Novocure announces results from Phase 3 PANOVA-3 trial
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Medscape
16 hours ago
- Medscape
Expanding Treatment Options for Ovarian Cancer
This transcript has been edited for clarity. My name is Brian Slomovitz. I'm a gynecologic oncologist and I look forward to presenting some of the recent trends in ovarian cancer management, what we're doing to better treat our patients, and some of the latest updates from the ASCO 2025 meeting. Let's talk about surgery. Until now, studies haven't shown a statistical difference between neoadjuvant chemotherapy followed by interval debulking and upfront primary debulking surgery for the management of this disease. At this year's ASCO meeting, the TRUST trial was presented. It looked at furthering the role of upfront surgery vs neoadjuvant chemotherapy. This was a well-balanced study conducted at leading surgical centers throughout Europe and the United States, with overall survival as the primary endpoint. Unfortunately, the trial was negative: There was no improvement in overall survival for patients who underwent primary debulking surgery compared to those who had interval debulking surgery after neoadjuvant chemotherapy. There was a benefit in progression-free survival, but that wasn't the primary endpoint. We're looking forward to future research that may further answer this question, but as of now, primary debulking surgery hasn't demonstrated a survival advantage. We'll have to see how this continues to evolve. Turning to primary systemic therapy, there have been several recent studies looking at the addition of checkpoint inhibitors to standard chemotherapy — with or without bevacizumab and PARP inhibitors — to determine whether this could improve outcomes. One of the key studies presented at this year's meeting was the FIRST trial. It was a well-designed trial, with an appropriate control arm using standard therapies and adding immunotherapy in the experimental arm. This study did show a statistically significant improvement. However, when we talk about clinically meaningful, are we going to put that into our practice? The difference was only 1 month. Although this was statistically significant, it is unclear whether this finding will change clinical practice at this point. In the recurrent setting, a great unmet need is better treatment options for our patients with platinum-resistant disease. One recent advance is mirvetuximab, an antibody-drug conjugate targeting the folate receptor alpha. This therapy demonstrated a positive overall survival benefit, but it applies only to a subset of patients who overexpress this receptor protein. Also at this year's ASCO meeting, results from the ROSELLA trial were presented. All patients received nab-paclitaxel, an active agent for recurrent ovarian cancer, and the experimental arm included the addition of relacorilant, a glucocorticoid receptor. The study showed a statistically significant improvement in progression-free survival among patients treated with relacorilant. There was also a clinically meaningful trend toward improved overall survival associated with the addition of relacorilant. Although the data are not yet mature, we may see this combination become increasingly significant over time. The findings were published on the same day in The Lancet . If the sponsors move forward with a regulatory strategy, this could become part of the standard of care — potentially making a real, day-to-day difference for our patients. Another exciting development in the management of recurrent disease is IL-2 gene therapy. At this meeting, Dr Premal Thaker presented results from the OVATION 2 trial, which showed a strong response rate and a promising signal in patients with ovarian cancer. I think the logical next step would be a phase 3 registrational trial to determine whether this IL-2 gene therapy can ultimately be incorporated into the standard of care for our patients. We're making significant strides in the management of ovarian cancer, and I believe ongoing and future studies will continue to improve outcomes and help our patients live longer with a good quality of life.
Business Wire
2 days ago
- Business Wire
Perfuze Presents Preliminary Results from MARRS Pivotal Trial at SNIS, Highlighting Millipede 88 Performance in Acute Ischemic Stroke
GALWAY, Ireland--(BUSINESS WIRE)--Perfuze, a medical device company developing catheter technology for interventional stroke care, today announced positive preliminary results from its pivotal IDE clinical trial, MARRS (Millipede Aspiration for Revascularization in Stroke Study). These preliminary results were presented at the Society for NeuroInterventional Surgery (SNIS) Annual Meeting in Nashville, Tennessee, USA. 'The MARRS data are truly exceptional. Achieving 77% First Pass Effect for M1 occlusions in a pivotal study is a major advance for stroke care," said Dr. Raul G. Nogueira, Principal Investigator of the MARRS Study. Share The trial is evaluating the safety and effectiveness of the Millipede System for revascularization in acute ischemic stroke. Conducted across a network of leading stroke centers in the U.S. and Europe, the study included patients with occlusions in the ICA, M1, M2 and basilar, or vertebral arteries. The Millipede System includes the Millipede 88 aspiration catheter, Perfuze's flagship Superbore aspiration catheter. The MARRS trial enrolled 180 evaluable subjects, with first pass direct aspiration being performed with the Millipede 88 in 101 of these patients. The preliminary analysis shows a high rate of First Pass Effect (FPE), defined as complete or near-complete revascularization (mTICI 2c) following a single device pass. For patients treated with Millipede 88, an FPE rate of 61% was observed across all target vessels in the Per Protocol (PP) population. Specifically, for M1 artery occlusions treated with Millipede 88 in the PP population, an FPE rate of 77% was achieved. 'The MARRS data are truly exceptional. Achieving 77% First Pass Effect for M1 occlusions in a pivotal study is a major advance for stroke care. The ability to reliably achieve rapid, complete reperfusion with a single aspiration pass is exactly what we need to improve efficacy. This technology is a powerful tool that simplifies thrombectomy and delivers outstanding performance,' said Dr. Raul G. Nogueira, Principal Investigator of the MARRS Study and Professor of Neurology and Neurosurgery at the University of Pittsburgh School of Medicine. Across the 180 patients enrolled, delivery success of the Millipede System was 99%, and the median number of passes was 1. Preliminary safety analysis showed a symptomatic intracranial hemorrhage (sICH) rate of 1.7%. Perforation was reported at 0% and the rate of intracranial dissection was 1.1%, indicating a promising safety profile. ' The MARRS study represents several years of work by the Perfuze team and our clinical partners,' said Wayne Allen, CEO and Co-Founder of Perfuze. ' We designed the Millipede 88 to navigate seamlessly to the clot face, enabling a superbore catheter that improves the likelihood of achieving First Pass Effect. This early data reflects that intent, and we're encouraged by the physician feedback we've received to date.' The MARRS trial completed enrollment earlier this year, executed ahead of schedule, reflecting strong engagement from stroke centers and interest in next-generation aspiration technology. These clinical results follow several successful milestones for Perfuze, including FDA 510(k) clearance for its Zipline™ Access Catheters and a €22 million funding round to support commercial expansion and operational scale-up. With these preliminary MARRS data, Perfuze is preparing for FDA submission. ' This is a significant inflection point for the company, ' said Perfuze Chairperson, Hooman Hakami. ' Preliminary MARRS results support the Millipede 88 catheter's safety and effectiveness and underpin our vision to advance stroke intervention.' About the Millipede System and MARRS Trial Millipede 88 is a superbore aspiration catheter developed to support effective clot retrieval while maintaining navigability through challenging cerebrovascular anatomy. The MARRS trial is a prospective, multicenter, single-arm pivotal IDE study designed to evaluate the safety and effectiveness of the Millipede System in patients with large vessel occlusion stroke. Revascularization outcomes were adjudicated by an independent core laboratory. About Perfuze Perfuze is a privately held medical device company based in Galway, Ireland. The company is dedicated to developing advanced catheter technologies that simplify stroke procedures and aim to improve outcomes for patients suffering from acute ischemic stroke. For more information, visit Follow us on LinkedIn and X (formerly Twitter). Disclaimer: United States: CAUTION – Investigational device. Limited by Federal law to investigational use. Europe: Exclusively for use in a clinical investigation. These are preliminary results from an ongoing clinical investigation. The Clinical Study Report has not yet been approved or reviewed by regulatory authorities. Data may be subject to change and may not fully reflect the contents of the Clinical Study Report.
UPI
3 days ago
- UPI
FDA adds new blue food dye from gardenia fruit
U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. testifies at a House committee on June 24. The FDA on Monday approved the use of a new blue color additive from the gardenia fruit, the fourth coloring from natural sources added in the last two months. Photo by Annabelle Gordon/UPI. | License Photo July 14 (UPI) -- The U.S. Food and Drug Administration on Monday approved the use of a new blue color additive from the gardenia fruit, the fourth coloring from natural sources added in the last two months. The blue color, which comes from the white flowering evergreen, can be used for sports drinks, flavored or enhanced non-carbonated water, fruit drinks, ready-to-drink teas plus hard and soft candy, the FDA said in a news release. The health agency also announced a letter was sent to manufacturers encouraging them to phase out Red No. 3 in foods sooner than Jan. 15, 2027, which is the required deadline announced in April by Health and Human Services Secretary Robert F. Kennedy Jr. The dye has been linked to cancer in rats at high amounts. At that time, Kennedy announced measures to work with the industry to phase out petroleum-based synthetic dyes in food. They have committed to ending 40% of the additives. "Every day, children are exposed to synthetic chemicals in food that serve no purpose," Kennedy said in a news release. "The FDA's approval of gardenia blue shows we're finally putting kids first. Thanks to Dr. Marty Makary's bold leadership, we're cutting through industry influence and taking decisive action to make American Healthy Again." Makary, the FDA commissioner, said: "Now, by extracting the palette of available colors derived from natural sources, food manufacturers have a variety of options available that will make it easier to end their use of petroleum-based dyes." The coloring is made by refining the compound genipin. It is derived from crushed gardenia jasminoides Ellis fruit, which often is used in traditional Chinese medicine. Soy, which is a potential allergen, is used to make gardenia blue, but the group said it is detected in the additive and won't cause allergic reactions. Gardenia Blue Interest Group asked to exempt it from labeling. The FDA on July 9 said it is reviewing the request. In May, three other colors were approved: galdieria extract blue, white calcium phosphate and butterfly pea flower extract in blue, purple and green. Color additives must be approved by the FDA before they may be used in foods. On Friday, Consumer Brands announced a voluntary commitment to encourage makers of consumer packaged goods and beverage products to remove certified Food, Drug and Cosmetic colors from products served in schools nationwide by the start of the 2026-2027 school year. The International Association of Color Manufacturers said in a news release that artificial dyes are "essential for consistency, visual appeal and consumer trust in food products." Several major food companies are removing synthetic food colorings from their products, including Kraft Heinz and General Mills by the end of 2027. But Mars, which makes M&M's and Skittles, said it will continue using the synthetic dyes in its candies, reversing a pledge the company made in 2016 to remove artificial colors from all foods and snacks. The company told The New York Times that its products are "safe to enjoy and meet the high standards and applicable regulations set by food safety authorities around the world." A spokesman for the National Confectionery Association, Christopher Gindlesperger, told the New York Post: "People can freely use cannabis, THC products, alcohol and cigarettes but vibrantly colored candy is an issue? Ge me a break."
