Month: 2026-03

TOKYO, Mar 27, 2026 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and MSD K.K. (Headquarters: Tokyo, Representative Director: Prashant Nikam, “MSD”), a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, announced today that an application for LENVIMA® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, has been submitted in Japan for the additional dosage and administration in combination with WELIREG® (belzutifan), the first-in-class oral hypoxiainducible factor-2 alpha (HIF-2α) inhibitor from MSD, for the treatment of unresectable or metastatic renal cell carcinoma that has progressed after chemotherapy.This application is based on the results of the Phase 3 LITESPARK-011 trial evaluating the dual regimen of LENVIMA plus WELIREG for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-programmed death receptor-1 (PD-1)/ programmed death-ligand 1 (PD-L1) therapy. The data from this trial were presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium in February 2026. At a pre-specified interim analysis with a median follow-up of 29.0 months (range, 19.3-49.2), the LENVIMA plus WELIREG combination therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the primary endpoints, reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. The safety profile of this combination was consistent with those reported for each agent administered as monotherapy, and no new safety signals were identified.In 2022, approximately 435,000 people worldwide were newly diagnosed with kidney cancer, and about 156,000 people died from the disease. 1 In Japan, it is estimated that roughly 21,000 people were newly diagnosed and about 7,000 died in 2022.2 RCC accounts for approximately 85% of kidney cancers3, and the five-year survival rates for patients with stage III and IV RCC have been reported as 63%–78% and 27%–28%4, respectively, indicating that the disease still has a high unmet medical needs.LENVIMA is approved in combination with KEYTRUDA ® (pembrolizumab) in Japan for the first-line treatment of unresectable or metastatic RCC. WELIREG is approved in Japan for the treatment of unresectable or metastatic RCC that has progressed following cancer chemotherapy. Additionally, supplemental New Drug Applications (sNDA) for the LENVIMA and WELIREG combination therapy for the treatment of adult patients with advanced RCC with a clear cell component following a PD-1 or PDL1 inhibitor has been accepted by the U.S. Food and Drug Administration (FDA), with a PDUFA (Prescription Drug User Fee Act) target action date set for October 4, 2026.Eisai and MSD have been collaborating through the provision of information on LENVIMA in Japan since October 2018, and will work together to expedite the maximization of contribution to patients with cancer.About LENVIMA (lenvatinib)LENVIMA, discovered and developed by Eisai, is an orally available multiple receptor tyrosine kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). LENVIMA inhibits other kinases that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1- 4, the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. In syngeneic mouse tumor models, LENVIMA decreased tumor-associated macrophages, increased activated cytotoxic T cells, and demonstrated greater antitumor activity in combination with an anti-PD-1 monoclonal antibody compared to either treatment alone. LENVIMA has been approved for the indications below.Thyroid cancer- Indication as monotherapy(Approved mainly in Japan, the United States, Europe, China and Asia)Japan: Unresectable thyroid cancerThe United States: The treatment of patients with locally recurrent or metastatic, progressive, radioiodine-refractory differentiated thyroid cancer (DTC)Europe: The treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI)Hepatocellular carcinoma- Indication as monotherapy(Approved mainly in Japan, the United States, Europe, China and Asia)Japan: Unresectable hepatocellular carcinomaThe United States: The first-line treatment of patients with unresectable hepatocellular carcinoma (HCC)Europe: The treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy- Indication in combination with KEYTRUDA (generic name: pembrolizumab) and transarterial chemoembolization (Approved in China)Thymic carcinoma- Indication as monotherapy (Approved in Japan)Japan: Unresectable thymic carcinomaRenal cell carcinoma (In Europe other than the United Kingdom, the agent was launched under the brand name Kisplyx®)- Indication in combination with everolimus(Approved mainly in the United States, Europe and Asia) The United States: The treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapyEurope: The treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy- Indication in combination with KEYTRUDA(Approved mainly in Japan, the United States, Europe and Asia)Japan: Radically unresectable or metastatic renal cell carcinomaThe United States: The first-line treatment of adult patients with advanced renal cell carcinomaEurope: The first-line treatment of adult patients with advanced renal cell carcinomaEndometrial carcinoma- Indication in combination with KEYTRUDA(Approved mainly in Japan, the United States, Europe and Asia)Japan: Unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapyThe United States: The treatment of patients with advanced endometrial carcinoma that is pMMR or not microsatellite instability-high (MSI-H), 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 radiationEurope: The treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery.About WELIREG (belzutifan)WELIREG, Merck & Co., Inc., Rahway, NJ, USA’s, known as MSD outside of the United States and Canada, first-in-class hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, is an orally administered small-molecule designed to reduce transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth. By inhibiting HIF-2α signaling, WELIREG aims to disrupt key pathways certain tumors may use to adapt to low-oxygen conditions, including those that help promote abnormal blood vessel formation and support tumor survival. WELIREG has demonstrated antitumor activity in certain von Hippel-Lindau (VHL) diseaseassociated tumors, renal cell carcinoma and in pheochromocytoma or paraganglioma. As part of a broader clinical program, Merck & Co., Inc., Rahway, NJ, USA continues to research WELIREG monotherapy and combination approaches for people with genitourinary, breast and gynecologic cancers across a range of treatment settings to further define where HIF-2α inhibition may provide clinical benefit and to better understand which patients are most likely to respond. WELIREG has been approved in Japan for the treatment of certain von Hippel–Lindau (VHL) disease–associated tumors, as well as for unresectable or metastatic renal cell carcinoma that has progressed after chemotherapy.LITESPARK-011 ResultsData from LITESPARK-011 (ClinicalTrials.gov, NCT04586231) were presented at the ASCO GU Symposium held in February 2026. LITESPARK-011 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT04586231) evaluating WELIREG in combination with LENVIMA compared to cabozantinib for the treatment of patients with advanced clear cell RCC that has progressed on or after anti-PD-1/L1 therapy. The dual primary endpoints are progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as assessed by blinded independent central review (BICR), and overall survival (OS). Secondary endpoints include objective response rate (ORR) per RECIST v1.1 as assessed by BICR, duration of response (DOR) per RECIST v1.1 as assessed by BICR, and safety. The trial enrolled 747 patients who were randomized to receive WELIREG (120 mg orally once daily) plus LENVIMA (20 mg orally once daily) or cabozantinib (60 mg orally once daily).At a pre-specified second interim analysis with a median follow-up of 29.0 months (range, 19.3- 49.2), WELIREG plus LENVIMA demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS, reducing the risk of disease progression or death by 30% (HR=0.70 [95% CI, 0.59-0.84]; p=0.00007) compared to cabozantinib. For WELIREG plus LENVIMA, the median PFS was 14.8 months (95% CI, 11.2-16.6) versus 10.7 months (95% CI, 9.2-11.1) for cabozantinib. A trend toward improvement in overall survival (OS), the trial’s other primary endpoint, was also observed for WELIREG plus LENVIMA (HR=0.85 [95% CI, 0.68-1.05]; p=0.06075). The median OS was 34.9 months (95% CI, 27.5-NR) for WELIREG plus LENVIMA versus 27.6 months (95% CI, 24.0-31.4) for cabozantinib. The trial is continuing, and OS will be evaluated at a subsequent analysis per the clinical trial protocol. Regarding secondary endpoints, at the first interim analysis with a median follow-up of 19.6 months (range, 9.9-39.8), WELIREG plus LENVIMA met ORR, demonstrating a statistically significant improvement compared to cabozantinib. A confirmed ORR of 52.6% (95% CI, 47.3-57.7) was observed for WELIREG plus LENVIMA versus 39.6% (95% CI, 34.6-44.8) for cabozantinib. At the second interim analysis with a median follow-up of 29.0 months, the median DOR was 23.0 months (95% CI, 2.0-44.3+) for WELIREG plus LENVIMA versus 12.3 months (95% CI, 1.8+-35.9+) for cabozantinib. WELIREG plus LENVIMA was administered to 370 patients and cabozantinib was administered to 371 patients. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 71.6% of patients receiving WELIREG plus LENVIMA versus 65.8% of patients receiving cabozantinib. Adverse events led to treatment discontinuation in 11.1% of patients receiving WELIREG plus LENVIMA and in 11.3% of patients receiving cabozantinib, respectively. Serious adverse events were observed in 51.6% of patients receiving WELIREG plus LENVIMA versus 43.9% of patients receiving cabozantinib, and AEs led to death in 5.4% of patients (two were treatment-related: thrombotic microangiopathy [n=1] and pneumonitis [n=1]) versus 3.2% (one was treatment-related: hemoptysis [n=1]) of patients, respectively.About the Eisai and Merck & Co., Inc., Rahway, NJ, USA Strategic CollaborationIn March 2018, Eisai and Merck & Co., Inc., Rahway, NJ, USA through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, KEYTRUDA, and HIF-2α inhibitor, WELIREG.Eisai’s focus on cancerEisai acknowledges “Oncology” as one of its key strategic areas, and will continue to focus on the discovery and development of anti-cancer drugs within drug discovery domains including “microenvironment”, “protein integrity and homeostasis”, and “cell lineage and cell differentiation” under the Deep Human Biology Learning (DHBL) drug discovery and development organization. Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.6. About EisaiEisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept [also known as our human health care (hhc) Concept], we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners. For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia, and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X (U.S. and global), LinkedIn (for U.S. and EMEA) and Facebook (global).Merck & Co., Inc., Rahway, NJ, USA’s Focus on CancerEvery 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 https://www.merck.com/research/oncologyAbout MSDAt MSD (the name by which Merck & Co., Inc., Rahway, NJ, USA, is known 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.msd.co.jp and connect with us on Facebook, Twitter, and YouTube.Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, et al. (2024) Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf, accessed 27 Mar 2026.Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, et al. (2024) Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer, Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/392-japan-fact-sheet.pdf, accessed 27 Mar 2026.National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. 2025; 2026 Version 1. Rose TL and Kim WY. Renal cell carcinoma: a review. JAMA. 2024 Sep 24;332(12):1001– 10.Media InquiriesEisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120MSD K.K.Communications DivisionTatsuro MuraseTEL: +81 (0)70-8700-0112 Copyright 2026 JCN Newswire. All rights reserved. www.jcnnewswire.com

TOKYO, Mar 27, 2026 - (JCN Newswire) - Hitachi, Ltd. (TSE: 6501, “Hitachi”) and MUFG Bank, Ltd. (“MUFG Bank”), a consolidated subsidiary of Mitsubishi UFJ Financial Group, Inc. (TYO: 8306, “MUFG”) today announced a new Memorandum of Understanding (MoU) to expand NextGen, their business co-creation model. Building on their collaboration launched in May 2024*1 and further developed as announced in May 2025*2 , NextGen combines Hitachi’s technology and operational expertise with MUFG’s financial capabilities to accelerate the transition to decarbonized mobility.*1 MUFG’s Business Co-Creation and Investment into UK Battery as a Service project by Hitachi ZeroCarbon May 2024*2 Hitachi ZeroCarbon and MUFG unite technology expertise with financial support to accelerate fleet electrification May 2025NextGen was initially validated through a UK pilot project with First Bus, where the parties collaborated via a special purpose vehicle (SPV) to support the procurement and operation of electrification assets under a Battery-as-a-Service model. This expanded MoU extends NextGen beyond battery-focused structures, enabling broader and more scalable deployment across additional markets outside the UK and across a wider range of asset classes. These include emobility assets such as electric vehicles and charging infrastructure, associated energy management systems, and potentially extending to energy hubs supporting industrial assets, power grids and data centers.Hitachi and MUFG Bank will also develop and scale SPV structures to finance decarbonized mobility assets for fleet and transport operators. This approach removes capital constraints and accelerates implementation, enabling operators to focus on their core transport services. From Hitachi’s side, the initiative is led by its Strategic SIB Business Unit, bringing together expertise from across Hitachi including Hitachi Energy, as ‘One Hitachi’. Hitachi will also provide managed services for asset performance and lifecycle optimization, supported by data-driven solutions from Hitachi ZeroCarbon. Through this initiative, Hitachi aims to further advance and streamline mobility and charging infrastructure operations by expanding HMAX by Hitachi, a suite of next-generation solutions that embodies Lumada 3.0, differentiated by deep domain knowledge and AI.Electrifying commercial transport at pace will require an unprecedented deployment of vehicles, charging and energy infrastructure - alongside innovative financing models to support it. Global investment in electrified transport reached around US$750 billion in 2024, making it the largest segment of the energy transition worldwide*3 - yet many fleet operators face limited access to capital and the operational complexity of transitioning at scale. Against this backdrop, Hitachi and MUFG Bank aim to expand NextGen as a repeatable model to accelerate implementation by combining structured asset financing with managed services and data-driven optimization.*3 Sources: BloombergNEF’s Energy transition Investment Trends 2025In demonstration of the expanded pipeline, Hitachi ZeroCarbon and MUFG Bank have also entered into an MoU with Boreal Norge AS and its subsidiary Boreal Buss AS, one of Norway’s primary transport operators, providing transport services across several counties and employing around 3,000 employees across its fleet, which includes over 850 buses and 35 ferries. The parties will explore how they can support Boreal’s transition planning, de-risk operations, optimize services and strengthen competitiveness as concessions evolve.Jun Taniguchi, Senior Vice President and Executive Officer, CEO of Strategic SIB Business Unit, at Hitachi, Ltd. said:“We are delighted to advance this partnership which combines Hitachi’s deep expertise in social infrastructure and digital technologies with MUFG Bank, Ltd.’s financial strength to accelerate the transition to a decarbonized society. By improving the performance of assets such as batteries and charging infrastructure through Hitachi’s digital services led by HMAX, we can truly help customers optimize the total cost of ownership. This partnership embodies our One Hitachi approach, leveraging our diverse capabilities across the Group to support our customers in achieving their net-zero ambitions.”Masakazu Osawa, Senior Managing Executive Officer Chief Executive, Japanese Corporate & Investment Banking Business Unit of MUFG Bank, Ltd., said:“Building on MUFG’s Business Co‑Creation and Investment approach, this collaboration with Hitachi aims to create value through strategic partnerships that improve society and the environment. For the global EV market, our focus is not only on strengthening Hitachi’s leading position in Battery as a Service, but also on fostering a holistic value chain — including second‑ life battery markets — that supports the acceleration of electric mobility and the achievement of 2050 net‑zero targets. Together with our partners, we are committed to co‑creating sustainable businesses that become a driving force for progress worldwide.”Nikolai Knudsmoen Utheim, Group CEO, Boreal Norge AS said:“Our priority has always been to deliver first-class transport services to our customers, whether that’s on the road, rail or over water. In exploring how we can unlock the power of electrified fleets, we can not only deliver more sustainable operations, but upgrade our infrastructure and thread technology across our entire business model for more efficient, smart transport and energy management.”About Hitachi, Ltd.Through its Social Innovation Business (SIB) that brings together IT, OT (Operational Technology) and products, Hitachi contributes to a harmonized society where the environment, wellbeing, and economic growth are in balance. Hitachi operates globally in four sectors – Digital Systems & Services, Energy, Mobility, and Connective Industries – and the Strategic SIB Business Unit for new growth businesses. With Lumada at its core, Hitachi generates value from integrating data, technology and domain knowledge to solve customer and social challenges. Revenues for FY2024 (ended March 31, 2025) totaled 9,783.3 billion yen, with 618 consolidated subsidiaries and approximately 280,000 employees worldwide. Visit us at www.hitachi.com.About MUFGMitsubishi UFJ Financial Group, Inc. (MUFG) is one of the world’s leading financial groups. Headquartered in Tokyo and with over 360 years of history, MUFG has a global network with approximately 2,000 locations in more than 40 countries. The Group has about 150,000 employees and offers services including commercial banking, trust banking, securities, credit cards, consumer finance, asset management, and leasing. The Group aims to “be the world’s most trusted financial group” through close collaboration among our operating companies and flexibly respond to all of the financial needs of our customers, serving society, and fostering shared and sustainable growth for a better world. MUFG’s shares trade on the Tokyo, Nagoya, and New York stock exchanges. For more information, visit https://www.mufg.jp/english.About BorealBoreal is a leading mobility provider, operating buses, fast ferries, passenger ferries and trams in Norway and Sweden. We remain firmly committed to our societal mission of encouraging more people to travel collectively. At the same time, we are more than public transport. As the only company operating buses, ferries, fast ferries, trams and tourism services, we deliver integrated mobility solutions and travel experiences. Although Boreal is a young company in name, its heritage extends back more than 150 years. The company has around 3,000 employees and is headquartered in Stavanger, Norway. Copyright 2026 JCN Newswire. All rights reserved. www.jcnnewswire.com

TOKYO and NEW YORK, NY., Mar 27, 2026 - (JCN Newswire) - Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”), a human-centered global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas, and Nuvation Bio Inc. (NYSE: NUVB, Corporate Headquarters: New York, NY, CEO: David Hung, M.D., “Nuvation Bio”), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). The filing will follow a standard review timeline.Taletrectinib (marketed as IBTROZI® in the U.S. and Japan) is a highly selective, next-generation oral treatment for patients living with advanced ROS1+ NSCLC.1 In January 2026, Eisai and Nuvation Bio announced they had entered into an exclusive licensing and collaboration agreement in Europe and additional countries* outside the U.S., China and Japan to extend the global reach of taletrectinib. Following this filing to the EMA, additional filings are planned for the U.K., Canada and other regions included in Eisai’s licensed territories.Across Europe, nearly 400,000 people are diagnosed with lung cancer each year with NSCLC accounting for 80% of cases.2,3 It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.4,5“The validation of the MAA is a significant moment for patients in Europe with ROS1+ NSCLC,” said Terushige Iike, Chief Business Officer of Eisai Co., Ltd. “With its efficacy and safety profile, we believe taletrectinib has the potential to become a standard of care therapy for the thousands of patients living with this aggressive disease in Europe. We look forward to working closely with the EMA during the review process with the goal of making this treatment available to appropriate patients who urgently need targeted options.”The application is based on data from the two pivotal Phase 2 clinical studies, TRUST-I and TRUST-II, evaluating taletrectinib in patients globally.6,7 Results from a pooled analysis of the TRUST clinical program were published in the Journal of Clinical Oncology in April 20258, and Nuvation Bio anticipates near-term disclosure of updated data reflecting even longer patient follow-up, further building on the depth and durability of responses observed to date. Additionally, given the comprehensive nature of the taletrectinib clinical dataset and based on favorable feedback received at a pre-submission meeting with the CHMP Rapporteur and Co-Rapporteur, the accepted MAA will be considered to support full approval.“Having seen the meaningful impact taletrectinib has already made for patients with ROS1+ NSCLC in the U.S., China and Japan, we are thrilled to partner with Eisai and have an accepted MAA for review in Europe,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “This accepted filing represents an important milestone in our global development strategy and brings us one step closer to delivering this highly selective, next-generation oral therapy to more patients who need it in Europe and around the world.”In June 2025, the U.S. Food and Drug Administration (FDA) granted full approval to taletrectinib for the treatment of locally advanced or metastatic ROS1+ NSCLC across lines of therapy, following a Priority Review and double Breakthrough Therapy designations. Taletrectinib is also approved for patients with advanced ROS1+ NSCLC in Japan, where it is marketed by Nippon Kayaku, and in China, where it is marketed by Innovent Biologics under the brand name DOVBLERON®.* Eisai’s licensed territories: Europe, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam and IndiaAbout ROS1+ NSCLCEach year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer.9 It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease.4,5 About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain.10 The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.10,11About TaletrectinibTaletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com. 1About the TRUST Clinical ProgramThe TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of taletrectinib. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating taletrectinib for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating taletrectinib for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating taletrectinib versus crizotinib in 138 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.6,7About Eisai Co., Ltd.Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe.About Nuvation BioNuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients’ lives. Our diverse pipeline includes taletrectinib (IBTROZI®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.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 www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc).U.S. IndicationIBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ nonsmall cell lung cancer (NSCLC).IMPORTANT SAFETY INFORMATION FOR IBTROZI® (taletrectinib)1WARNINGS AND PRECAUTIONSHepatotoxicity: 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 REACTIONSAmong 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 INTERACTIONSStrong 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 CONSIDERATIONSPregnancy: 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 U.S. Prescribing Information.(1) Nuvation Bio Inc. IBTROZI (taletrectinib) US prescribing information. Available at: https://ibtrozipi.com/IBTROZI_taletrectinib-prescribing-information.pdf. Last accessed: March 2026(2) Wood R, Taylor-Stokes G. Cost burden associated with advanced non-small cell lung cancer in Europe and influence of disease stage. Available here. Last accessed: March 2026(3) European Lung Foundation. Lung cancer. Available here. Last accessed: March 2026(4) Patil T, Smith DE, Bunn PA Jr, et al. The incidence of brain metastases in stage IV ROS1-rearranged non-small cell lung cancer and rate of central nervous system progression on crizotinib. J Thorac Oncol. 2018;13(11):1717-1726. doi:10.1016/j.jtho.2018.07.012.(5) Drilon A, Camidge DR, Lin JJ, et al. Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer. N Engl J Med. 2024;390(2):118-131. doi:10.1056/NEJMoa2302299. (6) ClinicalTrials.gov. A Study of AB-106 in Advanced NSCLC With ROS1 Fusion (NCT04395677). Available at: https://clinicaltrials.gov/study/NCT04395677 . Last accessed: March 2026(7) ClinicalTrials.gov. A single-arm Phase 2 study of taletrectinib in advanced ROS1-positive NSCLC (NCT04919811). Available at: https://clinicaltrials.gov/study/NCT04919811 . Last accessed: March 2026(8) Pérol M, A., et al. Taletrectinib in ROS1-positive non-small cell lung cancer: TRUST. Journal of Clinical Oncology, 43(16), 1920–1929. https://doi.org/10.1200/JCO-25-00275(9) Global Data. Diagnosed incident cases of non-small cell lung cancer across 8MM to reach 1.46 million in 2032, forecasts GlobalData. Available here. Last accessed: March 2026(10) Patil T, Smith DE, Bunn PA Jr, et al. The incidence of brain metastases in stage IV ROS1-rearranged non-small cell lung cancer and rate of central nervous system progression on crizotinib. J Thorac Oncol. 2018;13(11):1717-1726. doi:10.1016/j.jtho.2018.07.012.(11) Drilon A, Camidge DR, Lin JJ, et al. Repotrectinib in ROS1 fusion-positive non-small-cell lung cancer. N Engl J Med. 2024;390(2):118-131.MEDIA CONTACTSEisai Co., Ltd.Public Relations DepartmentTEL: +81 (0)3-3817-5120Nuvation Bio Inc.Kaitlyn Nealymedia@nuvationbio.comINVESTOR CONTACTSEisai Co., Ltd.Investor Relations DepartmentTEL: +81 (0) 3-3817-5122Nuvation Bio Inc.JR DeVitair@nuvationbio.comForward-Looking Statements of Nuvation Bio Inc.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, statements regarding taletrectinib’s therapeutic potential and the urgent need for new therapeutic options for patients with advanced ROS1+ NSCLC in Europe, our expectations that the MAA filing for taletrectinib will follow a standard review with a decision in 1H 2027 and be considered for full approval, plans for additional filings for the U.K., Canada and other regions included in Eisai’s licensed territories, and expectations for near-term disclosure of updated data. 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 commercialization, 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; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K filed with the SEC on March 2, 2026 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. Copyright 2026 JCN Newswire. All rights reserved. www.jcnnewswire.com