BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors), MEK inhibitors(Dual specificity mitogen-activated protein kinase kinase inhibitors)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases+ [9]

Active Indication

Borderline serous tumour of ovaryOvarian Serous TumorDifferentiated Thyroid Gland Carcinoma+ [36]

Inactive Indication

Adenocarcinoma of large intestineAdvanced Colorectal AdenocarcinomaKRAS mutant Colorectal Cancer+ [1]

Originator Organization

F. Hoffmann-La Roche Ltd.

Active Organization

Eli Lilly & Co.

Verastem, Inc.

Chugai Pharma USA LLC

+ [2]

Inactive Organization

Hoffmann-La Roche, Inc.

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Priority Review (US)

Structure/Sequence

Molecular FormulaC21H18FN5O5S

InChIKeyLMMJFBMMJUMSJS-UHFFFAOYSA-N

CAS Registry946128-88-7

Clinical Trials associated with Avutometinib

NCT06369259

/ SuspendedPhase 2IIT

Open-label Phase 2 Study of Avutometinib (RAF/MEK Clamp) in Combination with Defactinib (FAK Inhibitor) and Cetuximab in Patients with Unresectable, Anti-EGFR-Refractory Advanced Colorectal Cancer

To learn if avutometinib in combination with defactinib and cetuximab can help to control unresectable, anti-EGFR-refractory, advanced colorectal cancer.

Start Date01 Apr 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT06630260

/ RecruitingPhase 1/2IIT

A Phase 1/2 Trial of the Doublet Combination of Avutometinib and Defactinib and As a Triplet in Combination with Temozolomide in Patients with High Grade Malignant Brain Tumours Within the 5G Platform

The purpose of this clinical trial is to evaluate the safety and tolerability of avutometinib and defactinib and to determine the preliminary antitumour activity of avutometinib and defactinib administered at the recommended Phase 2 dose (RP2D). In the Phase 1b of this study parallel biomarker defined arms will be opened, initially in the relapsed GMB setting, enrolling 12 patients onto each arm. These patients will be treated with avutometinib and defactinib double therapy. Avutometinib will be administered orally at 3.2mg twice a week (e.g., on Monday / Thursday or Tuesday / Friday) with or without a meal. The total weekly dose of avutometinib is 6.4mg. Defactinib will be administered orally, at 200mg, twice a day within 30 min after a meal. The total daily dose of defactinib is 400mg.
Once a treatment in any biomarker arm has met the "GO" decision (≥3 successes/12 patients) for relapsed GBM in Phase 1b, that arm can progress to Phase 2. The primary objective of Phase 2 is to determine the antitumour activity of investigational agents administered at the RP2D in patients with molecularly defined malignant brain tumours.

Start Date15 Nov 2024

Sponsor / Collaborator

The Institute of Cancer Research: Royal Cancer Hospital

[+5]

NCT06682572

/ RecruitingPhase 2

A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) in Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Japanese Patients

This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Start Date30 Oct 2024

Sponsor / Collaborator

Verastem, Inc.

100 Clinical Results associated with Avutometinib

100 Translational Medicine associated with Avutometinib

100 Patents (Medical) associated with Avutometinib

Literatures (Medical) associated with Avutometinib

27 Feb 2025·CHEMISTRY & BIODIVERSITY

Integrated Computational and Experimental Insights into MEK1/2 Inhibitors: Structural Validation, Docking, ADMET, Molecular Dynamics, and Anticancer Evaluation.

Article

Author: Teli, Ghanshyam ; Matada, Gurubasavaraja Swamy Purawarga ; Pal, Rohit

This study investigates the therapeutic potential of novel MEK1/2 inhibitors targeting the MAPK pathway, pivotal in cancer progression. An integrated computational approach, including molecular docking, pharmacophore modeling, molecular dynamics (MD) simulations, and DFT analysis, was employed to evaluate binding affinity, stability, and pharmacological properties of FDA-approved and experimental compounds. Structural validation of MEK1 (PDB ID: 1S9J) and MEK2 (PDB ID: 1S9I) showed Z-scores of -6.89 and -7.13, with 90.6% and 86.7% of residues in favored regions, confirming model reliability. Docking identified RO5126766 as a lead compound, with binding energies of -10.1 kcal/mol (MEK1) and -9.5 kcal/mol (MEK2). MD simulations demonstrated complex stability (RMSD: 0.95-4.22 Å). In-vitro assays revealed exceptional potency, with IC50 values of 12.87 ± 98.36 nM (MCF-7), 15.08 ± 94.36 nM (MDA-MB-231), and 60.89 ± 70.58 nM (A549). ADMET analysis confirmed high gastrointestinal absorption, favorable drug-likeness, and lack of blood-brain barrier permeability. DFT studies highlighted an optimal HOMO-LUMO energy gap (0.15816 eV), chemical hardness (0.16189 eV), and strong molecular interactions corroborated by MEP analysis. These findings position RO5126766 as a potent and selective MEK1/2 inhibitor, demonstrating significant potential as a targeted therapeutic agent for aggressive, treatment-resistant cancers.

01 Feb 2025·Cell Reports Medicine

Combined inhibition of focal adhesion kinase and RAF/MEK elicits synergistic inhibition of melanoma growth and reduces metastases

Article

Author: Parkman, Gennie L ; Coma, Silvia ; Almazan, Jared ; Stanley, Karly A ; Field, MiKaela N ; Holmen, Sheri L ; Culver, Katie ; Colman, Howard ; Pachter, Jonathan A ; Turapov, Tursun ; Kircher, David A ; Medellin, A Paulina

This study addresses the urgent need for effective therapies for patients with brain metastases from cutaneous melanoma, a major cause of treatment failure despite recent therapeutic advances. Utilizing mouse models that mimic human melanoma brain metastases, this study investigates the necessity of focal adhesion kinase (FAK) in the development of distant metastases and its potential as a therapeutic target. Pharmacological inhibition of FAK demonstrates significant efficacy in reducing the development of brain metastases in preclinical mouse models. Importantly, the study provides insight into the crosstalk between FAK and mitogen-activated protein kinase (MAPK) pathway signaling and highlights the synergistic effects of combined inhibition of FAK, rapidly accelerated fibrosarcoma (RAF), and mitogen-activated protein kinase kinase (MEK) in cutaneous melanoma. These findings provide the rationale for clinical evaluation of the efficacy of the FAK inhibitor defactinib and the RAF/MEK inhibitor avutometinib in patients with brain metastases from cutaneous melanoma.

31 Dec 2024·Future Science OA

SARS-CoV-2-induced phosphorylation and its pharmacotherapy backed by artificial intelligence and machine learning

Article

Author: Salman, Saad ; Haider, Sana ; Wasim, Asif ; Idrees, Jawaria ; Sharif, Zubair ; Qamar, Fouzia

Aims: To investigate the role of phosphorylation in SARS-CoV-2 infection, potential therapeutic targets and its harmful genetic sequences. Materials & Methods: Data mining techniques were employed to identify upregulated kinases responsible for proteomic changes induced by SARS-CoV-2. Spike and nucleocapsid proteins' sequences were analyzed using predictive tools, including SNAP2, MutPred2, PhD-SNP, SNPs&Go, MetaSNP, Predict-SNP and PolyPhen-2. Missense variants were identified using ensemble-based algorithms and homology/structure-based models like SIFT, PROVEAN, Predict-SNP and MutPred-2. Results: Eight missense variants were identified in viral sequences. Four damaging variants were found, with SNPs&Go and PolyPhen-2. Promising therapeutic candidates, including gilteritinib, pictilisib, sorafenib, RO5126766 and omipalisib, were identified. Conclusion: This research offers insights into SARS-CoV-2 pathogenicity, highlighting potential treatments and harmful variants in viral proteins.

News (Medical) associated with Avutometinib

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

30 Jan 2025

·www.chugai-pharm.co.jp

Chugai Announces Consolidated 2024 Full Year Results and Forecasts for 2025

Record high core revenue, core operating profit and core net income for the fiscal year 2024 at ¥1,170.6 billion (+5.3%), ¥556.1 billion (+23.4%) and ¥397.1 billion (+19.0%) respectively (all changes year-on-year [YoY]) Steady progress in R&D activities of in-house projects for both early and late-stage development, with new investment activities In early-stage development, NXT007 and AMY109 proceeded to Phase II clinical trials, and several projects started clinical trials. BRY10, a project applied with Chugai’s AI-assisted drug discovery technology, entered the clinical trial stage PiaSky, Alecensa, and NEMLUVIO received global approval In addition, Chugai Venture Fund made three investments Planned 2024 year-end dividends are ¥57 per share (annual dividends for the fiscal year: ¥98 per share) Core revenue and core operating profit in 2025 are expected to reach record highs of ¥1,190.0 billion (+1.7%, YoY) and ¥570.0 billion (+2.5%, YoY), respectively Annual dividend forecast for 2025 is ¥250 per share, including 100th Anniversary Special Dividends of ¥150 per share TOKYO, January 30, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced its consolidated financial results for the fiscal year ended December 31, 2024, and forecasts for the fiscal year ending December 31, 2025. “In 2024, Chugai marked record high revenue, operating profit, and net income. Despite the decrease in domestic sales due to impact of the completion of government supply of Ronapreve® for COVID-19, NHI drug price revisions and penetration of biosimilars, the greatly increased export of Hemlibra® to Roche and other factors contributed to the growth. In R&D, this year saw many achievements of global approvals for our in-house products. PiaSky® obtained initial approval for the treatment of paroxysmal nocturnal hemoglobinuria, and Alecensa® obtained approval for the additional indication of adjuvant treatment of non-small cell lung cancer in Japan, the United States, Europe and China. In addition, NEMLUVIO®, out-licensed to Galderma, obtained approval for the treatment of prurigo nodularis and atopic dermatitis in the United States. In early development of in-house projects, NXT007 and AMY109 proceeded to phase II clinical trials, and several projects including GYM329, DONQ52 and RAY121, have started new clinical trials. Furthermore, BRY10 marked the first project to enter the clinical development stage, which utilized Chugai’s proprietary AI-based antibody drug discovery support technology, MALEXA®. Chugai Venture Fund, which became fully operational in 2024, is implementing multiple investments that are expected to strengthen our company’s technology and drug discovery capabilities. 2025 marks the 100-year anniversary of the company’s founding. With the aspiration of ‘Creating drugs that benefit the world’ which has been consistently carried from the time of our founding, and by focusing on our unique science and technology capabilities and creating our unique innovation, Chugai will strive in the next 100 years, to continue to expand the benefit of medical community and human health around the world for the sake of patients,” said Dr. Osamu Okuda, Chugai’s President and CEO. Chugai reported that revenue for the fiscal year ended December 2024 totaled ¥1,170.6 billion (+ ¥59.2 billion, +5.3%, YoY). Domestic sales were ¥461.1 billion (- ¥96.9 billion, -17.4%, YoY). In the oncology field, although our new product Phesgo® performed well, products including our mainstay product Avastin® were affected by NHI drug price revisions and biosimilars. Also, sales of Perjeta® and Herceptin® fell along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients, resulting in a decrease by 4.8% compared to the previous year. In the specialty field, sales decreased by 28.3% compared with previous year, mainly due to the completion of supply of Ronapreve to the government, despite that our new product Vabysmo® grew and our mainstay products Hemlibra and Actemra® performed well. Overseas sales were ¥536.8 billion (+ ¥120.3 billion, +28.9%, YoY), driven by a substantial increase in exports of Hemlibra to Roche. Other revenue increased by 26.2% mainly due to increase in one-time income, etc., in addition to the increase in income related to Hemlibra. Cost to sales ratio improved by 8.4 percentage points year-on-year to 33.9%, mainly due to a change in the product mix. Research and development expenses amounted to ¥176.9 billion (+8.7%, YoY) due to investments into drug discovery and early development, and the progress of development projects. Selling, general and administration expenses were comparable to the previous year, amounting ¥102.2 billion (+0.2%, YoY). For other operating income (expense), an income of ¥2.7 billion was recorded, mainly due to the recognition of income from disposal of product rights. As a result, Core operating profit totaled ¥556.1 billion (+ ¥105.4 billion, +23.4%, YoY), which marked the first time exceeding ¥500.0 billion, and Core net income increased to ¥397.1 billion (+ ¥63.5 billion, +19.0%, YoY). Reflecting the favorable results and based on our principles of “a stable allocation of profit” and “aiming for a consolidated dividend payout ratio of 45% on average in comparison with Core EPS,” year-end dividends for the fiscal year ended December 31, 2024 are planned to be ¥57 per share. As a result, the annual dividend per share will be ¥98 per share, and the Core dividend payout ratio is 40.6% (an average of 40.3% for the past five years). Regarding research and development, Chugai made good progress in both early and late-stage development toward achieving TOP I 2030. Chugai made important progress in both in-house and in-licensed products, and in addition, through new investments, Chugai strengthened its efforts to create innovative solutions. For in-house projects that will drive mid to long-term growth, NXT007 and AMY109, both applying Chugai’s proprietary antibody engineering technologies, have entered Phase II clinical trials. Additionally, RAY121 (for autoimmune diseases), BRY10 (for chronic diseases), GYM329 (for neurological disorders and obesity), and DONQ52 (for celiac disease) each have entered new clinical trials. In late-stage projects, PiaSky, a treatment for paroxysmal nocturnal hemoglobinuria, was launched in Japan and approved in the U.S., Europe, and China. Alecensa was approved for expanded indication as post-operative adjuvant therapy for ALK-positive non-small cell lung cancer in Japan, the U.S., Europe, China and Taiwan. In-house products out-licensed to third parties excluding Roche also progressed steadily. NEMLUVIO (nemolizumab), being developed overseas by Galderma, has advanced significantly as a global product, having been approved for prurigo nodularis and moderate-to-severe atopic dermatitis in the U.S. and having been recommended for approval for the same indications by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Avutometinib, out-licensed to Verastem Oncology, has been accepted for review of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for accelerated approval in KRAS-mutant recurrent low-grade serous ovarian cancer and has been granted Priority Review. As for projects in-licensed from Roche, Lunsumio® has received regulatory approval in Japan for relapsed or refractory follicular lymphoma. Elevidys (SRP-9001), Chugai’s first gene therapy product, has been filed with a regulatory application in Japan for Duchenne muscular dystrophy. Vabysmo and Evrysdi® received approvals for expanded indications, and Tecentriq® filed an application for expanded indication. In 2024, to further accelerate our drug discovery engine through open innovation, Chugai Venture Fund, LLC made investments in Leal Therapeutics, HYKU Biosciences, and one other company, strengthening Chugai’s efforts in creating innovative solutions. In 2025, Core revenues, Core operating profit, and Core net income are expected to be ¥1,190.0 billion (+ ¥19.4 billion, +1.7%, YoY), ¥570.0 billion (+ ¥13.9 billion, +2.5%, YoY), and ¥410.0 billion (+ ¥12.9 billion, +3.2%, YoY), resulting in an increase in both revenues and profits. Sales are expected to increase in Japan and overseas, totaling ¥1,018.0 billion (+ ¥20.1 billion, +2.0%, YoY). Domestic sales are expected to be ¥462.5 billion (+ ¥1.4 billion, +0.3%, YoY), including increase in volume of new product Phesgo, PiaSky and our mainstay products. Overseas sales are expected to be ¥555.5 billion (+ ¥18.7 billion, +3.5%, YoY) due to growth in sales of Hemlibra, Alecensa and NEMLUVIO, despite decrease in Actemra. Other revenues are expected to be ¥172.0 billion (- ¥0.7 billion, -0.4%, YoY). Royalty and profit-sharing income are forecasted to increase to ¥165.7 billion (+ ¥18.3 billion, +12.4%, YoY), due to an increase in income related to Hemlibra, despite a decrease in income related to Actemra. On the other hand, other operating income is expected to decrease to ¥6.3 billion (- ¥19.0 billion, -75.1%, YoY), due to a decrease in one time income. For the following fiscal year ending December 31, 2025, Chugai expects annual dividends of ¥100 in regular dividends (interim dividends of ¥50 and year-end dividends of ¥50) and ¥150 as special dividends for the company's 100th anniversary (interim dividends of ¥75 and year-end dividends of ¥75) for a total of ¥250 per share. As a result, the Core dividend payout ratio for 2025 is expected to be 100.0% (54.1% on a five-year average basis). [2024 full year results] [Sales breakdown] [Oncology field (Domestic) Top5-selling medicines] +2.3% [Specialty field (Domestic) Top5-selling medicines plus Ronapreve] *Ronapreve has not been listed in the National Health Insurance (NHI) price list. [2025 full year forecast] [Progress in R&D activities from Oct 26th, 2024 to Jan 30th, 2025] About Core results Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders. Trademarks used or mentioned in this release are protected by law. [PDF 1.3MB] Contact: For Media Chugai Pharmaceutical Co., Ltd. Media Relations Group, Corporate Communications Dept., Hideki Sato Tel: +81-3-3273-0881 E-mail: pr@chugai-pharm.co.jp For Investors Chugai Pharmaceutical Co., Ltd. Investor Relations Group, Corporate Communications Dept., Takayuki Sakurai Tel: +81-3-3273-0554 E-mail: ir@chugai-pharm.co.jp Back

Drug ApprovalPhase 2Financial Statement

23 Jan 2025

·www.businesswire.com

Verastem Oncology Outlines 2025 Strategic Priorities and Milestones for Novel Pipeline Targeting RAS/MAPK Pathway-Driven Cancers

BOSTON--( BUSINESS WIRE )--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced its 2025 priorities and upcoming catalysts for its novel clinical pipeline. " We ended 2024 having made tremendous progress across our pipeline programs, including FDA acceptance of our NDA with Priority Review for avutometinib plus defactinib in recurrent KRAS mutant low-grade serous ovarian cancer. As we head into 2025, we are building on the foundational milestones achieved in 2024 and are poised for a transformative year of growth as we evolve into a commercial-stage company while advancing several clinical programs,” said Dan Paterson, president and chief executive officer at Verastem Oncology. “ With the addition of VS-7375, a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, we are well-positioned to further establish our leadership in targeting RAS/MAPK pathway-driven cancers, including metastatic pancreatic cancer, non-small cell lung cancer, and KRAS G12D mutant solid tumors.” In 2025, Verastem will focus on three strategic priorities to drive sustainable long-term growth: Successfully launch avutometinib plus defactinib in recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC) in the U.S. and continue to advance the regulatory pathway in Japan and Europe Maximize the synergistic potential of the avutometinib plus defactinib combination in other advanced solid tumors for market expansion opportunities Advance its novel, early-stage pipeline, including its potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, to create multiple opportunities to demonstrate transformative outcomes for people living with RAS/MAPK pathway-driven cancers Successfully Launch Avutometinib Plus Defactinib in the U.S. and Continue to Advance the Regulatory Pathway in Japan and Europe On December 30, 2024, the U.S. Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) under the accelerated approval pathway and granted Priority Review for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral, selective FAK inhibitor, in adult patients with recurrent KRAS mutant LGSOC and designated June 30, 2025, as the Prescription Drug User Fee Act (PDUFA) action date. The NDA was based on the positive, mature safety and efficacy data from the RAMP 201 trial as presented at the International Gynecologic Cancer Society (IGCS) 2024 Annual Meeting. The NDA also includes supportive data from the FRAME Phase 1 trial, the first study conducted with the combination therapy in recurrent LGSOC. These data underscore how avutometinib plus defactinib could address a significant unmet medical need among patients with recurrent LGSOC, if approved. To further strengthen its positioning for a potential mid-2025 launch, Verastem previously announced agreements with Oberland Capital and IQVIA. The agreements with Oberland Capital include a debt refinancing and an equity investment, which strengthens the Company’s cash position and will help fund commercialization past FDA approval and other pipeline programs. The strategic collaboration with IQVIA leverages IQVIA’s world-class infrastructure and commercialization solutions to complement the Company’s launch strategy in recurrent LGSOC. Key Milestones Expected for 2025: Primary analysis from both the FRAME and RAMP 201 clinical trials will be published in H1 2025; submit RAMP 201 primary analysis publication for NCCN consideration in H1 2025. Present additional analyses from the RAMP 201 trial at a medical meeting in Q1 2025. Plan for FDA decision on approval of the combination of avutometinib plus defactinib in recurrent KRAS mutant LGSOC, expected by June 30, 2025. Complete enrollment for the international Phase 3 confirmatory RAMP 301 clinical trial for patients with recurrent LGSOC regardless of KRAS mutation status by the end of 2025. Report initial data from the RAMP 201J Phase 2 clinical trial being conducted in Japan with the Japanese Gynecologic Oncology Group (JGOG) evaluating the safety and efficacy of avutometinib in combination with defactinib for recurrent LGSOC in H2 2025. Continue to advance the regulatory pathway in Japan and Europe. Maximize the Synergistic Potential of Avutometinib Plus Defactinib for Advanced Solid Tumor Market Expansion Opportunities RAMP 205: Avutometinib Plus Defactinib in Combination with Chemotherapy in First-Line Metastatic Pancreatic Cancer At the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024, Verastem presented initial interim data from the ongoing RAMP 205 Phase 1/2 clinical trial evaluating multiple dose cohorts of avutometinib plus defactinib in combination with gemcitabine and Nab-paclitaxel as first-line systemic treatment for patients with metastatic pancreatic cancer. Patients receiving the combination in the dose level 1 cohort achieved a confirmed overall response rate (ORR) of 83% (5/6). One dose-limiting toxicity (DLT) was observed in the dose level 1 cohort, and the dose level was subsequently cleared. Key Milestones Expected for 2025: Report updated data from the ongoing RAMP 205 trial in Q1 2025 and present data at a medical meeting in mid-year 2025. Choose a Recommended Phase 2 Dose (RP2D) for trial expansion in H1 2025. RAMP 203: Avutometinib Plus Defactinib in Combination with a KRAS G12C Inhibitor in Non-Small Cell Lung Cancer (NSCLC) In December 2024, the Company announced preliminary clinical data for the triplet combination cohort of avutometinib and LUMAKRAS™ (sotorasib) plus defactinib in the RAMP 203 Phase 1/2 study in KRAS G12C mutant advanced NSCLC. No DLTs have been observed in the triplet combination. Key Milestones Expected for 2025: Complete enrollment in the KRAS G12C inhibitor, prior-treated Stage 1 Part B cohort in Q1 2025. Continue to follow patients in both doublet cohorts (KRAS G12C inhibitor naïve and prior-treated) for safety and efficacy to determine if observed efficacy supports expanded enrollment. Complete enrollment and evaluate the safety and efficacy of the triplet combination in H1 2025. Present an interim update at a medical meeting in H2 2025. Advance Novel, Early-stage Pipeline to Create Multiple Opportunities to Demonstrate Potentially Transformative Outcomes in RAS/MAPK Pathway-driven Cancers VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Advanced Solid Tumors In July 2024, GenFleet Therapeutics began dosing several patients in a Phase 1/2 trial in China that is evaluating VS-7375 in patients with KRAS G12D-mutated advanced solid tumors. Verastem announced on January 14, 2025, that it has exercised its option early to license VS-7375 from GenFleet. In addition, the Company announced preliminary clinical data from the Phase 1 dose-escalation study conducted by GenFleet in China. In the study, VS-7375, demonstrated oral bioavailability, no dose-limiting toxicities across six dose levels, and several partial responses, including patients with pancreatic and lung cancers. Enrollment in the Phase 1 dose-escalation cohort is ongoing. Key Milestones Expected for 2025: File an investigational new drug (IND) application in the U.S. for VS-7375 in Q1 2025. Initiate a Phase 1/2a trial in the U.S. by mid-2025. Share preclinical and clinical data from the Phase 1 study of VS-7375 in China in H1 2025. Discovery/lead optimization continues for the second and third programs in the GenFleet collaboration. About the Avutometinib and Defactinib Combination Avutometinib is an oral RAF/MEK clamp that potentially inhibits MEK1/2 kinase activities and induces inactive complexes of MEK with ARAF, BRAF, and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. In contrast to currently available MEK-only inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of the MEK-only inhibitors. Defactinib is an oral, selective inhibitor of focal adhesion kinase (FAK) and proline-rich tyrosine kinase-2 (Pyk2), the two members of the focal adhesion kinase family of non-receptor protein tyrosine kinases. FAK and Pyk2 integrate signals from integrin and growth factor receptors to regulate cell proliferation, survival, migration, and invasion. FAK activation has been shown to mediate resistance to multiple anti-cancer agents, including RAF and MEK inhibitors. Verastem Oncology is currently conducting clinical trials with avutometinib with and without defactinib in RAS/MAPK-driven tumors as part of its R af A nd M ek P rogram or RAMP. Verastem is currently enrolling patients and activating sites for RAMP 301 (GOG-3097/ENGOT-ov81/NCRI) (NCT06072781), an international Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for the treatment of recurrent low-grade serous ovarian cancer (LGSOC). Verastem was granted Priority Review and a Prescription Drug User Fee Act (PDUFA) date of June 30, 2025, for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who received at least one prior systemic therapy. Verastem initiated a rolling NDA in May 2024 to the FDA and completed its NDA submission in October 2024. The FDA granted Breakthrough Therapy Designation for the treatment of patients with recurrent LGSOC after one or more prior lines of therapy, including platinum-based chemotherapy, in May 2021. Avutometinib alone or in combination with defactinib was also granted Orphan Drug Designation by the FDA for the treatment of LGSOC. Verastem Oncology has established a clinical collaboration with Amgen to evaluate LUMAKRAS™ (sotorasib) in combination with avutometinib and defactinib in both treatment-naïve patients and in patients whose KRAS G12C mutant non-small cell lung cancer progressed on a G12C inhibitor as part of the RAMP 203 trial (NCT05074810). Verastem has received Fast Track Designation from the FDA for the triplet combination in April 2024. RAMP 205 (NCT05669482), a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer, is supported by the PanCAN Therapeutic Accelerator Award. FDA granted Orphan Drug Designation to the avutometinib and defactinib combination for the treatment of pancreatic cancer. About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024. Verastem plans to file a U.S. investigational new drug (IND) application for VS-7375 during the first quarter of 2025 and expects to initiate a Phase 1/2a study in mid-2025. About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with RAS/MAPK pathway-driven cancers. Our pipeline is focused on novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn . Forward-Looking Statements This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning. Such forward-looking statements address various matters about, among other things, Verastem Oncology’s programs and product candidates, strategy, future plans and prospects, including statements related to the potential for and timing of commercialization of product candidates, the anticipated timing for the IND application for VS-7375/GFH375, the expected outcome and benefits of the Company’s collaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of commencing and completing trials and compiling data, the expected timing of the presentation of data by the Company and the potential clinical value of various of the Company’s clinical trials. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others: the uncertainties inherent in research and development, such as negative or unexpected results of clinical trials; that we may not see a return on investment on the payments we have and may continue to make pursuant to the collaboration and option agreement with GenFleet, or that GenFleet may fail to fully perform under the agreement; that the development and commercialization of our product candidates may take longer or cost more than planned, including as a result of conducting additional studies or our decisions regarding execution of such commercialization; that data may not be available when expected; risks associated with preliminary and interim data, which may not be representative of more mature data; that our product candidates may not receive regulatory approval, become commercially successful products, or result in new treatment options being offered to patients; and the risks identified under the heading "Risk Factors" the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (SEC) on March 14, 2024, as well as the other information we file with the SEC. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

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Indication	Highest Phase	Country/Location	Organization	Date
Borderline serous tumour of ovary	NDA/BLA	US	Verastem, Inc.	24 May 2024
Ovarian Serous Tumor	Phase 3	AU	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	BE	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	CA	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	FR	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	DE	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	IT	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	NZ	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	ES	Verastem, Inc.	18 Mar 2024
Ovarian Serous Tumor	Phase 3	GB	Verastem, Inc.	18 Mar 2024

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05074810 (RAMP 203, BusinessWire) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C	3	Defactinib，Avutometinib, sotorasib	rtfcyhehwp(ayfiljdnai) = None oxosapqztc (osmrftvmnw ) View more	Positive	18 Dec 2024
NCT04625270 (ENGOT-OV60/GOG-3052/RAMP 201 Part A, SGO2024)	Phase 2	Ovarian Serous Tumor RAS/MAPK pathway alterations	29	Avutometinib + Defactinib	xebvhpbxeb(rukjcfvvgg) = vgvssqscpl ecotmaatdk (vcioenalrm, 26 - 64)	Positive	01 Nov 2024
NCT04625270 (RAMP 201 \| ENGOTov60/GOG3052, Company_Website) Manual	Phase 2	Ovarian Serous Tumor	109	Avutometinib and Defactinib Combination	ieyxdrxfcp(gxakpvwtsi) = brgxsaklil xkajgkwwtb (tdhrqmlqmm, 23 - 41) View more	Positive	17 Oct 2024
				Avutometinib and Defactinib Combination (KRAS mutant)	ieyxdrxfcp(gxakpvwtsi) = vegjfrcwoa xkajgkwwtb (tdhrqmlqmm, 31 - 58) View more
NCT05669482 (RAMP 205, ASCO2024) Manual	Phase 1/2	Metastatic Pancreatic Ductal Adenocarcinoma First line	18	Avutometinib/defactinib + gemcitabine/nab-paclitaxel	zfbaeieaqe(ebjqiuxiwq) = kycnyuodgz xdznwwdieq (lgczbjenmw ) View more	Positive	24 May 2024
NCT05074810 (RAMP 203, Corporate Publications) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C	-	Avutometinib+sotorasib	edkaxzqrni(bwlzguvrso) = Avutometinib 4.0 mg PO BIW 21/28 days + sotorasib 960 mg PO QD 28/28 days cxujldoyso (whwpgeyqtl )	Positive	14 Oct 2023
NCT04625270 (ENGOT-Ov60/GOG-3052/RAMP 201, ESGO2023)	Phase 2	Ovarian Serous Tumor KRAS mutant \| KRAS wild-type	151	Avutometinib	eskrygxejr(gmhrfzueat) = syotslefua perickgryo (ocyjsoqmrz ) View more	Positive	27 Sep 2023
				Avutometinib + Defactinib	eskrygxejr(gmhrfzueat) = fwbjdjtcyb perickgryo (ocyjsoqmrz ) View more
NCT04625270 (RAMP 201, ASCO 12023 \| ASCO 22023) Manual	Phase 2	Ovarian Cancer	121	avutometinib 4 mg	erjrbvthbj(ppmeycjeap) = zlmiqpisuz evmapswzto (wcftsyzizl ) View more	Positive	31 May 2023
				avutometinib 3.2 mg+defactinib 200 mg	erjrbvthbj(ppmeycjeap) = hkrejwkwun evmapswzto (wcftsyzizl ) View more
NCT04620330 (RAMP 202, ASCO 12023 \| ASCO 22023) Manual	Phase 2	KRAS mutant Non-small Cell Lung Cancer KRAS G12V Mutantion	35	Avutometinib	eltvmotalw(ravgymqjpg) = gupynafbya syxqfmwdoh (hcldznjjwh )	Negative	26 May 2023
				Defactinib+Avutometinib	eltvmotalw(ravgymqjpg) = urfxbramag syxqfmwdoh (hcldznjjwh )
NCT04620330 (RAMP 202, Corporate Publications) Manual	Phase 2	Non-Small Cell Lung Cancer	56	VS-6766+defactinib (KRAS G12V NSCLC)	shhioargmx(crypxaddxy) = vfwkcpffdr gksmqsugln (rexosabnlm ) View more	Negative	04 Oct 2022
				VS-6766+defactinib (non-G12V KRAS mutations)	shhioargmx(crypxaddxy) = bwjpjfzguq gksmqsugln (rexosabnlm ) View more
NCT02407509 (ASCO2022) Manual	Phase 1	Non-Small Cell Lung Cancer KRAS Mutation	16	everolimus+VS-6766 (dose escalation )	vuewxtwcqr(kenvaiiilu) = assvvdvnte pgwuuuvskj (gjqokiadrx ) View more	Positive	02 Jun 2022
				everolimus+VS-6766 (KRAS mt NSCLC )	htipdlzssw(xbzkakpjvj) = yhuhgoocgy avjtsoygyw (txswilpzqe, 3.52 - NR) View more

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