On March 31, 2025 AstraZeneca reported that Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation (Press release, AstraZeneca, MAR 31, 2025, View Source [SID1234651659]).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the ECHO Phase III trial which were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) 2024 Congress.

Results from the ECHO trial showed Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). Median progression-free survival (PFS) was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.

This recommendation for Calquence as a combination treatment in the 1st-line MCL setting follows the recent CHMP positive opinion for Calquence as a monotherapy for the treatment of adult patients with relapsed or refractory MCL.

Martin Dreyling, MD, Department of Medicine, University Hospital LMU Munich, and investigator in the trial, said: "Results from the pivotal ECHO trial demonstrated the significant benefits of the Calquence combination in managing this rare and aggressive cancer. Today’s recommendation is an important advance within the mantle cell lymphoma first-line treatment landscape, especially for older patients who need a balance of efficacy and tolerability."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "Today’s positive recommendation from the CHMP further reinforces the potential of Calquence to advance first-line treatment options in mantle cell lymphoma, with the Calquence combination demonstrating an almost one and a half year improvement in progression-free survival in this setting. If approved, Calquence has the potential to transform the standard of care as the first BTK inhibitor approved for these patients in Europe."

MCL is a rare and typically aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage.1,2 It is estimated that more than 6,000 patients were diagnosed with MCL in the UK, France, Germany, Spain and Italy in 2024.3

The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified.

Calquence plus bendamustine and rituximab is approved in the US and several other countries in this setting based on the ECHO results. Regulatory applications are currently under review in Japan and several other countries in this indication.

Notes

Mantle cell lymphoma (MCL)
While MCL patients initially respond to treatment, patients do tend to relapse.4 MCL comprises about 3-6% of non-Hodgkin lymphomas, with an annual incidence of 0.5 per 100,000 population in Western countries; It is estimated that there are more than 21,000 patients diagnosed with MCL in the US, UK, France, Germany, Spain, Italy, Japan and China.5

ECHO
ECHO is a randomised, double-blind, placebo-controlled, multi-centre Phase III trial evaluating the efficacy and safety of Calquence plus bendamustine and rituximab compared to SoC chemoimmunotherapy (bendamustine and rituximab) in adult patients at or over 65 years of age (n=635) with previously untreated MCL.6 Patients were randomised 1:1 to receive either Calquence or placebo administered orally twice per day, continuously, until disease progression or unacceptable toxicity. Additionally, all patients received six 28-day cycles of bendamustine on days 1 and 2 and rituximab on day 1 of each cycle, followed by rituximab maintenance for two years if patients achieved a response after induction therapy.6

The primary endpoint is PFS assessed by an Independent Review Committee; other efficacy endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR) and time to response (TTR).6 The trial was conducted in 27 countries across North and South America, Europe, Asia and Oceania.6

The ECHO trial enrolled patients from May 2017 to March 2023, continuing through the COVID-19 pandemic. Prespecified PFS and OS analyses censoring for COVID-19 deaths were conducted to assess the impact of COVID-19 on the study outcome in alignment with the FDA. Patients with blood cancer remain at a disproportionately high risk of severe outcomes from COVID-19, including hospitalisation and death compared to the general population.6,7,8

Calquence
Calquence (acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.

Calquence is approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the US and Japan, approved for CLL in the EU and many other countries worldwide and approved in China for relapsed or refractory CLL and SLL. Calquence is also approved for the treatment of adult patients with previously untreated MCL in the US and other countries. It is also approved for the treatment of adult patients with MCL who have received at least one prior therapy in the US, China and several other countries. Calquence is not currently approved for the treatment of MCL in Japan.

As part of an extensive clinical development programme, Calquence is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma.

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On March 31, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical stage pharmaceutical company, reported it will conduct a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found in cancer cells can be eliminated by treatment with LIXTE’s proprietary compound LB-100 (Press release, Lixte Biotechnology, MAR 31, 2025, View Source [SID1234651678]).

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"In addition to our ongoing clinical trials in ovarian and colorectal cancer, this study represents a new opportunity in cancer prevention," said Bas van der Baan, LIXTE’s Chief Executive Officer. "Thus far in our Phase 1 clinical trials, LB-100 has shown patient tolerance, with little toxicity, making it a promising candidate as a broad and effective cancer prevention modality."

Increasing evidence indicates that as individuals age, certain mutations accumulate that are found in cancer cells. While these "initiated" cells behave essentially normally, they can propagate to form reservoirs of pre-malignant cells from which malignant cells may eventually emerge. Recent data from LIXTE’s ongoing clinical collaboration with NKI shows that LB-100 activates oncogenic signaling and that this is detrimental to cancer cells.

The new study in animal models will investigate whether "initiated" cells, harboring a mutant RAS oncogene, can be eliminated with LB-100. If successful, LB-100 could have a significant role in the elimination of initiated cells in aged individuals and could reduce the risk of developing a wide range of cancers as a person ages.

The study will be led by René Bernards, Ph.D., a global leader in the field of molecular carcinogenesis and Senior Staff Scientist at NKI, one of the world’s leading comprehensive cancer centers. Dr. Bernards also is a member of LIXTE’s Board of Directors.

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 Apollomics Inc. (Nasdaq: APLM) ("Apollomics"), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, and LaunXP International Co., Ltd., an affiliate of LaunXP Biomedical Co., Ltd. (TWO: 6876) ("LaunXP"), reported that the parties have entered into an agreement for the development and commercialization in Asia (excluding mainland China, Hong Kong and Macau) (the "LaunXP Territory") of vebreltinib (Press release, Apollomics, MAR 31, 2025, View Source [SID1234654275]). Apollomics’ proprietary c-Met inhibitor, in combination with an EGFR inhibitor ("EGFRi") for the treatment of NSCLC. The EGFRi class of targeted kinase inhibitors is currently a foundational targeted therapy for the treatment of NSCLC and other tumor types.

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"We are delighted to partner with LaunXP, who share our vision for the commercial opportunity for vebreltinib. EGFRi is currently the frontline treatment for many patients with NSCLC, and combining it with our c-Met inhibitor vebreltinib is expected to transform the standard of care," said Dr. Guo-Liang Yu, CEO of Apollomics. "We believe that LaunXP can advance this development program rapidly in this patient population, bringing us closer to potentially improving outcomes for many patients with NSCLC. We will continue to seek opportunities to maximize the global opportunity for vebreltinib, both as a single agent and in combination approaches for the treatment of cancers."

"We are thrilled to announce this collaboration with Apollomics. We believe the preclinical and clinical data supporting the combination of a c-Met inhibitor with an EGFRi is compelling," said Dr. Chiu-Heng Chen, Chairman and President of LaunXP. "By delaying the emergence of mutations which cause EGFRi resistance, we hope to demonstrate clinically that better patient outcomes can be achieved."

Under the terms of the agreement, Apollomics is to receive upfront payments totaling $10 million within 60 days of the date of the agreement. Apollomics is also eligible for regulatory and other pre-commercial milestones up to $50 million, and royalties on net product sales. LaunXP will be primarily responsible for the development of vebreltinib in combination with an EGFRi in the LaunXP territory for the treatment of NSCLC.

About Vebreltinib

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-MET inhibitor. It works by inhibiting the aberrant activation of the HGF/c-MET axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies such as osimertinib. By targeting c-MET dysregulation, vebreltinib has demonstrated strong tumor inhibitory effect in a variety of preclinical c-MET dysregulated human gastric, hepatic, pancreatic and lung cancer xenograft animal models and patient-derived xenograft models (PDX).

Details on the Phase 1/2 SPARTA global clinical trial can be found on clinicaltrials.gov: NCT03175224. Apollomics is developing vebreltinib as single-agent cancer therapy in a variety of tumor types and actively assessing the potential of vebreltinib in combination with novel therapies. Avistone, Apollomics’ partner in China, has received conditional approval from the National Medical Products Administration (NMPA) of China for vebreltinib for multiple indications. Vebreltinib is currently under clinical investigation and not approved for any use in any other regions in the world.

On March 31, 2025 BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) (Press release, BeiGene, MAR 31, 2025, View Source [SID1234651660]).

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"The aggressive nature of extensive-stage small cell lung cancer makes it an extremely difficult type of lung cancer to treat, and currently available treatments may not adequately control disease progression," said Prof. Silvia Novello, M.D., Ph.D., President Women Against Lung Cancer in Europe (WALCE) and Head of Medical Oncology Unit of San Luigi Hospital in Orbassano, Italy. "The compelling data from the RATIONALE-312 study demonstrates the potential of TEVIMBRA plus chemotherapy as a further first-line treatment option to extend overall survival for patients with ES-SCLC."

The extension of indication for ES-SCLC is based on results from BeiGene’s RATIONALE-312 (NCT04005716), a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate the efficacy and safety of TEVIMBRA, in combination with platinum (investigator’s choice of cisplatin or carboplatin) plus etoposide, as first-line treatment in adult patients with ES-SCLC. The study, which randomized 457 patients, met its primary endpoint, exhibiting a statistically significant and clinically meaningful improvement in overall survival (OS) with TEVIMBRA in combination with chemotherapy, compared with placebo plus chemotherapy in the intent-to-treat (ITT) population. As reported in the Journal of Thoracic Oncology, at the protocol-defined final analysis, the median OS was 15.5 months for TEVIMBRA with chemotherapy versus 13.5 months for placebo plus chemotherapy (HR 0.75 [95% CI: 0.61–0.93]; one-sided p = 0.0040), resulting in a 25% reduction in the risk of death. TEVIMBRA plus chemotherapy was generally well tolerated, with no new safety signals identified.

"Today’s positive CHMP opinion marks another important step for TEVIMBRA to potentially expand its indications in a fourth disease area in Europe to reach more patients affected by cancer," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "TEVIMBRA is the cornerstone of our solid tumor portfolio with 58 regulatory approvals in 18 months and is being studied in combination with multiple novel molecules with the potential to herald the next wave of cancer therapeutics."

The pooled safety data in this extension of indication included more than 3,900 patients who received TEVIMBRA as either monotherapy (n=1,952) or in combination with chemotherapy (n=1,950) at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 2%) for TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, thrombocytopenia, hyponatremia, hypokalemia, fatigue, pneumonia, lymphopenia, rash, decreased appetite, increased aspartate aminotransferase, and increased alanine aminotransferase.

TEVIMBRA is currently approved in the EU as a first-line treatment for eligible patients with unresectable esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy, as a second line treatment in unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy, and for three non-small lung cancer (NSCLC) indications covering both the first- and second-line settings.

The Company recently announced its intent to change its name to BeOne Medicines, reaffirming its commitment to develop innovative medicines to eliminate cancer by partnering with the global community to serve as many patients as possible.

About Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

Lung cancer is the leading cause of cancer-related deaths worldwide.1 SCLC is an aggressive, high-grade cancer that accounts for 15% of all lung cancers,2 and is typically classified as limited-stage or extensive-stage disease.3 Approximately 70% of SCLC patients are diagnosed with extensive-stage disease,4 defined as cancer that has spread throughout or beyond the lungs, or exceeding an area that can be treated with radiation alone.5 In Europe, the estimated prevalence of SCLC is 1-5 per 10,000 people.6 ES-SCLC is associated with a very poor prognosis with a median OS of 8 to 13 months and an expected 2-year survival rate of only 5%.7

About TEVIMBRA (Tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1(PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeiGene’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 45 countries, and more than 1.3 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

This information is intended for a global audience. Product indications vary by region.