[Translation] A randomized, controlled, open-label, global, multicenter phase III trial to evaluate the efficacy and safety of zipalertinib combined with chemotherapy compared with chemotherapy alone in patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations

主要目的：比较治疗组之间的无进展生存期（PFS）次要目的：进一步比较治疗组之间的有效性。评价zipalertinib与化疗联用相比单纯化疗的安全性和耐受性。对于接受zipalertinib治疗的患者，评价zipalertinib联合培美曲塞和铂类药物的PK特征。比较治疗组间的患者报告结局（PRO）。探索性目的：探索zipalertinib与培美曲塞和铂类药物联用的有效性和安全性的暴露量-效应关系。评价EGFR突变状态和zipalertinib的生物标志物。

[Translation]

Primary objective: To compare progression-free survival (PFS) between treatment groups Secondary objectives: To further compare the efficacy between treatment groups. To evaluate the safety and tolerability of zipalertinib combined with chemotherapy compared with chemotherapy alone. For patients receiving zipalertinib, to evaluate the PK characteristics of zipalertinib combined with pemetrexed and platinum drugs. To compare patient-reported outcomes (PROs) between treatment groups. Exploratory objectives: To explore the exposure-effect relationship of the efficacy and safety of zipalertinib combined with pemetrexed and platinum drugs. To evaluate the EGFR mutation status and biomarkers of zipalertinib.

Start Date01 Apr 2024

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

[+2]

CTIS2023-503865-48-00

/ RecruitingPhase 2

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations - TAS6417-201

Start Date21 Feb 2024

Sponsor / Collaborator

Taiho Oncology, Inc.

NCT05967689

/ RecruitingPhase 2

An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.

Start Date27 Jul 2023

Sponsor / Collaborator

Taiho Oncology, Inc.

100 Clinical Results associated with Zipalertinib

100 Translational Medicine associated with Zipalertinib

100 Patents (Medical) associated with Zipalertinib

Literatures (Medical) associated with Zipalertinib

01 Mar 2025·LUNG CANCER

Novel strategies for rare oncogenic drivers in non-small-cell lung cancer: An update from the 2024 Annual ESMO meeting

Review

Author: van der Wel, J W T ; de Langen, A J

Across the landscape of oncogene-addicted non-small-cell lung cancer (NSCLC), various tyrosine kinase inhibitors (TKIs) have been introduced in the last twenty years. During the 2024 Annual ESMO meeting new therapeutic options were presented for EGFR exon 20 insertion mutation, ALK fusion and ROS1 fusion positive advanced stage NSCLC. For EGFR exon 20 insertion mutation positive NSCLC, results from REZILIENT-1, a single arm phase II study with zipalertinib, were presented, showing an objective response rate (ORR) of 50% in patients that were pretreated with amivantamab, and 25% in patients pretreated with amivantamab and an EGFR exon 20 insertion-directed TKI. The vast majority of these patients also received platinum-doublet chemotherapy. For ALK, results from ALKOVE-1, a single arm phase I/II study with NVL-655, a next generation ALK TKI, were presented. The ORR was 35 % in patients pretreated with ≥ 2 ALK TKIs including lorlatinib and 57 % in patients pretreated with ≥ 1 ALK TKI, excluding lorlatinib. The median number of prior anticancer therapies was 3. Intracranial responses were seen in lorlatinib naïve- and lorlatinib pretreated patients and toxicity was manageable. In addition, results of the first-line randomized phase III INSPIRE study were presented, in which iruplinalkib, an ALK and ROS1 selective TKI, is being evaluated versus crizotinib. Iruplinalkib showed a superior median PFS (36.8 versus 14.55 months for crizotinib), but no difference in 36-month overall survival (OS) rate. Finally, results from ARROS-1, a single arm phase I/II study with zidesamtinib, a ROS1 selective and TRK-sparing TKI, were presented. An ORR of 73% was obtained in patients that were pretreated with crizotinib and an ORR of 38% in patients pretreated with repotrectinib. In this review, we will discuss the relevant study results presented at ESMO 2024 for these three genomic drivers and hypothesize on their respective place in the sequence of treatment options.

19 Feb 2025·Future Oncology

REZILIENT3: randomized phase III study of first-line zipalertinib plus chemotherapy in patients with EGFR exon 20 insertion-mutated NSCLC

Article

Author: Tan, Daniel SW. ; Cheng, Ying ; Heymach, John V. ; Besse, Benjamin ; Wacheck, Volker ; Yu, Helena A. ; Nishio, Makoto ; Wei, Li

There remains a significant unmet need for effective and tolerable treatments for patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations in the first-line setting. First and later generation EGFR tyrosine kinase inhibitors (TKIs) have shown efficacy for common EGFR mutations; however, their effectiveness against ex20ins mutations is limited, and platinum-based chemotherapy remains part of the standard of care. Data suggest that combining chemotherapy with EGFR inhibitors offers promise for EGFR ex20ins-mutated NSCLC. REZILIENT3 is an ongoing phase III study evaluating the efficacy and safety of zipalertinib (an orally available, irreversible EGFR-TKI) plus first-line standard-of-care platinum-based chemotherapy with chemotherapy alone in previously untreated patients with nonsquamous NSCLC harboring EGFR ex20ins mutations.Clinical Trial Registration: NCT05973773 (ClinicalTrials.gov).

05 Nov 2024·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Biochemical analysis of EGFR exon20 insertion variants insASV and insSVD and their inhibitor sensitivity

Article

Author: Beyett, Tyler S. ; Eck, Michael J. ; Rana, Jaimin K. ; Schaeffner, Ilse K. ; Zhao, Hanchen ; Jiang, Jie ; Santana, Jhasmer ; Jänne, Pasi A.

Somatic mutations in the epidermal growth factor receptor (EGFR) are a major cause of non–small cell lung cancer. Among these structurally diverse alterations, exon 20 insertions represent a unique subset that rarely respond to EGFR tyrosine kinase inhibitors (TKIs). Therefore, there is a significant need to develop inhibitors that are active against this class of activating mutations. Here, we conducted biochemical analysis of the two most frequent exon 20 insertion variants, V769_D770insASV (insASV) and D770_N771insSVD (insSVD) to better understand their drug sensitivity and resistance. From kinetic studies, we found that EGFR insASV and insSVD are similarly active, but have lower K m, ATP values compared to the L858R variant, which contributes to their lack of sensitivity to 1st-3rd generation EGFR TKIs. Biochemical, structural, and cellular studies of a diverse panel of EGFR inhibitors revealed that the more recently developed compounds BAY-568, TAS6417, and TAK-788 inhibit EGFR insASV and insSVD in a mutant-selective manner, with BAY-568 being the most potent and selective versus wild-type (WT) EGFR. Cocrystal structures with WT EGFR reveal the binding modes of each of these inhibitors and of poziotinib, a potent but not mutantselective inhibitor, and together they define interactions shared by the mutant-selective agents. Collectively, our results show that these exon20 insertion variants are not inherently inhibitor resistant, rather they differ in their drug sensitivity from WT EGFR. However, they are similar to each other, indicating that a single inhibitor should be effective for several of the diverse exon 20 insertion variants.

News (Medical) associated with Zipalertinib

11 Mar 2025

·www.prnewswire.com

TAGRISSO Sets the Stage for Market Leadership in Oncology with Strong Growth Prospects | DelveInsight

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

Drug ApprovalPhase 3Priority ReviewAccelerated ApprovalASCO

06 Mar 2025

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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

27 Feb 2025

·investors.cullinantherapeutics.com

Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2024 Financial Results

Initial clinical data from global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) expected in Q4 2025; CLN-978 remains the first and only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S. Zipalertinib pivotal Phase 2b study met primary endpoint; full results mid-year 2025 and NDA submission planned H2 2025, pending regulatory discussions Cash and investments of $606.9 million as of December 31, 2024, continues to provide runway into 2028 CAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2024. “Building on our execution throughout 2024, we are positioned to again deliver meaningful catalysts in 2025, starting with key updates for CLN-978 and zipalertinib,” said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. “We have established an important competitive advantage in the immunology space as CLN-978 remains the first and only development-stage CD19 T cell engager with U.S. Food and Drug Administration (FDA) IND clearance in autoimmune diseases. We are further strengthening our leadership position by rapidly expanding our site footprint and preparing to deliver initial clinical data in SLE in the fourth quarter of 2025. For zipalertinib, we recently announced that the pivotal Phase 2b portion of the REZILIENT1 study met the primary endpoint of overall response rate. This milestone marks a significant achievement for Cullinan, our partner, Taiho, and most importantly, patients with EGFR exon20 insertion mutation NSCLC who have received prior therapy. Together with Taiho, we look forward to discussing next steps with the U.S. FDA and expect to submit an NDA in the second half of 2025. We look forward to continuing to progress these programs along with the rest of our pipeline.” Portfolio Highlights Immunology CLN-978 (CD19xCD3 T cell engager): Systemic lupus erythematosus and rheumatoid arthritis The global Phase 1 study in moderate to severe SLE is ongoing with site expansion in the United States, Europe and Australia, and the Company plans to share initial clinical data in the fourth quarter of 2025. The Company remains on track to initiate a Phase 1 study in rheumatoid arthritis (RA) in the second quarter of 2025. The company-sponsored trial will be designed and executed in collaboration with FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Italy. The global Phase 1 study in moderate to severe SLE is ongoing with site expansion in the United States, Europe and Australia, and the Company plans to share initial clinical data in the fourth quarter of 2025. The Company remains on track to initiate a Phase 1 study in rheumatoid arthritis (RA) in the second quarter of 2025. The company-sponsored trial will be designed and executed in collaboration with FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Italy. Oncology CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors and hematological malignancies The Company continues enrollment of disease-specific expansion cohorts of its Phase 1 study. Cullinan remains on track to report initial data for endometrial and cervical cancers in the second quarter of 2025. Enrollment continues in the ongoing Phase 1 study of CLN-619 in patients with relapsed/refractory multiple myeloma. Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC In January 2025, Cullinan announced that the pivotal Phase 2b portion of REZILIENT1 met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The full results will be submitted for presentation at an upcoming international medical conference and shared mid-year 2025. Pending discussions with the U.S. FDA, Taiho and Cullinan plan to submit for U.S. regulatory approval in the second half of 2025. Taiho continues enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC. CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS Enrollment continues in the ongoing Phase 1 study in patients with relapsed/refractory AML or MDS, and in the ongoing Phase 1 study in patients with measurable residual disease (MRD) in AML. CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors. The Company continues enrollment of disease-specific expansion cohorts of its Phase 1 study. Cullinan remains on track to report initial data for endometrial and cervical cancers in the second quarter of 2025. Enrollment continues in the ongoing Phase 1 study of CLN-619 in patients with relapsed/refractory multiple myeloma. In January 2025, Cullinan announced that the pivotal Phase 2b portion of REZILIENT1 met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The full results will be submitted for presentation at an upcoming international medical conference and shared mid-year 2025. Pending discussions with the U.S. FDA, Taiho and Cullinan plan to submit for U.S. regulatory approval in the second half of 2025. Taiho continues enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC. Enrollment continues in the ongoing Phase 1 study in patients with relapsed/refractory AML or MDS, and in the ongoing Phase 1 study in patients with measurable residual disease (MRD) in AML. Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors. Fourth Quarter and Full Year 2024 Financial Results Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $606.9 million as of December 31, 2024. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan. R&D Expenses: Research and development expenses were $40.5 million for the fourth quarter of 2024, compared to $34.8 million for the same period in 2023, and $142.9 million for the full year 2024, compared to $148.2 million for the full year 2023. G&A Expenses: General and administrative expenses were $14.6 million for the fourth quarter of 2024, compared to $10.6 million for the same period in 2023, and $54.0 million for the full year 2024, compared to $42.5 million for the full year 2023. Net Loss: Net loss attributable to Cullinan was $47.6 million for the fourth quarter of 2024, compared to $23.8 million for the same period in 2023, and $167.4 million for the full year 2024, compared to $153.2 million for the full year 2023. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan’s portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow us on LinkedIn and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for our product candidates, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our plans regarding future data presentations, our cash runway, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Contacts: InvestorsNick Smith+1 401.241.3516nsmith@cullinantx.com Media Rose Weldon +1 215.801.7644 rweldon@cullinantx.com

Phase 1Phase 2Financial StatementClinical Result

100 Deals associated with Zipalertinib

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	Phase 3	United States	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Japan	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Belgium	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Brazil	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Bulgaria	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Canada	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	France	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Germany	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Greece	Taiho Oncology, Inc.	30 Jun 2023
EGFR-mutated non-small Cell Lung Cancer	Phase 3	Israel	Taiho Oncology, Inc.	30 Jun 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04036682 (REZILIENT1, PRNewswire) Manual	Phase 2	EGFR ex20ins mutation in non-small cell lung cancer Second line EGFR Exon 20 Insertion	-	Zipalertinib	xyxoqhpwnd(zbxkitpbis) = met its primary endpoint of overall response rate mpegpaxgmq (ifzqfiopro ) Met	Positive	28 Jan 2025
NCT05973773 (REZILIENT3, ESMO_ASIA2024) Manual	Phase 3	EGFR ex20ins mutation in non-small cell lung cancer First line EGFR exon 20 insertion	6	Zipalertinib 100 mg PO BID + Chemotherapy	vezpcjjlsg(qlvzphonjb) = pcyaxydjmu pinrrvgytp (dyicxvrnin )	Positive	07 Dec 2024
NCT04036682 (REZILIENT1, ESMO2024) Manual	Phase 2	EGFR ex20ins mutation in non-small cell lung cancer Second line EGFR Exon 20 Insertion	45	Zipalertinib 100 mg oral twice daily	spbismcdbs(anbesvkizk) = jonbewndjh wahjiprkpx (cwcakofudf ) View more	Positive	14 Sep 2024
NCT04036682 (REZILIENT1, Biospace) Manual	Phase 2	EGFR ex20ins mutation in non-small cell lung cancer	18	Zipalertinib	fadowpqdec(mkggmpjvah) = smyjpmxvnh tvhkrgdqmm (oawsrluypc ) View more	Positive	01 Jun 2024
NCT04036682 (Pubmed)	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer	73	Zipalertinib	uioxusqgki(thcjcbajce) = offvvwvgnk umevwtwukt (rbcspbmfsv ) View more	-	29 Jun 2023
NCT04036682 (Ins20, ASCO2022) Manual	Phase 1/2	Non-Small Cell Lung Cancer EGFR Exon 20 Insertion	73	CLN-081	wbssjgmyya(pnhvatxqlo) = kewcjzqqjx urgubdilhu (llwawpcmsu ) View more	Positive	02 Jun 2022
NCT04036682 (Ins20, ASCO 12021 \| ASCO 22021) Manual	Phase 1/2	Non-Small Cell Lung Cancer EGFR Mutation	37	CLN-081	cmpgbcokcg(aclppkvlrv) = fpltgfzsdo udzjrqubiq (apeyinhdgf ) View more	Positive	20 May 2021

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