unresectable, locally advanced pancreatic adenocarcinoma in a Phase 3 trial The OS benefit observed with TTFields therapy is supported by significantly improved quality of life and extended pain-free survival, a key outcome for patients with pancreatic cancer Results from PANOVA-3 accepted as a late-breaking abstract for oral presentation at ASCO and simultaneous publication in the Journal of Clinical Oncology SHANGHAI & CAMBRIDGE, Mass. & BAAR, Switzerland, May 31, 2025--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology. "The data presented today from the PANOVA-3 trial of Tumor Treating Fields show a clinically meaningful and statistically significant improvement in overall survival for people with locally advanced pancreatic cancer," said Vincent Picozzi, MD, MMM, medical oncologist and investigator in the PANOVA-3 trial. "Importantly, we also saw an extension in the duration of time before pain progressed. Pain is a hallmark of this disease, and as a clinician, the potential of this therapy to address this aspect of pancreatic cancer is very encouraging. These results illustrate the potential of Tumor Treating Fields therapy concomitant with gemcitabine and nab-paclitaxel to become a standard of care for unresectable, locally advanced pancreatic cancer." The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields. "The encouraging data from the Phase 3 PANOVA-3 study demonstrate a meaningful improvement in outcomes for patients with unresectable, locally advanced pancreatic cancer—including pain reduction and a statistically significant improvement in overall survival," said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. Zai Lab participated in this trial and looks forward to continuing our collaboration with Novocure to bring this innovative therapy to patients in China as quickly as possible." "Most people with pancreatic cancer are diagnosed with advanced disease, which is very difficult to treat and only about 1 in 10 people are alive five years after diagnosis," said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. "The results shared today at ASCO and in the Journal of Clinical Oncology demonstrate that Tumor Treating Fields therapy improved overall survival and pain-free survival in unresectable, locally advanced pancreatic cancer. We plan to submit these data to the FDA in the second half of 2025 to support a premarket approval for Tumor Treating Fields therapy." Results from PANOVA-3 In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement [hazard ratio (HR) 0.82; p=0.039 (N=571)]. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate and pain-free survival. Pancreatic cancer can cause significant pain as the disease progresses and managing pain is a key clinical challenge. The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group with 68.1% [95% CI: 62.0–73.5] compared to those who received gemcitabine and nab-paclitaxel alone, 60.2% [95% CI: 54.2–65.7], p=0.029. Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months [95% CI: 10.3–22.8] compared to a median 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone [95% CI: 7.4–12.7]; HR 0.74 [95% CI: 0.56–0.97], p=0.027. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual scale for pain or until death. Quality of life was also measured as a secondary endpoint. Analyses were performed for all patients using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum. Deterioration-free survival in global health status, pain and digestive problems were significantly improved in patients receiving TTFields therapy concomitant with gemcitabine and nab-paclitaxel compared to the gemcitabine and nab-paclitaxel alone group. Full analysis of the quality of life results in PANOVA-3 will be shared at a future scientific conference. There was no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms. TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. Data Presentation & Publication Details The PANOVA-3 data, (LBA 3500) Phase 3 study of Tumor Treating Fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC), will be presented today by Dr. Picozzi in Hall D1 during the 3:00 – 6:00 p.m. Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary oral session. The Phase 3 PANOVA-3 publication in the Journal of Clinical Oncology, Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase 3 PANOVA-3 study, will be available online at Novocure Investor Event Novocure will host an investor event featuring Dr. Picozzi and Novocure leadership after the oral presentation. Event details and a link to a live webcast of the event are available on the investor relations page of For more information or to request in-person attendance, please contact Novocure investor relations at investorinfo@ Regulatory & Ongoing Clinical Study of TTFields for Pancreatic Cancer Novocure plans to file for regulatory approval for use of TTFields therapy in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 in the U.S. in the second half of 2025. The company also plans to file for regulatory approval in EU, Japan and other key markets. 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 the first half of 2026. About PANOVA-3 PANOVA-3 is an international 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 for 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. The PANOVA-3 trial enrolled 571 patients who were 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 treatment 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 and enrollment is complete. About Pancreatic Cancer in China Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases in 2022, and it is now the eighth most common cancer type1. The current median survival of patients with locally advanced, unresectable pancreatic cancer is nine to twelve months, and the five-year survival rate was 7.2%2, making it the malignancy with the lowest survival rate in China. 1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590. 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 About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at , 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 Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit and follow @Novocure on LinkedIn and Twitter. 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 China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at View source version on Contacts For more information, please contact: Zai Lab Investor Relations: Christine Chiou / Lina Zhang+1 (917) 886-6929 / +86 136 8257 / Zai Lab Media: Shaun Maccoun / Xiaoyu Chen+1 (857) 270-8854 / +86 185 0015 / Novocure Investors: Ingrid Goldberginvestorinfo@ Novocure Media: Catherine Falcettimedia@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
3 days ago
- Business
- Business Wire
Zai Lab and Novocure Announce Results From the Phase 3 PANOVA-3 Trial of Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer to be Presented at 2025 ASCO Annual Meeting
SHANGHAI & CAMBRIDGE, Mass. & BAAR, Switzerland--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) announced that results from the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy for pancreatic cancer will be presented today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and simultaneously published in the Journal of Clinical Oncology. 'The data presented today from the PANOVA-3 trial of Tumor Treating Fields show a clinically meaningful and statistically significant improvement in overall survival for people with locally advanced pancreatic cancer,' said Vincent Picozzi, MD, MMM, medical oncologist and investigator in the PANOVA-3 trial. 'Importantly, we also saw an extension in the duration of time before pain progressed. Pain is a hallmark of this disease, and as a clinician, the potential of this therapy to address this aspect of pancreatic cancer is very encouraging. These results illustrate the potential of Tumor Treating Fields therapy concomitant with gemcitabine and nab-paclitaxel to become a standard of care for unresectable, locally advanced pancreatic cancer.' The Phase 3 PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to gemcitabine and nab-paclitaxel alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) for patients treated with TTFields. 'The encouraging data from the Phase 3 PANOVA-3 study demonstrate a meaningful improvement in outcomes for patients with unresectable, locally advanced pancreatic cancer—including pain reduction and a statistically significant improvement in overall survival,' said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. 'Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone. Zai Lab participated in this trial and looks forward to continuing our collaboration with Novocure to bring this innovative therapy to patients in China as quickly as possible.' 'Most people with pancreatic cancer are diagnosed with advanced disease, which is very difficult to treat and only about 1 in 10 people are alive five years after diagnosis,' said Nicolas Leupin, MD, PhD, Chief Medical Officer, Novocure. 'The results shared today at ASCO and in the Journal of Clinical Oncology demonstrate that Tumor Treating Fields therapy improved overall survival and pain-free survival in unresectable, locally advanced pancreatic cancer. We plan to submit these data to the FDA in the second half of 2025 to support a premarket approval for Tumor Treating Fields therapy.' Results from PANOVA-3 In the intent-to-treat population, patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel had an mOS of 16.2 months compared to 14.2 months for patients treated with gemcitabine and nab-paclitaxel alone, a statistically significant 2.0-month improvement [hazard ratio (HR) 0.82; p=0.039 (N=571)]. TTFields therapy concomitant with gemcitabine and nab-paclitaxel demonstrated improvement in several secondary endpoints including the one-year survival rate and pain-free survival. Pancreatic cancer can cause significant pain as the disease progresses and managing pain is a key clinical challenge. The one-year survival rate showed a statistically significant improvement in the TTFields concomitant with gemcitabine and nab-paclitaxel treated group with 68.1% [95% CI: 62.0–73.5] compared to those who received gemcitabine and nab-paclitaxel alone, 60.2% [95% CI: 54.2–65.7], p=0.029. Patients treated with TTFields concomitant with gemcitabine and nab-paclitaxel had a median pain-free survival of 15.2 months [95% CI: 10.3–22.8] compared to a median 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone [95% CI: 7.4–12.7]; HR 0.74 [95% CI: 0.56–0.97], p=0.027. This is a statistically significant 6.1-month extension in pain-free survival. Pain-free survival was defined as the time from baseline until an increase of 20 or more points was reported by patients on a visual scale for pain or until death. Quality of life was also measured as a secondary endpoint. Analyses were performed for all patients using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer specific PAN26 addendum. Deterioration-free survival in global health status, pain and digestive problems were significantly improved in patients receiving TTFields therapy concomitant with gemcitabine and nab-paclitaxel compared to the gemcitabine and nab-paclitaxel alone group. Full analysis of the quality of life results in PANOVA-3 will be shared at a future scientific conference. There was no statistically significant difference in additional secondary outcome measures of progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumor resectability rate between the TTFields with gemcitabine and nab-paclitaxel and the gemcitabine and nab-paclitaxel arms. TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs. Data Presentation & Publication Details The PANOVA-3 data, (LBA 3500) Phase 3 study of Tumor Treating Fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC), will be presented today by Dr. Picozzi in Hall D1 during the 3:00 – 6:00 p.m. Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary oral session. The Phase 3 PANOVA-3 publication in the Journal of Clinical Oncology, Tumor Treating Fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase 3 PANOVA-3 study, will be available online at Novocure Investor Event Novocure will host an investor event featuring Dr. Picozzi and Novocure leadership after the oral presentation. Event details and a link to a live webcast of the event are available on the investor relations page of For more information or to request in-person attendance, please contact Novocure investor relations at investorinfo@ Regulatory & Ongoing Clinical Study of TTFields for Pancreatic Cancer Novocure plans to file for regulatory approval for use of TTFields therapy in unresectable, locally advanced pancreatic adenocarcinoma based on PANOVA-3 in the U.S. in the second half of 2025. The company also plans to file for regulatory approval in EU, Japan and other key markets. 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 the first half of 2026. About PANOVA-3 PANOVA-3 is an international 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 for 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. The PANOVA-3 trial enrolled 571 patients who were 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 treatment 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 and enrollment is complete. About Pancreatic Cancer in China Pancreatic cancer is one of the most common and deadliest cancers globally. In China, there were an estimated 134,374 new cases in 2022, and it is now the eighth most common cancer type 1. The current median survival of patients with locally advanced, unresectable pancreatic cancer is nine to twelve months, and the five-year survival rate was 7.2% 2, making it the malignancy with the lowest survival rate in China. 1 Xia C, Dong X, Li H et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl) 2022; 135: 584-590. 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 About Zai Lab Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit or follow us at 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 Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit and follow @Novocure on LinkedIn and Twitter. 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 China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at and the SEC's website at
