AdvanTIG-211: A Randomized, Double-blind, Placebo-controlled, Phase II Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118) Combined With Tislelizumab (VDT482) Plus Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Chemotherapy as First-line Therapy for Participants With Advanced Triple Negative Breast Cancer (TNBC)

The primary scientific question of interest of this study is whether the combination of ociperlimab, tislelizumab and chemotherapy improves progression-free survival (PFS) compared to the combination of placebo, pembrolizumab and chemotherapy as first-line therapy for adult men and women with advanced triple negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD - L1) [combined positive score (CPS) ≥10], regardless of study treatment discontinuation or start of new anti-neoplastic therapy.

Start Date15 Sep 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05791097

/ WithdrawnPhase 3

AdvanTIG-306: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Ociperlimab (WCD118/BGB-A1217) Combined With Tislelizumab (VDT482/BGB-A317) Plus Platinum-based Doublet Chemotherapy Versus Placebo Combined With Pembrolizumab Plus Platinum-based Doublet Chemotherapy as First-line Therapy for Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

The primary scientific question of interest is whether the addition of ociperlimab to platinum-based chemotherapy and tislelizumab improve progression-free survival (PFS) or overall survival (OS) compared to pembrolizumab and platinum-based chemotherapy as first-line therapy for participants with locally advanced or metastatic squamous or non-squamous NSCLC with PD-L1 expression of ≥1%.

Start Date28 Jul 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05577702

/ CompletedPhase 2

A Randomized, Open-Label, Multicenter, Phase 2, Umbrella Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacodynamics of Tislelizumab Monotherapy and Multiple Tislelizumab-based Immunotherapy Combinations With and Without Chemotherapy as Neoadjuvant Treatment in Chinese Patients With Resectable Stage II to IIIA Non-Small Cell Lung Cancer

This is a randomized, open-label, multicenter, Phase 2, umbrella study to evaluate the preliminary efficacy, safety, and pharmacodynamics of tislelizumab as monotherapy and in combination with investigational agents as neoadjuvant treatment in Chinese participants with resectable Stage II to IIIA non-small cell lung cancer (NSCLC). The study is designed with the flexibility of adding treatment arms as new treatments become available or discontinuing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and of modifying the participant population.

Start Date15 Mar 2023

Sponsor / Collaborator

BeiGene Ltd.

100 Clinical Results associated with Ociperlimab

100 Translational Medicine associated with Ociperlimab

100 Patents (Medical) associated with Ociperlimab

Literatures (Medical) associated with Ociperlimab

01 May 2024·Structure (London, England : 1993)

Structural insights into the unique pH-responsive characteristics of the anti-TIGIT therapeutic antibody Ociperlimab

Article

Author: Li, Kang ; Chen, Xin ; Zhang, Xiangxiang ; Xue, Liu ; Huang, Chichi ; Song, Jing ; Shen, Zhirong ; Cheng, Liang ; Sun, Jian ; Wang, Lai ; Zhang, Jing

TIGIT is mainly expressed on T cells and is an inhibitory checkpoint receptor that binds to its ligand PVR in the tumor microenvironment. Anti-TIGIT monoclonal antibodies (mAbs) such as Ociperlimab and Tiragolumab block the TIGIT-PVR interaction and are in clinical development. However, the molecular blockade mechanism of these mAbs remains elusive. Here, we report the crystal structures of TIGIT in complex with Ociperlimab_Fab and Tiragolumab_Fab revealing that both mAbs bind TIGIT with a large steric clash with PVR. Furthermore, several critical epitopic residues are identified. Interestingly, the binding affinity of Ociperlimab toward TIGIT increases approximately 17-fold when lowering the pH from 7.4 to 6.0. Our structure shows a strong electrostatic interaction between ASP103_HCDR3 and HIS76_TIGIT explaining the pH-responsive mechanism of Ociperlimab. In contrast, Tiragolumab does not show an acidic pH-dependent binding enhancement. Our results provide valuable information that could help to improve the efficacy of therapeutic antibodies for cancer treatment.

01 Oct 2023·Journal for immunotherapy of cancer

AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors

Article

Author: Rizwan, Ahsan ; Frentzas, Sophia ; Budha, Nageshwar ; Tan, Wei ; Zheng, Hao ; Meniawy, Tarek ; Kao, Steven ; de la Hoz Pedroza, Luz ; Gao, Rang

Background:

Ociperlimab, a novel, humanized monoclonal antibody (mAb), binds to T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) with high affinity and specificity. Tislelizumab is an anti-programmed cell death protein 1 mAb. We report results from a phase I, first-in-human, dose escalation study evaluating the safety, pharmacokinetics (PK), and preliminary antitumor activity of ociperlimab plus tislelizumab in patients with advanced solid tumors.

Methods:

Eligible patients previously treated with standard systemic therapy, or for whom treatment was not available or tolerated, received ociperlimab intravenously on Cycle (C) 1 Day (D) 1 and tislelizumab 200 mg intravenously on C1 D8. If tolerated, patients received ociperlimab plus tislelizumab 200 mg sequentially on D29 and every 3 weeks (Q3W) thereafter until discontinuation. Dose escalation for ociperlimab was planned with four dose levels (50 mg, 150 mg, 450 mg, and 900 mg) according to a 3+3 design. An additional dose level of ociperlimab 1800 mg was also assessed. Primary endpoints were safety, determination of the maximum tolerated (or administered) dose, and the recommended phase II dose (RP2D). Secondary endpoints included overall response rate (ORR), duration of response (DoR), disease control rate (DCR) (Response Evaluation Criteria in Solid Tumors version 1.1), PK, and biomarker analysis.

Results:

At data cut-off (September 29, 2022), 32 patients had received ≥1 dose of ociperlimab plus tislelizumab 200 mg Q3W. The maximum administered dose was ociperlimab 1800 mg plus tislelizumab 200 mg Q3W. The median age of enrolled patients was 59.5 years (range: 31–79). Most patients (96.9%) experienced ≥1 treatment-emergent adverse event (TEAE); 62.5% of patients experienced ≥grade 3 TEAEs and 50.0% of patients experienced serious TEAEs. No dose limiting toxicity events were reported. The maximum tolerated dose was not reached. The RP2D was ociperlimab 900 mg plus tislelizumab 200 mg Q3W. Overall, ORR was 10.0%, median DoR was 3.6 months, and DCR was 50.0%.

Conclusions:

Ociperlimab plus tislelizumab was well tolerated in patients with advanced solid tumors, and preliminary antitumor activity was observed with 450 mg, 900 mg, and 1800 mg ociperlimab. Phase II/III trials of ociperlimab 900 mg plus tislelizumab 200 mg Q3W are underway in a range of solid tumors.

Trial registration number:

NCT04047862.

01 Nov 2022·Cancer control : journal of the Moffitt Cancer Center

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody

Article

Author: Geng, Qing ; Geng, Zhihua ; Zhang, Lin ; Hao, Bo

Tislelizumab is an anti-programmed death receptor 1 (PD-1) monoclonal immunoglobulin G 4 antibody developed by BeiGene. The structure of tislelizumab has been modified to maximally inhibit the binding of PD-1 to programmed death ligand 1 (PD-L1) and minimize the binding of tislelizumab to Fcγ receptors. In clinical studies, tislelizumab has shown preliminary anti-tumor effects in various solid tumors, such as Hodgkin’s lymphoma, urothelial carcinoma, lung cancer, gastric and esophageal cancer, liver cancer, nasopharyngeal carcinoma, colorectal cancer, and microsatellite instability-high/mismatch repair-deficient tumors. In addition, it also showed new promise in solid tumor treatment in combination with ociperlimab. Due to its satisfactory anti-tumor effects, tislelizumab has received approvals in China for the treatment of classical Hodgkin’s lymphoma, urothelial carcinoma, squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, and hepatocellular carcinoma, and it is now under investigation for a new indication in microsatellite instability-high/mismatch repair-deficient tumors. Moreover, it has been granted orphan designations in hepatocellular carcinoma, esophageal cancer, and gastric cancer, including cancer of the gastroesophageal junction, by the US Food and Drug Administration. Tislelizumab has an acceptable safety profile; the most common adverse effects include fatigue, anemia, and decreased neutrophil count, while the most fatal events have been related to respiratory infection or failure, and hepatic injury. Tislelizumab has an economic advantage compared with other well-studied PD-1/PD-L1 inhibitors; thus, the introduction of it could provide clinical oncologists with an effective weapon against tumors and may alleviate the burden of cancer patients.

News (Medical) associated with Ociperlimab

06 Mar 2025

·www.prnewswire.com

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyPriority Review

18 Apr 2024

·synapse.patsnap.com

Decoding Ociperlimab: a comprehensive study of its R&D trends and its clinical results in 2024 AACR

Despite a high response rate to cCRT, patients with limited-stage SCLC generally experience recurrence of disease after a few months and survival remains poor. Immunotherapy has shown benefit in many tumor types, including SCLC. In preclinical and clinical studies of solid tumors, co-inhibition of T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitor motif domains (TIGIT) and PD-1 enhanced antitumor activity of anti-PD-1. On April 7, 2024, the latest clinical data of ociperlimab + tislelizumab + cCRT in patients with untreated limited-stage SCLC was reported in 2024 AACR. Ociperlimab's R&D ProgressOciperlimab is a monoclonal antibody drug that targets TIGIT, a protein involved in immune regulation. Ociperlimab has shown potential in treating a wide range of therapeutic areas, including neoplasms (abnormal growth of cells), respiratory diseases, digestive system disorders, skin and musculoskeletal diseases, urogenital diseases, and other diseases. According to the Patsnap Synapse, Ociperlimab is currently in Phase 3 clinical trials, which is the highest phase of development both globally and in China. And the clinical trial distributions for Ociperlimab are primarily in the United States, China and France. The key indication is Non-Small Cell Lung Cancer. Detailed Clinical Result of OciperlimabThis phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC). In this study, patients with limited-stage SCLC and no prior systemic therapy were randomized 1:1:1 to Arm A (ociperlimab [900 mg IV Q3W] + tislelizumab [200 mg IV Q3W] + cCRT for 4 cycles, then ociperlimab + tislelizumab), Arm B (tislelizumab + cCRT for 4 cycles, then tislelizumab), or Arm C (cCRT for 4 cycles). Study drugs (Arms A and B) were continued for up to 12 months or until progression, unacceptable toxicity, or withdrawal. Primary endpoint: investigator-assessed PFS per RECIST v1.1. Secondary analyses included additional efficacy and safety endpoints in the ITT population, and efficacy in patient subgroups by PD-L1 and TIGIT expression (both <1% vs ≥1%), using tumor area positivity (PD-L1) and immune cell scoring (TIGIT). No hypothesis testing was predefined (p-value for descriptive purposes only). Descriptive comparisons were conducted for Arm A vs C, B vs C, and A vs B. The result showed that as of July 26, 2023, 126 patients (median age, 61.5 years) were randomized to Arm A (n=41), Arm B (n=42), or Arm C (n=43). Median follow-up: ~18 months (all arms). There was a trend of improvement in median PFS in Arm A (12.6 months) and Arm B (13.2 months) vs Arm C (9.5 months); HR (95% CI): Arm A vs C, 0.84 (0.46-1.52; p=0.2793); Arm B vs C, 0.80 (0.45-1.44; p=0.2414). ORR was 85.4% (3 CR) in Arm A, 88.1% (4 CR) in Arm B, and 76.7% (1 CR) in Arm C. Median DoR was 10.1 months in Arm A, 11.5 months in Arm B, and 8.2 months in Arm C. Median OS was not reached in any arm. Analyses showed that PD-L1 or TIGIT expression did not correlate with efficacy, however, small subgroup size limits interpretability. All patients experienced ≥1 treatment-related adverse event (TRAE); rates of grade ≥3 TRAEs were 73.2%, 78.6% and, 65.1% in Arms A, B, and C, respectively. The most common TRAEs included anemia (80.5% in Arm A vs 83.3% in Arm B vs 81.4% in Arm C), nausea (80.5% vs 76.2% vs 65.1%), and WBC count decreased (78.0% vs 76.2% vs 62.8%). Rates of TRAEs leading to any treatment discontinuation were 26.8%, 21.4%, and 4.7% in Arms A, B, and C, respectively. One patient in each arm experienced a TRAE leading to death. It can be concluded that in patients with untreated limited-stage SCLC, tislelizumab + cCRT yielded a trend of improvement in PFS and ORR vs cCRT; addition of ociperlimab did not show detectable improvement. The overall safety profile of the treatments was tolerable, manageable, and generally consistent with the known risks of ociperlimab, tislelizumab, and cCRT. How to Easily View the Clinical Results Using Synapse Database?If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. If you would like to view more information about this result, you can go to the result detail page by clicking on the title. Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. Click on the image below to embark on a brand new journey of drug discovery!

06 Mar 2024

·www.biospace.com

BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024

Multiple trials underscore the potential of tislelizumab-containing immuno-oncology combinations in a variety of solid tumor settings Additional highlights include preclinical characterization data for an investigational BTK degrader, BGB-16673, currently in clinical development for B-cell malignancies, including mantle cell lymphoma BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced the presentation of emerging oncology pipeline data at the American Association for Cancer Research (AACR) Annual Meeting April 5-10 in San Diego. BeiGene has nine abstracts scheduled for poster presentations at AACR. “Our presentations at this year’s AACR showcase our ongoing development of tislelizumab combinations in solid tumors as we assess the clinical potential of multiple novel immuno-oncology candidates and make data-driven decisions for further development,” said Lai Wang, Ph.D., Global Head of Research & Development at BeiGene. “More broadly, they reflect our deep commitment to discovering innovative new medicines for cancer patients, including by pioneering novel mechanisms like targeted degradation.” BeiGene will present results from the AdvanTIG-204 Phase 2 study of tislelizumab (anti-PD1) plus ociperlimab (anti-TIGIT) in first-line limited-stage small cell lung cancer (SCLC) as well as results of a biomarker study of the same doublet in the setting of first-line non-small cell lung cancer (NSCLC). An ongoing, global Phase 3 trial of ociperlimab plus tislelizumab in stage IV, PD-L1 high NSCLC, AdvanTIG-302, will complete enrollment this month (NCT04746924). An additional clinical presentation includes the first data from a Phase 1a dose escalation study of BGB-10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, plus tislelizumab in patients with solid tumors. BeiGene will also be presenting preclinical characterizations of several novel molecules from its internal discovery engine, including a CEA x 4-1BB bispecific antibody and a chimeric degradation activation compound (CDAC) targeting BTK, BGB-16673. Clinical data from an ongoing Phase 1 study of BGB-16673 in relapsed/refractory B-cell malignancies were presented at ASH 2023, demonstrating clinical responses and a tolerable safety pro heavily pre-treated patients with B-cell malignancies, including those with BTK inhibitor-resistant disease (NCT05006716). An additional preclinical presentation highlights the therapeutic potential of the triple-combination of tislelizumab with anti-LAG-3 (LBL-007) and anti-TIM-3 (surzebiclimab); this combination is being evaluated in an ongoing Phase 2 study in head and neck squamous cell carcinoma (NCT05909904). BeiGene Presentations During AACR 2024 Abstract Title Abstract # Presentation Time (PDT) Lead Author Preclinical Characterization of the correlation between BTK degradation and tumor growth inhibition of the BTK target protein degraders using PK/PD modeling 2110 Monday, April 8 9 a.m. – 12:30 p.m. Section 30 Board #1 Y. Wu BGB-B167, a first-in-class 4-1BB/CEACAM5 bispecific antibody, exhibits potent in vitro and in vivo anti-tumor activity and superior safety pro > in preclinical models 2371 Monday, April 8 9 a.m. – 12:30 p.m. Section 38 Board #17 Z. Li Translational assessment of triple combination with tislelizumab (anti-PD-1), LBL-007 (anti-LAG- 3) and surzebiclimab (anti-TIM-3) highlights its strong anti-tumor activity and clinical potential in solid tumors such as HNSCC 4041 Tuesday, April 9 9 a.m. – 12:30 p.m. Section 3 Board #17 H. Zhu Clinical Exploration of potential biomarkers correlated with efficacy of ociperlimab (anti-TIGIT) plus tislelizumab (anti-PD1) in 1L PD-L1+ non-small cell lung cancer (NSCLC) CT053 Monday, April 8 9 a.m. – 12:30 p.m. Section 48 Board #3 S. Kim A first in human, phase 1a, dose escalation study of BGB 10188, a phosphatidylinositol 3 kinase delta (PI3Kδ) inhibitor, + tislelizumab (anti-PD-1) in patients with solid tumors CT189 Tuesday, April 9 9 a.m. – 12:30 p.m. Section 48 Board #17 R. Cosman AdvanTIG-204: A phase 2, multicenter, randomized, 3-arm, open-label study investigating the preliminary efficacy and safety of ociperlimab (anti-TIGIT) + tislelizumab (anti-PD-1) + concurrent chemoradiotherapy (cCRT) in patients with untreated limited-stage small cell lung cancer (SCLC) CT255 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 48 Board #14 Y. Gong BGB-A317-LBL-007-202 (NCT06010303): A phase 2, randomized, active-controlled, open- label study to evaluate the efficacy and safety of LBL 007 (anti-LAG-3) in combination with tislelizumab (TIS; anti-PD-1) plus chemotherapy (chemo) as first-line (1L) treatment in patients with unresectable locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) CT274 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #4 S. Park Liberty-201 (NCT05609370): Maintenance fluoropyrimidine and bevacizumab with or without anti-lymphocyte activation gene-3 (LAG-3) antibody LBL-007 plus anti-programmed cell death protein-1 (PD-1) antibody tislelizumab (TIS) for patients (pts) with metastatic or unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR)colorectal cancer (CRC) CT276 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #6 H.-J. Lenz BGB-LC-201 (NCT05635708): A phase 2, open- label, multi-arm study of tislelizumab (TIS; anti- PD-1) in combination with investigational agents +/- chemotherapy as first-line treatment for patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) CT277 Tuesday, April 9 1:30 p.m. – 5 p.m. Section 50 Board #7 G. Blumenschein About Tislelizumab Tislelizumab 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. About BeiGene BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit and follow us on LinkedIn and X (formerly known as Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s ability to discover innovative new medicines for cancer patients and pioneer novel mechanisms; the future development, regulatory filing and approval, and commercialization of tislelizumab, BGB-16673, and other novel molecules; and BeiGene’s plans, commitments, aspirations, and goals under the heading “About BeiGene.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. View source version on businesswire.com: Contacts Investor: Liza Heapes +1 857-302-5663 ir@beigene.com Media: Kyle Blankenship +1 667-351-5176 media@beigene.com Source: BeiGene, Ltd. View this news release online at:

Phase 2Phase 1ImmunotherapyPhase 3

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	BeiGene Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	BeiGene Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	BeiGene Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Spain	BeiGene Ltd.	17 Jun 2021
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Taiwan Province	BeiGene Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	United States	BeiGene Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	China	BeiGene Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	Australia	BeiGene Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	Spain	BeiGene Ltd.	17 Jun 2021
Unresectable Lung Non-Small Cell Carcinoma	Phase 3	Taiwan Province	BeiGene Ltd.	17 Jun 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04732494 (AdvanTIG-203, CTgov)	Phase 2	Metastatic Esophageal Squamous Cell Carcinoma	125	Tislelizumab+Ociperlimab (Arm A: Tislelizumab Plus Ociperlimab)	rhqaantfqs = zjwozvxjoy bmrkevhliv (dddnghqytk, dlsscxgtra - xftfksdeyc) View more	-	25 Mar 2025
				Placebo+Tislelizumab (Arm B: Tislelizumab Plus Placebo)	rhqaantfqs = jmlqriofjm bmrkevhliv (dddnghqytk, qyjynhnzzs - penyctrrxg) View more
NCT04948697 (AdvanTIG-206, CTgov)	Phase 2	Advanced Hepatocellular Carcinoma	94	Tislelizumab+BAT1706+Ociperlimab (Arm A: Ociperlimab + Tislelizumab + BAT1706)	ubuoccjkog = obvsfiuzeg ecczamaeuj (zgwcxwvpto, yrwdcomsjr - ljbnbhxsgw) View more	-	25 Mar 2025
				Tislelizumab+BAT1706 (Arm B: Tislelizumab + BAT1706)	ubuoccjkog = owgvhabwtp ecczamaeuj (zgwcxwvpto, asmfabqnig - iddmqoogks) View more
NCT04866017 (CTgov)	Phase 3	Unresectable Lung Non-Small Cell Carcinoma \| Locally Advanced Lung Non-Small Cell Carcinoma	63	Radiotherapy+Tislelizumab+Ociperlimab (Ociperlimab + Tislelizumab + cCRT)	hjnlazytae = qpqyznjcuo cqurhzfjjk (czihevuigh, lksybcstgk - iswxatlqhk) View more	-	31 Oct 2024
				Radiotherapy+Tislelizumab (Tislelizumab + cCRT)	hjnlazytae = yzdamfoohv cqurhzfjjk (czihevuigh, thecxrzijb - pbsxbgjlgu) View more
NCT04952597 (AdvanTIG-204, CTgov)	Phase 2	Small Cell Lung Cancer	126	Concurrent Chemoradiotherapy+Tislelizumab+Ociperlimab (Arm A: Ociperlimab + Tislelizumab)	ighgbqadtb(oiqnkbjqwz) = rgrbwrpoyb wbokdlodki (nnvzurjmzd, qcyqkjtrea - bqkzupobgx) View more	-	19 Sep 2024
				Concurrent Chemoradiotherapy+Tislelizumab (Arm B: Tislelizumab)	ighgbqadtb(oiqnkbjqwz) = vrqfctgirb wbokdlodki (nnvzurjmzd, mtunnnhigr - ibgyikpnvo) View more
NCT04952597 (AdvanTIG-204, AACR2024) Manual	Phase 2	Small Cell Lung Cancer	126	ociperlimaberlimab 90tislelizumab + tislelizumab [200 mg IV Q3W] + cCRT for 4 cycles, then ociperlimab + tislelizumab)	nrblxbeixo(oneszdmiax) = lgnsargnrf rvuvxnpdxp (qmcgahatvx ) View more	Positive	05 Apr 2024
				tislelizumablizumab + cCRT for 4 cycles, then tislelizumab)	nrblxbeixo(oneszdmiax) = ietkwhdeoh rvuvxnpdxp (qmcgahatvx ) View more
NCT04693234 (AdvanTIG-202, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Uterine Cervical Cancer Second line PD-L1	178	Tislelizumab 200 mg + Ociperlimab 900 mg	mocqecrtbi(kguoirslkh) = kgcuhqhkrn ibjfpokriv (fmbsyeuija, 15.8 - 30.3) View more	Positive	22 Oct 2023
				Tislelizumab 200 mg + Ociperlimab 900 mg (PD-L1 +)	mocqecrtbi(kguoirslkh) = cadaialgqt ibjfpokriv (fmbsyeuija, 17.2 - 36.9) View more
NCT04732494 (AdvanTIG-203, ESMO 12023 \| ESMO 22023) Manual	Phase 2	PD-L1 positive Esophageal Squamous Cell Carcinoma Second line PD-L1 High Expression	125	Ociperlimab (OCI) + Tislelizumab (TIS)	nogmnzuwae(wuudarfafg) = tugbgsdyjr tsmxvcbphq (genryodndf ) View more	Negative	21 Oct 2023
				Placebo + Tislelizumab (TIS)	nogmnzuwae(wuudarfafg) = cvjedyzyrz tsmxvcbphq (genryodndf ) View more
NCT04948697 (AdvanTIG-206, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Advanced Hepatocellular Carcinoma	94	Ociperlimab + Tislelizumab + BAT1706	ggcohoyohr(wrvapurpca) = rvkjhntpmt fijemtrnmi (kyxtrbmrbf, 23.7 - 48.7) View more	Positive	21 Oct 2023
				Tislelizumab + BAT1706	ggcohoyohr(wrvapurpca) = goemimubyw fijemtrnmi (kyxtrbmrbf, 21.1 - 56.3) View more
NCT04047862 (AdvanTIG-105, Pubmed \| J Immunother Cancer)	Phase 1	Advanced Malignant Solid Neoplasm	32	Ociperlimab 50 mg	cenjaywnft(pmxlsviouk) = mpucktcuhv xwsefzkzew (jhnjpgmmgi ) View more	Positive	01 Oct 2023
				Ociperlimab 150 mg	cenjaywnft(pmxlsviouk) = eeshtmowjp xwsefzkzew (jhnjpgmmgi ) View more
NCT04047862 (BGB-900-105, ASCO 12023 \| ASCO 22023) Manual	Phase 1	stomach adenocarcinoma \| Malignant neoplasm of gastro-oesophageal junction	60	Ociperlimab+Tislelizumab+chemotherapy	cgzjnykrcr(sxskyzuzjv) = lqubhwtfdx uyaufomije (vmcqyfbltp, 37.5 - 64.1) View more	Positive	26 May 2023
				Ociperlimab+Tislelizumab+chemotherapy (PD-L1 tumor area positivity (TAP) score ≥5%)	cgzjnykrcr(sxskyzuzjv) = otfhqscfqw uyaufomije (vmcqyfbltp, 38.8 - 77.6)

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