Latest news with #TRUST
Glasgow Times
03-07-2025
- Entertainment
- Glasgow Times
Unique restaurant with with no menu opens in Glasgow
TRUST by Moudou has no set menu and instead invites guests to place their full trust in the chef, who prepares a five-course tasting menu, changing every couple of days. Located at 1132 Argyle Street, the restaurant will serve customers ever-changing dishes, celebrating seasonality, bold flavours and will aim to tell a story through food. This will be critically acclaimed chef Modou Diagne's second restaurant in the city after the success of 111 by Nico. (Image: Supplied) New unique restaurant with with no menu opens in Glasgow READ NEXT: Legendary author to make appearance at Glasgow store (Image: Supplied) He said: "TRUST is designed to be about more than just exceptional food, it's fundamentally about fostering connection, delivering delightful surprises, and giving our guests a compelling reason to return. "We aim for them to come back not merely for a specific dish, but for the unique feeling and experience we provide. "My aspiration is for people to walk through our doors, release any preconceptions or need for control, and simply savour whatever we have cooked and prepared for them at that very moment." The new eatery is now open and foodies can reserve a spot for £30pp with curated drinks pairings priced at £28pp.
Hindustan Times
28-06-2025
- Business
- Hindustan Times
Clearing the fog on the state of India-US relations
'The administration is bullish on India' is how a senior US official put it to me last week in Washington D.C. This sentiment would seem at odds with the broader reporting on the US-India relationship. In a Financial Times newsletter on India, one writer argued that the Indian Prime Minister (PM) 'made the mistake of counting on his warm personal connection with Trump'. The general assertion being that the Indian government has mortgaged this crucial relationship to 'personal friendships' alone. Others suggest that the US President's recent luncheon with Asim Munir, the recently decorated Pakistani Field Marshal, and his 'sneaky attempt' to bring PM Narendra Modi and Munir into the same room in the White House is 'threatening the future of US-India partnership'. Structures like TRUST were created for top political leaders to monitor progress on crucial initiatives. (REUTERS) Between social media and popular reporting, it would seem as though this relationship has been iced. Yet, in meetings with over 30 officials, experts, think tankers, and industry representatives last week, the story that emerged was diametrically opposed to the one that has been paraphrased above. Modi's engagements with Trump matter more than it is perhaps realised. It clearly provides a political basis of what can be achieved between the two countries, even at this time of shrinking administrative capacities in the US, and the many unplanned shifts in the bureaucratic body politic. To be sure, you could start the week with a meeting with official X and end up receiving a phone call from his/her successor the next day. Yet, what was clear to me was that the vision laid out by the two leaders in a lengthy joint statement following PM Modi's meeting with President Trump in February, guides the different contours of the relationship at the functional level. Notwithstanding the game of political catch between outlandish tweets and measured official responses, the guidelines for those moving the relationship across government and the private sector are more or less clear. First, there is a concerted effort to realise outcomes in the strategic technology partnership between the two sides. Under the banner of TRUST (Transforming the Relationship Utilising Strategic Technology), the administrative State and technology companies between the two countries are working towards outcomes to do more on pharmaceuticals with the view to de-risk the production of key ingredients from China; fuse infrastructure partnerships between firms invested in the present and the future of Artificial Intelligence (AI); and actively looking for ways to cooperate on extracting and processing critical minerals. The latter needs work, but the zest to find the right compact is real. Second, American private sector actors are preparing the ground to sell different kinds of reactors to meet India's nuclear energy needs. They are, at this time, hoping that the proposed legislative changes to the Indian Civil Nuclear Liability Act 2010 streamline liability clauses in consonance with global standards — delinking liabilities on suppliers and operators. Further, they remain hopeful that changes to India's Atomic Energy Act would allow private sector participation to meet India's nuclear energy needs. This is a top priority for the White House and the US President. This was made clear in several exchanges. This is 'unfinished business' following the conclusion of the 2008 US-India Civil Nuclear Agreement, as one Washington insider put it. My own sense is that progress on this front is almost as important as the conclusion of the first tranche of the trade deal between the two countries. The first tranche of this deal needs to be completed by July 9, when the US President's 90-day pause on 'reciprocal tariffs' ends. Officials suggested that there is a fair chance that the first tranche of the deal with India will be completed by this deadline. 'The trickier parts will come later,' they made plain. Third, efforts across bureaucracies in Washington D.C. that deal with India are almost uniformly focussed on the Quad Leader's Summit in October or November, which provides an opportunity for another bilateral between the two leaders. 'Deliverables' is the name of the game. Yet, at least some of the deliverables need to be real. The ongoing process is less about padding a joint statement and more about searching for right-sized deals. There is a fire in the system to make something happen by the time the leaders meet, including a considerable push to realise new AI infrastructure partnerships. 'India and Brazil are the two most important countries for the US when it comes to data centres,' as one technocrat stated. 'We need to get this right on both sides', the official made plain. In the US, this would mean producing revised rules for export controls that make it easier to access chips from the US into India. In turn, India will possibly need to negotiate certain guarantees to make sure that the chips are not off-shored. Moreover, there is a significant push to deregulate the data centre market in India, and streamline processes to encourage the expansion of AI infrastructure in India. None of this will be easy. Deregulation takes time. Negotiating guarantees can be cumbersome and is a process that cuts across several administrative buildings in and across New Delhi and other Indian states. If Indian officials conclude that data centre investments are an advantage for India, this is the bureaucratic work that will be required to realise this unique moment. It is exactly why structures like TRUST were created, for top political leaders to monitor progress on crucial initiatives. The enthusiasm for investments and partnerships will not last long. This also might be kept in mind. This is a zero-sum play. In sum, while there is little doubt that Munir, Pakistan, Twitter exchanges, and the politics that shape these expressions and incidents to an extent inform the current state of US-India ties, at times exercising officials on both sides, it is also plainly clear that the functional relationship — which produces material results — is one that is working to produce outcomes, and not without the direction of the political leadership. Rudra Chaudhuri is director, Carnegie India. The views expressed are personal.
The Hindu
25-06-2025
- Business
- The Hindu
‘Indo-US ties evolved from trade to collaborations in science, technology, innovation in 50 years'
A group of industry leaders, tech gurus, and policy experts who spoke at U.S. Chamber of Commerce's U.S.-India Business Council (USIBC) conclave here on Wednesday emphasised the importance of increased convergence between India and the U.S. across several areas, including AI infrastructure, quantum technologies, biotech. defence, space, AIOT (artificial intelligence of things). The conclave was held in connection with USIBC's 50th anniversary. U.S. Consul General in Chennai Chris Hodges said commerce today remained at the heart of partnership between India and the U.S. ''Top institutes of higher learning, laboratories, research and development centres, IT firms, start-up incubators, and deep pools of human resources talent make it a natural focus for collaboration under the TRUST (Transforming the Relationship Utilising Strategic Technology) initiative on AI, quantum, semiconductors, biotechnology, and space.' In his opening address, USIBC president Ambassador Atul Keshap (retd) said: 'Fifty years ago, USIBC was born out of a belief that the U.S. and India could accomplish more together. Today, we are building the next 50 on that same foundation of trust.' Speaking on the occasion, Priyank Kharge, Minister of Electronics, Information Technology & Biotechnology and Rural Development & Panchayat Raj, emphasised Karnataka's readiness to be a central partner in global innovation. Kiran Mazumdar-Shaw, president and founder, Biocon Ltd., said over the decades, the two nations have evolved from trade and investment to deep collaborations in science, technology, and innovation. ''We must envision a U.S.-India technology ecosystem that moves beyond transactions toward joint capability-building that delivers resilience, inclusivity and global impact. In a world where geopolitical uncertainties and shifting alliances increasingly influence global supply chains and technology leadership, our partnership stands as a beacon of stability,'' she observed. The next 50 years Going forward, Ms. Shaw said economic growth would be led by digital technologies, AI and high-quality data that support LLMs. 'Data exchanges will form the foundation of a bilateral trade agreement between US and India which is to be announced shortly,'' she anticipated. According to Ms. Shaw, India provides the largest pool of STEM talent to the U.S., with over 2 million professionals contributing to technology, research, and innovation. U.S. companies were investing in areas like AI, semiconductors, clean energy, and digital infrastructure in India. At the same time, Indian companies have been investing in IT services, and now increasingly in technology R&D, digital health, biomanufacturing, and advanced analytics, she said. Pharmaceuticals, she said, remained a cornerstone of this partnership, as India played a vital role in global and U.S. healthcare by ensuring a steady supply of affordable medicines. ''India supplies over 45% of generic and 15% of biosimilar volumes consumed in the U.S. annually. Over the past decade, generics and biosimilars have saved the U.S. healthcare system over $3 trillion,'' she said, adding these savings have enabled broader insurance coverage and made essential medicines accessible to a larger population.
Yahoo
11-06-2025
- Business
- Yahoo
U.S. Food and Drug Administration Approves Nuvation Bio's IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer
Approval follows Priority Review and is supported by the robust TRUST clinical program, in which IBTROZI treatment demonstrated high, durable response rates and brain-penetrant efficacy across different lines of therapy The safety and tolerability of IBTROZI have been well established in the pivotal program, with one of the largest safety datasets in ROS1+ NSCLC showing a favorable and consistent profile Company to host conference call tomorrow, June 12 at 7:30 a.m. EDT NEW YORK, June 11, 2025--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). IBTROZI is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. "The FDA approval of IBTROZI marks a major milestone in the evolution of targeted therapy for advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We believe one of the greatest threats to ROS1-positive lung cancer patients is disease progression, especially in the first-line setting. In pivotal trials, IBTROZI delivered high response rates with sustained durability—truly meaningful benefits for patients. With its clinically proven efficacy and safety profile, we believe IBTROZI has the potential to become a new standard for what targeted therapies can achieve in this type of lung cancer. With approvals for IBTROZI now in the U.S. and China, and additional global filings underway, we remain committed to delivering innovative therapies that help patients stay ahead of their disease." ROS1+ NSCLC is a rare and aggressive form of lung cancer, accounting for approximately 2% of new NSCLC cases, or about 3,000 new diagnoses of advanced disease annually in the U.S. The median age at diagnosis for patients with this type of lung cancer is approximately 50 years old, and the disease is more likely to occur in people who have never smoked. Brain metastases are common and a leading cause of disease progression and mortality in this population. "For people living with advanced ROS1-positive lung cancer, who tend to be diagnosed at a younger age, having another treatment option can make a real difference for them and their loved ones," said Janet Freeman-Daily, Co-Founder and President of The ROS1ders. "The approval of this new targeted therapy is a meaningful step forward for the advanced ROS1+ lung cancer community and offers hope for patients facing the added challenge of cancer spreading to the brain." The FDA approval of IBTROZI is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies. In TRUST-I, IBTROZI achieved a confirmed overall response rate (cORR) of 90% in TKI-naïve patients. These findings were reinforced by the TRUST-II results, with a cORR of 85% in TKI-naïve patients. The median duration of response (DOR) was not yet reached for either trial, based on a cutoff date that is nearly five months later than that of the pooled TRUST-I and TRUST-II analysis published in April in the Journal of Clinical Oncology. For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and ongoing. For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and ongoing as of October 2024. Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label. Across the pivotal studies, consistent results were also observed among patients who were previously treated with a ROS1 TKI (TKI-pretreated). In TRUST-I, treatment with IBTROZI achieved a cORR of 52% and median DOR of 13.2 months for TKI-pretreated patients, with median follow-up for responses of 33 months. In TRUST-II, treatment with IBTROZI achieved a cORR of 62%, and as of October 2024 the median DOR was 19.4 months in these patients, with a median follow-up for responses of 19 months. Brain metastases are among the most common and devastating complications in advanced ROS1+ NSCLC. IBTROZI was designed to penetrate the central nervous system (CNS) and has demonstrated consistent intracranial responses in patients with measurable brain metastases at baseline. An intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24). "Patients living with advanced ROS1+ non-small cell lung cancer and their healthcare providers are in need of new treatment options," added Nathan Pennell, M.D., Ph.D., TRUST study investigator and Professor of Medicine at the Cleveland Clinic. "IBTROZI's durability of response and ability to effectively penetrate the brain, coupled with a well-characterized and manageable safety profile, further addresses these critical needs for patients. I believe this now-approved therapy offers providers and patients a promising new option for the treatment of advanced ROS1+ non-small cell lung cancer." Dr. Pennell is a compensated member of Nuvation Bio's advisory committee. IBTROZI was generally well-tolerated, with most adverse events being low grade, transient and manageable. Patients infrequently (7%) discontinued treatment due to treatment-emergent adverse events (TEAEs). The most common adverse reactions (≥20%) included diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). Overall, the majority of CNS events were mild to moderate (~90%) and resolved within days, and dose modifications due to these events were low (~5%). Approximately 90% of reported cases of dizziness were Grade 1 (mild) and transient. Liver enzyme elevations (AST 87%/ALT 85%) and QT prolongation (19%) were manageable with standard monitoring and dose modifications. IBTROZI is approved as a 600 mg once-daily oral dose, supported by a half-life of approximately 66 hours and broad tissue distribution, including the brain, enabling sustained systemic and CNS exposure. Nuvation Bio also announced the launch of NuvationConnect, a program designed to support patients prescribed IBTROZI. The program will offer financial assistance, access to resources and personalized support for eligible patients. Prescribers can learn more at or by calling 1-877-NUV-CON1 (1-877-688-2661). Conference Call & Business Update Nuvation Bio will host a conference call on June 12, 2025 at 7:30 a.m. EDT / 4:30 a.m. PDT, where company executives will provide an overview of the FDA approval of IBTROZI and our plans to now bring this medicine to patients. As a reminder to investors, the approval, together with the first commercial sale, makes the funding secured from Sagard Healthcare Partners in March fully available to the company. Nuvation Bio expects that this finances the launch of IBTROZI in full and provides further resources to continue advancing our pipeline in areas of unmet need. Investors and the general public are invited to register and listen to a live webcast of the event through the company website at Those unable to register can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access code 783971. A replay of the event will be available shortly after the conclusion. About ROS1+ NSCLC Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing CNS metastases. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options. About IBTROZI IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive non-small cell lung cancer. Learn more at About the TRUST Clinical Program The TRUST clinical program evaluating IBTROZI for the treatment of adult patients with advanced ROS1+ NSCLC included two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, which enrolled 173 patients, and TRUST-II (NCT04919811), a global study, which enrolled 164 patients. The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, duration of response, progression-free survival, and safety. Indication IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZITM (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc. Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman. ADVERSE REACTIONS Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes IBTROZI (taletrectinib), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, our expectations regarding IBTROZI's therapeutic potential in advanced ROS1+ NSCLC and its potential to become a new standard of care. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 7, 2025 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. View source version on Contacts Media and Investor ContactsNuvation Bio Investor Contact ir@ Nuvation Bio Media Contact media@ 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
Medscape
06-06-2025
- Health
- Medscape
Surgery Before or After Chemo for Advanced Ovarian Cancer?
The optimal timing of surgery in patients with resectable advanced ovarian cancer remains controversial. Should these patients receive the standard radical surgery followed by chemotherapy, or could patients do better with chemotherapy before surgery? The long-awaited TRUST trial aimed to settle this question, but the results paint a somewhat mixed picture. Among patients with resectable stage IIIB-IVB ovarian cancer, primary cytoreductive surgery followed by chemotherapy led to a statistically significant 2.4-month median progression-free survival (PFS) benefit over neoadjuvant chemotherapy followed by interval cytoreductive surgery. While the median overall survival was 6 months longer in the upfront surgery group, the difference was not statistically significant. Patients in both groups reported similar quality of life over a 3-year period on a global health survey. 'TRUST is the first randomized controlled trial to show a significant benefit in median PFS without compromising short- or long-term quality of life,' said lead investigator Sven Mahner, MD, with Ludwig Maximilian University Hospital, Munich, Germany, who presented the results at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. Mahner called the PFS and overall survival findings in the upfront surgery group 'excellent' but acknowledged that the primary endpoint of significant overall survival was not met. ASCO discussant Emma Barber, MD, gynecologic oncologist with Northwestern Memorial Hospital, Chicago, was less enthusiastic about the benefits of upfront surgery, given the lack of significant overall survival benefit. Additionally, the upfront surgery group had a higher rate of any complication and more than a twofold higher rate of stoma formation. 'There is upfront toxicity with primary debulking surgery compared to neoadjuvant chemotherapy — even in the highest quality surgical centers,' she said. TRUST Rationale The aim of surgery in advanced ovarian cancer is to prolong patients' remission and improve overall survival while sustaining quality of life, said Mahner. Primary cytoreductive surgery followed by chemotherapy has been considered standard for decades in this patient population. However, there's an alternative strategy — neoadjuvant chemotherapy followed by interval cytoreductive surgery. Several trials have compared upfront surgery with upfront chemotherapy, but limitations in these studies have not helped answer which approach is better. TRUST was designed to evaluate the optimal timing of cytoreductive surgery in patients with resectable advanced ovarian cancer who are fit enough to tolerate radical surgery. Patients received care in cancer centers that used defined surgical quality assurance metrics. Quality criteria were based on the European Training Centre in Gynaecological Oncology certification and included evaluations of cytoreductive surgery in the operating room as well as assessments of surgical proficiency and infrastructure. In addition, participating centers had to have high complete resection rates (at least 50% in upfront surgery for patients with FIGO IIIB-IVB) and high surgical volumes (at least 36 cytoreductive surgeries per year). Patients were randomly assigned and stratified by center and age-Eastern Cooperative Oncology Group (ECOG) combination (ECOG 0 and age ≤ 65 years vs ECOG > 0 and age older than 65 years) to either primary cytoreductive surgery followed by six cycles of intravenous chemotherapy (n = 345) or three cycles of neoadjuvant chemotherapy followed by interval cytoreductive surgery plus three more cycles of chemotherapy (n = 343). Most patients had FIGO stage IIIc disease, and over 90% had high-grade serous histology. Surgical effort was very high in both treatment groups; the median duration of surgery was 5.5 hours in the primary cytoreductive surgery group and 4.5 hours in the interval cytoreductive surgery group, Mahner noted. High surgical effort led to high complete resection rates — 70% in the primary group and 85% in the interval group — which meant the recommended systemic treatment of carboplatin and paclitaxel could be given in more than 90% of the patients, with a considerable number of patients also receiving bevacizumab or a PARP inhibitor during the course of their disease, Mahner said. Survival Outcomes Overall, 219 (64%) PFS events occurred in the primary cytoreductive surgery group and 253 (74%) in the neoadjuvant chemotherapy group. Median PFS after primary surgery was 22.1 months compared to 19.7 months after interval surgery — a 2.4-month benefit (hazard ratio [HR], 0.80; P = .018). The researchers also conducted a restricted mean survival analysis and found PFS was 31.7 months with primary surgery compared to 26.6 months with neoadjuvant chemotherapy — a 5.1-month benefit ( P = .07). On the overall survival front, the primary surgery group had a 6-month benefit, but the difference was not significant — median overall survival was 54.3 months with primary surgery compared to 48.3 months with interval surgery (HR, 0.89; P = .24). Careful Patient Selection Necessary In subgroup analyses, patients with complete cytoreduction after primary surgery had the best outcomes, with a median PFS of 27.9 months vs 21.8 months with interval surgery (HR, 0.69; P = .0009) and median overall survival of 67.0 months vs 55.0 months (HR, 0.80; P = .0521). In addition, the benefit of primary cytoreductive surgery was most prominent in stage III patients with a median PFS of 26.3 months vs 21.4 months (HR, 0.73; P = .005) and a median overall survival of 63.7 months vs 53.2 months, respectively (HR, 0.84; P = .14). However, patients with stage IV disease did not benefit more from upfront surgery in PFS (HR, 1.01; 95% CI, 0.74-1.38) or overall survival (HR, 0.97; 95% CI, 0.71-1.33). Mahner also noted that 5 years after randomization, 23% of the patients who had primary surgery had no disease progression compared to 11% of the patients who had interval surgery. The complication rate was higher in the primary surgery group at 18% vs 12% after interval surgery. The 30-day post-operative mortality rate was less than 1% in both treatment groups. Patients in both groups reported similar quality of life outcomes. Barber noted that the data suggest that some populations may benefit more from upfront surgery and others may not. 'For example, patients with stage IV disease clearly do not seem to benefit, whereas those with stage III disease seem to show a trend towards improved survival,' she explained. Given the higher upfront toxicity associated with primary debulking surgery, 'selection for primary debulking surgery instead of neoadjuvant chemotherapy should be considered carefully and performed for selected populations,' Barber said.
