Paclitaxel

Approval introduces the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS ≥1) RAHWAY, NJ, USA I June 13, 2025 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. The approval is based on data from the pivotal Phase 3 KEYNOTE-689 trial, the results of which were presented at the American Association for Cancer Research (AACR) Annual Meeting on April 27, 2025. At the trial’s first pre-specified interim analysis, KEYTRUDA before surgery (neoadjuvant), then continued after surgery (adjuvant) in combination with standard of care (SOC), RT with or without cisplatin, followed by KEYTRUDA alone, reduced the risk of event-free survival (EFS) events (defined as disease recurrence, disease progression, or death) by 30% (HR=0.70 [95% CI, 0.55–0.89]; p=0.00140) in patients whose tumors expressed PD-L1 (CPS ≥1) compared to adjuvant SOC. Among the CPS ≥1 population, median EFS was 59.7 months (95% CI, 37.9-not reached) in the KEYTRUDA arm versus 29.6 months (95% CI, 19.5-41.9) in the SOC arm. “The introduction of KEYTRUDA as a perioperative treatment option for certain patients with resectable locally advanced head and neck squamous cell carcinoma represents a potentially significant shift in how we manage this disease,” said Dr. Ravindra Uppaluri, the study’s overall principal investigator, director of Head and Neck Surgical Oncology, Brigham and Women’s Hospital and Dana-Farber Cancer Institute. “With this approval, we can now offer appropriate patients with resectable locally advanced head and neck squamous cell carcinoma a new treatment regimen that has been shown to reduce the risk of recurrence, progression, or death by 30%, compared with standard of care adjuvant chemoradiotherapy or radiotherapy alone.” Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, other transplant (including corneal graft) rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below. “As the first perioperative anti-PD-1 treatment option for appropriate patients with resectable locally advanced head and neck squamous cell carcinoma, this new treatment regimen has the potential to shift the treatment paradigm for patients and their families affected by this disease,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “Based on these trial results, KEYTRUDA as part of this regimen shows potential to change long-standing standards of care for treating certain patients with locally advanced HNSCC.” This approval was reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent review of oncology drugs among its international partners. Under Project Orbis, marketing authorization applications for KEYTRUDA based on the results of KEYNOTE-689 are under review by health authorities in Israel, Canada, Australia, Singapore, Brazil and Switzerland. Marketing Authorization Applications are also under review by regulatory authorities worldwide, including Europe and Japan. In the U.S., KEYTRUDA is currently approved as monotherapy and in combination regimens for certain patients with recurrent or metastatic HNSCC as follows: Study design and additional data supporting the approval KEYNOTE-689 is a randomized, multicenter, open-label, active-controlled Phase 3 trial (ClinicalTrials.gov, NCT03765918 ) evaluating KEYTRUDA as neoadjuvant treatment, continued as adjuvant treatment in combination with standard of care (SOC), radiotherapy (RT) with or without cisplatin, then as a single agent in patients with resectable locally advanced (Stage III-IVA) head and neck squamous cell carcinoma (HNSCC). Patients with active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible. Randomization was stratified by primary tumor site (oropharynx/oral cavity vs. larynx vs. hypopharynx), tumor stage (III vs. IVA) and PD-L1 status (Tumor Proportion Score [TPS] ≥ 50% vs. TPS<50%). The study enrolled 714 patients who were randomized 1:1 to receive: On both treatment arms, patients received cisplatin with adjuvant RT if high-risk pathological features (i.e., positive margins <1 mm or extranodal extension) were present at surgery. Treatment with KEYTRUDA continued until disease progression by RECIST v1.1 per BICR during the neoadjuvant phase that precluded surgery, local or metastatic recurrence during the adjuvant phase, completion of treatment, or unacceptable toxicity. Assessment of tumor status was performed prior to surgery at Week 6 in the neoadjuvant phase. Following the start of the adjuvant phase, assessment of tumor status was performed 12 weeks after end of RT with or without cisplatin treatment and then every three months until the end of Year 3; then every six months thereafter up to the end of Year 5. The trial was not designed to isolate the effect of KEYTRUDA in each phase (neoadjuvant or adjuvant) of treatment. The major efficacy outcome measure was event-free survival (EFS) by BICR defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precluded definitive surgery, local or distant disease progression or recurrence, or death due to any cause. Among the CPS ≥1 population, at the time of the first pre-specified interim analysis, the EFS hazard ratio (HR) was 0.70 (95% CI, 0.55-0.89; p=0.00140) and the number of events was 128 (37%) in the KEYTRUDA arm versus 156 (47%) in the SOC arm. In an exploratory subgroup analysis of patients with PD-L1-positive (Combined Positive Score [CPS] ≥1) hypopharyngeal tumors who were randomized (n=51), the EFS HR was 2.28 (95% CI, 0.79-6.56). Additional efficacy outcome measures were major pathological response (mPR) as assessed by BIPR, and overall survival (OS). While OS results were not mature at this interim analysis, with 76% of pre-specified OS events in the CPS ≥1 population, no trend towards a detriment was observed. The most common adverse reactions (≥ 20%) on the KEYTRUDA arm were stomatitis (48%), radiation skin injury (40%), weight loss (36%), fatigue (33%), dysphagia (29%), constipation (27%), hypothyroidism (26%), nausea (24%), rash (22%), dry mouth (22%), diarrhea (22%), and musculoskeletal pain (22%). The median duration of exposure to KEYTRUDA in the neoadjuvant phase was 3.1 weeks (range: 1 day to 4.9 weeks). The median duration of exposure to KEYTRUDA in the adjuvant phase was 42 weeks (range: 1 day to 82 weeks). Of the 361 patients who received KEYTRUDA as neoadjuvant treatment, 11% (n=38) did not receive surgery. Of the 351 patients randomized to SOC, 12% (n=43) did not receive surgery. In the adjuvant phase of the KEYTRUDA arm, 100 patients received KEYTRUDA and cisplatin with concurrent RT while 154 patients received KEYTRUDA alone with concurrent RT. In the SOC arm, 139 patients received cisplatin with concurrent RT while 136 patients received RT alone. For the KEYTRUDA arm, a total of 222 patients received single-agent KEYTRUDA following RT. Of the 361 patients who received at least one dose of single agent KEYTRUDA as neoadjuvant treatment, 11% of patients experienced serious adverse reactions. Serious adverse reactions that occurred in more than one patient were pneumonia (1.4%), tumor hemorrhage (0.8%), dysphagia (0.6%), immune mediated hepatitis (0.6%), cellulitis (0.6%), and dyspnea (0.6%). Of the 255 patients who received at least one dose of KEYTRUDA in the adjuvant phase, 38% experienced serious adverse reactions. The most frequent serious adverse reactions reported in ≥1% of KEYTRUDA-treated patients were pneumonia (2.7%), pyrexia (2.4%), stomatitis (2.4%), acute kidney injury (2.0%), pneumonitis (1.6%), COVID-19 (1.2%), death not otherwise specified (1.2%), diarrhea (1.2%), dysphagia (1.2%), gastrostomy tube site complication (1.2%), and immune-mediated hepatitis (1.2%). About head and neck cancer Head and neck cancer describes a number of different tumors that develop in or around the throat, larynx, nose, sinuses and mouth. In the U.S., it is estimated there will be approximately 72,680 new cases of head and neck cancer diagnosed and more than 16,680 deaths from the disease in 2025. These data include cancers of the oral cavity, pharynx and larynx. Most head and neck cancer is squamous cell carcinoma which begins in the flat, squamous cells that make up the thin mucosal lining of the head and neck. Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is cancer that has spread from where it started to nearby tissue or lymph nodes but has not yet spread to distant parts of the body. There are several factors that greatly increase the risk of developing head and neck cancer, including tobacco and alcohol use and human papillomavirus (HPV). About KEYTRUDA ® (pembrolizumab) injection, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Head and Neck Squamous Cell Cancer KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA approved test. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. About the Merck Access Program for KEYTRUDA At Merck, we are committed to supporting accessibility to our cancer medicines. Merck provides multiple programs to help appropriate patients who are prescribed KEYTRUDA have access to our anti-PD-1 therapy. The Merck Access Program provides reimbursement support for patients receiving KEYTRUDA, including information to help with out-of-pocket costs and co-pay assistance for eligible patients. More information is available by calling 855-257-3932 or visiting www.merckaccessprogram-keytruda.com . About Merck’s Patient Support Program for KEYTRUDA Merck is committed to helping provide patients and their caregivers support throughout their treatment with KEYTRUDA. The KEY+YOU Patient Support Program provides a range of resources and support. For further information and to sign up, eligible patients may call 85-KEYTRUDA (855-398-7832) or visit www.keytruda.com . Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit http://www.merck.com.libproxy1.nus.edu.sg/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck

CLEVELAND, June 13, 2025 /PRNewswire/ -- Primary Investigator, Bernardo Cortese MD, proudly announces the successful completion of patient enrollment in the TRANSFORM II randomized controlled trial (RCT). This pivotal study aims to evaluate the safety and efficacy of the MagicTouch Sirolimus-Coated Balloon (SCB) compared to an everolimus-eluting stent (EES) in treating de-novo coronary vessels. Continue Reading Fondazione Ricerca e Innovazione Cardiovascolare Announces Completion of Patient Enrollment in TRANSFORM II RCT - A Landmark Global Study Comparing MagicTouch Sirolimus Coated Balloon with Drug Eluting Stent in Native Coronary Vessels TRANSFORM II (Sirolimus-Coated Balloon Versus Drug-Eluting Stent in Native Coronary Vessels) is an investigator-driven trial sponsored by Fondazione Ricerca e Innovazione Cardiovascolare in Milano, Italy, and has now achieved its target enrollment of >1,820 patients. The final patient was enrolled on 6th June 2025, marking a major milestone for the trial. Led by Study Chairman Prof. Bernardo Cortese (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA) and a distinguished steering committee, TRANSFORM II is one of the largest global randomized controlled trials evaluating drug-coated balloon and has enrolled patients from 52 centers across Europe, Asia and South America. Key features of the TRANSFORM II trial include: Comparative Arms: MagicTouch SCB vs. Everolimus-Eluting Stent (EES) Patient Population: 1,832 patients with de-novo lesions in coronary arteries (vessel diameter >2.0 mm to ≤3.5 mm; lesion length ≤50 mm) Primary Endpoint: Target Lesion Failure at 12 months, non-inferiority design Follow-Up: Patients will be monitored for up to 60 months (5 years) Sub-Study: Optical Coherence Tomography (OCT) imaging in 70 patients at 9 months to assess angiographic outcomes Prof. Bernardo Cortese, Study Chairman of TRANSFORM II, commented: "After 3 and a half years we were able to complete the enrollment in TRANSFORM II trial, a study that involved 52 centers across 3 continents, and this is amazing. The effort put by our Team in Fondazione RIC and each Investigator of the study led to a quite fast enrollment in such a big, ambitious study. Our goal is to advance the adoption of DCB in the coronary space, testing this sirolimus DCB with the most studied and used DES, in a daily patient population. Along with the guidance of the recently published DCB ARC guidelines, we are paving the route for the modern angioplasty era!". Coronary vessels of this size (which account for roughly 80% of patients undergoing percutaneous coronary interventions) present unique treatment challenges. Currently, interventional cardiologists must often choose a permanent implant namely a drug-eluting stent — effectively "caging" a small vessel — which may compromise long-term outcomes. The head-to-head comparison of MagicTouch SCB against a current standard of care (the EES family of drug-eluting stents) in TRANSFORM II is poised to provide critical evidence for an alternative approach. This trial has the potential to reshape treatment practices by establishing drug-coated balloons as the next viable option for patients with coronary artery disease. Drug-coated balloon technology has long been viewed as a promising solution for small, de-novo coronary lesions, and sirolimus is a viable alternative to the first generation of DCB eluting paclitaxel. Data from this large-scale RCT are expected to support a paradigm shift towards broader use of drug-coated balloons. Implanting a drug-eluting stent in a tiny artery is far from ideal for both patients and physicians, so a rigorous study validating the use of SCB was needed. TRANSFORM II is set to fulfill that need, with initial 12-month outcomes anticipated to shed light on the long-term benefits of avoiding permanent implants in coronary vessels. Dr. Manish Doshi, Founder & Managing Director of Concept Medical Group, commented: "The completion of patient enrollment in TRANSFORM II is a significant milestone in our mission to bring innovative drug-delivery technologies to the forefront of interventional cardiology. We are proud to scientifically support one of the largest global randomized trials evaluating sirolimus-coated balloon technology. This achievement reflects our commitment to clinical excellence, scientific rigor, and ultimately, better outcomes for patients around the world." About MagicTouch SCB The MagicTouch SCB, developed by Concept Medical Inc., utilizes proprietary Nanoluté technology to deliver sub-micron particles of sirolimus encapsulated in a biocompatible carrier, ensuring deep penetration into the vessel wall. The device has received CE Mark approval in Europe alongwith Breakthrough Device Designation & IDE Approval from the U.S. FDA for the treatment of small coronary vessels and in-stent restenosis with ongoing clinical trials. About Concept Medical Inc. Concept Medical Inc., headquartered in Tampa, Florida, has a global presence and is dedicated to enhancing patient care through cutting-edge research and development of drug-delivery technologies. Its proprietary platforms are designed to deliver pharmaceutical agents across vascular luminal surfaces with unparalleled precision. Concept Medical is the developer of the MagicTouch family of Sirolimus-Coated Balloons (SCB) – the world's first and most utilized SCB technology – well recognized for its versatility and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have been used to treat over a million patients globally, setting a new standard for vascular therapy. 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