RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Breakthrough Therapy (China), Orphan Drug (South Korea), Priority Review (United States)

Structure/Sequence

Sequence Code 143885L

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Sequence Code 13387733H

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Sequence Code 13387743H

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Sequence Code 13387747L

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Clinical Trials associated with Amivantamab-VMJM

NCT06855849

/ Not yet recruitingPhase 2IIT

An Open-label, Single-arm, Multicenter Phase II Study to Evaluate the Efficacy of Amivantamab in Combination With FOLFIRI as a Second-line Treatment in Patients With RAS/BRAF Wild-type Advanced Colorectal Cancer Progressing on Prior Anti-EGFR Based Treatment.

This trial is a multicenter, single arm study of efficacy of amivantamab in combination with FOLFIRI in RAS/BRAF wild-type advanced colorectal cancer patients progressed prior treatment including oxaliplatin based chemotherapy. This trial will be conducted by Severance Hospital that is responsible for the project management of the trial. Patient recruitment will take at 3 institutions.
Participants will be treated for up to 24 cycles (approximately 2 years) after initiation of treatment with intravenous 1050mg(BW<80kg) or 1400mg(BW≥80kg) of amivantamab every 4 weeks in combination with FOLFIRI. FOLFIRI includes folic acid, 5-FU and irinotecan. FOLFIRI will be administered intravenously with folic acid 400 mg/m², 5-FU 2400 mg/m², and irinotecan 180 mg/m² every 2 weeks. This study will use ORR based on RECIST 1.1 criteria as the primary endpoint and the tumor assessment will be done every 8 weeks. Secondary endpoints are DCR, PFS, OS, and safeties. Exploratory biomarkers in tumor tissue and ctDNA in blood will be investigated in both pre-treatment and post-treatment periods.

Start Date01 May 2025

Sponsor / Collaborator

Yonsei University

ChiCTR2500100101

/ SuspendedPhase 2IIT

Phase 1b/2, Open-label Study of Amivantamab Monotherapy and Amivantamab in Addition to Standard of Care Therapeutic Agents in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Start Date14 Apr 2025

Sponsor / Collaborator

Shanghai East Hospital

NCT06816992

/ RecruitingPhase 1

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.

Start Date27 Feb 2025

Sponsor / Collaborator

Oric Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Amivantamab-VMJM

100 Translational Medicine associated with Amivantamab-VMJM

100 Patents (Medical) associated with Amivantamab-VMJM

187

Literatures (Medical) associated with Amivantamab-VMJM

01 Dec 2025·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

Author: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

01 Aug 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Evolving treatment for advanced non-small cell lung cancer harbouring common EGFR activating mutations

Review

Author: Califano, Raffaele ; Bria, Emilio ; Monaca, Federico ; Gomez-Randulfe, Igor ; Planchard, David

A clinically important subgroup of non-small cell lung cancer (NSCLC) is driven by common mutations in the epidermal growth factor receptor (EGFR). Over the past decade, first-, second-, and third-generation EGFR tyrosine kinase inhibitors (TKIs) have substantially improved clinical outcomes, although acquired resistance inevitably emerges. In particular, the third-generation TKI osimertinib has demonstrated superior progression-free survival (PFS) and overall survival (OS) compared to earlier-generation TKIs in the frontline setting, yet median OS remains approximately three years in pivotal trials. Efforts to extend disease control have led to various upfront intensification strategies, including combining EGFR TKIs with antiangiogenics or chemotherapy (e.g., the FLAURA-2 trial), and pairing novel bispecific antibodies such as amivantamab with third-generation TKIs. Upon progression on third-generation EGFR TKIs, platinum-based chemotherapy remains the standard second-line treatment, albeit with modest response rates. Emerging therapies targeting MET amplification (e.g., savolitinib plus osimertinib), leveraging antibody-drug conjugates (e.g., patritumab deruxtecan), or adding immunotherapy and antiangiogenics have shown preliminary promise in overcoming resistance. Ongoing trials are assessing optimal treatment sequencing and the use of circulating tumor DNA (ctDNA) to guide therapy escalation or de-escalation. Ultimately, the evolving landscape of EGFR-mutant NSCLC underscores the need for refined biomarker-driven approaches and personalized regimens to achieve further gains in survival. In this review, we discuss these strategies in detail, highlighting current evidence and future directions for EGFR-mutant NSCLC treatment.

01 Jul 2025·Respiratory Investigation

Current treatment landscape for patients with non–small cell lung cancer with common EGFR mutations

Review

Author: Hayashi, Hidetoshi ; Miyata, Masayuki

Common EGFR mutations including exon-19 deletions and the L858R point mutation in exon 21 constitute predominant actionable genomic alterations in individuals with non-small cell lung cancer (NSCLC). The introduction of EGFR tyrosine kinase inhibitors (TKIs) has fundamentally changed the treatment landscape for such patients by improving both progression-free survival (PFS) and overall survival (OS). Among EGFR-TKIs, third-generation agents such as osimertinib have shown marked efficacy and favorable safety profiles and have become the standard of care in the first-line setting. The combination of osimertinib with platinum-based chemotherapy has recently been shown to improve PFS compared with osimertinib monotherapy in the FLAURA2 trial. Similarly, the MARIPOSA trial demonstrated clinical benefit of the combination of the EGFR-MET bispecific antibody, amivantamab, with the third-generation EGFR-TKI, lazertinib, further supporting the use of combination therapies as first-line treatment for EGFR-mutated NSCLC. Despite these advances, however, challenges such as brain metastases remain substantial barriers to successful treatment outcomes. Management of patients with such metastases often requires a multidisciplinary approach that integrates systemic treatment with local interventions such as radiation therapy. Finally, circulating tumor DNA has emerged as a promising biomarker for real-time monitoring of treatment response and evolution of drug resistance mechanisms. Analysis of such biomarkers can facilitate dynamic and personalized therapeutic adjustments, potentially improving outcomes. This review provides a comprehensive overview of the latest clinical evidence supporting therapeutic advances in the management of EGFR-mutated NSCLC, emphasizing the importance of tailoring treatment strategies based on tumor biology, patient-specific factors, and evolving therapeutic options.

263

News (Medical) associated with Amivantamab-VMJM

22 May 2025

·www.einpresswire.com

Cullinan Therapeutics, Taiho Pharmaceutical, and Taiho Oncology to Present Positive Results from Pivotal Phase 2b REZILIENT1 Trial of Zipalertinib at ASCO 2025

CAMBRIDGE, Mass. and TOKYO, Japan and PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. today announced new positive results from the pivotal Phase 2b cohorts of the REZILIENT1 trial , a Phase 1/2 clinical trial of zipalertinib monotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy. These data will be presented on Sunday, June 1 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation during the “Lung Cancer – Non-Small Cell Metastatic” session from 9:00 AM-9:12 AM CDT (Abstract #8503). “People living with EGFR ex20ins NSCLC urgently need well-tolerated targeted therapies with durable clinical benefit,” said Helena A. Yu, MD, Thoracic Medical Oncologist & Early Drug Development Specialist, Memorial Sloan Kettering Cancer Center. “It is encouraging to see a program that can potentially offer a meaningful option for some of the sickest patients with lung cancer. The findings from the REZILIENT1 trial may support zipalertinib as a potential new oral treatment option for patients whose disease progressed after prior therapies.” Summary of Efficacy Results As of the December 2024 data cutoff, 244 patients were enrolled in REZILIENT1 and received at least one dose of 100 mg zipalertinib. The overall efficacy population (n=176) consisted of all patients who received at least one dose of 100 mg zipalertinib and had approximately 8 months of minimum follow-up at data cutoff. Patients had received a median of 2 prior therapies, and 39% of patients had a history of brain metastases. With median follow-up of 9.3 months, zipalertinib demonstrated: In the overall efficacy population (n=176), confirmed overall objective response rate (ORR) was 35% with median duration of response (mDOR) of 8.8 months In patients with prior platinum-based chemotherapy only (n=125), ORR was 40% with mDOR of 8.8 months, consistent with REZILIENT1 Phase 1/2a results 1 In patients with prior chemo and amivantamab (without the addition of other prior ex20ins-targeted therapy) (n=30), ORR was 30% with mDOR of 14.7 months In patients with prior chemo and amivantamab (with or without other ex20ins-targeted therapy) (n=51), ORR was 24% with mDOR of 8.5 months In patients with brain metastases (n=68), the ORR was 31% with mDOR of 8.3 months Summary of Safety and Tolerability Results The safety analysis population included all REZILIENT1 patients who received at least one dose of 100 mg zipalertinib (n=244). The results showed that zipalertinib demonstrated a manageable safety profile in this heavily pre-treated patient population, consistent with previously reported data. The most common treatment-related adverse events (TRAEs, all-grade) were paronychia (38.5%), rash (30.3%), dermatitis acneiform (24.6%), dry skin (24.6%), diarrhea (21.7%), and stomatitis (20.1%). The majority of TRAEs were grade 1 or 2. The most common grade ≥3 TRAEs were anemia (7%), pneumonitis and rash (2.5% each), increased alanine aminotransferase, diarrhea, and decreased platelet count (2.0% each). About REZILIENT1 REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial ( NCT04036682 ) to evaluate efficacy and safety of zipalertinib in adult patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. Patients were treated with oral zipalertinib 100 mg twice daily. The primary endpoints were ORR and DOR as assessed by blinded independent central review (ICR) per RECIST v1.1. Adverse events were characterized and graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0). About Zipalertinib Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S. About the EGFR Exon 20 Insertion Mutations NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype. 2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, 3 with insertions at exon 20 accounting for up to 12% of these mutations. 2 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 . About Taiho Pharmaceutical Co., Ltd. (Japan) Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. ( https://www.otsuka.com/en/ ), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives. For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en . About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit https://www.taihooncology.com/ , and follow us on LinkedIn and X . Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries. 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 plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address this unmet need, 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, NDAs 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: Cullinan Therapeutics Investors Nick Smith +1 401.241.3516 nsmith@cullinantx.com Media Rose Weldon +1 215.801.7644 rweldon@cullinantx.com Taiho Pharmaceutical Co., Ltd. Junko Onishi +81-80-1009-7683 junn-onishi@taiho.co.jp Taiho Oncology Leigh Labrie +1 609.664.9878 llabrie@taihooncology.com ----- Piotrowska Z, Tan DS, Smit EF, et al. Safety, tolerability, and antitumor activity of zipalertinib among patients with non-small-cell lung cancer harboring epidermal growth factor receptor exon 20 insertions. Journal of Clinical Oncology . Available at: https://ascopubs-org.libproxy1.nus.edu.sg/doi/full/10.1200/JCO.23.00152 . Last accessed: January 2025. Burnett H, Emich H, Carroll C, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. PLOS ONE . 2021;16(3):e0247620. Available at: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247620 . Last accessed: January 2025. Riess JW, Gandara DR, Frampton GM, et al. Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC. Journal of Thoracic Oncology . 2018 Jul 5;13(10):1560–1568 . Available at: https://www.jto.org/article/S1556-0864(18)30770-6/pdf . Last accessed: May 2025. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Clinical ResultASCOBreakthrough TherapyPhase 2

22 May 2025

·www.prnewswire.com

Taiho Oncology Presents Data at the 2025 American Society of Clinical Oncology Annual Meeting

Data will be shared in two oral presentations, a poster and two online abstracts Highlights include a potential novel, all-oral therapy for AML; and Phase 2 data for a novel treatment targeting NSCLC that harbors EGFR exon 20 insertion mutations PRINCETON, N.J., May 22, 2025 /PRNewswire/ -- Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, today announced new data to be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 through June 3 at McCormick Place in Chicago. An oral presentation will highlight data describing the combination of decitabine and cedazuridine paired with venetoclax as a potential all-oral regimen for acute myeloid leukemia (AML).1 "The design of an all-oral regimen for the treatment of AML is in line with our mission to improve the lives of patients with cancer, their families and their caregivers, giving patients access to anti-cancer agents that allow more flexibility in treatment," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. Another oral presentation will highlight positive safety and efficacy findings for the investigational drug candidate zipalertinib as a treatment for non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.2 Taiho Oncology will also present data from three real-world studies of two FDA-approved therapies. "We're pleased to share these important data in several cancer types at the ASCO Annual Meeting," said Tim Whitten, President and CEO, Taiho Oncology. "Our purpose is grounded in ensuring we make a tangible impact for patients and their caregivers. These data continue to demonstrate our unwavering commitment to meaningful innovation across numerous disease states." Oral regimen of decitabine and cedazuridine plus venetoclax in newly diagnosed AML1 This Phase 1/2 trial evaluated the regimen of decitabine and cedazuridine plus venetoclax in 101 patients with newly diagnosed AML who were ineligible for first-line induction chemotherapy. Complete remission (CR) and CR with incomplete hematologic recovery rates were 46.5% and 63.4%, respectively. Median time to CR was 2.4 months. Median CR duration was not reached; among patients who achieved CR, 80% maintained that status at 6 months and 75.3% at 12 months. Median OS was 15.5 months. Ninety-eight percent of patients reported treatment-emergent adverse events of grade 3 or lower, most commonly febrile neutropenia (49.5%), anemia (38.6%) and neutropenia (35.6%). The 30- and 60-day mortality rates were 3% and 9%, respectively. Zipalertinib in NSCLC harboring EGFR exon 20 insertion mutations2 The Phase 2b REZILIENT1 study of zipalertinib monotherapy in patients with NSCLC harboring the EGFR exon 20 insertion mutations who have received prior therapy met its primary endpoint of overall response rate. The overall efficacy population (n=176) consisted of all patients who received at least one dose of 100 mg zipalertinib at data cutoff in December 2024. Patients had received a median of two prior therapies, and 38.6% of patients had a history of brain metastases. With median follow-up of 9.3 months, zipalertinib demonstrated: Among all patients treated, zipalertinib demonstrated a confirmed overall response rate (cORR) of 35.2%, with a median duration of response (mDOR) of 8.8 months. In patients who had received previous chemotherapy only (n=125), the cORR was 40.0%. Among patients with brain metastases, the systemic cORR was 30.9%. In patients with prior chemo and amivantamab (without the addition of other prior ex20ins-targeted therapy) (n=30), confirmed ORR was 30%. In a larger group of patients, including patients with prior chemo and amivantamab (with or without other ex20ins-targeted therapy) (n=51), ORR was 23.5 % with mDOR of 8.5 months. The most common treatment-emergent AEs were paronychia, rash, anemia, diarrhea, dry skin, nausea and stomatitis and the majority of TEAEs were CTCAE grade 1 or 2. Poster Presentation Title: Real-world treatment patterns and outcomes with trifluridine/tipiracil monotherapy or in combination with bevacizumab in metastatic colorectal cancer Abstract Number: 3580 Session Name: Gastrointestinal Cancer—Colorectal and Anal Session Type: Poster Presentation Session Date: May 31, 2025 Presentation Time: 9 a.m. – 12 p.m. CDT Location: Hall A - Posters and Exhibits | On Demand Presenter: Donald Richards, MD, PhD, of Texas Oncology Online Abstracts Title: Real-world Clinical Outcomes of Patients with Metastatic Colorectal Cancer (mCRC) Treated with Trifluridine-Tipiracil + Bevacizumab by Performance Status Abstract Number: E15606 Session Type: Publication Only Publication Date: May 22, 2025 Publication Time: 5 p.m. EDT Lead Author: Maliha Nusrat, MD, MS, Memorial Sloan Kettering Cancer Center Title: Real-World patient characteristics and treatment patterns among cholangiocarcinoma patients treated with FGFR inhibitors Abstract Number: E16262 Session Type: Publication Only Publication Date: May 22, 2025 Publication Time: 5 p.m. EDT Lead Author: Amit Mahipal, MD, University Hospitals Seidman Cancer Center and Case Comprehensive Cancer Center About Zipalertinib Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc. Cullinan Pearl Corp., which Taiho Pharmaceutical Co., Ltd., acquired from Cullinan Oncology, Inc. in 2022. About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company's European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X. Taiho Oncology and the Taiho Oncology logo are registered trademarks of Otsuka Holdings Co., Ltd. or its subsidiaries. Taiho Oncology Contact: Leigh Labrie (609) 664-9878 [email protected] References: 1. Zeidan A et al. An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a Phase 2 cohort of 101 pts 2. Yu H et al. Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab SOURCE Taiho Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOPhase 2Clinical ResultBreakthrough TherapyAcquisition

07 May 2025

·www.biospace.com

Summit’s Campaign To Conquer Keytruda Nears First Global Phase III Data

iStock, Nauval Wildani Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars. Meanwhile, other branded drugmakers are also seeking to improve on the blockbuster checkpoint inhibitor. Summit Therapeutics’ attempt to dislodge Merck’s mega blockbuster Keytruda is nearing a key moment. Building on results that supported ivonescimab’s approval in China , Summit is closing in on the first of a series of readouts from global Phase III trials of the bispecific antibody that could shape the future of cancer treatment. Akeso, Summit’s Chinese partner, sent interest in PD-1/L1xVEGF bispecifics into overdrive in September 2024 when ivonescimab was linked to a 49% reduction in the risk of disease progression or death when used as a first-line treatment in non-small cell lung cancer (NSCLC), compared to Keytruda. Beating Keytruda, a drug that generated sales of almost $30 billion last year, established ivonescimab as one of the hottest assets in biopharma R&D. Within three months of Akeso sharing the data, BioNTech paid $800 million to buy its PD-L1xVEGF bispecific partner Biotheus and Merck handed LaNova Medicines $588 million to enter the race. The companies are eager to carve out opportunities in a market that Summit values at more than $90 billion. Ivonescimab Nears the Summit Ivonescimab is the frontrunner. In May 2024, Chinese authorities approved the bispecific for use in a subset of NSCLC patients who have progressed after tyrosine kinase inhibitor (TKI) therapy. Akeso secured a broader Chinese label, covering first-line NSCLC patients, last month. The biotech published overall survival (OS) data alongside news of the label expansion, sparking a debate about the chances that ivonescimab will unseat Keytruda. Akeso linked the bispecific to a 22.3% reduction in the risk of death compared to Keytruda in an interim OS analysis. The difference fell short of statistical significance and analysts were split on the implications for the asset. Summit’s share price fell in the wake of the OS update but the biotech has chances to reverse the dip. Results from a global Phase III trial that is testing ivonescimab in NSCLC patients who progressed on a TKI are due in mid-2025. The indication is the setting where ivonescimab first won approval in China. Johnson & Johnson won approval for Rybrevant in patients who progress on the TKI Tagrisso last year. Jack West, vice president of clinical development at Summit, discussed the competition on an earnings call May 1. The Rybrevant regimen “has a combination of efficacy with toxicity liabilities that looks very different from what chemo and ivonescimab offers,” West said, adding that clinicians see “a great need for alternatives that have a very different and potentially less challenging toxicity profile.” The upcoming Phase III data will provide a first look at whether Summit can replicate the results of Akeso’s Chinese trials. Analysts are looking to the readout for hints about the prospects of global first-line NSCLC trials that are comparing ivonescimab to Keytruda. One trial is enrolling patients with high PD-L1 expression. The other study is accepting participants with any level of PD-L1 expression. Merck established Keytruda as the go-to drug in PD-L1-high NSCLC patients in 2016, claiming a decisive edge over Bristol Myers Squibb in the process. BMS included patients with lower PD-L1 levels in its Phase III Opdivo study and missed its primary endpoint. Merck subsequently showed Keytruda improved OS in squamous NSCLC of any level of PD-L1 expression. BioSpace /Annalee Armstrong The studies made Keytruda the drug to beat in key NSCLC settings targeted by Summit, but the biotech could face a fight for the market even if it beats Merck’s blockbuster in the clinic. Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars, and other branded drugmakers are seeking to improve on the blockbuster checkpoint inhibitor. BioNTech and Merck Give Chase Summit’s competition includes other PD-1/L1xVEGF bispecifics. BioNTech started a Phase II/III trial of its PD-L1xVEGF bispecific BNT327 in first-line NSCLC in January. Truist Securities analysts said in a note to investors that the candidate has a longer half-life than ivonescimab. BioNTech CEO Ugur Sahin said on an earnings call in November 2024 that BNT327 might achieve better response rates and durability, too, because it hits PD-L1 rather than PD-1. However, Sahin added that it is too early to tell if BNT327 has an edge . Merck is the big name in the pack of companies chasing Summit and BioNTech. LM-299, a candidate that Merck licensed from LaNova, entered the clinic in October 2024. Merck executives defended themselves on an earnings call last month against an analyst’s suggestion that they are “chasing the frontrunners” rather than trying to do something innovative. Part of the defense rested on the potential for Merck to leapfrog the competition and take the lead if PD-1/L1xVEGF bispecifics are combined with other assets. Speaking before Akeso’s interim OS miss last month, Dean Li, president of Merck Research Laboratories, said the field was still waiting to see overall survival benefits better than achieved from drugs such as Keytruda and to confirm in global studies the efficacy seen in China-based trials. “Should that PD-1xVEGF show that OS benefit, we have an advantage of having unique portfolio agents that have clear potential for combinability,” Li said. “We are looking at our own data and the data in the field as we make those decisions.” Merck’s rivals are also planning combinations, with BioNTech looking to pair BNT327 with candidates in its pipeline and Summit teaming with Pfizer to access the pharma’s antibody-drug conjugates (ADCs). The companies could face competition from other mechanisms and modalities, including ADCs. Jefferies analysts said in a note that Akeso’s OS miss could be good news for Daiichi Sankyo’s AstraZeneca-partnered ADC Datroway. “Datroway and ivonescimab work by completely different mechanisms but may wind up competing for the same pool of non-squamous [NSCLC] patients,” the analysts said. “We remain bullish on Daiichi Sankyo ahead of upcoming Datroway events.” Topline data from a trial of Datroway in first-line NSCLC patients are due in the second half of 2025. Expanding Beyond NSCLC The trials of PD-1/L1xVEGF bispecifics in NSCLC are part of a broader R&D push. Developers are racing to prove their bispecifics can beat standalone PD-1/L1 drugs in indications where checkpoint inhibitors are established as well as unlock markets where treatments such as Keytruda never won approval. Small cell lung cancer and triple-negative breast cancer are among the indications the companies are targeting. Data from the trials will affect thousands of patients and shape markets worth tens of billions of dollars. The full story will take years to play out, but the mid-2025 readout on ivonescimab could go down as a key early chapter in the tale.

Phase 3Drug ApprovalClinical ResultAcquisition

100 Deals associated with Amivantamab-VMJM

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
EGFR positive non-small cell lung cancer	Japan	Janssen Pharmaceutical KK	27 Mar 2025
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	United States	Janssen Biotech, Inc.	19 Aug 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	United States	Janssen Biotech, Inc.	19 Aug 2024
Non-Small Cell Lung Cancer	Canada	Janssen, Inc.	30 Mar 2022
EGFR ex20ins mutation in non-small cell lung cancer	United States	Janssen Biotech, Inc.	21 May 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Janssen-Cilag International NV	26 Jan 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Shanghai Johnson & Johnson Pharmaceutical Ltd.	26 Jan 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	China	Cilag AG	26 Jan 2024
Colorectal Cancer	Phase 3	United States	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	China	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Japan	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Australia	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Belgium	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	Brazil	Janssen Research & Development LLC	12 Dec 2024
Colorectal Cancer	Phase 3	France	Janssen Research & Development LLC	12 Dec 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04988295 (MARIPOSA-2, CTgov)	Phase 3	EGFR-mutated non-small Cell Lung Cancer	776	ACP-L+Amivantamab+Carboplatin+Pemetrexed+Lazertinib (Main Study: Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed (LACP/ACP-L))	hkyukhhkje(sniilyqzcs) = snelsozgha whhwtgnzwt (abjqnmbbhk, gtumzcmdfq - tueprbgzcy) View more	-	16 Apr 2025
				Carboplatin+Pemetrexed (CP) (Main Study: Arm B: Carboplatin + Pemetrexed (CP))	hkyukhhkje(sniilyqzcs) = cklmqrvtyl whhwtgnzwt (abjqnmbbhk, ecjnkxkzlz - vfmiykccis) View more
NCT05601973 (AMAZE-lung, ESMO_ELCC2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	61	Amivantamab+lazertinib+bevacizumab	tobmlszpde(dteiblqmxo) = vaootieuqq nsdbvonmuu (eherygwucw, 21 - 47) Met View more	Positive	27 Mar 2025
NCT06120140 (COCOON, ESMO_ELCC2025) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line EGFR Exon 19 Deletion \| EGFR L858R	138	amivantamab+lazertinib	qhzdpzdzzk(vpiduswtnw) = judsavdgrk tsqgjiwnnv (nvuehxrxfz ) Met View more	Positive	27 Mar 2025
				SoC	qhzdpzdzzk(vpiduswtnw) = jfijhliivs tsqgjiwnnv (nvuehxrxfz ) Met View more
NCT04487080 (MARIPOSA, ESMO_ELCC2025) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer First line EGFR L858R \| EGFR Exon 19 Deletion	-	Amivantamab plus Lazertinib	kqzanlwzwo(epshrnxtmw) = ijesudlhzn tkfhdvjtmh (psiiyrmevd, 42.9 - NE) View more	Positive	26 Mar 2025
				Osimertinib	kqzanlwzwo(epshrnxtmw) = mdrsmehwtw tkfhdvjtmh (psiiyrmevd, 33.4 - 41.0) View more
NCT04077463 (CHRYSALIS-2, ESMO_ELCC2025) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	49	Amivantamab plus Lazertinib	lemsdcndaf(pbbqnyityh) = vvcfvahdqi lfmdsbmqhm (hbquzdobcr ) View more	Positive	26 Mar 2025
				EGFR TKIs (Osimertinib, Afatinib)	lemsdcndaf(pbbqnyityh) = yubukqtovx lfmdsbmqhm (hbquzdobcr ) View more
ATLAS (ESMO_ELCC2025)	Not Applicable	EGFR Exon 20 insertion mutations	64	Amivantamab	nfeympxzgo(niocowrubf) = 53.1% with G33 in 7.8% mlyjwnbkrp (wbprparxpb ) View more	Positive	26 Mar 2025
NCT05379595 (OrigAMI-1, ASCO_GI2025) Manual	Phase 1/2	Metastatic Colorectal Carcinoma	30	Amivantamab monotherapy	dwtpxsrymk(nescjwzbae) = oslzrcwmav oiiywygfzo (bkczeajslv, 56 - 93) View more	Positive	23 Jan 2025
				Amivantamab + FOLFOX or FOLFIRI	dwtpxsrymk(nescjwzbae) = edkfrorlan oiiywygfzo (bkczeajslv, 42 - 100) View more
NCT04487080 (MARIPOSA, Company_Website) Manual	Phase 3	Non-Small Cell Lung Cancer First line EGFR Exon 19 Deletion \| EGFR L858R	1,074	RYBREVANT+LAZCLUZE	weflvosuas(yvpuyhwxig) = clinically meaningful and statistically significant improvement in OS versus the current standard of care osimertinib. Improvement in median OS is expected to exceed one year. xbvftmbzqe (anoelxtdot ) Met	Positive	07 Jan 2025
				osimertinib
NCT04077463 (CHRYSALIS-2, Pubmed) Manual	Phase 1	EGFR-mutated non-small Cell Lung Cancer EGFR L858R \| EGFR Exon 19 Deletion	162	Amivantamab 1050 mg + Lazertinib 240 mg	ioilofnasd(jryzkmisiv) = cdovfqcwmq yyxrpovfsq (vdahnussny, 22 - 36) View more	Positive	02 Jan 2025
NCT02609776 (CHRYSALIS, ESMO_ASIA2024) Manual	Not Applicable	Non-Small Cell Lung Cancer EGFR Exon 20 Insertion	114	Amivantamab	htqeawopgw(mmrnbljmas) = gzsohqulzu kgdlbyxfdl (hmhlgolefg ) View more	Positive	07 Dec 2024
				External control（Taiwan real-world setting）	htqeawopgw(mmrnbljmas) = zssjefeyzy kgdlbyxfdl (hmhlgolefg ) View more

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