On March 31, 2024 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported its financial results for the year ended December 31, 2024 (Press release, Harbour BioMed, MAR 31, 2025, View Source [SID1234651697]).

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Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: "The year 2024 was a pivotal period for Harbour BioMed, marked by significant progress in research and development, strategic business expansion, and operational excellence. Despite a challenging macroeconomic environment, the Company demonstrated remarkable resilience, navigating inflationary pressures, global supply chain disruptions, and geopolitical uncertainties while remaining focused on its long-term growth objectives.

Throughout the year, Harbour BioMed advanced its strategic transition toward becoming a sustainably profitable global biotech engine. The Company expanded its research and development pipeline with a strong focus on immunology, autoimmune diseases, and inflammation therapeutics. Several key clinical-stage programs progressed significantly, reinforcing our vision of delivering life-changing medicines to patients worldwide.

The Company also made substantial investments in its technology platforms to ensure its core antibody discovery capabilities remain at the forefront of biopharmaceutical innovation. The strategic growth of Nona Biosciences, a subsidiary of Harbour BioMed, further solidified our position as a leading partner in the global biotech ecosystem. Additionally, we strengthened our business collaborations, securing multiple licensing and co-development agreements with top-tier pharmaceutical companies to drive sustainable revenue growth.

As we look ahead to 2025, we remain committed to expanding our global presence and delivering breakthrough therapies to patients."

Full Year 2024 Financial Highlights

Harbour BioMed reported total revenue of US$38.1 million for the year ended December 31, 2024, with an overall profit of approximately US$2.7 million. The company has been profitable for two consecutive years, demonstrating the uniqueness and resilience of its business model.

Compared to 2023, the company’s revenue sustainability has continued to improve. Annual recurring revenue increased from US$5.7 million to US$16.9 million, reflecting a growth rate of 196.5%. Cash profit[1] reached a record high of US$30.68 million. Meanwhile, Harbour BioMed has maintained a strong financial position. As of December 31, 2024, the company’s cash and cash equivalents totaled approximately US$166.8 million, providing a solid financial foundation for future growth.

Advancing a Robust and Differentiated Pipeline

Harbour Therapeutics, a sub-brand parallel to Nona Biosciences, is now individually responsible for the development of the Company’s products pipeline. With a growing focus on immunology, inflammation and oncology, Harbour Therapeutics manages a highly differentiated portfolio that includes multiple innovative drug candidates in both clinical and Investigational New Drug (IND)/IND-enabling stages.

In inflammation and immunology, the Company has built a robust preclinical pipeline encompassing bispecific and multi-specific antibodies generated using the HCAb-based Bispecific Immune Cell Antagonist (HBICATM) technology, as well as ultra long-acting biotherapeutics for immune-related diseases.

In oncology, the Company is leveraging its HBICE platform to develop bispecific and multi-specific antibodies with novel designs and differentiated mechanisms, such as HBM9027 (PD-L1xCD40) and HBM7004 (B7H4xCD3). In addition, the Company is utilizing its Harbour Mice and XDC platforms to explore multiple therapeutic modalities, including HBM9033, a mesothelin-targeted ADC, and other ADC/RDC programs in early-stage development.

Main products in the clinical stage include:

Batoclimab (HBM9161) is the first anti-FcRn monoclonal antibody completed Phase I to pivotal trials in China. As a novel, fully human anti-FcRn monoclonal antibody, batoclimab has the potential to be a breakthrough treatment option for a wide range of autoimmune diseases. In December 2023, the Company voluntarily planned to include additional long-term safety data and re-submitted the Biologic License Application (BLA) for batoclimab to the National Medical Products Administration of China (NMPA) in June 2024. In July 2024, NMPA accepted the BLA for batoclimab for the treatment of gMG. The Phase III pivotal clinical trial results of batoclimab were published in JAMA Neurology in March 2024, demonstrating sustained efficacy and safety with long-term use of batoclimab in the treatment of gMG.

HBM9378 is a fully human monoclonal antibody against thymic stromal lymphopoietin (TSLP) generated from the H2L2 Harbour Mice platform. It is a co-development project conducted by the Company and Kelun-Biotech, with both parties equally sharing the rights. HBM9378 has fully human sequences with a lower immunogenicity risk and better bioavailability compared to other TSLP-targeting competitors. Its long half-life optimization and outstanding biophysical properties support favourable dosing and formulation advantages.

The Company received IND approval of HBM9378 for moderate-to-severe asthma from the NMPA in February 2022 and completed a Phase I clinical trial in healthy subjects in China. In November 2024, the Company submitted an IND application for HBM9378 for chronic obstructive pulmonary disease (COPD) to the NMPA, which was approved in February 2025.
In January 2025, the Company and Kelun-Biotech entered into an exclusive license agreement with Windward Bio, under which Windward Bio was granted an exclusive license for the research, development, manufacturing and commercialization of HBM9378 globally (excluding Greater China and several Southeast and West Asian countries). Currently, Windward Bio is preparing a global Phase II clinical trial for HBM9378.
Porustobart (HBM4003) is a next-generation, fully human heavy-chain-only anti-CTLA-4 antibody discovered and developed using the HCAb Harbour Mice platform. It is also the first fully human heavy-chain-only antibody which entered clinical development globally. Compared with conventional CTLA-4 antibodies, porustobart has unique, favourable properties, including significant Treg cell depletion and optimized pharmacokinetics for improved safety. Additionally, by enhancing antibody-dependent cellular cytotoxicity (ADCC), porustobart increases the potential to selectively deplete intratumoral Treg cells, helping to overcome the efficacy and toxicity bottleneck of current CTLA-4 therapies. The Company has implemented a global development plan for multiple types of solid tumors with an adaptive treatment design for porustobart. Positive efficacy and safety data have been observed in the monotherapy trial targeting advanced solid tumors, as well as in combination trials with PD-1 inhibitors for melanoma, CRC, NEN and HCC.

HBM1020 is a first-in-class fully human monoclonal antibody generated from the H2L2 Harbour Mice platform targeting B7H7. As a newly discovered member of the B7 family, B7H7 expression is found to be non-overlapping with PD-L1 expression in multiple tumor types, potentially playing a more significant role in tumor immune evasion. With its excellent product design and target features, HBM1020 presents great potential to address significant unmet medical needs for solid tumors. In September 2024, the Company presented the latest clinical data for patients with advanced solid tumors at the ESMO (Free ESMO Whitepaper) Congress 2024. The data demonstrated excellent safety and tolerability profiles for HBM1020. Of the 15 patients who received post-treatment tumor assessments, 7 patients (46.7%) achieved stable disease (SD), with two patients showing tumor shrinkage of 11% and 25%.

Main products in IND and IND-enabling stages include:

HBM7020 is a BCMAxCD3 bispecific antibody generated using the fully human HBICE bispecific technology and Harbour Mice platform. HBM7020 can crosslink targeted cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and cell elimination. By incorporating dual anti-BCMA binding sites for optimal cell targeting and monovalent-optimized CD3 activity to minimize CRS, HBM7020 demonstrated potent cytotoxicity with broad applications in both immunological and oncology diseases. In August 2023, HBM7020 obtained IND clearance from the NMPA to commence a Phase I trial for cancer in China. In 2024, the Company restructured its development strategy to target immunological diseases and is currently preparing an IND application.

HBM9027 is a novel PD-L1xCD40 bispecific antibody developed using the HBICE bispecific antibody technology and Harbour Mice platform. The development of PD-L1xCD40 bispecific antibody further expands the Company’s bispecific immune cell engager into the cutting-edge DC/myeloid cell engager field, showcasing the HBICE platform’s versatile geometry formats and plug-and-play advantages. In January 2024, HBM9027 obtained IND approval from the Food and Drug Administration (FDA) to initiate a Phase I clinical trial in the U.S.

HBM7004 is a novel B7H4xCD3 bispecific antibody. Using HBICE bispecific technology and Harbour Mice platform, this bispecific antibody was designed to provide innovative solutions for cancer immunotherapy from both efficacy and safety perspectives. The development of B7H4xCD3 bispecific HBICE further consolidates the Company’s bispecific immune cell engager platform, demonstrating the HBICE platform’s versatility and plug-and-play advantages. In preclinical studies, HBM7004 demonstrated an intratumor B7H4-dependent T cell activation manner. In multiple animal models, HBM7004 showed strong anti-tumor efficacy, remarkable in vivo stability, and reduced systemic toxicity. Additionally, in preclinical models, HBM7004 exhibited a strong synergistic effect when combined with a B7H4x4-1BB bispecific antibody at a low effector-to-target cell ratio, indicating an encouraging therapeutic window. The Company is currently conducting IND-enabling studies for HBM7004.

HBM9014 is a first-in-class, fully human antibody targeting leukemia inhibitory factor receptor (LIFR) for cancer treatment. It was discovered using the Harbour Mice platform. HBM9014 blocks multiple IL-6 family cytokine pathways via LIFR to inhibit their function in promoting tumor progression, metastasis and chemoresistance. In preclinical studies, HBM9014 showed significant in vivo antitumor efficacy and enhanced efficacy in combination with cisplatin in multiple tumor models. In addition, HBM9014 exhibited strong tolerability in toxicology studies conducted on primates. In 2025, the Company will continue to actively explore drug development strategies and seek collaboration opportunities.

Strategic Business Collaborations Maximizing Platform Value

Harbour BioMed’s ongoing commitment to global partnerships is critical to driving both scientific and commercial success. In 2024, the Company continued expanding its business collaborations with leading academic institutions and select industrial partners, focused on driving innovation and efficiency worldwide.

Leveraging its technological advantages, Harbour BioMed established Nona Biosciences to better empower industry innovators and support collaborators from Idea to IND (I to ITM). Nona Biosciences is a global biotechnology company committed to providing integrated solutions for partners worldwide, across academia, biotechnology startups, and biopharmaceutical giants. Since its launch in late 2022, Nona Biosciences has achieved remarkable success, securing numerous international collaborations across various innovative formats. The subsidiary has established four leading technology units based on HCAb, including protein engineering, conjugation technology, delivery technology, and cell therapy, to accelerate the development of next-generation therapies.

Nona Biosciences signed a global out-license and option agreement with AstraZeneca in May 2024 for preclinical monoclonal antibodies to be used in developing targeted oncology therapies. In December 2024, Nona Biosciences entered a research collaboration and license agreement with Candid Therapeutics to discover next-generation T-cell engagers. Over the past year, Nona Biosciences has also formed research collaborations with multiple partners across various therapeutics areas, including Boostimmune, Alaya.bio, Umoja Biopharma, Alkyon Therapeutics, OverT Bio, and Kodiak Sciences.

In January 2025, the Company announced a license agreement with Windward Bio for HBM9378, an anti-TSLP fully human antibody for immunological diseases. In February 2025, HBM Alpha Therapeutics, an innovative biotechnology company incubated by the Company, announced a strategic collaboration and license agreement with a business partner to advance novel therapies targeting corticotropin-releasing hormone (CRH) for various disorders.

These collaborations further highlight the Company’s unique strengths in pushing technological boundaries and exploring new innovation pathways. With its industry-leading technology platforms and a flexible business model, the Company will continue seeking new opportunities to expand its collaboration network and maximize the value of its platforms.

Incubating Breakthrough Collaborations for the Future

To fully harness the potential of its unique platform technologies, Harbour BioMed continues to explore the scalability of its platform applications. The Company is incubating several joint ventures focused on next-generation therapeutics, ranging from multivalence antibodies to cell therapies. These ventures aim to broaden the application of platform technologies and create additional value for the Company. This innovative incubation model facilitates the integration of incremental resources for the diversified development of next-generation innovations, requiring minimal marginal investment while offering a high return on value growth. Representative projects include HBM Alpha Therapeutics and Shanghai NK Cell Technology Limited.

2025 Outlook: Expanding Global Presence and Driving Innovation

Looking ahead to 2025, Harbour BioMed will continue driving business growth and accomplishing its mission through two key pillars, Harbour Therapeutics and Nona Biosciences. Harbour Therapeutic will advance multiple clinical trials of its internal pipeline to fully advance the global clinical development project, while Nona Biosciences will continue providing integrated discovery solutions to biotech and pharmaceutical companies, ultimately fostering an innovation ecosystem that promotes biological advancement.

A range of products derived from the Company’s Harbour Mice technology platform and T-cell engager technology will be advanced in immunology, and the ADC platform will be upgraded to the next generation. Through a combination of in-house development and business collaborations, Harbour BioMed will build a portfolio of products with differentiated competitive advantages both in immunology and immuno-oncology.

Maximizing the value of its platform through strategic collaborations will continue to drive the Company’s global expansion. In 2025, as the preclinical product pipeline matures, the company expects to expand its collaboration network even further and enter into broader global partnerships, solidifying its leading position in the global market.

On March 31, 2025 UZ Leuven and VIB-KU Leuven, in collaboration with Seattle-based Presage Biosciences, reported the first patient treated in a Non-randomized (phase I – pharmacodynamic only) open label, single center single arm interventional pilot study (Press release, Presage Biosciences, MAR 31, 2025, View Source [SID1234651696]). By combining intratumoral treatment with systemic anti-PD1 therapy in first line patients with metastatic (stage IV) or inoperable stage III melanoma, the trial studies how patient tumors respond to up to 7 different drugs simultaneously dosed intratumorally with the help of Presage’s Comparative In Vivo Oncology (CIVO) microinjection device.

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The drugs are spatially microdosed in a patient’s tumor while they are also undergoing anti-PD1 systemic therapy with the goal of identifying drugs that have an enhanced combination effect in this patient population. The localized effect of the different drugs is analyzed with cutting edge single cell spatial technology providing new insights into melanoma biology and the anti-tumor action of the CIVO dosed drugs when combined with systemic anti-PD1 therapy.

Prof. Dr. Oliver Bechter, Medical Oncologist at UZ Leuven, comments on this innovative study design: "This is the first study of its kind studying locally administered anti-cancer drugs in combination with systemic anti-PD1 therapy in first line treated melanoma patients. With this pilot study we intend to study the effect of novel combination therapies intratumorally very early in the treatment course of melanoma patients. This pilot study will show the feasibility of such an approach to find new treatments especially for anti-PD1 refractory patients."

Prof. Dr. Chris Marine, Cancer Biologist of the VIB-KU Leuven Center for Cancer Biology added: "The introduction of this groundbreaking technology has ushered us into a new frontier in translational research, enabling us to translate our most promising laboratory discoveries directly into patients. By utilizing our expertise in advanced spatial multi-omics, we will gain an unparalleled understanding of each tumor’s biology and its sensitivity to various drug combinations. The unique data generated from this will be invaluable in accelerating our efforts to combat this disease."

This first of its kind study is made possible by the multiplex CIVO delivery technology developed by Presage that is now being used in early phase clinical studies to evaluate multiple investigational new drugs and combinations all within a single intact patient tumor. Jason Frazier, VP of Technology and Research Operations at Presage echoed the enthusiasm for this novel clinical study design: "Drs. Bechter and Marine and their teams at UZ Leuven and VIB-KU Leuven have come up with an exciting and innovative clinical study design to assess tumor response to multiple different drugs in combination with Check Point blockade using our CIVO technology. This personalized approach to identify effective combination therapies holds great promise for the treatment of melanoma patients."

On March 31, 2025 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company") reported that its Board of Directors has approved a revised operating plan focused on evaluating strategic alternatives while reducing operational cash burn (Press release, Carisma Therapeutics, MAR 31, 2025, View Source [SID1234651695]).

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The Company’s goal is to maximize the value of its assets, including its liver fibrosis and oncology development programs, its macrophage and monocyte engineering platform and the CAR-M platform and to realize value from the potential future milestone and royalty payments under Carisma’s agreement with Moderna. To support this transition, the Company has reduced its workforce, retaining only those employees deemed essential to pursue strategic alternatives. With these actions, the Company estimates that it has cash and cash equivalents sufficient to fund its operations into the second half of 2025.

The Company will assess a full range of strategic alternatives, including but not limited to, the sale, license, monetization, and/or divestiture of one or more of the Company’s assets or technologies, a strategic collaboration, partnership, or merger with one or more parties, or the sale of the Company. The Company’s exploration of strategic alternatives may not result in the consummation of any transaction or the realization of any value for the Company or its stockholders.

"While difficult, we believe pursuing strategic alternatives coupled with a reduction in operating costs has the potential to maximize the value of our science and other assets given the challenging funding environment," said Steven Kelly, President and Chief Executive Officer of Carisma Therapeutics. "We believe deeply in the potential of our liver fibrosis and oncology programs, which have shown compelling preclinical results, and are well-positioned for future development. We are focused on finding a strategic transaction that would allow this important work to continue and maximize the value of all our assets. I’m incredibly proud of our team’s pioneering efforts and remain optimistic about the future of our technology."

Pipeline Updates

Fibrosis

Our liver fibrosis program is based upon the discovery of a key efferocytosis defect in the macrophages that reside within the livers of patients with fibrosis. Using a novel mRNA/LNP approach, our product candidate, CT-2401, aims to reverse fibrotic disease and improve the outcomes of patients with advanced liver fibrosis.
In the second quarter of 2024, we achieved pre-clinical proof of concept in our liver fibrosis program, demonstrating the anti-fibrotic potential of engineered macrophages in two liver fibrosis models.
CT-2401 has the potential to be a first-in-class efferocytosis therapy for advanced metabolic associated liver disease.
Ex Vivo Oncology

CT-1119 is a next generation CAR-monocyte designed to treat patients with advanced mesothelin-positive solid tumors, including pancreatic cancer, ovarian cancer, lung cancer, mesothelioma, and others.
Prior to pausing our research and development activities, we planned to initiate a Phase 1 clinical trial of CT-1119, a mesothelin-targeted CAR-Monocyte, in combination with tislelizumab, an anti-PD-1 antibody, in adult patients with mesothelin-positive solid tumors, in China.
In Vivo Program (Moderna Collaboration)

In June 2024, we announced that Moderna nominated the first development candidate under the collaboration, which targets Glypican-3, or GPC3.
In November 2024, we announced new pre-clinical data on our anti-GPC3 in vivo CAR-M therapy for treating hepatocellular carcinoma. These pre-clinical data demonstrated robust anti-tumor activity.
In February 2025, Moderna nominated ten additional oncology research targets and ceased development of two oncology research targets and two autoimmune research targets.
As of February 2025, Moderna has nominated all 12 oncology research targets under the collaboration for which we have the potential to receive future milestones and royalty payments.
The Company will not conduct any additional research activities under the collaboration agreement, and we will not be receiving any further research funding from Moderna under the collaboration agreement.
Moderna agreed to terminate the in vivo oncology field exclusivity, which would allow us to pursue in vivo CAR-M programs outside of the 12 nominated oncology targets and product polypeptides.
Corporate Update

On March 25, 2025, the Company’s Board of Directors approved a revised operating plan focused on evaluating strategic alternatives and preserving capital.
The Company has reduced operations to core functions necessary to support this strategic review and has paused all research and development activities at this time, pending the outcome of the review.
The Company may engage external advisors to support the evaluation of strategic alternatives and prepare for a potential wind-down of operations, if necessary.

On March 31, 2025 Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics") reported that Merck has exercised the global commercialization option for pimicotinib (ABSK021), with an option exercise fee of USD85.0 million, under the licensing agreement signed in December 2023 (Press release, Merck & Co, MAR 31, 2025, View Source [SID1234651694]). The development represents further deepening of the collaboration, underscoring the unwavering commitment and confidence that both parties possess for the ongoing advancement of pimicotinib.

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In December 2023, Abbisko Therapeutics entered into an exclusive licensing agreement (the "Agreement") with Merck regarding pimicotinib, a CSF-1R inhibitor. Under the terms of the Agreement, Merck initially had an exclusive license to commercialize pimicotinib for all indications in the Chinese mainland, Hong Kong, Macau and Taiwan with an exclusive option for global commercial rights of pimicotinib. Merck now has exercised such option and has the exclusive license to commercialize pimicotinib worldwide. Abbisko Therapeutics has already received the one-time, non-refundable upfront payment of USD70.0 million in February 2024, and is now entitled to receive the additional option exercise fee of USD85.0 million. Additionally, Merck has the option to co-develop pimicotinib for additional indications under certain conditions. In total, Abbisko Therapeutics is eligible to receive up to USD605.5 million in payments, including upfront, development, and commercial milestones, as well as double-digit percentage royalties on annual net sales.

Pimicotinib is a novel, orally administered, highly selective, and potent small molecule CSF-1R inhibitor, independently developed by Abbisko Therapeutics. Pimicotinib’s positive topline results from the Global Phase III MANEUVER Study in tenosynovial giant cell tumor ("TGCT") were successfully released in November 2024, where MANEUVER met the primary endpoint with an objective response rate ("ORR") at Week 25 of 54.0% for pimicotinib compared with 3.2% for placebo (p<0.0001), and treatment with oral, once-daily pimicotinib was well-tolerated with very low rates of discontinuation due to treatment-related adverse events, and with no evidence of cholestatic hepatotoxicity.

Yao-Chang Xu, Chairman and CEO of Abbisko Therapeutics, said, "Pimicotinib represents a key advancement within the emerging class of CSF-1R inhibitors, demonstrating a meaningful clinical efficacy and safety profile that positions it as an innovative treatment option for worldwide TGCT patients. We look forward to deepening our collaboration with the Merck team to expedite the registration process of pimicotinib to bring benefits to patients as quickly as possible."

"Today marks a significant milestone in our partnership with Abbisko as we work together to deliver a potentially best-in-class therapy for patients with TGCT around the world," said Andrew Paterson, Chief Marketing Officer for the Healthcare business sector of Merck. "This collaboration underscores our commitment to advancing new treatment options in rare oncology for patients who need them. With this important step forward, we aim to transform the treatment landscape and offer hope to those living with TGCT, who today have very limited treatment options."

On March 31, 2025 Daiichi Sankyo reported first patient has been dosed in the DESTINYGastric05 phase 3 trial evaluating ENHERTU (trastuzumab deruxtecan) in combination with a fluoropyrimidine chemotherapy (5-FU or capecitabine) and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) versus trastuzumab in combination with platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) and pembrolizumab in previously untreated patients with unresectable, locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) cancer with PD-L1 CPS ≥1 (Press release, Daiichi Sankyo, MAR 31, 2025, View Source [SID1234651693]). An exploratory cohort of patients with PD-L1 CPS <1 will be randomized to either ENHERTU plus fluoropyrimidine or trastuzumab plus platinum-based chemotherapy.

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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN).

Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%. 1 Current recommended first-line treatment for HER2 positive advanced gastric cancer with PD-L1 CPS ≥1 is trastuzumab in combination with platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) and pembrolizumab. 2,3 New treatment strategies are needed to continue to improve survival, including additional HER2 directed treatment options.

"Following the positive overall survival results seen with DESTINY-Gastric04 in the second-line HER2 positive metastatic gastric cancer setting, the DESTINY-Gastric05 trial will explore the role of ENHERTU earlier in the metastatic setting as a first-line treatment," said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. "With DESTINY-Gastric05, we are evaluating whether a potential platinum-free chemotherapy regimen of ENHERTU combined with immunotherapy and a fluoropyrimidine chemotherapy can further improve survival in patients with previously untreated HER2 positive metastatic gastric cancer."

ENHERTU is currently approved in more than 65 countries in the second-line or third-line metastatic setting of HER2 positive gastric cancer based on DESTINY-Gastric01, a randomized phase 2 trial, and DESTINYGastric02 and DESTINY-Gastric06, two single-arm phase 2 trials. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About DESTINY-Gastric05

DESTINY-Gastric05 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) in combination with a fluoropyrimidine-based chemotherapy (5-FU or capecitabine) and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA (pembrolizumab) versus trastuzumab in combination with platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) and pembrolizumab in approximately 576 previously untreated patients with unresectable, locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or GEJ cancer with PD-L1 CPS ≥1.

The primary endpoint is progression-free survival (PFS) as assessed by blinded independent central review. The key secondary endpoint is overall survival. Additional secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response and safety.

An exploratory cohort of 150 patients with PD-L1 CPS <1 will be randomized to either ENHERTU plus fluoropyrimidine (5-FU or capecitabine) or trastuzumab plus platinum-based chemotherapy (cisplatin plus 5- FU or oxaliplatin plus capecitabine).

DESTINY-Gastric05 will enroll patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Positive Gastric Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth leading cause of cancerrelated death.
4 Approximately one million cases were diagnosed in 2022.4 Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the five-year survival rate is 5% to 10%.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including gastric cancer.5 Approximately one in five gastric cancers globally are HER2 positive.Recommended first-line treatment for HER2 positive advanced gastric cancer with PD-L1 CPS ≥1 is trastuzumab in combination with platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine) and pembrolizumab.2,3 In patients with PD-L1 CPS <1 recommended first-line treatment is trastuzumab plus platinum-based chemotherapy (cisplatin plus 5-FU or oxaliplatin plus capecitabine). 2 New treatment strategies, including additional HER2 directed treatment options, are needed to continue to improve survival in patients with previously untreated advanced gastric cancer.