On October 20, 2025 Remegen reported a Phase III clinical study on disitamab vedotin plus toripalimab versus chemotherapy as first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma (RC48-C016) was presented at the Presidential Symposium by Professor Jun Guo from Beijing Cancer Hospital at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. It’s the first time a research led by Chinese scholars in the field of urological oncology has ever been selected in this honorable session. The full manuscript was simultaneously published online in The New England Journal of Medicine (NEJM). This marks the first time that the results of a Chinese evidence-based medical research in the field of urothelial carcinoma have been recognized by both an authoritative international academic conference and a top-tier journal.

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The results showed that the RC48-C016 study met the dual primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS). The Blinded Independent Central Review (BICR)-assessed median PFS reached 13.1 months, and the median OS reached 31.5 months, demonstrating both statistical and clinical significance.

The RC48-C016 trial is by now the only randomized controlled study from China providing high-level evidence for HER2-ADC as a first-line treatment of HER2-expressing (IHC 1+/2+/3+) locally advanced/metastatic urothelial carcinoma (la/mUC). The results garnered high attention and sparked lively discussion among global scholars upon release.

Comprehensive Superiority: Meeting Both PFS and OS Primary Endpoints

On the afternoon of October 19 (local time), a pivotal moment arrived at the ESMO (Free ESMO Whitepaper) Congress: Professor Guo Jun, the principal investigator of the RC48-C016 study, delivered a featured oral presentation at the Presidential Symposium, unveiling the breakthrough results globally for the first time.

The RC48-C016 study is a randomized controlled, multi-center, phase III clinical trial. It compares the efficacy and safety of disitamab vedotin combined with toripalimab versus gemcitabine combined with cisplatin or carboplatin in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who have not received systemic treatment and have HER2 expression (HER2 IHC 1+/2+/3+). The study was initiated in June 2022, with 76 clinical research centers across the country participating, and a total of 484 patients were enrolled. The dual primary endpoints of the study are PFS and OS, and the secondary endpoints include objective response rate (ORR), disease control rate (DCR), and safety, etc.

Results as of March 31, 2025, showed:

Regarding PFS, the median PFS in the disitamab vedotin combination group reached 13.1 months, more than doubling the 6.5 months in the chemotherapy group and reducing the risk of disease progression or death by 64% (Hazard Ratio [HR] =0.36, 95% CI: 0.28 – 0.46, P < 0.0001).
The OS data were equally exciting. In this interim survival analysis, the median OS in the disitamab vedotin combination group was 31.5 months, compared to 16.9 months in the platinum-based chemotherapy group. The delayed disease progression has been well translated into long-term survival benefit as the overall survival time almost doubled as compared to chemotherapy, with a 46% reduction in the risk of death (HR = 0.54, 95% CI: 0.41 – 0.73, P < 0.0001).
Regarding tumor response, the ORR assessed by BICR reached 76.1% in the disitamab vedotin combination group, far exceeding the 50.2% in the chemotherapy group. For disease control, the DCR in the disitamab vedotin combination group reached 91.4%, significantly higher than the 77.6% in the chemotherapy group.
In key subgroup analyses, significant improvements in median PFS and median OS were observed in the disitamab vedotin combination group compared to the platinum-based chemotherapy across subgroups, regardless of cisplatin eligibility, HER2 expression status, or primary tumor site.
Furthermore, the combination regimen demonstrated a better safety profile. The overall incidence of Grade ≥3 treatment-related adverse events was only 55.1% in the disitamab vedotin combination group, significantly lower than the 86.9% in the chemotherapy group.
"This is the world’s first large-scale Phase III randomized controlled clinical study in the first-line treatment of HER2-expressing Chinese mUC patients, which demonstrated that HER2-ADC combined with immunotherapy was superior to standard platinum-based chemotherapy, potentially establishing the combination therapy of disitamab vedotin and immunotherapy as the standard of care in the first-line treatment of advanced HER2-expressing mUC. This not only signifies that China’s innovative drug development is leading transformations in cancer treatment globally but also provides critical rationale for exploring similar combination strategies in treating other cancers." As Professor Guo Jun commented, the result of the RC48-C016 study confirmed that the efficacy of disitamab vedotin + toripalimab combination regimen surpassed that of traditional chemotherapy as first-line treatment for advanced mUC, potentially marking a major shift in the treatment landscape for urothelial carcinoma. It promotes innovation in Chinese diagnostic and treatment pathways while providing valuable evidence for global clinical practice.

During the subsequent expert commentary session, Professor Andrea Necchi from Italy’s IRCCS San Raffaele Hospital spoke highly of RC48-C016 study. He pointed out that the study represents a significant breakthrough in the treatment of HER2-positive urothelial carcinoma. Compared to chemotherapy, the combination therapy of disitamab vedotin and toripalimab significantly improves patients’ PFS and OS, demonstrating substantial statistical significance and clinical value, thereby offering a novel treatment option for this patient population.

Precision Treatment, Benefiting the Full Spectrum of HER2-Expressing Population (IHC 1+/2+/3+)

Urothelial carcinoma is the most common malignant tumor of the urinary system, representing a significant area of clinical unmet need.

Chinese researchers have been at the forefront of exploring HER2-ADC therapy for UC. The HER2-ADC disitamab vedotin was first approved in China in 2021 for the treatment of HER2-overexpressing (IHC 2+/3+) advanced or metastatic urothelial carcinoma, demonstrating excellent efficacy and consistent safety with that observed in prior clinical trials.

RC48-C016 study prospectively extended its clinical design to the full HER2-expressing population (IHC 1+/2+/3+). Among 765 patients tested for HER2, 632 patients had HER2-expressing characteristics (IHC 1+/2+/3+), accounting for approximately 82.6% of the tested population. The study enrolled 484 patients, who were randomized in a 1:1 ratio to groups. Stratification factors were pre-specified in the study design, primarily including cisplatin eligibility, HER2 expression status (IHC 1+ vs. IHC 2+/3+), and presence of visceral metastasis.

The results showed that the efficacy observed in the disitamab vedotin plus toripalimab regimen were consistent across all pre-specified subgroups. Regardless of HER2 expression status, cisplatin eligibility, or whether the tumor originated in the upper or lower urinary tract, disitamab vedotin combined with toripalimab significantly improved PFS and OS compared to chemotherapy, robustly demonstrating its benefit for the full demonstrating its benefit for the full HER2-expressing population (IHC 1+/2+/3+) with urothelial carcinoma.

"The significant survival benefit achieved by disitamab vedotin combined with toripalimab is not subject to the level of HER2 expression or cisplatin eligibility status, delivering benefit to populations with different characteristics," Professor Guo Jun stated, noting that its benefit for the full HER2-expressing population (IHC 1+/2+/3+) is one of the most groundbreaking findings of this study.

Disitamab Vedotin Combined with Immunotherapy, Establishing a New Benchmark in UC First-Line Treatment

Undoubtedly, RC48-C016 study is a milestone in the global first-line treatment landscape for advanced urothelial carcinoma, signifying a fundamental shift in the treatment paradigm for HER2-expressing patients:

Firstly, RC48-C016 study is the world’s first Phase III head-to-head trial to demonstrate that the combination of HER2-ADC and immunotherapy is significantly superior to traditional platinum-based chemotherapy in the first-line treatment of HER2-expressing (IHC 1+/2+/3+) advanced urothelial carcinoma. The release of its outstanding data on PFS, OS, ORR, and safety provides strong decision-making basis for clinicians, which will promote this combination to become a new first-line treatment standard for Chinese mUC patients and is expected to rewrite clinical guidelines.

Secondly, the study successfully implements the concept of precision medicine in urothelial carcinoma based on significant biomarker characteristics. By extending the beneficiary population from the traditional HER2-high (IHC 2+/3+) to the full HER2-expressing (IHC 1+/2+/3+) population, it enables over 80% of urothelial carcinoma patients to potentially benefit significantly from this treatment regimen. In the current clinical practice in China where HER2 routine detection in urothelial carcinoma has been achieved, the study provides a preferred precise treatment plan for the majority of patients and precise basis for anti-HER2 treatment, promoting a comprehensive upgrade in the global treatment concept and strategy for urothelial carcinoma and leading the continuous exploration of this combination therapy in different disease stages of urothelial carcinoma.

Thirdly, this combination regimen substantially reduces the toxicity associated with traditional platinum-based chemotherapy, significantly improving patient treatment tolerance and compliance, and providing a foundation for subsequent continuous therapy, achieving an optimized balance between tumor control, long-term survival, and quality of life.

Since its marketing four years ago, disitamab vedotin, relying on its outstanding efficacy, has achieved a progress from late-line to first-line treatment in the field of urothelial carcinoma, comprehensively breaking through the bottlenecks of traditional chemotherapy and continuously expanding the boundaries of its clinical value. The revelation of RC48-C016 study data once again demonstrates its huge clinical treatment potential.

Based on the breakthrough results of the RC48-C016 study, RemeGen Co., Ltd. submitted a New Drug Application (NDA) in China in July of this year for the new indication of disitamab vedotin combined with toripalimab for the first-line treatment of HER2-expressing locally advanced or metastatic urothelial carcinoma. This will not only address domestic clinical needs but also holds the potential to become a "Chinese Solution" influencing the global treatment landscape.

It is believed that with extended follow-up, disitamab vedotin will continue to yield clinical benefit data for broader treatment prospects.

(Press release, RemeGen, OCT 20, 2025, View Source;disitamab-vedotin-achieves-major-breakthrough-as-first-line-treatment-for-urothelial-carcinoma-302588752.html [SID1234656833])

On October 20, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that the results from the Phase III registrational clinical study OptiTROP-Lung04—led by Professor Zhang Li’s team from Sun Yat-sen University Cancer Center—were published in the New England Journal of Medicine (Impact Factor = 78.5). The study evaluated the efficacy and safety of the TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) monotherapy versus pemetrexed plus platinum chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed failed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy. The study was also selected as a Late-Breaking Abstract (LBA) at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and was presented as an oral report in the Presidential Symposium (Presentation # LBA5).

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OptiTROP-Lung04 is a randomized, open-label, multicenter Phase III study designed to evaluate the efficacy and safety of sac-TMT monotherapy versus pemetrexed plus platinum in patients with EGFR-mutated locally advanced or metastatic NSCLC who had progressed on prior EGFR-TKI therapy. Eligible patients were those with histologically and/or cytologically confirmed disease. The primary endpoint was Progression-Free Survival (PFS) assessed by a Blinded Independent Review Committee (BIRC) per RECIST v1.1, and the key secondary endpoint was overall survival (OS). Results showed that compared with platinum-based doublet chemotherapy, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in both PFS and OS. Consistent PFS and OS benefits were observed across all prespecified subgroups, including prior EGFR-TKI therapy, presence of liver or brain metastases, and EGFR mutation subtype.

Based on the positive results of the OptiTROP-Lung04 study, sac-TMT has been approved by the National Medical Products Administration (NMPA) in China for the treatment of adult patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have progressed after EGFR-TKI therapy. To date, sac-TMT monotherapy remains the only approved treatment option for advanced EGFR-mutant NSCLC patients who have progressed after prior TKI therapy, as well as those who have progressed after prior TKI and platinum-based chemotherapy (either concurrently or sequentially). This achievement provides comprehensive coverage for the entire population of TKI-resistant patients.

Dr. Michael Ge, Chief Executive Officer of Kelun-Biotech, commented: "OptiTROP-Lung04 is a key study that propels sac-TMT from late-line to an earlier-line treatment-setting in lung cancer, achieving a significant improvement in overall survival. We are thrilled that the results have been published in The New England Journal of Medicine, allowing this important finding to be shared widely among medical professionals and providing a reference for future lung cancer research. Together with our partner MSD, we will continue to advance sac-TMT’s clinical development and regulatory approvals, covering broader lung cancer and other indications, with the goal of making sac-TMT a cornerstone therapy for the benefit of patients."

Professor Shengxiang Ren from the Department of Oncology at Shanghai Pulmonary Hospital, Tongji University, stated: "The application of third-generation EGFR-TKIs has significantly improved the overall prognosis for patients with advanced EGFR-mutant NSCLC. However, drug resistance is almost inevitable. Traditional treatment after resistance involves platinum-based doublet chemotherapy, which offers limited overall benefit. In recent years, regimens of chemotherapy plus immune checkpoint inhibitors+anti-angiogenic agents, or EGFR/c-Met bsAb, or PD-1/VEGF bsAb, have been successively approved for this indication. However, all these approaches are chemotherapy-based, highlighting an urgent need to explore novel treatment regimens. The OptiTROP-Lung04 study confirms sac-TMT as the first treatment option as a monotherapy to deliver clear dual benefits in both PFS and OS following EGFR-TKI progression. The sequential application of sac-TMT prior to chemotherapy demonstrates strong competence, establishing itself as a new standard of care for patients with advanced EGFR-mutant lung cancer after TKI resistance."

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases the payload KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, three indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting), EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy and EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC who progressed after treatment with EGFR-TKI therapy. Sac-TMT is the first TROP2 ADC drug approved for marketing in lung cancer globally. In addition, the new indication application for sac-TMT for the treatment of adult patients with unresectable locally advanced, metastatic hormone receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting was accepted by the Center for Drug Evaluation of the NMPA, and was included in the priority review and approval process.

As of today, the Company has initiated 9 registrational clinical studies in China. MSD has initiated 15 ongoing Phase Ⅲ global clinical studies of sac-TMT as a monotherapy or with pembrolizumab1 or other anti-cancer agents for several types of cancer. These studies are sponsored and led by MSD.

(Press release, Kelun, OCT 20, 2025, View Source [SID1234656832])

On October 20, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, and the University of Oxford, reported that positive long-term results from an extended registry follow-up of the SYMPLIFY study will be presented on Oct. 21 at the Early Detection of Cancer Conference (EDCC) in Portland, Oregon.

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SYMPLIFY, a prospective observational study, is the first large-scale evaluation of a multi-cancer early detection (MCED) test in individuals who presented with symptoms to primary care and were referred for diagnostic follow-up for suspicion of cancer. In SYMPLIFY, the Galleri test was used to assess blood samples from more than 6,000 participants with symptoms of cancer who followed standard diagnostic pathways. However, as a non-interventional study, the results of the tests were unknown to physicians and did not inform the approach to diagnosis. No MCED results were returned to participants or their clinicians during the study.

"The conversion of false positive results to cancer diagnosis in this updated analysis of the SYMPLIFY study highlights the importance of proactive follow-up on positive MCED results, as one third of the apparent false positive results were actually cancers the standard-of-care diagnostic process couldn’t immediately identify," said Brian D. Nicholson, MRCGP, DPhil, Associate Professor at the Nuffield Department of Primary Care Health Sciences, University of Oxford, United Kingdom and co-lead investigator of the study. "Additionally, the results underscore the value of Galleri’s Cancer Signal Origin prediction, which aligned with the eventual diagnosis in almost all of the cases initially considered to be false positives. We are pleased to present these data at EDCC and have submitted this analysis for full publication."

Previous SYMPLIFY results showed potential of MCED testing in people with symptoms suggestive of cancer

Most people diagnosed with cancer visit primary care with symptoms before diagnosis1. Many of these people report common, non-specific symptoms such as bloating, unexplained weight loss or abdominal pain, which can be attributed to various conditions as well as cancer2.

The primary analysis of the SYMPLIFY study, previously published in The Lancet Oncology, supported the feasibility of using the Galleri test to assist clinicians with decisions regarding referral from primary care. In that analysis, which followed participants until diagnostic resolution or up to nine months, Galleri’s positive predictive value (PPV) was 75.5%. When a cancer signal was detected, the test accurately predicted the Cancer Signal Origin (CSO) in 84.8% of cases.

Updated results demonstrate importance of continued follow-up after a cancer signal is detected

Patients reported to have a false positive Galleri result were followed for 24 months in national cancer registries for England and Wales. The analysis showed that 35.4% (28 of 79 participants) were later diagnosed with cancer within 24 months of enrollment. This reduction in false positives from 79 to 51 resulted in an increase of PPV to 84.2%. In aggregate, 27 of these 28 participants had a correct CSO prediction which could have led to a faster or more efficient diagnosis. In more than half of these cases, the cancer type diagnosed was not congruent with the original diagnostic clinic to which the patient was referred by the general practitioner based on the clinical presentation:

16 of the 28 (57.1%) were diagnosed with cancer within nine months of enrollment.
Eight of the 16 (50%) were diagnosed with cancers that were correctly predicted by the Galleri test’s CSO finding, but were incongruent with the diagnostic pathway chosen by the general practitioner based on the participants’ presenting symptoms.
12 of the 28 (42.9%) were diagnosed 10-24 months after enrollment.
Seven of the 12 (58.3%) were diagnosed outside the original referral pathway; in those cases, the CSO also was correct, matching the site that was ultimately diagnosed.
"The SYMPLIFY study, focused on patients presenting with symptoms, adds to the breadth of our clinical experience in asymptomatic populations. This robust data demonstrates the potential benefit of the Galleri test as a diagnostic tool for individuals presenting with symptoms of cancer, particularly where those symptoms are non-specific. The fact that, in all but one of the additional patients diagnosed with cancer, a Galleri CSO prediction correctly identified the cancer type, including in many cases where the symptoms were non-specific, further reinforces the value of the Galleri test’s CSO capability," said Sir Harpal Kumar, President, International Business & BioPharma at GRAIL. "Furthermore, the 24-month follow-up data being presented at EDCC underscore the importance of continued follow-up to help identify cancers that may initially be missed in diagnostic evaluation. These latest results add to the body of evidence that Galleri could support clinical decision-making in primary care for referral to urgent diagnostic investigations of cancer and drive more efficient use of diagnostic capacity."

About the SYMPLIFY Study
SYMPLIFY is a prospective multicentre observational study and represents the first large-scale evaluation of an MCED test in symptomatic patients who were referred from the primary care setting due to clinical suspicion of cancer. The study enrolled 6,238 patients, aged 18 years and older, in England and Wales who were referred for urgent imaging, endoscopy or other diagnostic modalities to investigate symptoms suspicious for possible cancer. Of the total enrolled patients, there were 5,461 evaluable patients who achieved diagnostic resolution. GRAIL’s MCED test was performed in batches, blinded to clinical outcome, and results were compared with the diagnosis obtained by standard of care pathways to assess the test’s performance.

The University of Oxford sponsored the SYMPLIFY study and was responsible for data collection, analysis and interpretation. The study was funded by GRAIL with support from National Health Service (NHS) England, NHS Wales, the National Institute for Health and Care Research (NIHR) and NIHR Oxford Biomedical Research Centre.

(Press release, Grail, OCT 20, 2025, View Source [SID1234656831])

On October 20, 2025 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported that it has entered into a securities purchase agreement for a private placement that is expected to result in gross proceeds of approximately $325.0 million, before deducting placement agents’ fees and other expenses.

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The private placement included the participation by new and existing institutional investors, including Deep Track Capital, Farallon Capital Management, Hims & Hers, Braidwell LP, three life sciences investment firms, and a tech and life sciences focused family office investment firm.

GRAIL currently expects to use the net proceeds from the private placement to fund its commercial activities and reimbursement efforts, as well as for working capital and other general corporate purposes.

GRAIL believes its cash, cash equivalents and investments, including the expected net proceeds from the private placement, will provide sufficient funding of planned operations into 2030, not including the previously announced agreement by Samsung C&T and Samsung Electronics to invest $110 million in the Company, subject to closing conditions.

Pursuant to the terms of the securities purchase agreement, GRAIL has agreed to issue and sell 4,639,543 shares of common stock (or pre-funded warrants in lieu thereof) at a price per share of $70.05 (or per pre-funded warrant in lieu thereof, less the nominal exercise price of $0.001 per share).The private placement is expected to close on October 21, 2025, subject to the satisfaction of customary closing conditions.

Morgan Stanley acted as lead placement agent and Goldman Sachs & Co. LLC acted as joint placement agent for the private placement.

The securities sold in this private placement, including the shares of common stock underlying the pre-funded warrants, have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. GRAIL granted registration rights to the purchasers in the private placement and has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock and the shares of common stock underlying the pre-funded warrants issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Grail, OCT 20, 2025, View Source [SID1234656830])

On October 20, 2025 MEDSIR, the leading international oncology research company, reported the positive results of its EMPRESS study, conducted in collaboration with Roche Farma. This is an international, multicenter Phase II trial that evaluates the potential benefit of the drug giredestrant, a potent oral selective estrogen receptor degrader (SERD), in premenopausal women with early-stage ER+/HER2- breast cancer.

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The results, presented at the congress during an oral session, demonstrated that giredestrant, administered as a single agent in the preoperative setting, shows greater activity compared to standard treatment with tamoxifen in slowing the proliferation of tumor cells. The study met its primary endpoint by showing that, after 15 days of treatment, patients receiving giredestrant experienced a significant reduction in the tumor proliferation marker Ki-67. This protein appears in cells when they are dividing, so its reduction indicates a positive response to treatment.

One of the most relevant findings of the study is that, for the first time, this reduction in tumor activity is achieved without suppressing the patient’s ovarian function. This suggests that giredestrant could represent a more effective oral therapeutic alternative to the current standard therapy, with the potential to improve patients’ quality of life by avoiding the adverse effects associated with ovarian suppression, which is typically performed with injections of luteinizing hormone-releasing hormone (LHRH) analogs.

"The results of the EMPRESS study are very promising, as they indicate greater activity of giredestrant compared to tamoxifen in slowing tumor proliferation, as measured by Ki-67," said Dr. Antonio Llombart-Cussac, principal investigator of the study, during the presentation. He also emphasized that "this study opens the door to exploring the potential use of giredestrant without ovarian function suppression in premenopausal women, which could significantly improve patients’ quality of life by avoiding the side effects associated with traditional treatment."

Theranostics: The Revolution in Oncology

As part of the congress and its commitment to international collaboration and innovation, MEDSIR held a new edition of its MEDTalks forum in Berlin, supported by Telix Pharma. During the event, the company brought together leading national and international oncology experts, including Dr. Matthias Preusser (Medical University of Vienna), Dr. Nathalie Albert (Ludwig Maximilian University of Munich), Dr. Christophe Deroose (KU Leuven), and Dr. Jaume Capdevila (Vall d’Hebron Institute of Oncology, VHIO). The goal of this edition was to explore the crucial role of theranostics in optimizing cancer research.

Under the title "Understanding the Challenge in Clinical Trials," the discussion addressed the importance of implementing this new approach in oncology, which combines imaging-based diagnosis with precision therapy. This therapeutic strategy benefits patients in more advanced stages with limited treatment options through the administration of a radiopharmaceutical—first to visualize the tumor (diagnosis) and then to treat it (therapy).

MEDSIR Reinforces Its Commitment to Breast Cancer at ESMO (Free ESMO Whitepaper) 2025

In addition to the oral presentation of EMPRESS results, MEDSIR’s active participation in the ESMO (Free ESMO Whitepaper) congress includes the poster presentation of the TELESCOPE study. This ongoing national phase II clinical trial, conducted in collaboration with pharmaceutical company Merck Sharp & Dohme, evaluates the addition of pembrolizumab to carboplatin and paclitaxel treatment during 12 weeks prior to surgery for patients with stage I triple-negative breast cancer. The goal is to assess the pathological complete response (pCR) rate to preoperative treatment.

(Press release, MedSIR, OCT 20, 2025, View Source;breast-cancer-at-early-stages-without-the-need-for-ovarian-function-suppression-302588871.html [SID1234656829])