A Randomized Phase III Trial of Checkpoint Blockade in Lung Cancer Patients in the Adjuvant Setting Based on Pathologic Response Following Neoadjuvant Therapy (CLEAR)

This phase III trial compares the effect of adding AZD6738 to durvalumab versus durvalumab alone to increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery. AZD6738 may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Adding AZD6738 to durvalumab may increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery.

Start Date10 Mar 2026

Sponsor / Collaborator

National Cancer Institute

NCT06769126

/ Not yet recruitingPhase 2IIT

PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Start Date08 Sep 2025

Sponsor / Collaborator

SWOG

[+1]

NCT06929260

/ RecruitingPhase 1

A Phase I, Open-label, Fixed-sequence Study to Evaluate the Effect of Ceralasertib on Pharmacokinetics of Drug X, Drug Y and Drug Z in Participants With Advanced Solid Tumours

The study aims to assess the effect of ceralasertib on the pharmacokinetics (PK) of Drug X, Drug Y and Drug Z in participants with advanced solid tumours.

Start Date21 May 2025

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Ceralasertib

100 Translational Medicine associated with Ceralasertib

100 Patents (Medical) associated with Ceralasertib

286

Literatures (Medical) associated with Ceralasertib

01 Jul 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

Comparative in vivo toxicology of ATR inhibitors ceralasertib, elimusertib, and berzosertib alone and in combination with ionizing radiation

Article

Author: Clump, D Andy ; Pandya, Pinakin ; Knizner, Paul ; Deppas, Joshua J ; Green, Anthony ; Bakkenist, Christopher J ; Vendetti, Frank P ; Rigatti, Lora H ; Beumer, Jan H ; Latoche, Joseph D ; Guo, Jianxia ; Kiesel, Brian F

Ionizing radiation (IR) induces damage in the form of DNA strand breaks. As an apical initiator of the DNA damage response, Ataxia telangiectasia and Rad3-related (ATR) mitigates DNA damage, limiting therapeutic efficacy. Small molecule ATR inhibitors (ATRi) restrict this effect and sensitize cancer cells to radiation-induced damage. However, the impact of ATR inhibition in non-malignant tissues following IR is currently unknown. Here, we document the impact of ATRi on murine toxicity profiles following total body irradiation (TBI). Mice were stratified to receive single-dose ATRi (ceralasertib, elimusertib, or berzosertib), 6 Gy TBI, or the combination. Mice were euthanized 48 h post TBI. Blood and tissues were collected for analysis of complete blood counts and histopathology. To further distinguish toxicity profiles, IC₅₀ values were compared between ATRi. Pharmacokinetics (PK) and pharmacodynamics (PD) were considered as potential explanatory factors of differences in toxicity profiles. Elimusertib was determined to be the most potent ATRi, and ceralasertib the least. We observed neutrophilia with all ATRi. We found that ATRi did not exacerbate any TBI-induced toxicities in mice. Berzosertib presented a unique profile among all ATRi across several toxicity endpoints, including modest amelioration of TBI-associated effects on spleen and lymphocyte and white blood cell counts. Cardiotoxicity was observed following single-dose ceralasertib, but no other ATRi, possibly due to high unbound plasma drug concentrations. Our results further support and guide clinical development of ATRi in clinic.

01 Jul 2025·CANCER CELL

KEAP1 and STK11/LKB1 alterations enhance vulnerability to ATR inhibition in KRAS mutant non-small cell lung cancer

Article

Author: Arrechedera, Claudio ; Galan-Cobo, Ana ; Iyer, Sonia ; Hughes, Adina ; Conway, James ; Valge-Archer, Viia ; Young, Lucy ; Critchlow, Susan E ; Karmokar, Ankur ; Lau, Alan ; Byers, Lauren A ; Qian, Yu ; Cosaert, Jan ; Barrett, J Carl ; Keshvani, Caezaan ; Kong, Yifan ; Heymach, John V ; Karimi, Amirali ; Poteete, Alissa ; Vokes, Natalie I ; Sargeant, Rebecca ; Ramkumar, Kavya ; Do, Minh Truong ; Floc'h, Nicolas ; Wang, Jing ; Barry, Simon T ; Molkentine, David ; Paula, Alvaro G ; Schlacher, Katharina ; Pisegna, Marlese ; de Toma, Ilario ; Cho, Sungnam ; Shen, Li ; Milo, Marta ; McGrail, Daniel J ; Hernandez, Sharia ; Kar, Gozde ; Keddar, Mohamed Reda ; Solanki, Anisha

KRAS mutations frequently co-occur with alterations in STK11/LKB1 and/or KEAP1, defining an aggressive subset of lung cancers resistant to immuno- and chemotherapy. While LKB1 loss is associated with vulnerability to DNA damage response-based therapies, the impact of KEAP1 alterations remains unknown. We demonstrate that KEAP1-NRF2 pathway drives a compensatory modulation of ATR-CHK1 signaling, enhancing vulnerability to ATR inhibitors (ATRi), particularly in the setting of increased replication stress associated with LKB1 loss. ATRi shows enhanced anti-tumor activity in LKB1 and/or KEAP1-deficient non-small cell lung cancer (NSCLC) models and synergizes with gemcitabine. ATRi also enhances antitumor immunity and mitigates the immunosuppressed phenotype of LKB1/KEAP1-deficient tumors. In the HUDSON trial, LKB1/KEAP1-deficient NSCLC patients demonstrate enhanced benefits to the ATRi ceralasertib plus durvalumab. These findings suggest that alterations in the KEAP1-NRF2 pathway and/or LKB1 are associated with enhanced sensitivity to ATRi and could serve as biomarkers for predicting response to ATRi combination regimens.

01 Jun 2025·CANCER SCIENCE

ATR Inhibition Synergizes With Alkylating PI Polyamide Targeting MYCN by Suppressing DNA Repair in MYCN‐Amplified Neuroblastoma

Article

Author: Lai, Xiaoyi ; Qiao, Yuming ; Takenaga, Keizo ; Koshikawa, Nobuko ; Yoda, Hiroyuki ; Takatori, Atsushi ; Shinozaki, Yoshinao ; Kida, Yuki

ABSTRACT:

Amplification of MYCN is a major oncogenic driver of high‐risk neuroblastomas. We previously developed CCC‐002, a MYCN‐selective pyrrole‐imidazole polyamide conjugated to a DNA alkylating agent. Administration of CCC‐002 to MYCN‐amplified (MYCN‐amp) neuroblastoma cells triggered the activation of DNA damage responses. Here, we demonstrated that among the DNA damage response inhibitors, ataxia telangiectasia and Rad3‐related (ATR) inhibitors synergized with CCC‐002 to suppress DNA repair‐related genes and induce apoptosis in MYCN‐amp neuroblastoma cells. A synergistic antitumor effect was verified in an SK‐N‐BE(2) xenograft mouse model, in which the combined use of CCC‐002 and ATR inhibitor at low doses significantly inhibited tumor progression. Notably, SK‐N‐BE(2) and SK‐N‐DZ cells, which showed ATM activation after CCC‐002 treatment, exhibited high sensitivity to the combined treatment of ATR inhibitors. Comprehensive analysis of the gene expression profiles revealed that the combination treatment upregulated apoptosis‐related pathways and downregulated DNA repair‐related pathways. After the combined treatment of CCC‐002 and ATR inhibitor, MYCN‐amp cells showed less FISH probe signal and mRNA expression of MYCN, which was accompanied by an increase in DNA damage markers in the genomic region of MYCN, highlighting that ATR inhibitors synergize with CCC‐002 and play a crucial role in the development of a novel MYCN‐targeting therapy for MYCN‐amp neuroblastoma.

News (Medical) associated with Ceralasertib

14 Jul 2025

·www.biospace.com

AstraZeneca’s Baxdrostat Pushes Blood Pressure Lower in Phase III Trial

iStock, HuiLiu The drug came to AstraZeneca through its acquisition of CinCor Pharma in 2023, with the hopes of beefing up its cardiovascular and kidney disease pipelines. AstraZeneca’s $1.3 billion gamble on CinCor may be paying off, after baxdrostat, an aldosterone synthase inhibitor it got in the deal, achieved a “statistically significant and clinically meaningful” drop in blood pressure in a late-stage trial, according to a company press release Monday. The results are from the Phase III BaxHTN trial, comparing patients with uncontrolled or treatment-resistant hypertension on two different doses—1 mg or 2 mg—to patients who received placebo. All patients either received baxdrostat or placebo on top of standard of care. AstraZeneca originally took on baxdrostat via the $1.3 billion acquisition of CinCor Pharma in 2023 . The deal also involved regulatory milestones involving baxdrostat that could kick the total value up to $1.8 billion—a gamble for shareholders as baxdrostat had flunked a previous Phase II trial run by CinCor after failing to reduce blood pressure in patients with uncontrolled hypertension. Data from a subgroup, however, kept hopes alive that the drug could address the condition. AstraZeneca did not go into specific details of the results, only saying that both doses met the primary endpoint, which was the difference in seated systolic blood pressure (SBP) after 12 weeks. The trial also met secondary endpoints in specific patient subpopulations and other measures of hypertension. AstraZeneca said that the drug was “generally well tolerated with a favorable safety profile.” AstraZeneca plans to reveal more details at the European Society of Cardiology Congress in August 2025. Baxdrostat works by blocking aldosterone synthase, a protein responsible for synthesizing aldosterone, a steroid involved in sodium retention and maintaining homeostatic blood pressure in the body. AstraZeneca is also testing baxdrostat in a Phase III trial in combination with dapagliflozin for treating chronic kidney disease progression in patients with both kidney disease and high blood pressure. Baxdrostat is part of a spate of drugs that AstraZeneca is hoping will help the company hit $80 billion in revenue by 2030, according to analysts at Leerink Partners, writing in a note to investors in April. Those also include ceralasertib, currently in a Phase I trial for solid tumors; gefurulimab for treating myasthenia gravis; and efzimfotase alfa, currently in Phase III trials for hypophosphatasia.

Phase 3Clinical ResultPhase 2AcquisitionPhase 1

29 Apr 2025

·endpts.com

Artios drug exploits ‘replication stress’ in cancer, shrinking subset of tumors in early study

Artios Pharma, a startup developing drugs that weaken a tumor’s ability to maintain its DNA, announced positive results in a subset of patients with advanced cancer. It’s the first big data reveal for the Cambridge, UK-based startup, which has been relatively quiet since 2021, when it struck a drug discovery partnership with Novartis and raised $153 million in Series C financing. The company’s drug, called ART0380, inhibits a DNA repair enzyme called ATR. When administered with a low dose of the chemotherapy irinotecan, the drug shrank tumors in 37% of patients whose cancer was considered “deficient” in another DNA damage response protein dubbed ATM, according to data from a Phase 1/2 study. In patients whose tumors lacked the ATM protein entirely, the response rate was 50%, with a median duration of response of 5.7 months so far. The response rate was 22% in patients with low levels of ATM. Patients with the ATM protein, however, did not respond to the therapy. “All those patients unfortunately progress quickly and unfortunately die very quickly,” Artios Chief Medical Officer Ian Smith told Endpoints News in an interview. The new data, presented Tuesday at the American Association for Cancer Research meeting, comes from 58 patients with advanced-stage and metastatic solid tumors who were treated at the dose the company plans to use in a Phase 2 study. Artios CEO Niall Martin told Endpoints that the company has funds “through 2026.” He said the startup is looking to raise another round of private funding to test its ATR inhibitor in pancreatic and colorectal cancers before pursuing bigger and broader tissue-agnostic studies. Martin said the company’s partnership with Novartis, which wasn’t focused on its ATR inhibitor, identified several targets that could potentially be paired with Novartis’ radioligand therapies, including its prostate cancer drug Pluvicto, and discussions are underway on next steps. Artios had struck a partnership with Merck KGaA in 2020 to search for drugs that target other DNA repair proteins, but Martin told Endpoints that partnership has ended. Artios was founded in 2016 to discover a new wave of drugs that target complex networks of proteins dedicated to the faithful replication and preservation of our genomes. While cancer can survive, and even thrive, with some DNA repair enzymes missing, too many missing pieces can cause the cancer to self-destruct. A class of drugs called PARP inhibitors exploit this vulnerability by blocking the eponymous DNA repair protein in tumors that have mutations in genes called BRCA1 and BRCA2, which are also important for DNA repair. Several companies have been searching for the next combination of targets that can deliver a similar double whammy to tumors, but progress has been slow. “The field hasn’t really evolved much since PARP inhibitors,” Martin said. “So we’ve been really thinking about what are the layers of DNA damage that are created in tumors that could be used as their sort of Achilles heel.” One of those layers, according to Artios, is a phenomenon called replication stress, which can occur when DNA replication, a key step for dividing cells, is blocked. ATR and ATM are two proteins that detect and clear up these blockages. Many forms of chemotherapy obstruct DNA replication. By first inducing a bit more of that stress with a low dose of chemo — but not enough to kill the cancer itself — and then blocking ATR in tumors with little to no ATM, Artios hoped to deliver a triple whammy to tumors. “There’s always been a push to get rid of chemotherapy and have targeted drugs,” Smith said.“But if you can’t get rid of chemotherapy, what you can do is really minimize it. And that’s what we’ve done here.” Smith said the company saw two complete responses, including one in a 62-year-old female who had pancreatic cancer but has been off treatment and cancer-free since August 2023. Neutropenia, a decline in white blood cells, was the most common side effect seen in 53% of patients, with grade 3 neutropenia in 45% of patients. Anemia occurred in 41% of patients. Fatigue, diarrhea, nausea and vomiting were also common side effects. Several other drugmakers have developed their own ATR inhibitors, but lackluster results have caused some pharma companies, including Bayer and Roche, to discontinue or pare back these efforts. “ATR inhibitors have been languishing,” Smith said. “The response rates are low relative to the toxicity that you tend to get.” Roche cut its partnership with Repare Therapeutics in 2024, which paused its ATR inhibitor program earlier this year after modest responses in only 19% and 17% of endometrial and ovarian cancer patients, respectively. Merck KGaA dropped its first ATR inhibitor, berzosertib, but is still testing a second one, called tuvusertib. And AstraZeneca is testing its ATR inhibitor ceralasertib in a Phase 3 study in lung cancer with its immunotherapy Imfinzi, which is expected to complete in August. Artios executives told Endpoints that other ATR inhibitors have faltered for three reasons: the drug’s half-life was too long, leading to intolerable toxicity; the drug was tested as a monotherapy, leading to low efficacy; or the drug was paired with the wrong therapies or tested in the wrong genetic subtypes of cancer. Martin said the company plans to develop a companion diagnostic to identify patients that are most likely to respond to its drug, with an initial focus on ATM. But Artios is looking for other biomarkers that may make tumors vulnerable to ATM inhibitors too. “This whole process of replication stress can be in up to 30% to 40% of tumors,” Martin said. “So there’s a huge area of biology which no one really has tapped into.”

Clinical ResultPhase 3Phase 2

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

100 Deals associated with Ceralasertib

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KEGG	Wiki	ATC	Drug Bank
D11787	-	-	DB14917

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Argentina	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Belgium	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	AstraZeneca PLC	15 Sep 2022
Advanced Lung Non-Small Cell Carcinoma	Phase 3	Germany	AstraZeneca PLC	15 Sep 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05061134 (MONETTE, CTgov)	Phase 2	Locally Advanced Melanoma	194	Durvalumab+Ceralasertib	fetelibobo = iimsygcerl gzqyyhgaqr (udgisuizmc, cmaryangbs - jhabetjtrw) View more	-	21 May 2025
ASH2024	Not Applicable	Chronic Myelomonocytic Leukemia \| Myelodysplastic Syndromes	-	Ceralasertib 160mg BID 7on/7off	rjmwomirhn(pdwvzdcfqu) = n=1, grade 3 or higher AEs with 7on/7off dosing sufjhozjvx (ybqzjcpwum ) View more	-	07 Dec 2024
				Ceralasertib 160mg BID 14on/14off
NCT03787680 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	49	Olaparib+AZD6738 (Cohort 1 (DRPro))	ugcknzsxxr = wozxupbidz iyyijampuz (mukevqzgpe, sygxfbzptu - nxvrugabbr) View more	-	12 Aug 2024
				Olaparib+AZD6738 (Cohort 2 (DRDef))	nzkaukdlbl(bfqnksvnup) = ceevdtissc gczpwjazcv (qlzuamkwsh, ezxyovnfhm - mtpjniwuas) View more
NCT04564027 (PLANETTE, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm \| Advanced cancer	57	Ceralasertib (Cohort A (aST): 160 mg of Ceralasertib)	bdfqkjsyno = pvaurtndiz ctzraylcdy (kanybmdgwb, bdvqowutkq - npfkfokvke) View more	-	25 Jun 2024
				Ceralasertib (Cohort B (mCRPC): 160 mg of Ceralasertib)	slcswxeuvx = eyuvapkbxv jbakxwcvhp (iwhvaqgygi, ewzvdohktb - hgvamopfeh) View more
NCT03462342 (CAPRI, ASCO2024)	Phase 2	Platinum-sensitive epithelial ovarian cancer genomic instability \| HRD positive \| LOH	37	Ceralasertib 160mg	bdevbfnokr(iozgbzbwzc) = xwgezvbheb zecrauvkfl (notobibhjz ) View more	Positive	24 May 2024
NCT04564027 (PLANETTE, AACR2024) Manual	Phase 2	Solid tumor \| Metastatic castration-resistant prostate cancer ATM	45	Ceralasertib 160 mg BIDCeralasertib 160 mg BID	hnfsxjybjs(dbdqqhadfq) = ywnxuwbndq hyyqlrvkqq (zwbpczshxy, 1.9 - 17.9) View more	Negative	05 Apr 2024
				Ceralasertib (mCRPC)	hnfsxjybjs(dbdqqhadfq) = jedgkiuuqk hyyqlrvkqq (zwbpczshxy, 0.8 - 26.8) View more
NCT03334617 (HUDSON, Pubmed) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma PD-L1 Expression	268	Durvalumab-ceralasertib	ycinategwr(hpmvcozgdp) = yvmesszivh owfiecswwq (irlrmjadsy ) View more	Positive	01 Mar 2024
				Durvalumab-olaparibdanvatirsenoleclumab	ycinategwr(hpmvcozgdp) = xztuhskafm owfiecswwq (irlrmjadsy ) View more
NCT02223923 (PATRIOT, Pubmed) Manual	Phase 1	Refractory Malignant Solid Neoplasm Gene \| ARID1A Positive	67	Ceralasertib 20-240 mg BD	oitzvxbhfr(novilxtmhi) = krzegquvpr lddjnyaxxc (yfffmqyynn ) View more	Positive	16 Jan 2024
NCT02664935 (WCLC2023) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma RAS Mutations	31	Ceralasertib+Durvalumab (KRASmut patients received previous ICB)	ecjiiplhiv(pjxyhctqub) = zrvxxhnsvl tafltmdmxb (frwpfqvshh ) View more	Positive	10 Sep 2023
				Ceralasertib+Durvalumab (ICB exposed KRAS wild-type patients)	ecjiiplhiv(pjxyhctqub) = gyvlhpmonh tafltmdmxb (frwpfqvshh ) View more
NCT05450692 (LATIFY, ASCO2023)	Phase 3	metastatic non-small cell lung cancer \| Locally Advanced Lung Non-Small Cell Carcinoma Second line \| Third line	580	Ceralasertib + Durvalumab	fyzeasktwu(kaednyehxv) = qisfcodfgz catcbpmxwf (wzebdowpaw, 14.1–20.3) View more	-	31 May 2023

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