A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 selected non small cell lung cancer (GALAXIES LUNG 301) - GALAXIES LUNG 301

开始日期2024-12-16

申办/合作机构

GSK Plc

CTIS2023-504753-12-00

/ Recruiting临床3期

A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, locally advanced, unresectable or metastatic PD-L1 selected non small cell lung cancer (GALAXIES LUNG 301) - 213823

开始日期2024-10-01

申办/合作机构

GlaxoSmithKline Research & Development Ltd.

NCT06472076

/ Recruiting临床3期

A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

The goal of this clinical trial is to evaluate the efficacy and safety profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC. Researchers will compare belrestotug plus dostarlimab with pembrolizumab plus placebo to see if there is meaningful improvement in progression free survival (PFS) and overall survival (OS).

开始日期2024-06-10

申办/合作机构

GSK Plc

[+1]

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项与 Belrestotug 相关的新闻（医药）

2025-03-06

·PRNewswire

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

上市批准免疫疗法优先审批

2025-03-03

·BioSpace

The Search for the Next Keytruda: Immuno-Oncology’s Next Play

iStock/ Bulat Silvia More than a decade after Merck’s Keytruda and BMS’ Yervoy ushered in the immuno-oncology revolution, the space is at a crossroads, with experts highlighting novel targets, combinations and pre-emptive immunization as the next wave for IO. Last year marked 10 years since Keytruda’s seminal approval . That FDA greenlight signaled a new day in immuno-oncology and set the stage for the subsequent approvals of several more checkpoint inhibitors. Now, the field is looking for its next breakthrough—but it’s been a bumpy road. Overall, the immuno-oncology (IO) space “continues to be quite disappointing,” Graig Suvannavejh, senior biopharmaceuticals and biotechnology equity research analyst at Mizuho Americas, told BioSpace . “Industry is in search of that next great IO target, and they just haven’t been able to identify one that works.” In the last 15 years, the FDA has approved 11 checkpoint inhibitors — therapies targeting immune checkpoint proteins, including PD-1 and its partner protein PD-L1, plus CTLA-4 and LAG-3—to help the immune system locate and attack cancer cells. While Keytruda, an anti-PD-1, gets the most credit for having kickstarted the IO revolution, it was preceded by a CTLA-4 inhibitor called Yervoy, which BMS picked up in its $2.4 billion acquisition of Medarex in 2009. Two years later, the FDA approved Yervoy as the first anti-CTLA-4 drug. “That, really, along with the anti-PD-1s, kind of ushered in this whole immuno-oncology revolution,” Suvannavejh said. Jeremy Levin, now CEO of Ovid Therapeutics who was instrumental in BMS’ transformation to an immuno-oncology company in the aughts, agreed: “It became increasingly clear that there was science that said that this whole concept of immune modulation was beginning to evolve, and that CTLA-4 was breaking open the first concepts behind it.” Lately, however, the industry appears to have hit the proverbial therapeutic wall. But it’s not for a lack of trying, according to Christiana “Chris” Bardon, co-managing partner of MPM BioImpact. “When PD-1 was first released, we spent a lot of energy as an industry looking for the next PD-1 and we must have had tens of thousands of combinations of drugs in the clinic, testing everything with PD-1,” she told BioSpace . “Basically, we were looking for the next-generation IO checkpoint inhibitor.” But despite the emergence of more therapeutic options targeting the immune system, IO treatment response rates have plateaued at around 30%, Caroline Loew, CEO of Mural Oncology, wrote in a November 2024 opinion piece for BioSpace , meaning that 70% of patients do not respond to these therapies. “Despite the incredible efficacy of PD-1,” Bardon said, there is still a huge unmet need. “We still have many cancers that don’t respond to PD-1, things that are immunologically cold.” Striking Out With TIGITs Branching out has proven difficult, however. In the IO space, Suvannavejh said anti-TIGIT checkpoint therapies have been “probably the biggest disappointment” in the past two years. In December 2021, Roche ignited the field with promising results from the Phase II CITYSCAPE study of its anti-TIGIT drug tiragolumabin in metastatic non-small cell lung cancer (NSCLC). When combined with the company’s anti-PD-L1 blocker Tecentriq, tiragolumabin reduced the risk of disease worsening or death by 38% compared to Tecentriq alone. “I think the IO space was in kind of a low place about five years ago until Roche announced positive Phase II data for their TIGIT antibody,” he said. “All of a sudden, people were like, ‘oh my god, IO is back.” But in the Phase II/III data reported last year, the tiragolumab/Tecentriq combo failed to significantly improve progression-free and overall survival versus Keytruda and chemotherapy in patients with NSCLC and Roche elected to terminate that study. The excitement fizzled after that, Suvannavejh said. It was almost the nail in the coffin for TIGITs, or at least the buzz around the drug class. Seven months earlier, in December 2023, Merck had struck out in NSCLC with its experimental anti-TIGIT antibody vibostolimab when the candidate, in combination with Keytruda, failed to hit the endpoints in a mid-stage study. Recent results have breathed new life into the space, however. In September 2024, iTeos and GSK sparked excitement with Phase II results from patients with NSCLC taking a combination of iTeos’ anti-TIGIT candidate belrestotug and GSK’s anti-PD-1 therapy Jemperli. The combo elicited a 30% better confirmed objective response rate versus Jemperli alone. The partners are now studying the regimen as a first-line therapy for NSCLC in a Phase III trial . While it remains to be seen if TIGIT-targeting checkpoint inhibitors will reach the market, Bardon noted that the industry has seen some progress with drugs that hit CTLA-4 and LAG-3. In October 2022, the FDA greenlit AstraZeneca’s anti-CTLA-4 drug Imjudo, in combination with its first-generation PD-L1 inhibitor Imfinzi, for hepatocellular carcinoma, while the LAG-3 space saw its first approval in March of that year in BMS’ relatlimab (in combination with Opdivo and marketed as Opdualag) in unresectable or metastatic melanoma. Looking ahead, Bardon said ivonescimab—a PD-1/VEGF bispecific antibody in development by Summit Therapeutics, “is really the new . . . wave of checkpoint inhibitors.” “Ivonescimab has shown superiority to PD-1 alone, which is incredible,” she said. In September, Summit presented Phase III data at the International Association for the Study of Lung Cancer’s 2024 World Conference on Lung Cancer, showing that ivonescimab outperformed Keytruda in first-line advanced NSCLC. In the HARMONi-2 trial, Summit’s candidate cut the risk of disease progression or death by nearly 50% compared with Keytruda. While the results sent Summit’s stock skyrocketing by as much as 140%, some analysts urged caution , particularly noting that the data were from a trial run only in China. “Results may or may not be generalizable beyond the China-focused patient population initially assessed,” BMO Capital Markets wrote in an investor note at the time. Summit is currently studying ivonescimab in a multi-regional Phase III NSCLC study in the U.S. Bardon added that ivonescimab has the potential to work in multiple tumor types outside of lung cancer and predicted that it would be “a huge blockbuster in the future.” Pfizer appears to agree. Last week, the New York–based pharma struck a deal with Summit to combine its vedotin-based antibody-drug conjugates with ivonescimab. Part of the reason the industry has not been successful in developing checkpoint inhibitors “is that the development path is very, very hard,” Bardon said. One key challenge, she explained, is that most checkpoint therapies do not have monotherapy efficacy and therefore need to be developed in combination with PD-1 drugs. Definitive combination therapy can only be demonstrated in a comparator trial. “It’s just a very difficult and long path to de-risk the drug.” In this way, ivonescimab benefited from being created and developed in China, where there are faster enrollment times, limited treatment options and clinical trials are less expensive, Bardon said. Other IO targets of particular interest, Suvannavejh said, are PRAME (preferentially expressed antigen of melanoma) and the “very complicated RAS pathway, which includes the commonly mutated KRAS.” “This is a pathway that people have been trying to target for decades,” Suvannavejh said. “[It is] very difficult to do, trying to get that mix of efficacy and safety.” Amgen and BMS already have KRAS drugs — Lumakras and Krazati —on the market for NSCLC. The developmental “darling” of this space, Suvannavejh said, is Revolution Medicines, whose daraxonrasib is currently in a registrational trial to treat cancers with a wide range of common RAS mutations. Other players include Eli Lilly, Immuneering Corporation and Erasca. IO Developments On the Horizon Levin indicated that the IO space is at a crossroads. “The first wave of immuno-oncology has passed us by,” he said. “We know what we know about it.” Biopharma’s appetite for IO is certainly understandable. For Merck, Keytruda brought in a cool $29.5 billion in global sales in 2024 and ranks among the best selling drugs of all time. With that drug going off patent in just a few years’ time, many companies are eager to grab more of a market that is projected to be worth more than $17 billion by 2032. So, how does biopharma catch the next wave? For Suvannavejh, the answer lies in identifying novel targets—potentially through artificial intelligence and machine learning. As an example, he offered Compugen , a Tel Aviv–based biotech that uncovered a previously unidentified checkpoint called PVRIG using its proprietary computational discovery platform. Compugen is currently studying the resulting asset, COM701 , in trials of ovarian, gastric and other cancers. “That’s what companies can do if they want to go down this path of like, hey, maybe there’s another checkpoint inhibitor that we just haven’t identified yet,” Suvannavejh said. Meanwhile, Levin said the current focus is on combination therapies. “The world teaches you this repeatedly for complex diseases,” he continued, citing childhood leukemia, hypertension and congestive heart failure as examples of where combinations have ultimately been the answer. However it’s done, Levin continued, the holy grail for IO is pre-emptively engaging the human body to defeat a cancer cell before it has even proliferated. “Immuno-oncology is the clue that you can do this,” he told BioSpace . “It says that you can absolutely galvanize the human tissue to reawaken attack on a cancer cell. The big question is, can you actually pre-emptively immunize us such that we can be ready for this?”

临床结果免疫疗法临床3期临床2期上市批准

2025-02-12

·ioncology

SKYSCRAPER-06研究：Tiragolumab联合阿替利珠单抗未能改善晚期非鳞状NSCLC患者的OS

点击蓝字关注我们根据2024年ESMO免疫肿瘤学大会（摘要号LBA2）上公布的SKYSCRAPER-06研究结果，Tiragolumab（一种阻断TIGIT与其配体结合的单克隆抗体）联合PD-1抑制剂阿替利珠单抗和化疗的一线组合未能改善局部晚期不可切除或转移性非鳞状非小细胞肺癌（NSCLC）患者的无进展生存期（PFS）和总生存期（OS）。对于肿瘤不具有EGFR或ALK变异的晚期NSCLC患者，无论PD-L1表达情况如何，帕博利珠单抗联合化疗都是一线治疗的标准方案。TIGIT（含免疫球蛋白和免疫受体酪氨酸抑制基序结构域的T细胞免疫受体）在调节T细胞和NK细胞免疫突触的免疫反应中起着重要作用，是免疫肿瘤学中一个有前景的新靶点。 SKYSCRAPER-06是一项全球性II/III期随机双盲安慰剂对照试验，纳入542名未接受过治疗的局部晚期不可切除/转移性非鳞状NSCLC患者。各组基线特征相似，但在Tiragolumab+阿替利珠单抗+化疗组中，男性患者更多（68% vs 62%），PD-L1肿瘤比例评分（TPS）<1%的患者更少（34% vs 42%），且基线肝转移患者更多（14% vs 9%）。SKYSCRAPER-06研究组方案为Tiragolumab 600mg联合阿替利珠单抗1200mg联合卡铂/顺铂+培美曲塞，对照组为安慰剂联合帕博利珠单抗200mg联合卡铂/顺铂+培美曲塞，每三周进行一次，共四个周期，随后进行维持治疗，直至病情进展、临床获益丧失、毒性不可接受或撤回知情同意。在数据截止时，Tiragolumab+阿替利珠单抗+化疗组的疗效低于标准疗法，中位PFS分别为8.3个月vs 9.9个月（风险比[HR]=1.27；95%置信区间[CI]: 1.02-1.57；P=0.99），OS分别为18.9个月vs. 23.1个月（HR=1.33；95%CI：1.02-1.73；P=0.98）（表）。亚组分析观察到的结果一致，包括PD-L1亚组。两组的安全性相似，没有发现新的或意外的安全信号。表1. 疗效和安全性总结由于结果令人失望，SKYSCRAPER-06研究即将终止。“有许多II期研究正在评估不同的抗TIGIT抗体，例如ARC-7研究（NCT04262856）采用domvanalimab单药或联合方案，GALAXIES-Lung201研究使用belrestotug+dostarlimab（Annals of Oncology, Volume 35, S1242 - S1243），CITYSCAPE研究探索了Tiragolumab+阿替利珠单抗（Lancet Oncol. 2022 Jun;23(6):781-792），这些研究都获得了令人鼓舞的结果。然而，有两项III期试验结果为阴性，即最近已发布新闻稿的SKYSCRAPER-01研究和2024 ESMO免疫肿瘤学大会发布的SKYSCRAPER-06研究”，本次会议的点评专家、意大利帕尔马大学的Marcello Tiseo教授说道。“对于SKYSCRAPER-06研究阴性结果，有一种解释是两个治疗组之间存在不平衡，实验组中肝转移患者更多，实验组中5级AE的发生率在数值上更高，并且临床前数据假设同时进行化疗可能会减弱Tiragolumab+阿替利珠单抗的活性。但这种解释不适用于SKYSCRAPER-01的阴性结果。”Dr. Tiseo还总结道，综合起来看，这些阴性结果对TIGIT作为靶点的意义提出了一些质疑。（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期免疫疗法临床3期加速审批

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适应症	最高研发状态	国家/地区	公司	日期
PD-L1阳性非小细胞肺癌	临床3期	美国	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	中国	GlaxoSmithKline Research & Development Ltd.	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	日本	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	阿根廷	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	比利时	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	巴西	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	保加利亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	加拿大	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	克罗地亚	GSK Plc	2024-06-10
PD-L1阳性非小细胞肺癌	临床3期	捷克	GSK Plc	2024-06-10

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05565378 (GALAXIES Lung-201, GlobeNewswire) 人工标引	临床2期	PD-L1阳性非小细胞肺癌一线 PD-L1 High Expression	124	Dostarlimab	鬱膚膚網構淵鑰窪選鏇(積簾窪襯鹹餘夢憲衊窪) = 淵窪衊鏇鹽繭淵製鏇壓憲齋製製構淵構憲選壓 (遞築觸餘築糧廠積餘憲, 21.1–56.3) 更多	积极	2024-09-14
				Dostarlimab + belrestotug 100 mg	鬱膚膚網構淵鑰窪選鏇(積簾窪襯鹹餘夢憲衊窪) = 網糧鹽餘廠糧醖蓋餘鹹憲齋製製構淵構憲選壓 (遞築觸餘築糧廠積餘憲, 43.9–80.1) 更多
NCT05565378 (GALAXIES Lung-201, ESMO2024) 人工标引	临床2期	PD-L1阳性非小细胞肺癌一线 PD-L1 High Expression (TPS >= 50%)	124	Dostarlimab 500 mg	獵鹽網憲顧範淵簾鏇積(範鹹鹹構繭廠蓋淵築壓) = 鏇齋繭糧襯廠構壓顧鬱簾繭衊夢顧窪簾淵鹽糧 (鹽壓製蓋膚憲鏇壓齋構, 21.1 ~ 56.3) 更多	积极	2024-09-14
				Dostarlimab 500 mg + Belrestotug 100 mg	獵鹽網憲顧範淵簾鏇積(範鹹鹹構繭廠蓋淵築壓) = 築網糧鬱網獵憲願鬱艱簾繭衊夢顧窪簾淵鹽糧 (鹽壓製蓋膚憲鏇壓齋構, 43.9 ~ 80.1) 更多
NCT05565378 (GALAXIES Lung-201, Company_Website) 人工标引	临床2期	非小细胞肺癌	-	Belrestotug + dostarlimab	齋遞糧艱構蓋選獵鏇鹽(壓淵鹽憲鑰廠觸糧鏇鹽) = acceptable safety profile in line with the TIGIT:PD-1 class 鏇壓顧鏇網餘壓糧艱鏇 (鹹醖顧遞衊築鏇壓壓壓 )	积极	2024-05-10
				dostarlimab
NCT04335253 (AACR 12021 \| AACR 22021) 人工标引	临床1/2期	晚期癌症	22	EOS884448	鹹膚簾齋獵膚顧鑰觸鑰(繭鹽鹽網積襯積獵遞構) = 積廠艱壓艱夢蓋窪糧襯膚窪餘獵廠壓築選鏇餘 (積蓋願築鑰顧蓋膚獵壓 ) 更多	积极	2021-04-10
SITC2019	N/A	肿瘤 TIGIT- \| CD155 \| CD226	15	EOS884448	築鏇顧醖壓選積範蓋衊(蓋鏇壓範獵蓋壓繭夢顧) = 餘簾淵壓窪築齋艱鹽積鹽積壓鹹選蓋鬱艱製繭 (齋窪醖網蓋廠製淵積範 )	积极	2019-11-01
				Placebo	繭鏇膚艱構憲夢憲繭網(選鹹醖夢鑰願繭製鑰鬱) = 淵觸鑰衊淵築衊蓋醖繭襯襯鹹積襯鬱壓願簾鏇 (膚觸窪膚夢壓觸鏇構選 ) 更多