On May 27, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present clinical trial data from select pipeline candidates across the Company’s diversified oncology portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting, to be held in Chicago, IL, from May 30 to June 3, 2025 (Press release, BioNTech, MAY 27, 2025, View Source [SID1234653389]). The data highlight continued progress of the Company’s clinical programs consisting of complementary therapeutic modalities, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, including antibody-drug conjugates ("ADCs").

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"We believe that the next era of cancer medicine will be defined by the interplay of complementary mechanisms and innovative molecules, unlocking their full potential through synergy. Our data presentations at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting show how we aim to help shape this era," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "We will present clinical progress with two of our therapeutic modalities: our next generation immunomodulators, most notably our investigational anti-PD-L1xVEGF-A antibody BNT327, and for one of our ADC programs, which are an important pillar of our combination strategy. These data underline the potential of our assets to improve outcomes for patients."

Highlights of BioNTech’s oncology programs to be presented at ASCO (Free ASCO Whitepaper) 2025:

•Three presentations on BNT3271, an investigational anti-PD-L1xVEGF-A antibody, will detail data from ongoing later-stage and potentially registrational clinical trials: An oral presentation will feature the first data from a Phase 2 clinical trial (NCT05918107) of BNT327 in combination with chemotherapy as first-line treatment for patients with unresectable malignant mesothelioma. Malignant mesothelioma is a type of cancer that develops in the tissue that covers the lung or the abdomen. The preliminary data indicated anti-tumor activity and a manageable safety profile. Two posters will detail the ongoing global Phase 3 and Phase 2/3 clinical trials, ROSETTA Lung-01 (NCT06712355) in extensive-stage small cell lung cancer ("ES-SCLC") and ROSETTA Lung-02 (NCT06712316) in non-small cell lung cancer ("NSCLC"). BNT327 combines the two complementary anti-tumor mechanisms of PD-L1 checkpoint and VEGF-A signaling blockade in the tumor microenvironment, thereby aiming to enhance anti-tumor activity.

•Data on BNT324/DB-1311, a B7H3-targeted ADC candidate, from an ongoing Phase 1/2 clinical trial (NCT05914116) in patients with heavily pre-treated castration-resistant prostate cancer ("CRPC") will be presented during an oral session. The data indicated early clinical activity and a manageable safety profile. BNT324/DB-1311 received Fast Track Designation by the U.S. Food & Drug Administration ("FDA") for this patient population in 2024 and is being developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. ("DualityBio").

•Preliminary data on BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, from two ongoing Phase 1/2 clinical trials evaluating the antibody candidate in combination with current standard of care treatments will be presented. Data from the PRESERVE-001 clinical trial (NCT04140526) in patients with advanced melanoma indicated a manageable safety profile and early signs of anti-tumor activity. The data included an analysis of overall survival ("OS") and an ad-hoc analysis of next-treatment free survival ("NTFS"), a measure for potential long-lasting benefit after initial treatment. Data from the PRESERVE-006 clinical trial (NCT05682443) in patients with metastatic CRPC indicated a manageable safety profile and preliminary efficacy. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. ("OncoC4").

•Data on BNT142 from an exploratory Phase 1/2 dose finding trial (NCT05262530) in patients with CLDN6-positive advanced solid tumors will be featured in an oral presentation. BNT142 is an investigational lipid nanoparticle-formulated mRNA immunotherapy that encodes a CD3xCDLN6 T cell engager antibody. Preliminary data indicated a manageable safety profile and early signs of clinical activity, supporting scientific proof-of-concept and underscoring the potential of mRNA-encoded bispecific antibodies.

BioNTech has established a diversified oncology portfolio to develop novel treatment approaches for patients living with cancer. The Company is advancing its oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.

The full abstracts are available on the ASCO (Free ASCO Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentations

Asset: BNT327
Session Title: Clinical Science Symposium | Two Targets, One Goal: The Potential for Bispecific Antibodies in Thoracic Malignancies
Abstract Title: First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line (1L) treatment in unresectable malignant mesothelioma 
Location: E451
Abstract Number: 8511
Date: June 3, 2025
Time: 9:45 AM – 11:15 AM CDT

Asset: BNT324/DB-1311
Session Title: Rapid Oral Abstract Session | Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: DB-1311/BNT324 (a novel B7H3 ADC) in patients with castrate-resistant prostate cancer (CRPC)
Location: Hall D2
Abstract Number: 5015
Date: June 1, 2025
Time: 4:30 PM – 6:00 PM CDT

Asset: BNT142
Session Title: Oral Abstract Session | Developmental Therapeutics—Immunotherapy
Abstract Title: First-in-human phase I/II trial evaluating BNT142, a first-in-class mRNA encoded, bispecific antibody targeting Claudin 6 (CLDN6) and CD3, in patients (pts) with CLDN6-positive advanced solid tumors.
Location: Hall D2
Abstract Number: 2501
Date: May 31, 2025
Time: 3:00 PM – 6:00 PM CDT

Poster Presentations

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: A global Phase 3 double-blind, randomized trial of BNT327/PM8002 plus chemotherapy (chemo) compared to atezolizumab plus chemo in patients (pts) with first-line (1L) extensive-stage small cell lung cancer (ES-SCLC)
Poster Board: #242a
Abstract Number: TPS8129
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT327
Session Title: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Abstract Title: Phase 2/3, global, multisite, randomized, open-label trial of BNT327/PM8002 in combination with chemotherapy (chemo) in first-line (1L) non-small cell lung cancer (NSCLC)
Poster Board: #138b
Abstract Number: TPS8670
Date: May 31, 2025
Time: 1:30 PM – 4:30 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Melanoma/Skin Cancers
Abstract Title: Gotistobart in combination with pembrolizumab in patients with advanced melanoma who have progressed on PD-1 inhibitors with or without CTLA-4 inhibitors
Poster Board: #34
Abstract Number: 9551
Date: June 1, 2025
Time: 9:00 AM – 12:00 PM CDT

Asset: BNT316/ONC-392 (gotistobart)
Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile
Abstract Title: Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC)
Poster Board: #266
Abstract Number: 5067
Date: June 2, 2025
Time: 9:00 AM – 12:00 PM CDT

On May 27, 2025 Volastra Therapeutics, a clinical-stage cancer biotechnology company, reported the appointment of David P. Southwell as Chief Executive Officer (Press release, Volastra Therapeutics, MAY 27, 2025, View Source [SID1234653405]). Mr. Southwell brings over 30 years of C-level executive biotechnology experience to Volastra as the company continues to advance its pipeline, which is led by two novel clinical stage KIF18A inhibitors.

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"We are delighted to welcome David to Volastra," said Sandi Peterson, Chair of Volastra’s Board of Directors. "David’s deep biotech leadership experience and proven track record make him the ideal CEO to lead Volastra through this exciting period of growth."

"Volastra has pioneered novel therapeutic approaches in the emerging field of chromosomal instability, which is central to the progression of many cancers," said David Southwell. "With exciting early clinical data and a world-class team of management and investors, Volastra is well-positioned to be a leader in oncologic therapies."

Mr. Southwell has built a strong foundation of financial, operational and strategic expertise throughout his career leading innovative biotechnology and pharmaceutical companies. He most recently served as President and Chief Executive Officer of TScan Therapeutics, an immune-oncology company advancing T-cell receptor-based therapies. Prior to that, he was President, Chief Executive Officer, and Board member of Inotek Pharmaceuticals, guiding the company through its merger with Rocket Pharmaceuticals in early 2018. Mr. Southwell also held senior executive roles as CFO at Human Genome Sciences through its acquisition by GlaxoSmithKline, and at Sepracor Inc., where he served as Executive Vice President and CFO for over a decade. He has served on the Boards of several public and private life sciences companies and currently serves on the Boards of PTC Therapeutics and Rocket Pharmaceuticals.

Mr. Southwell succeeds Charles Hugh-Jones, who has led Volastra Therapeutics from its inception as CEO. The Board greatly appreciates Charles’ leadership, vision and substantial contributions to the Company’s success over the past 5 years. He will continue as an advisor to the Company.

Separately, Volastra will be presenting dose escalation data from its first-in-human VLS-1488 trial in an oral presentation on June 2nd at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

On May 27, 2025 REVEAL GENOMICS, S.L., a biotechnology company advancing precision oncology through biomarker innovation, reported the presentation of four independent studies at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting (Press release, REVEAL GENOMICS, MAY 27, 2025, View Source [SID1234653421]). The studies, involving more than 800 patients, evaluated the clinical utility of its flagship test, HER2DX, in early-stage HER2-positive (HER2+) breast cancer.

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The four studies, CompassHER2 pCR, BionHER, RESPECT and DFCI, validate HER2DX as a powerful genomic tool for predicting response to therapy and long-term prognosis, addressing critical questions. The findings, which provide valuable insights for optimizing treatment strategies in early-stage HER2+ breast cancer and metastatic breast cancer, will be shared in oral and poster sessions led by academic investigators from the U.S., Europe, and Japan.

CompassHER2 pCR or EA1181 (U.S.): HER2DX determining response to THP-based de-escalated therapy

This study is led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer, comprising nearly 1,400 member institutions in the U.S. and around the world.

HER2DX was evaluated as a secondary aim as part of a pre-specified, prospectively planned analysis embedded in the CompassHER2 pCR trial, also known as EA1181 (NCT04266249). This large, prospective multicenter phase II trial is assessing neoadjuvant taxane, trastuzumab, and pertuzumab (THP) in more than 2,000 patients with stage II–III HER2+ breast cancer, without the use of anthracyclines, cyclophosphamide, and carboplatin. The HER2DX assay was defined as a key secondary endpoint, with profiling of all available baseline samples planned.

Among 569 patients assessed to date for the HER2DX pathologic complete response (pCR) score, those with higher scores achieved significantly greater pCR rates, independent of estrogen receptor (ER) status. These findings confirm the ability of HER2DX to identify tumors more likely to respond to THP. Importantly, additional results are expected from this trial, as patients continue to be followed for the primary endpoints of 3-year survival outcomes, and the study team plans to profile many more baseline samples.

"The ability to predict response to THP is extremely valuable," said Dr. Nadine Tung, Director of Breast Medical Oncology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School, and Principal Investigator of the CompassHER2 pCR (EA1181) trial. "HER2DX provides a biology-driven tool that contributes to the selection of patients who can safely reduce chemotherapy, something we’ve long needed in HER2-positive early breast cancer."

"It is encouraging to see the assay’s performance in both ER-positive and ER-negative subgroups," added Dr. Tung. "The plan is to profile all available samples from the trial, and these early data already provide valuable insights for guiding treatment selection."

BionHER trial (Spain): Validation of HER2DX-guided de-escalation strategy

The BionHER phase II trial (NCT05912062) evaluated HER2DX in 83 patients with stage I–III HER2+ breast cancer treated with neoadjuvant THP for up to 15 weeks at the Catalan Institute of Oncology (ICO L’Hospitalet, Barcelona, Spain). HER2DX was successfully performed in all baseline FFPE tumor samples.

The HER2DX pCR score was significantly associated with pCR with a performance AUC of 0.835. Patients classified by HER2DX pCR score into low, medium, and high groups had increasing pCR rates of 13.3%, 51.6%, and 81.8%, respectively. HER2DX outperformed traditional biomarkers, such as ER, Ki-67, and tumor-infiltrating lymphocytes, in predicting pCR.

"HER2DX is transforming the way we approach treatment selection in HER2-positive disease," said Dr. Sònia Pernas, head of the breast cancer unit at ICO L’Hospitalet, and Principal Investigator of the BionHER study. "By identifying tumors more likely to respond to dual HER2 blockade with a single taxane, we are increasingly able to personalize treatment intensity without compromising efficacy."

RESPECT trial (Japan): a response for an unrepresented population

Trans-RESPECT is a prespecified translational analysis within the Japanese RESPECT non-inferiority trial (NCT01104935), in which 266 patients aged 70–80 years with stage I-III HER2+ breast cancer were randomized to receive adjuvant trastuzumab with or without chemotherapy (Sawaki et al. J Clin Oncol 2020). HER2DX was assessed in 154 of these patients, with a median follow-up of 9.1 years. The HER2DX risk score effectively stratified patients by 10-year relapse-free survival (86.6% in the low-risk group vs. 68.4% in the high-risk group) and overall survival (94.5% vs.72.5%). Notably, chemotherapy conferred an overall survival benefit only in tumors classified as pCR-high by HER2DX, with a significant interaction p-value of 0.045.

"HER2DX provided clear long-term prognostic information in this elderly population," said Dr. Kazuki Nozawa, Lead Investigator of Trans-RESPECT, from the Department of Advanced Clinical Research and Development and the Department of Breast Surgery at Nagoya City University Graduate School of Medical Sciences. "Importantly, its ability to help identify which patients may benefit from adjuvant chemotherapy is highly relevant to clinical decision-making. Older patients with HER2DX low-risk scores, particularly those classified as pCR-low or -medium, appear to be ideal candidates for trastuzumab alone, without chemotherapy."

DFCI T-DXd study (U.S.): predicting survival outcome to T-DXd

Dana-Farber Cancer Institute (DFCI) conducted a retrospective analysis of 41 patients with metastatic breast cancer (25 HER2-positive, 16 HER2-negative) treated with trastuzumab deruxtecan (T-DXd) monotherapy between 2017 and 2023. The HER2DX HER2 signature score was significantly associated with time to next treatment (p=0.001). When stratified into tertiles, patients in the highest tertile had a median time to next treatment of 12.03 months compared to 4.7 months in the lowest tertile (p=0.02).

"Quantitative measurement of HER2 amplicon expression by HER2DX is a key determinant of T-DXd activity in metastatic breast cancer," said Dr. Sara M. Tolaney, Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute. She added, "Further evaluation of this genomic test in ongoing T-DXd trials is warranted."

HER2DX makes a significant impact at ASCO (Free ASCO Whitepaper) 2025

"ASCO 2025 marks a pivotal milestone for HER2DX," said Dr. Aleix Prat, Chief Scientific Officer and co-founder of REVEAL GENOMICS. "This test is demonstrating clinical value in real-world practice across continents and care settings, assisting in the tailoring of chemotherapy intensity in the neoadjuvant setting and supporting chemotherapy-free decisions in the adjuvant setting."

Patricia Villagrasa, CEO and co-founder, added, "HER2DX was developed with HER2+ disease at its core, and these four high-quality, independent studies reinforce its clinical value. As we continue to grow globally, this is a clear example of how REVEAL GENOMICS is turning cutting-edge science into meaningful solutions that advance personalized cancer care worldwide."

About HER2DX

HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, the HER2DX is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.

HER2DX️predicts:

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.

On May 27, 2025 Circle Pharma, a clinical-stage biopharmaceutical company advancing macrocycle therapeutics for difficult-to-treat cancers, reported the presentation of preclinical data on CID-078 at the Advances in Neuroblastoma Research (ANR) Meeting in Washington, D.C., May 25 -28, 2025 (Press release, Circle Pharma, MAY 27, 2025, View Source;utm_medium=rss&utm_campaign=preclinical-data-on-circle-pharmas-cid-078-featured-in-poster-presentation-at-advances-in-neuroblastoma-research-meeting [SID1234653390]). The data, which explore the therapeutic potential of CID-078 in neuroblastoma (NB), were presented in a poster entitled:

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"Cyclin A/B-RxL Inhibition as a Novel Therapeutic Strategy in Neuroblastoma"
Dylan M.M. Jongerius et al.
Poster #P010

The poster highlights the work of researchers from the Princess Máxima Center for Pediatric Oncology (Utrecht, the Netherlands), the Hopp Children’s Cancer Center Heidelberg (KiTZ) (Heidelberg, Germany), and Circle Pharma, demonstrating the potent anti-tumor activity of CID-078 in preclinical neuroblastoma (NB) models.

CID-078 is a first-in-class oral macrocycle cyclin A/B RxL inhibitor that selectively disrupts RxL-mediated interactions between cyclin A2/B1 and their substrates, a novel mechanism of action that targets cell cycle dysregulation in cancer. In neuroblastoma, where CDK-RB-E2F axis deregulation and oncogenic E2F activity are common, this mechanism is particularly relevant.

Key Findings Presented:

Potent Single agent CID-078 activity was observed across multiple neuroblastoma cell line models.

Mechanism of action studies confirmed induction of DNA damage, G2/M arrest and the activation of the spindle assembly checkpoint (SAC).

Deletion of CDKN2A sensitized cells to CID-078 suggesting CDKN2A status maybe be used as a potential patient stratification strategy.

"A greater understanding of the biology of neuroblastoma, the most common extra-cranial solid tumor diagnosed in children, has shown specific genomic alterations which deregulate the cell cycle leading to E2F activation," said Michael C. Cox, PharmD, MHSc, BCOP, SVP and head of early development of Circle Pharma. "Circle’s collaboration with these two premier pediatric oncology research institutions has shown again the potential of our macrocycle platform to develop new therapies for historically challenging targets. The exciting CDKN2A deletion biomarker data, as well as the in vitro data in a pediatric tumor with a need for better treatments support our clinical development plans for CID-078."

The full poster is available here.

About CID-078, Circle Pharma’s Cyclin A/B RxL Inhibitor Program

CID-078 is an orally bioavailable macrocycle with dual cyclin A and B RxL inhibitory activity that selectively targets tumor cells with oncogenic alterations that cause cell cycle dysregulation. In biochemical and cellular studies, Circle Pharma’s cyclin A/B RxL inhibitors have been shown to potently and selectively disrupt the protein-to-protein interaction between cyclins A and B and their key substrates and modulators, including E2F (a substrate of cyclin A) and Myt1 (a modulator of cyclin B). Preclinical studies have demonstrated the ability of these cyclin A/B RxL inhibitors to cause single-agent tumor regressions in multiple in vivo models. A multi-center phase 1 clinical trial (NCT06577987) is currently enrolling patients.

On May 27, 2025 BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that will 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 gemcitabine and cisplatin, for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic NPC (Press release, BeiGene, MAY 27, 2025, View Source [SID1234653406]).

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"Chemotherapy has been the standard treatment for metastatic NPC; however, distant metastasis continues to be a significant cause of treatment failure and death, making new treatment options essential," said Prof. Lisa Licitra, Chief of Head and Neck Cancer Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. "Results from the RATIONALE-309 study support the robust clinical benefit of TEVIMBRA plus chemotherapy, which has the potential to significantly reduce the risk of disease progression or death for patients with recurrent or metastatic NPC."

The extension of indication for NPC is based on results from BeiGene’s RATIONALE-309 (NCT03924986), a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate the efficacy and safety of TEVIMBRA, in combination with gemcitabine plus cisplatin, as first-line treatment in adult patients with recurrent or metastatic NPC. At the time of the prespecified interim analysis, the study, which randomized 263 treatment-naïve patients, met its primary endpoint, significantly prolonging progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001). The median PFS in the TEVIMBRA with chemotherapy arm was 9.2 months compared to 7.4 months in the placebo with chemotherapy arm. An updated analysis showed consistent efficacy results with the interim analysis. The median overall survival (OS) was 45.3 months for TEVIMBRA plus chemotherapy versus 31.8 months for placebo plus chemotherapy. TEVIMBRA plus chemotherapy was generally well tolerated, with no new safety signals identified.

"Today’s announcement marks a second positive CHMP opinion for TEVIMBRA in 2025, signifying the potential to expand into yet another disease area in the European Union and to support even more patients living with cancer," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "As the foundation of our solid tumor portfolio, we are encouraged by TEVIMBRA’s momentum in achieving more than 100 regulatory approvals for a range of cancer indications across the world, including major markets such as the US, the EU, China, and Japan, demonstrating the strength of evidence across a range of indications."

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 gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) in combination with chemotherapy, and for three non-small lung cancer (NSCLC) indications covering both the first- and second-line settings.

About Nasopharyngeal Cancer (NPC)

Nasopharyngeal cancer is a type of head and neck cancer that starts in the nasopharynx,1 the upper throat passage that connects the nose to the lungs.2 NPC is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging.3 Globally, NPC accounts for approximately 133,000 new cancer cases and 80,000 deaths per year and exhibits a unique geographical pattern, with its prevalence notably concentrated in Asia.4 While the overall 5-year survival rate for NPC is approximately 63%, in advanced disease the survival rate decreases to 49%.5

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 46 countries, and more than 1.5 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.