RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (European Union), Conditional marketing approval (United Kingdom), Priority Review (United States)

Structure/Sequence

Molecular FormulaC32H35ClFN7O2

InChIKeyPEMUGDMSUDYLHU-ZEQRLZLVSA-N

CAS Registry2326521-71-3

Clinical Trials associated with Adagrasib

NCT07382726

/ Not yet recruitingPhase 1IIT

Combination Of Izalontamab Brengitecan And Adagrasib In Advanced KRAS G12Ci-Refractory Non-Small Cell Lung Cancer - The IZA-A Trial

This research is being done to test a combination of two drugs, Izalontamab Brengitecan (iza-bren) and Adagrasib, in patients with advanced KRAS G12C-mutant NSCLC that hasn't responded to other treatments. The purpose is to see if this combination works better than existing treatments for people whose cancer keeps growing despite KRAS G12C inhibitors.

Start Date01 Jul 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07318389

/ Not yet recruitingEarly Phase 1IIT

ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer

To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.

Start Date10 Jun 2026

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT07543172

/ Not yet recruitingPhase 2IIT

Phase II Study of CIMAVAX-EGF in Combination With KRAS G12C Inhibitors as Treatment for Advanced Stage KRAS G12C Mutated NSCLC

This phase II trial tests how well giving CIMAvax-EGF with KRAS G12C inhibitor (sotorasib or adagrasib) for the treatment of patients with KRAS G12C mutated non small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Vaccines, such as CIMAvax-EGF, made from specific peptides or antigens may help the body build an effective immune response to kill tumor cells. Sotorasib and adagrasibare in a class of medications called kinase inhibitors. They work by blocking the signals that cause tumor cells to multiply. This helps to stop the spread of tumor cells. Giving CIMAvax-EGF with a KRAS G12C inhibitor may be effective for treating advanced, KRAS G12C mutated non small cell lung cancer.

Start Date01 Jun 2026

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

100 Clinical Results associated with Adagrasib

100 Translational Medicine associated with Adagrasib

100 Patents (Medical) associated with Adagrasib

376

Literatures (Medical) associated with Adagrasib

01 Aug 2026·BIOORGANIC CHEMISTRY

Romidepsin inhibits NRF2 and enhances the efficacy of adagrasib by inducing autophagic cell death in KRAS-mutant tumor cells

Article

Author: Chen, Yunzhi ; Shu, Chongchong ; Xia, Yiqun ; Chen, Jundixia ; Jiang, Yiyan ; Zou, Peng ; Yang, Fan ; Ni, Daoyong ; Yan, Ying ; Fu, Wenying ; Tian, Fei ; Cui, Ri ; Chen, Xiao

KRAS-mutant tumors remain a major challenge in cancer therapy. Although current targeted drugs show initial promise, their efficacy is often limited by the development of resistance. Therefore, identifying effective drug combinations to target KRAS-mutant tumors is of great significance. This study investigates the synergistic potential of romidepsin (RO), a class I HDAC inhibitor, in combination with adagrasib (ADA). In vitro experiments demonstrated that RO exhibits potent antitumor activity, with significant efficacy against KRAS-mutant cells. Mechanistic studies revealed that RO exerts its effect by suppressing NRF2. More importantly, its combination with ADA enhanced cytotoxicity and further suppressed NRF2 expression, resulting in increased ROS levels, induction of cytotoxic autophagy, and inhibition of the downstream AKT pathway. In vivo xenograft models confirmed that the combination of RO and ADA significantly reduced tumor growth. These findings suggest that RO and ADA act synergistically against KRAS-mutant tumors by suppressing NRF2, supporting their potential as a targeted combination strategy for KRAS-driven cancers.

01 Jul 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

From G12C To pan-RAS: The expanding therapeutic landscape of KRAS-mutant NSCLC

Review

Author: Başbınar, Yasemin ; Canaslan, Kübra ; Öztop, İlhan

KRAS mutations represent the most prevalent oncogenic drivers in non-small cell lung cancer (NSCLC), defining a clinically heterogeneous subset that was historically considered "undruggable." The identification of a mutant-specific allosteric pocket in KRAS G12C led to the development of sotorasib and adagrasib, fundamentally altering the treatment paradigm for pretreated patients. However, modest response durability and the rapid emergence of resistance underscore the limitations of current monotherapies. This review provides a comprehensive synthesis of the expanding therapeutic landscape, moving beyond G12C-selective inhibition toward next-generation allele-specific agents, such as G12D inhibitors, and groundbreaking pan-RAS/RAS(ON) tri-complex inhibitors like RMC-6236. The molecular biology of the KRAS conformational cycle is examined alongside the critical role of co-mutations, specifically STK11, KEAP1, and TP53, which act as gatekeepers of metabolic reprogramming and modulate the tumor immune microenvironment. Furthermore, primary and acquired resistance mechanisms are delineated into on-target pocket alterations and off-target bypass signaling, involving the reactivation of the MAPK and PI3K pathways via RTKs like EGFR and MET. The review also explores the integration of KRAS inhibitors with immune checkpoint blockade, chemotherapy, and SHP2/MEK inhibitors, highlighting a shift toward biology-driven combination strategies. As the field transitions from single-allele blockade to multi-selective RAS(ON) inhibition and rational vertical pathway targeting, personalized, biomarker-guided treatment algorithms will be essential. By outlining the trajectory from G12C to pan-RAS strategies, this review captures the evolving precision oncology framework necessary to achieve durable clinical benefit in KRAS-mutant NSCLC.

01 Jun 2026·CANCER TREATMENT REVIEWS

KRAS G12C-mutant non-small cell lung cancer: A practical guide for clinicians

Review

Author: La-Cava, Giulia ; Ricciuti, Biagio ; Borgeaud, Maxime ; Saw, Stephanie P L ; Hendriks, Lizza El ; Remon, Jordi

KRAS G12C-mutant non-small cell lung cancer (NSCLC) occurs in approximately 15% of NSCLC with historically limited targeted treatment options. Both KRAS "OFF"" G12C inhibitors, sotorasib and adagrasib, are considered standard second-line therapy, albeit with a modest progression-free survival benefit over standard chemotherapy. Emerging next-generation KRAS "OFF" G12C inhibitors, as well as KRAS "ON", dual "ON/OFF", and pan-(K)RAS "ON" inhibitors, show promising early efficacy and safety profiles in second-line, though confirmatory phase III trials are pending. In the first-line setting, KRAS inhibitor-immunotherapy combinations appear particularly promising in tumors with high programmed death-ligand 1 (PD-L1) expression. However, incorporating KRAS inhibitors into chemoimmunotherapy regimens may yield more consistent and clinically meaningful benefit across patient populations, irrespective of PD-L1 expression. Critical clinical questions remain open regarding the optimal patient population for combinations, the influence of co-occurring genomic alterations, intracranial activity of KRAS inhibitors and dose optimization. This review synthesizes current evidence on the biology, clinical efficacy, safety, and practical considerations for treating KRAS G12C-mutant NSCLC, providing clinicians with an up-to-date, evidence-based framework for therapeutic decision-making and highlighting areas requiring further investigation.

425

News (Medical) associated with Adagrasib

15 Jun 2026

·www.prnewswire.com

EGFR Inhibitors Market to Witness Upsurge in Growth at a CAGR of 7.9% During the Forecast Period (2026-2036) Owing to the Entry of Next-generation TKIs, ADCs, and Combination Strategies with Immunotherapy| DelveInsight

The outlook for the EGFR inhibitor market continues to be highly promising, supported by the increasing adoption of precision medicine in oncology and the broader use of targeted therapies across various cancer indications. Additionally, the expected launch of therapies such as Zipalertinib (CLN-081) (Cullinan Oncology/Taiho Pharma), Firmonertinib (ArriVent BioPharma), Ivonescimab (SMT112) (Akeso Biopharma/Summit Therapeutics), PF-08046054 (Pfizer), Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), and others will further propel the market growth. LAS VEGAS, June 15, 2026 /PRNewswire/ -- DelveInsight's EGFR Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Head and neck cancer (HNC), and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging EGFR inhibitors, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets (the US, EU4, UK, and Japan). Key Takeaways from the EGFR Inhibitors Market Report The market size for EGFR inhibitors was found to be USD 7 billion in the 7MM in 2025. The United States accounted for the largest EGFR inhibitor treatment market size, approximately 60% of the total market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The report provides the total potential number of patients in the indications, such as Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Head and neck cancer (HNC), and others. In 2025, the 7MM had approximately ~330,000 incident cases of EGFR Inhibitors. Leading EGFR inhibitor companies, such as Cullinan Oncology, Taiho Pharma, ArriVent BioPharma, Akeso Biopharma, Summit Therapeutics, Pfizer, Daiichi Sankyo, AstraZeneca, Merck, Kelun-Biotech, CSPC Pharmaceutical, Shanghai JMT-Bio, Bristol-Myers Squibb, AbbVie, Lantern Pharma, Wayshine Biopharm, Teligene US, Genprex, J Ints Bio, Black Diamond Therapeutics, BlossomHill Therapeutics, Scorpion Therapeutics, Pierre Fabre, Antares Therapeutics, A2 Biotherapeutics, BioNTech, Dragonfly Therapeutics, Merus, DualityBio, ORIC Pharmaceuticals, BeOne Medicines (formerly BeiGene), and others, are developing novel EGFR inhibitors that can be available in the EGFR inhibitors market in the coming years. Some of the key EGFR inhibitors in clinical trials include Zipalertinib (CLN-081), Firmonertinib, Ivonescimab (SMT112), PF-08046054, Patritumab Deruxtecan, Sacituzumab Tirumotecan, (MK-2870), SYS6010, JMT101, Izalontamab Brengitecan (BMS-986507), Telisotuzumab Adizutecan (Temab-A/ABB-400), LP-300, WSD0922-FU, Sutetinib, Quaratusugene ozeplasmid (REQORSA), JIN-A02, Silevertinib, (BDTX-1535), BH-30643, STX-241/PFL-241, STX-721/PFL-271, A2B395, BNT326 (YL 202), DF9001, Pamvatamig (MCLA-129), TAS3351, DB-1310, Enozertinib (ORIC-114 ), BG-60366, and others. In 2036, among all the therapies for EGFR NSCLC, the highest revenue is estimated to be generated by amivantamab (RYBREVANT) ± lazertinib (LAZCLUZE), followed by osimertinib (TAGRISSO), in the US. Discover which EGFR drugs will lose patent exclusivity @ Key Factors Driving the EGFR Inhibitors Market Rising Prevalence of Cancer: Increasing incidence of non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer, and head & neck cancers is driving demand for targeted therapies. The growing global cancer burden is expanding the patient pool eligible for EGFR-targeted treatment. Advancements in Precision Medicine: Greater adoption of biomarker-based treatment approaches is supporting the use of EGFR inhibitors in mutation-specific patient populations. Routine molecular testing for EGFR mutations has improved patient identification and treatment selection. Growth in Combination Therapy Approaches: Increasing use of EGFR inhibitors in combination with immunotherapies, chemotherapy, and anti-angiogenic agents is improving clinical outcomes. Combination regimens are helping overcome resistance mechanisms and extending treatment duration. Strong Pipeline and Ongoing Clinical Research: The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Zipalertinib (CLN-081) (Cullinan Oncology/Taiho Pharma), Firmonertinib (ArriVent BioPharma), Ivonescimab (SMT112) (Akeso Biopharma/Summit Therapeutics), PF-08046054 (Pfizer), Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), Sacituzumab Tirumotecan (MK-2870) (Merck/Kelun-Biotech), SYS6010 (CSPC Pharmaceutical), JMT101 (Shanghai JMT-Bio), Izalontamab Brengitecan (BMS-986507) (Bristol-Myers Squibb), Telisotuzumab Adizutecan (Temab-A/ABB-400) (AbbVie), LP-300 (Lantern Pharma), WSD0922-FU (Wayshine Biopharm), Sutetinib (Teligene US), Quaratusugene ozeplasmid (REQORSA) (Genprex), JIN-A02 J (Ints Bio), Silevertinib (BDTX-1535) (Black Diamond Therapeutics), BH-30643 (BlossomHill Therapeutics), STX-241/PFL-241 (Scorpion Therapeutics/Pierre Fabre), STX-721/PFL-271 (Antares Therapeutics), A2B395 (A2 Biotherapeutics), BNT326 (YL 202) (BioNTech), DF9001 (Dragonfly Therapeutics), Pamvatamig (MCLA-129) (Merus), TAS3351 (Taiho Oncology), DB-1310 (DualityBio), Enozertinib (ORIC-114) (ORIC Pharmaceuticals), BG-60366 (BeOne Medicines), and others. The expected launch of these therapies shall further create a positive impact on the market. Aparna Thakur, an oncology expert at DelveInsight, said that Exon 20 insertion has emerged as a key competitive arena, with the approvals of RYBREVANT and ZEGFROVY creating a new market segment, while several late-stage candidates, including furmonertinib and zipalertinib, are further heightening the competitive landscape. EGFR Inhibitors Market Analysis Treatment approaches for EGFR-mutated NSCLC have advanced significantly over the last two decades with the development of targeted EGFR tyrosine kinase inhibitors (TKIs). First-generation agents such as erlotinib and gefitinib, followed by second-generation therapies including afatinib and dacomitinib, and later the third-generation TKI osimertinib, have consistently demonstrated improved clinical outcomes over conventional chemotherapy in terms of response rates and survival. Osimertinib additionally addresses the T790M resistance mutation, although acquired resistance continues to limit long-term efficacy, leaving post-TKI treatment strategies an ongoing clinical challenge. Currently, osimertinib continues to serve as the global standard of care for EGFR-mutant NSCLC, supported by robust progression-free survival (PFS) and overall survival (OS) benefits along with extensive regulatory approvals across multiple disease stages. At the same time, amivantamab is emerging as a strong competitor, broadening its role beyond EGFR exon 20 insertion mutations through combination approaches involving lazertinib and chemotherapy. Competitive intensity within the market is increasing with the arrival of newer therapies such as datopotamab deruxtecan, sunvozertinib, and aumolertinib. Real-world evidence from the 7MM highlights the continued dominance of EGFR TKIs in treatment practice, particularly the widespread frontline adoption of osimertinib, while chemotherapy and immunotherapy continue to play roles in later-line settings and in patients harboring uncommon mutations such as exon 20 insertions. Cetuximab (ERBITUX), an anti-EGFR IgG1 monoclonal antibody, is projected to retain a steady but mature market presence in metastatic colorectal cancer (mCRC) and head and neck cancers. Its position is reinforced by extensive clinical experience, a well-established efficacy profile, and approvals from major regulatory agencies, including the U.S. FDA, EMA, and PMDA. In mCRC, cetuximab remains especially relevant in biomarker-driven settings, particularly among patients with EGFR-expressing and RAS wild-type tumors. Its utility is further strengthened through combination regimens with targeted agents such as encorafenib for BRAF V600E-mutated disease and adagrasib for KRAS G12C-mutated tumors. In head and neck cancers, cetuximab continues to see stable use in combination therapies and among patients who are unsuitable for certain systemic or immunotherapy-based approaches. Nevertheless, despite sustained clinical utilization across key markets, market expansion is expected to be moderate owing to product maturity, biosimilar competition, and the growing adoption of newer targeted therapies and immuno-oncology treatments. EGFR exon 20 insertion-positive NSCLC remains particularly challenging to manage with conventional TKIs. Following the withdrawal of mobocertinib, amivantamab became the primary approved therapeutic option in this segment. However, the approval of sunvozertinib in 2025 has intensified competition, while additional TKIs such as furmonertinib and zipalertinib continue to advance through clinical development. The emergence of ADCs such as PF-08046054 (Pfizer), Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), Sacituzumab Tirumotecan (MK-2870) (Merck/Kelun-Biotech), SYS6010 (CSPC Pharmaceutical), Izalontamab Brengitecan (BMS-986507) (Bristol-Myers Squibb), Telisotuzumab Adizutecan (Temab-A/ABB-400) (AbbVie), and others, and next-generation targeted therapies is further reshaping and intensifying the competitive dynamics within the EGFR NSCLC treatment landscape. Learn more about the fastest growing EGFR inhibitor market @ EGFR Inhibitors Analysis EGFR Inhibitors Competitive Landscape Some of the emerging EGFR inhibitors in the clinical trial landscape include Zipalertinib (CLN-081) (Cullinan Oncology/Taiho Pharma), Firmonertinib (ArriVent BioPharma), Ivonescimab (SMT112) (Akeso Biopharma/Summit Therapeutics), PF-08046054 (Pfizer), Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), Sacituzumab Tirumotecan (MK-2870) (Merck/Kelun-Biotech), SYS6010 (CSPC Pharmaceutical), JMT101 (Shanghai JMT-Bio), Izalontamab Brengitecan (BMS-986507) (Bristol-Myers Squibb), Telisotuzumab Adizutecan (Temab-A/ABB-400) (AbbVie), LP-300 (Lantern Pharma), WSD0922-FU (Wayshine Biopharm), Sutetinib (Teligene US), Quaratusugene ozeplasmid (REQORSA) (Genprex), JIN-A02 J (Ints Bio), Silevertinib (BDTX-1535) (Black Diamond Therapeutics), BH-30643 (BlossomHill Therapeutics), STX-241/PFL-241 (Scorpion Therapeutics/Pierre Fabre), STX-721/PFL-271 (Antares Therapeutics), A2B395 (A2 Biotherapeutics), BNT326 (YL 202) (BioNTech), DF9001 (Dragonfly Therapeutics), Pamvatamig (MCLA-129) (Merus), TAS3351 (Taiho Oncology), DB-1310 (DualityBio), Enozertinib (ORIC-114) (ORIC Pharmaceuticals), BG-60366 (BeOne Medicines), and others. Akeso's ivonescimab (AK112, SMT112) is a novel PD-1/VEGF bispecific antibody and the first agent of its kind to advance into Phase III clinical testing. Developed using the company's proprietary Tetrabody platform, the therapy is designed to simultaneously inhibit PD-1 interactions with PD-L1 and PD-L2 while also blocking VEGF from binding to its receptors. Simultaneous inhibition of the PD-1 and VEGF pathways has demonstrated notable clinical benefits across several cancers, including NSCLC, renal cell carcinoma, and hepatocellular carcinoma. By integrating both mechanisms into a single therapeutic molecule, ivonescimab may enable broader pathway suppression and potentially provide superior antitumor efficacy compared with conventional combination approaches. The US FDA has accepted Summit Therapeutics' Biologics License Application (BLA) for ivonescimab, supported by findings from the Phase III HARMONi trial, and has set a PDUFA action date of November 14, 2026. ArriVent BioPharma and Shanghai Allist Pharmaceuticals' Firmonertinib, previously referred to as furmonertinib, is an orally administered, mutation-selective EGFR inhibitor recognized for its strong CNS penetration and activity against a broad spectrum of EGFR mutations, including uncommon variants such as PACC and Exon 20 insertion mutations. The therapy is currently being investigated in the global Phase III FURVENT trial (NCT05607550) as a first-line option for NSCLC patients with EGFR Exon 20 insertion mutations. At the same time, the global Phase Ib FURTHER study (NCT05364043) is evaluating its efficacy in patients with EGFR PACC mutations. In addition, firmonertinib is being explored in combination regimens for advanced or metastatic NSCLC with classical EGFR mutations through a collaboration with InnoCare Pharma. Cullinan Therapeutics and Taiho Pharma's Zipalertinib is a next-generation, irreversible oral EGFR inhibitor specifically developed to selectively target tumors carrying EGFR exon 20 insertion mutations while sparing wild-type EGFR activity. Preclinical findings indicate that this mutant-selective design may help mitigate the toxicities commonly associated with inhibition of wild-type EGFR. The molecule's distinct chemical structure is also intended to minimize HER2 inhibition, thereby improving selectivity further. Due to its targeted mechanism and encouraging clinical data, zipalertinib is gaining attention as a potential treatment option for EGFR exon 20 insertion-mutated NSCLC. Taiho Pharmaceutical and Cullinan Therapeutics recently announced that the FDA has accepted the NDA for zipalertinib for patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease progressed after platinum-based chemotherapy, with or without prior amivantamab treatment. The application has been assigned a PDUFA target date of February 27, 2027. The anticipated launch of these emerging therapies are poised to transform the EGFR inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the EGFR inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about companies developing EGFR inhibitors, visit @ EGFR Inhibitors Treatment Recent Developments in the EGFR Inhibitors Market In April 2026, Taiho Oncology, Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. announced that the FDA had accepted the NDA for zipalertinib to treat patients with locally advanced or mNSCLC harboring EGFR ex20ins mutations whose disease has progressed following platinum-based chemotherapy, with or without prior amivantamab treatment. The FDA has assigned a PDUFA target action date of February 27, 2027. In February 2026, J INTS BIO announced that research findings on JIN-A02 had been published in Clinical Cancer Research, a leading oncology journal published by the American Association for Cancer Research (AACR). In February 2026, the FDA approved once-monthly RYBREVANT FASPRO + LAZCLUZE for 1L EGFR-mutated advanced NSCLC. In January 2026, the US FDA accepted for filing Summit's Biologics License Application (BLA) seeking approval for the HARMONi trial (Phase III). The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. In December 2025, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for AUMSEQA in adult NSCLC, covering first-line EGFR-mutant disease and EGFR T790 M-mediated acquired resistance. What are EGFR Inhibitors? EGFR inhibitors are a class of targeted therapies designed to block the activity of the epidermal growth factor receptor (EGFR), a protein that plays a critical role in regulating cell growth, survival, and proliferation. In many cancers, including non-small cell lung cancer (NSCLC), colorectal cancer, head and neck cancer, and glioblastoma, EGFR is either overexpressed or mutated, leading to uncontrolled tumor growth. EGFR inhibitors work by interfering with the signaling pathways activated by this receptor, thereby slowing or stopping cancer cell proliferation. These therapies are broadly categorized into tyrosine kinase inhibitors (TKIs), which target the intracellular kinase domain of EGFR, and monoclonal antibodies, which bind to the extracellular portion of the receptor. Over the past decade, EGFR inhibitors have transformed the treatment landscape of several solid tumors by enabling more personalized and biomarker-driven therapeutic approaches. EGFR Inhibitors Epidemiology Segmentation The EGFR inhibitors market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2022–2036 across the leading markets. The EGFR inhibitors target patient pool is segmented into: Total Incident Cases of EGFR Inhibitor Total Incident cases of EGFR by Indication Scope of the EGFR Inhibitors Market Report EGFR Inhibitors Patient Population Forecast EGFR Inhibitors Therapeutics Market Size EGFR Inhibitors Pipeline Analysis EGFR Inhibitors Market Size and Trends EGFR Inhibitors Market Opportunity EGFR Inhibitors Market Unmet Needs KOL's Views on EGFR Inhibitors EGFR Inhibitors Market Access and Reimbursement Discover the best emerging EGFR inhibitors in pipeline @ EGFR Inhibitors Clinical Trials Table of Contents Related Reports EGFR NSCLC Market EGFR NSCLC Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hansoh Pharmaceutical, Johnson & Johnson Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Akeso Biopharma, Summit Therapeutics, and others. Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2036 report delivers 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 BeiGene , Merus and Partner Therapeutics, Johnson & Johnson Innovative Medicine, Betta Pharma, Xcovery, CStone Pharmaceuticals, Bristol-Myers Squibb, Haihe Biopharma, Taiho Pharmaceutical, Takeda Pharmaceuticals, EMD Serono (Merck KGaA), Eli Lilly and Company, Merck, Regeneron, Sanofi, Ono Pharmaceutical, Novartis, Genentech, Roche, Amgen, Chugai Laboratories, Moderna Therapeutics, Pfizer, GSK and others. Colorectal Cancer Market Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key CRC companies, including Shanghai Henlius Biotech, Agenus, Tizona Therapeutics, Surgimab, Novartis, Bexion Pharmaceuticals, Syndax Pharmaceuticals, Exelixis, AbbVie, Tyligand Pharmaceuticals, Bristol Myers Squibb, Eisai, Bold Therapeutics, Takeda, Merck Sharp & Dohme, and others Head and Neck Cancer Market Head and Neck Cancer Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key HNC companies, including CEL-SCI, Junshi Biosciences, Coherus, Exelixis, Immutep S.A.S., Merck Sharp & Dohme LLC, Iovance Biotherapeutics, BeiGene, Akeso, Chia Tai-Tianqing, Kura Oncology, Hoffmann-La Roche, Eli Lilly and Company, and 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 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Phase 3Drug ApprovalImmunotherapy

11 Jun 2026

·allsci.com

Merck’s KRAS G12C inhibitor calderasib gains FDA BTD for NSCLC

Merck & Co., Inc. (NYSE: MRK) announced that the US FDA has granted Breakthrough Therapy Designation (BTD) for calderasib (MK-1084), an investigational oral covalent KRAS G12C inhibitor. The award covers the molecule’s use in combination with pembrolizumab (Keytruda) for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation and with a PD-L1 tumor proportion score (TPS) ≥1%. This is the first BTD received for calderasib and was supported by data from the Phase I KANDLELIT-001 trial. BTD provides intensive FDA guidance, organizational commitment from senior review staff, rolling review, and potential eligibility for Priority Review. Calderasib is being co-developed with Japan-based Taiho Pharmaceutical Co. Ltd. and UK-based Astex Pharmaceuticals, a subsidiary of Otsuka Pharmaceutical Co., Ltd., under a collaboration announced in January 2020. The KANDLELIT-001 trial (NCT05067283) generated the efficacy data supporting this designation. In previously untreated metastatic NSCLC patients with PD-L1 TPS ≥1% receiving calderasib plus pembrolizumab (n\=69), the confirmed objective response rate (ORR) was 77% (95% CI: 65–86) at a median follow-up of 12.1 months. In the calderasib monotherapy arm in previously treated NSCLC (n\=21), confirmed ORR was 38% (95% CI: 18–62) at a median follow-up of 18.9 months. Across all arms, treatment-related adverse events occurred in 94% of patients in the calderasib plus pembrolizumab arm. These data were presented at the 2025 American Society of Clinical Oncology Annual Meeting. Merck has since initiated the Phase III KANDLELIT-007 trial (NCT07190248), evaluating calderasib with subcutaneous KEYTRUDA QLEX in newly diagnosed KRAS G12C-mutant nonsquamous NSCLC regardless of PD-L1 expression, enrolling approximately 675 patients with progression-free survival as the primary endpoint. The Phase III KANDLELIT-004 trial (NCT06345729) evaluates calderasib plus pembrolizumab in patients with PD-L1 TPS ≥50%, enrolling approximately 600 patients with co-primary endpoints of progression-free survival and overall survival. The KRAS G12C mutation occurs in approximately 14% of NSCLC adenocarcinoma cases. No KRAS G12C inhibitor has received regulatory approval for first-line NSCLC anywhere globally, creating the competitive context for calderasib’s program. Two approved agents — sotorasib (Lumakras) from Amgen and adagrasib (Krazati) from Bristol Myers Squibb — are indicated only in the previously treated setting. In the first-line space, calderasib’s principal competitor is olomorasib from Eli Lilly and Company (NYSE: LLY), which received its own BTD in September 2025 for the same indication — first-line KRAS G12C-mutant NSCLC with PD-L1 TPS ≥50% — in combination with pembrolizumab, supported by Phase I/II LOXO-RAS-20001 and Phase III SUNRAY-01 dose optimization data. China-based D3 Bio’s elisrasib (D3S-001) has also reported first-line NSCLC data, with an ORR of 81.3% in combination with pembrolizumab across all PD-L1 expression levels in 48 efficacy-evaluable patients. Unlike olomorasib, which is positioned primarily in the PD-L1 TPS ≥50% population, calderasib’s BTD covers the broader PD-L1 TPS ≥1% population, and the KANDLELIT-007 trial extends evaluation to a PD-L1-unselected population. The KRAS G12C mutation rate in NSCLC varies geographically — approximately 4% to 14% depending on region — a factor that will influence global trial enrollment and commercial positioning. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Phase 3ASCOBreakthrough TherapyClinical ResultPhase 1

10 Jun 2026

·www.biospace.com

Cytospire Therapeutics Appoints Samit Hirawat, M.D., as Non-Executive Director

Dr Hirawat i s the former CMO and Head of Global Drug Development at Bristol Myers Squibb and former EVP and Head of Oncology Development at Novartis Augments Cytospire’s clinical development experience as Cytospire prepares CYT X300 , its lead pan - gamma delta T cell engager , for clinical trials LONDON, UK – June, 10 2026 – Cytospire Therapeutics Limited (“Cytospire”), a UK based biotech developing differentiated multispecific immune cell engager antibodies designed to enhance and direct the activity of the body’s own immune system, today announces that Samit Hirawat, M.D., has been appointed as a non-executive director to the company’s board of directors. Dr Hirawat, an internationally recognized senior biopharmaceutical executive, has more than 30 years of experience in drug development spanning tenures at large global pharmaceutical and prestigious research organizations. Most recently, Dr Hirawat served as Chief Medical Officer, Executive Vice President, and Head of Global Drug Development at Bristol Myers Squibb, where he oversaw the worldwide clinical development portfolio and advanced multiple transformative therapies across diverse therapeutic areas. This included global approvals for 12 new molecular entities including Breyanzi (lisocabtagene), Abecma (idecabtagene), Opdualag (nivolumab + relatlimab), Augtyro (repotrectinib) and Krezati (adagrasib). Prior to that, he spent more than a decade at Novartis Pharmaceuticals in roles of increasing strategic and operational responsibility, culminating in his position as Executive Vice President and Head of Oncology Development. Dr Hirawat earned his Bachelor of Medicine and Bachelor of Surgery (MBBS) from Sawai Man Singh Medical College in Jaipur, India. He conducted his Internal Medicine residency and Medical Oncology fellowship in New York at North Shore University Hospital. Dr Hirawat has published more than 150 peer-reviewed manuscripts and abstracts across major therapeutic areas. “ Samit is a recognised leader in the field of clinical development and having the ability to access his vast expertise as a member of the Cytospire board will be an invaluable asset as we advance our innovative pipeline of pan-gamma delta T cell engagers ”  said Natalie Mount , Chief Executive Officer of Cytospire .  Peter Goodfellow, Non-Executive Chair of Cytospire added “ Samit is a fantastic addition to the Cytospire Board of Directors. He joins th e company at a particularly exciting time as the lead development programme, CYT X300, is being advanced into clinical trials as a treatment for EGFR-positive solid tumours, such as colorectal, head and neck and non-small cell lung cancers ”. “ I’m delighted to be joining Cytospire’s Board during this pivotal time in the Company’s journey” said Dr Samit Hirawat . “ Cytospire’s pan-gamma delta T cell engager technology has significant differentiation over conventional CD3 T cell engager approaches and huge potential to improve outcomes for patients in multiple cancer indications . I look forward to collaborating with the Cytospire team and contributing my experience to help advance the se important new therapies ”. Cytospire’s pan-gamma delta T cell engagers are uniquely engineered to target all gamma delta T cells rather than only specific subtypes. Through this approach, Cytospire seeks to overcome patient heterogeneity and generate broader, more effective antitumour immune responses through the activation of both tissue/tumour resident and blood resident effector cells. Cytospire recently announced the closing of an oversubscribed £61 million ($83 million) Series A financing supported by a strong syndicate of specialist biotech investors (see press release Cytospire Therapeutics announces Series A financing ). About Cytospire Therapeutics Cytospire is developing an innovative portfolio of differentiated multispecific engager antibodies to enhance and direct the activity of innate and adaptive effector immune cells.  Our core technology allows binding and activation of both tissue/tumour and blood resident gamma delta T cells. This opens a path to safer and more efficacious targeting of well-validated antigens that are intractable to CD3 T cell engagers due to toxicity. There are broad opportunities for Cytospire’s gamma delta T cell engagers in solid and haematological malignancies, as well as in autoimmune disease.  Based in London, UK, Cytospire Therapeutics is backed by a strong syndicate of life science investors including Abingworth, 4BIO Capital, Servier Ventures, British Business Bank, Sound Bioventures, LifeArc Ventures and Criteria Bio Ventures. For more information, visit  Contacts Andrew Fadden, Chief Business Officer contact@cytospiretx.com Frazer Hall, Mark Swallow MEDiSTRAVA cytospire@medistrava.com

Executive Change

100 Deals associated with Adagrasib

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KEGG	Wiki	ATC	Drug Bank
-	Adagrasib	-	DB15568

R&D Status

Approved

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Indication	Country/Location	Organization	Date
KRAS G12C mutant Colorectal Cancer	United States	Bristol Myers Squibb Co.	21 Jun 2024
KRAS G12C mutant Non-small Cell Lung Cancer	United States	Bristol Myers Squibb Co.	12 Dec 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	United States	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Japan	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Argentina	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Australia	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Austria	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Belgium	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Brazil	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Bulgaria	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Canada	Bristol Myers Squibb Co.	24 Apr 2025
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	Chile	Bristol Myers Squibb Co.	24 Apr 2025

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2026	Not Applicable	KRAS G12C mutation Solid Tumors Second line KRAS-G12C mutations	1,133	Sotorasib	isibytjsvk(elkmityocr) = yoteutcktx fynijbikwq (whaqlakudv ) View more	Positive	29 May 2026
ASCO2026	Not Applicable		1,133	Adagrasib	isibytjsvk(elkmityocr) = izpcdkigdy fynijbikwq (whaqlakudv ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	KRAS mutant Non-small Cell Lung Cancer KRAS G12C	53	Sotorasib and/or Adagrasib	tksnzplnqw(bupcfhjbqn) = idsaodfema dczabmybuj (uinzbbjjcp ) View more	Negative	29 May 2026
NCT06024174 (CTgov)	Phase 1/2	Advanced Malignant Solid Neoplasm \| KRAS G12C mutation Solid Tumors	5	Adagrasib+BMS986466	lyiagupkme = lkanceqmeg yhqvdzikge (wngsqvbbnb, hwdttulmig - phjuqdufwe) View more	-	22 Jul 2025
NEWS Manual	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C	-	Glecirasib	ugkxsyiyly(wizvscsadj) = wnqdzdhgjv qbrnwwmpek (vghsnnqjhu ) View more	Positive	16 Jul 2025
NEWS Manual	Phase 2		-	Sotorasib	ugkxsyiyly(wizvscsadj) = yutwzmzxar qbrnwwmpek (vghsnnqjhu ) View more	Positive	16 Jul 2025
ASCO2025	Not Applicable	KRAS G12C mutation Solid Tumors KRAS G12C mutations	400	Adagrasib	ibbjdbfjqj(uzjsuebyze) = kxrausiima qlvyyuiutl (vwbzphhkqg, 93% - 99) View more	Positive	30 May 2025
NCT03785249 (KRYSTAL-1, AACR2025)	Phase 2	Neoplasm Metastasis \| KRAS G12C mutation Solid Tumors First line STK11	35	Adagrasib 600 mg orally BID	qreaukbuye(klaxmtuzbg) = plrfqoowyr stmmlqxvxb (iutnogbjjr, 15.6 - 48.7) View more	Positive	29 Apr 2025
NCT04613596 (KRYSTAL-7, ESMO_ELCC2025 \| ASCO2025) Manual	Phase 2	Non-Small Cell Lung Cancer First line KRAS G12C \| PD-L1 Positive	149	Adagrasib (ADA)Adagrasib (ADA) + PembrolizumabPembrolizumab (PEMBRO) (PD-L1 <50%)	irzvvrdcby(vtvpzxfgxz) = fbbspsdyba wjgpbsgdau (rgihvecpdp, 26.2–46.3) View more	Positive	27 Mar 2025
NCT04613596 (KRYSTAL-7, ESMO_ELCC2025 \| ASCO2025) Manual	Phase 2		149	Adagrasib (ADA) + Pembrolizumab (PEMBRO) (PD-L1 ≥50%)	irzvvrdcby(vtvpzxfgxz) = ndcdmgrbwz wjgpbsgdau (rgihvecpdp, 45.0 - 72.4) View more	Positive	27 Mar 2025
NCT03785249 (KRYSTAL-1, ESMO_ELCC2025)	Phase 1	Advanced Lung Non-Small Cell Carcinoma KRASG12C-mutated	31	Adagrasib 400 mg BID + Cetuximab 500 mg/m2 Q2W	ohivkuoilu(vazenxxcom) = ximrngwypf bdunndqkxw (zdlkglmtvt, 22.7 - 59.4) View more	Negative	26 Mar 2025
NCT03785249 (KRYSTAL-1, ASCO_GI2025) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer Second line KRAS G12C	94	Adagrasib + Cetuximab	wtuyyfgcsq(nmlybexijr) = zftymqqzlu qqkizywkfz (jwsfrtyyzw, 32 - 53) View more	Positive	23 Jan 2025
NCT04685135 (KRYSTAL-12, CTgov)	Phase 3	KRAS G12C mutant Non-small Cell Lung Cancer	453	Docetaxel	pldeulpvnp(aygmsbogok) = uvapznuibf gqjrjvgxlb (cidasyntss, hqmkdfxamh - hlqotwfyge) View more	-	22 Jan 2025

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