Zanidatamab

TAGRISSO has become a standard treatment due to its strong efficacy in both first-line and adjuvant settings. The growing prevalence of EGFR mutations, a rise in lung cancer diagnoses, and broader approvals for early-stage treatment all contribute to its promising growth potential. LAS VEGAS , March 11, 2025 /PRNewswire/ -- DelveInsight's " TAGRISSO Market Size, Forecast, and Market Insight Report" highlights the details around TAGRISSO, a kinase inhibitor of the EGFR, which binds irreversibly to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletions) at approximately nine-fold lower concentrations than wild-type. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TAGRISSO. 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]. AstraZeneca's TAGRISSO (osimertinib) Overview TAGRISSO is a prescription medication for adults with non-small cell lung cancer (NSCLC) that carries specific EGFR gene mutations. It is used to help prevent cancer recurrence after surgical tumor removal, as a first-line treatment for metastatic NSCLC, or for patients whose cancer has spread and no longer responds to prior EGFR TKI therapy. As a kinase inhibitor, TAGRISSO irreversibly targets specific mutant forms of EGFR (T790M, L858R, and exon 19 deletions) with significantly higher selectivity than the wild-type EGFR. After oral administration, two active metabolites (AZ7550 and AZ5104) circulate at around 10% of the parent drug and exhibit similar inhibitory effects as osimertinib. In vitro studies also show that osimertinib inhibits HER2, HER3, HER4, ACK1, and BLK at clinically relevant levels. The recommended TAGRISSO dosage is 80 mg once daily, taken with or without food, and continued until disease progression or unacceptable toxicity occurs. Learn more about TAGRISSO projected market size for EGFR mNSCLC @ TAGRISSO Market Potential EGFR is a protein that plays a crucial role in cell growth. When mutations occur in the EGFR gene, they can lead to excessive cell growth, potentially causing cancer. These mutations can take various forms, including deletions, insertions, and point mutations. Among the most common EGFR mutations detected in test results are the EGFR exon 19 deletion and the EGFR L858R point mutation. In non-small cell lung cancer, targeted therapies primarily focus on EGFR-sensitizing mutations and EGFR exon 20 insertions. The most frequently observed EGFR mutations include exon 19 deletions and exon 21 L858R mutations. To address these, the FDA has approved several tyrosine kinase inhibitors (TKIs). In 2023, the EGFR-mutated NSCLC market across the 7MM was valued at approximately USD 4 billion. The NSCLC treatment landscape is becoming increasingly biomarker-driven, with EGFR emerging as one of the most lucrative targets. TAGRISSO remains the leading therapy in this segment, maintaining a strong market presence. However, resistance to EGFR TKIs, particularly after TAGRISSO treatment, is a growing challenge. Developing treatments for patients who experience resistance remains one of the most pressing unmet needs in this space. Discover more about the EGFR mNSCLC market in detail @ EGFR Metastatic Non-small Cell Lung Cancer Market Report Emerging Competitors of TAGRISSO The promising candidates in EGFR NSCLC pipeline include Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Zipalertinib (Cullinan Oncology/Taiho Pharma), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Savolitinib (AstraZeneca/Hutchison MediPharma), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), BNT327/PM8002 (Biotheus/BioNTech), Zanidatamab (Jazz Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sasanlimab (Pfizer), Pamvatamig (MCLA-129) (Merus), REQORSA (quaratusugene ozeplasmid) (Genprex), PT-112 (Promontory Therapeutics), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), Carotuximab (ENV-105) (Kairos Pharma), and others. To know more about the number of competing drugs in development, visit @ TAGRISSO Market Positioning Compared to Other Drugs Key Milestones of TAGRISSO In December 2024, TAGRISSO was approved in Europe for patients with unresectable EGFR-mutated lung cancer based on the results of the LAURA Phase III study. In September 2024, TAGRISSO was approved in the US for patients with unresectable stage III EGFR-mutated lung cancer based on LAURA Phase III trial results. In July 2024, TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, was approved in Europe for the first-line treatment of adult patients with advanced EGFR-mutated NSCLC whose tumors have exon 19 deletions or exon 21 (L858R) mutations. Approval was based on the results from the Phase III FLAURA2 study. In June 2024, TAGRISSO in combination with chemotherapy was approved in Japan as a first-line treatment for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In June 2024, TAGRISSO was granted priority review in the US for patients with unresectable, Stage III EGFR-mutated lung cancer. TAGRISSO was also recently granted BTD by the FDA in this setting. In February 2024, TAGRISSO in combination with chemotherapy was approved in the US for patients with EGFR-mutated advanced lung cancer based on Phase III FLAURA2 results. In October 2023, TAGRISSO plus chemotherapy was granted priority review in the US for patients with EGFR-mutated advanced lung cancer based on FLAURA2 Phase III trial results. In August 2022, TAGRISSO was approved in Japan for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the positive results from the global ADAURA Phase III trial. In May 2021, TAGRISSO was approved in Europe for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In December 2020, TAGRISSO was approved in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on unprecedented results from the ADAURA Phase III trial. In October 2020, TAGRISSO granted priority review in the US for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer based on the data from the ADAURA Phase III trial. In July 2020, TAGRISSO was granted BTD in the US for the adjuvant treatment of patients with Stage IB–IIIA EGFR-mutated lung cancer based on unprecedented results from the Phase III ADAURA trial. In August 2018, the MHLW approved TAGRISSO for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive NSCLC In June 2018, the EC granted marketing authorization for TAGRISSO as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations. In April 2018, the US FDA approved TAGRISSO for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. In April 2018, Molecular Partners and AstraZeneca announced a clinical collaboration for MP0250 in EGFR-mutated NSCLC with osimertinib. Under the collaboration, AstraZeneca will supply osimertinib for the clinical study. In April 2017, the EC granted full marketing authorization for TAGRISSO for treating adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. In March 2017, the US FDA granted full approval for TAGRISSO for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. TAGRISSO was granted accelerated approval for this indication in November 2015 based on tumor response rate and duration of response. In 2017, TAGRISSO was granted BTD and priority review by the US FDA for the first-line treatment of patients with metastatic NSCLC. In March 2016, the MHLW approved TAGRISSO for the treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR-TKI. In January 2016, AstraZeneca and Incyte Corporation announced a clinical trial collaboration to evaluate the efficacy and safety of INCB39110 in combination with osimertinib. In September 2014, the US FDA granted ODD to TAGRISSO for treating EGFR mutation-positive NSCLC. In April 2014, TAGRISSO received BTD from the US FDA for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. In November 2013, TAGRISSO was granted FTD for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after an EGFR TKI therapy. Discover how TAGRISSO is shaping the EGFR NSCLC treatment landscape @ TAGRISSO NSCLC TAGRISSO Market Dynamics TAGRISSO, developed by AstraZeneca, is a third-generation EGFR TKI that has become a key player in the treatment of NSCLC with EGFR mutations. Since its approval, TAGRISSO has gained significant traction due to its efficacy in treating both first-line and post-resistance settings, particularly in patients with the T790M resistance mutation. The drug's ability to penetrate the blood-brain barrier and show strong efficacy against brain metastases has further strengthened its market positioning, leading to widespread adoption among oncologists. A major driver of TAGRISSO's market dynamics is its dominance as the preferred first-line treatment for EGFR-mutated NSCLC. This shift from earlier-generation TKIs has been supported by clinical data demonstrating superior progression-free survival (PFS) and overall survival (OS) benefits. The expansion of TAGRISSO's indications, including its approval in the adjuvant setting for early-stage EGFR-mutated NSCLC, has further broadened its market reach. Additionally, AstraZeneca has aggressively pursued global regulatory approvals, ensuring market access across multiple geographies, particularly in high-prevalence regions such as East Asia, where EGFR mutations are more common. However, TAGRISSO faces growing challenges, including the emergence of resistance mechanisms such as MET amplification and C797S mutations, which limit long-term efficacy. To counteract this, AstraZeneca is exploring combination strategies with MET inhibitors and other targeted therapies. Furthermore, increasing competition from next-generation EGFR TKIs, such as those under development by companies like Takeda and Johnson & Johnson, poses a potential threat. Pricing and reimbursement pressures, particularly in cost-sensitive markets, also impact its commercial strategy, necessitating a balance between pricing optimization and maintaining accessibility. Despite these challenges, TAGRISSO remains a blockbuster drug with robust revenue growth, driven by strong clinical performance and strategic lifecycle management. Ongoing clinical trials evaluating its use in earlier disease stages and in combination therapies could further extend its market leadership. With its strong foothold in the EGFR-mutated NSCLC landscape, TAGRISSO is expected to remain a key driver of AstraZeneca's oncology portfolio in the foreseeable future. Dive deeper to get more insight into TAGRISSO's strengths & weaknesses relative to competitors @ TAGRISSO Market Drug Report Table of Contents Related Reports EGFR Non-small Cell Lung Cancer Market EGFR 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 EGFR NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Genentech/Roche, Eli Lilly, Hansoh Pharmaceutical, J&J Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Black Diamond Therapeutic, J INTS BIO, NALO Therapeutics, Scorpion Therapeutics, ORIC Pharmaceuticals, among others. EGFR Non-small Cell Lung Cancer Pipeline EGFR 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 EGFR non-small cell lung cancer companies, including Cullinan Oncology, Betta Pharmaceuticals, G1 Therapeutics, Janux Therapeutics, Daiichi Sankyo Company, Suzhou Puhe Pharmaceutical Technology, Genor Biopharma, J Ints Bio, Avistone Pharmaceuticals, Mythic Therapeutics, among others. 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. 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

CACA 微专辑 扫描二维码 可查看更多内容 编者按 随着精准医学的发展，CRC的治疗逐步走向个体化和精准化，尤其是在转移性结直肠癌（mCRC）的治疗中，靶向药物的应用为患者带来了新的希望。近日，中国医科大学附属盛京医院消化肿瘤内科的刘静教授在第九届中国医师协会结直肠肿瘤专业委员会年会上分享了结直肠癌（CRC）靶向治疗的最新进展。 刘静 教授 中国医科大学附属盛京医院 医学博士，主任医师、教授 中国医科大学附属盛京医院消化肿瘤内科 副主任 美国国立癌症研究所(NCI) 、 华盛顿大学医学院Fred Hutchinson Cancer Center访问学者 CSCO青年专家委员会副主任委员、胃癌专家委员会委员、肝癌专家委员会委员、抗肿瘤药物安全管理专家委员会委员 中国抗癌协会肿瘤支持治疗专委会青委会副主任委员、恶性间皮瘤专委会常委、肿瘤靶向治疗专委会委员 中国医疗保健国际交流促进会消化肿瘤综合诊疗学分会常务委员 国家癌症中心结直肠癌质控专家委员会委员 辽宁省预防医学会肿瘤防治专委会副主任委员 辽宁省细胞生物学学会肿瘤多学科协作诊疗和细胞学研究专委会副主任委员 辽宁省免疫学会肿瘤免疫分会常委 CSCO基金会评审专家、《中国医学前沿杂志（电子版）》、《肿瘤综合治疗电子杂志》编委 RAS/RAF野生型mCRC： 新型EGFR抗体的应用 对于RAS/RAF野生型的mCRC患者，新型EGFR-MET双特异性抗体Amivantamab的应用显示出初步的疗效。2024年ESMO会议上公布的研究（513MO）表明，针对左半和右半结肠癌的不同患者群体，Amivantamab在未暴露过或既往使用过EGFR单抗的患者中均表现出良好的治疗效果，特别是对于KRAS/NRAS/BRAF/EGFR野生型且无HER2扩增的患者，Amivantamab联合化疗在一线或二线治疗中显示出显著的临床获益：ORR 49%；DCR 88%；mDoR 7.4个月；mPFS 7.5个月（图1）。 图1. Amivantamab联合化疗的疗效 KRAS G12C抑制剂： 精准治疗的突破 KRAS突变在CRC中较为常见，其中KRAS G12C突变发生率约为3%～4%。近年来，针对KRAS G12C的抑制剂如AMG 510和MRTX849通过共价结合抑制KRAS蛋白的活性，展现出快速缩瘤的效果。然而，这些药物也面临耐药性产生较快的问题。2024年ESMO会议上公布的CodeBreaK 101 Ib期研究（505O）显示，KRAS G12C抑制剂Sotorasib联合帕尼单抗和FOLFIRI方案在晚期一线治疗中表现出良好的耐受性和显著的缩瘤效果，共入组38例患者，其中95%的患者取得了疾病控制，所有患者都取得了肿瘤病灶的缩小；中位随访6.7个月，68%的患者持续达到疾病缓解，PFS数据还未成熟。其它新型的KRAS non-G12C抑制剂及Pan-RAS抑制剂也正在进行临床试验。 BRAF V600E突变型mCRC： 联合治疗的进展 BRAF V600E突变型mCRC的治疗策略从单靶向治疗逐步发展为双靶向和三靶向联合治疗。BEACON研究结果证实，BRAF抑制剂Encorafenib联合EGFR抑制剂西妥昔单抗已成为二线治疗的标准方案，在ORR（客观缓解率）、mPFS（中位无进展生存期）和mOS（中位总生存期）方面均显著优于化疗。在晚期一线治疗中，2025年ASCO GI会议上公布了BREAKWATER研究（16O）的初步疗效数据，Encorafenib +西妥昔单抗+FOLFOX化疗对比标准治疗可显著提高ORR （60.9% vs. 40.0%），OS的期中分析也显示了生存获益趋势。此外，靶向治疗联合免疫治疗（如PD-1抑制剂）在BRAF V600E突变型mCRC中也显示出潜在的生存获益。2022 ASCO GI会议上的研究显示，Encorafenib +西妥昔单抗+纳武利尤单抗(抗PD-1)治疗MSS、BRAF v600e突变型mCRC (NCT04017650，N = 26)，ORR 为50%，DCR为 96%， DOR为7.7个月（BACON研究中，ORR为20%）；mPFS为7.4个月，mOS为15.1个月，而BACON研究中，mPFS为4个月（图2）。 图2. 靶免联合治疗MSS、BRAF V600E突变型mCRC生存获益可能更优 HER2阳性mCRC： 抗HER2治疗的进展 HER2阳性mCRC的治疗也取得了显著进展。DESTINY-CRC02研究是一项多中心、随机、Ⅱ期研究，旨在评估T-DXd（5.4mg/kg和6.4mg/kg）在HER2阳性mCRC患者中的疗效和安全性。研究对象均为中心实验室确认的HER2阳性（IHC3+或IHC2+/ISH+）、RAS野生型或突变型、BRAF野生型且既往接受过标准治疗mCRC患者，允许既往接受过抗HER2治疗。研究结果表明，5.4 mg/kg组和6.4 mg/kg组的中位随访时间分别为8.9个月和10.3个月，5.4 mg/kg组的cORR在数值上高于6.4 mg/kg组，分别为37.8%和27.5%。两组DCR分别为86.6%和85.0%，DoR均为5.5个月。BICR评估的中位PFS分别为5.8个月和5.5个月。中位OS分别为13.4个月和NE(图3)。 图3. DESTINY-CRC02研究的中位PFS和OS 2024年ESMO会议上公布的研究（516MO）显示，抗HER2双抗泽尼达妥（ZW25）联合FOLFOX化疗在晚期一线HER2阳性mCRC患者中表现出良好的抗肿瘤活性。研究结果显示，11例可评估患者中，ZW25+化疗的客观缓解率（ORR）和疾病控制率（DCR）均令人鼓舞，中位随访时间15.4个月，ORR 90.9%，DCR为100%。 无驱动基因mCRC： 抗血管生成药物的仍是标准 对于无驱动基因突变的mCRC患者，抗血管生成药物联合化疗仍然是标准治疗。2024年ASCO会议上公布的研究（199P）显示，呋喹替尼联合TAS-102在三线治疗中表现出良好的耐受性和临床活性。这是一项开放标签、单臂、多中心、2期研究（NCT05004831），招募了至少两种既往标准治疗方案失败的mCRC患者。研究结果显示，50例患者中46例患者至少有一次肿评：ORR 为10.9%;DCR为73.9%；中位无进展生存期（mPFS）为6.33个月;中位总生存期（mOS）为18.4个月(图4)。 图4. 呋喹替尼联合TAS-102在经治mCRC中的PFS和OS 展望 随着精准医学的不断发展，CRC的治疗策略正在从传统的化疗逐步转向精准的靶向治疗和免疫治疗。针对不同基因突变的个体化治疗方案为患者带来了更多的治疗选择和生存希望。未来，随着更多新型靶向药物和联合治疗策略的研发，CRC的治疗前景将更加广阔。刘静教授的分享为结直肠癌的精准治疗提供了宝贵的临床经验和研究数据，进一步推动了该领域的发展。 （来源：肿瘤瞭望消化时讯） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。