Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

Start Date22 Dec 2015

Sponsor / Collaborator

Daiichi Sankyo, Inc.

JPRN-JapicCTI-152841

/ Unknown statusPhase 1

Phase 1b study of Process 2 Patritumab in combination with erlotinib in subjects with advanced non-small cell lung cancer (NSCLC)

Start Date01 Apr 2015

Sponsor / Collaborator-

NCT02350712

/ CompletedPhase 1

An Open Label, Phase 1B Safety Evaluation of Patritumab (U31287) in Combination With Cetuximab Plus Platinum Containing Therapy In Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.

Start Date01 Dec 2014

Sponsor / Collaborator

Daiichi Sankyo, Inc.

100 Clinical Results associated with Patritumab

100 Translational Medicine associated with Patritumab

100 Patents (Medical) associated with Patritumab

Literatures (Medical) associated with Patritumab

01 Jan 2025·Current medicinal chemistry

The Therapeutic Significance of HER3 in Non-small Cell Lung Cancer (NSCLC): A Review Study

Article

Author: Ding, Ke ; Zhang, Jinwei ; Trinder, Amelia

HER3 (Human Epidermal Growth Factor Receptor 3) is frequently overexpressed in various cancers, including non-small cell lung cancer (NSCLC), with a prevalence of 83% in primary tumors. Its involvement in tumorigenesis and resistance to targeted therapies makes HER3 a promising target for cancer treatment. Despite being initially considered “undruggable” due to its lack of catalytic activity, significant progress has been made in the development of anti-HER3 therapeutics. Monoclonal antibodies such as lumretuzumab, seribantumab, and patritumab have shown potential in targeting HER3 to overcome resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs). Additionally, antibody-drug conjugates (ADCs) like HER3-DXd (patritumab deruxtecan) are new drug candidates that have demonstrated selective delivery of cytotoxic chemicals to NSCLC cells by exploiting HER3's widespread expression, minimizing cytotoxicity. This review aims to evaluate the efficacy of current HER3 therapeutics in development and their therapeutic potential in NSCLC, incorporating evidence from clinical trials.

05 Sep 2023·Molecular cancer therapeutics

AMT-562, a Novel HER3-targeting Antibody-Drug Conjugate, Demonstrates a Potential to Broaden Therapeutic Opportunities for HER3-expressing Tumors.

Article

Author: Weng, Weining ; Shen, Yi ; Qian, Yu ; Chen, Caiwei ; Shao, Siyuan ; Meng, Tao ; Wang, Lijun ; Wang, Mingqiao ; Meng, Xun ; Zhou, Biao ; Pan, Rong ; Pu, Junyi ; Liu, Shuhui ; Zhang, Jianjian ; Ma, Linjie ; Hu, Wenhao ; Wang, Zhaohui

HER3 is a unique member of the EGFR family of tyrosine kinases, which is broadly expressed in several cancers, including breast, lung, pancreatic, colorectal, gastric, prostate, and bladder cancers and is often associated with poor patient outcomes and therapeutic resistance. U3-1402/Patritumab-GGFG-DXd is the first successful HER3-targeting antibody-drug conjugate (ADC) with clinical efficacy in non-small cell lung cancer. However, over 60% of patients are nonresponsive to U3-1402 due to low target expression levels and responses tend to be in patients with higher target expression levels. U3-1402 is also ineffective in more challenging tumor types such as colorectal cancer. AMT-562 was generated by a novel anti-HER3 antibody Ab562 and a modified self-immolative PABC spacer (T800) to conjugate exatecan. Exatecan showed higher cytotoxic potency than its derivative DXd. Ab562 was selected because of its moderate affinity for minimizing potential toxicity and improving tumor penetration purposes. Both alone or in combination therapies, AMT-562 showed potent and durable antitumor response in low HER3 expression xenograft and heterogeneous patient-derived xenograft/organoid models, including digestive system and lung tumors representing of unmet needs. Combination therapies pairing AMT-562 with therapeutic antibodies, inhibitors of CHEK1, KRAS, and tyrosine kinase inhibitor showed higher synergistic efficacy than Patritumab-GGFG-DXd. Pharmacokinetic and safety profiles of AMT-562 were favorable and the highest dose lacking severe toxicity was 30 mg/kg in cynomolgus monkeys. AMT-562 has potential to be a superior HER3-targeting ADC with a higher therapeutic window that can overcome resistance to generate higher percentage and more durable responses in U3-1402-insensitive tumors.

01 Aug 2023·Annals of oncology : official journal of the European Society for Medical Oncology

Patritumab deruxtecan in untreated hormone receptor-positive/HER2-negative early breast cancer: final results from part A of the window-of-opportunity SOLTI TOT-HER3 pre-operative study

Article

Author: Cejalvo, J M ; Pernas, S ; Tolosa, P ; Oliveira, M ; Espinosa-Bravo, M ; Sellami, D ; Prat, A ; Fan, P-D ; Luna, A M ; Esker, S ; Ferrero-Cafiero, J M ; González-Farré, B ; Parul, P ; Arumi, M ; Santhanagopal, A ; Izarzugaza, Y ; Salvador-Bofill, F J ; Pascual, T ; Vidal, M ; Martínez-Sáez, O ; Falato, C ; Cruz, J ; Vila, M Margelí ; Ciruelos, E ; Villacampa, G ; Paré, L ; Guerra, J A ; Sanfeliu, E

BACKGROUND:

Patritumab deruxtecan (HER3-DXd) is a human epidermal growth factor receptor 3 (HER3)-directed antibody-drug conjugate composed of a fully human anti-HER3 monoclonal antibody (patritumab) covalently linked to a topoisomerase I inhibitor payload via a stable, tumor-selective, tetrapeptide-based cleavable linker. TOT-HER3 is a window-of-opportunity study designed to assess the biological activity, measured by CelTIL score [= -0.8 × tumor cellularity (in %) + 1.3 × tumor-infiltrating lymphocytes (TILs) (in %)], and clinical activity of HER3-DXd during short-term (21 days) pre-operative treatment in patients with primary operable HER2-negative early breast cancer.

PATIENTS AND METHODS:

Patients with previously untreated hormone receptor-positive/HER2-negative tumors were allocated to one of four cohorts according to baseline ERBB3 messenger RNA expression. All patients received one dose of HER3-DXd 6.4 mg/kg. The primary objective was to evaluate change from baseline in CelTIL score.

RESULTS:

Seventy-seven patients were evaluated for efficacy. A significant change in CelTIL score was observed, with a median increase from baseline of 3.5 (interquartile range, -3.8 to 12.7; P = 0.003). Among patients assessable for clinical response (n = 62), an overall response rate of 45% was observed (tumor measurement by caliper), with a trend toward an increase in CelTIL score among responders compared with non-responders (mean difference, +11.9 versus +1.9). Change in CelTIL score was independent of baseline ERBB3 messenger RNA and HER3 protein levels. Genomic changes occurred, including switching toward a less proliferative tumor phenotype based on PAM50 subtypes, suppression of cell proliferation genes, and induction of genes associated with immunity. Treatment-emergent adverse events were observed in 96% of patients (14% grade ≥3); most common were nausea, fatigue, alopecia, diarrhea, vomiting, abdominal pain, and neutrophil count decrease.

CONCLUSIONS:

A single dose of HER3-DXd was associated with clinical response, increased immune infiltration, suppression of proliferation in hormone receptor-positive/HER2-negative early breast cancer, and a tolerable safety profile consistent with previously reported results. These findings support further study of HER3-DXd in early breast cancer.

105

News (Medical) associated with Patritumab

27 Dec 2024

·pipelinereview.com

DATROWAY® Approved in Japan as the First TROP-2 Directed Therapy for Patients with Previously Treated Unresectable or Recurrent HR Positive, HER2 Negative Breast Cancer

First global approval based on TROPION-Breast01 where DATROWAY significantly reduced the risk of disease progression or death by 37% versus chemotherapy Second DXd antibody drug conjugate approved in Japan based on Daiichi Sankyo’s DXd technology TOKYO, Japan I December 27, 2024 I Daiichi Sankyo’s (TSE:4568) DATROWAY® (datopotamab deruxtecan) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy. In Japan, breast cancer is the most common cancer in women.1 Approximately 92,000 cases of breast cancer were diagnosed in Japan in 2022, with approximately 17,600 deaths.1 It is estimated that 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 DATROWAY is the first ever TROP-2 directed medicine to be approved in Japan for HR positive, HER2 negative breast cancer and is the second DXd antibody drug conjugate (ADC) approved based on Daiichi Sankyo’s DXd ADC Technology. The approval of DATROWAY by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on results from the TROPION-Breast01 phase 3 trial. In this trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY compared to 4.9 months in those treated with chemotherapy. “This first global approval of DATROWAY provides patients in Japan with metastatic HR positive, HER2 negative breast cancer a new alternative to conventional chemotherapy, which is often associated with poor response rates,” said Wataru Takasaki, PhD, Senior Advisor, Daiichi Sankyo. “DATROWAY also is the second DXd antibody drug conjugate approved in Japan based on technology invented by Daiichi Sankyo, emphasizing our commitment to creating new, innovative standards of care for patients with cancer.” In TROPION-Breast01, adverse reactions occurred in 93.6% (337/360 patients) of the 360 patients (including 31 Japanese patients) in the DATROWAY (6 mg/kg) arm. The most common adverse reactions included nausea (51.1%), stomatitis (50.0%), alopecia (36.4%), fatigue (23.6%), and dry eye (21.7%). In Japanese patients, interstitial lung disease (ILD) occurred in 6.5% of patients treated with DATROWAY. DATROWAY is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have occurred in DATROWAY-treated patients. DATROWAY is to be used in close collaboration with a respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs or symptoms of ILD (such as dyspnea, cough or fever) and performing periodical percutaneous oxygen saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue administration of DATROWAY and take appropriate measures, such as corticosteroid administration. Prior to initiation of DATROWAY therapy, a chest CT scan should be performed and medical history taken to confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the eligibility of the patient for DATROWAY therapy. Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China, U.S. and other regions. About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one additional systemic therapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and overall survival. Key secondary endpoints include overall response rate, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology . TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov. About Hormone Receptor Positive, HER2 Negative Breast Cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.3 More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.3 In Japan, breast cancer is the most common cancer in women, with approximately 92,000 cases of breast cancer diagnosed in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis.2 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).2 Endocrine therapies are widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer.4 However, after initial treatment, further efficacy from endocrine therapy is often limited.4 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.4,5,6,7 About DATROWAY DATROWAY (datopotamab deruxtecan) is a TROP-2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP-2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY (6 mg/kg) is approved in Japan for the treatment of adult patients with HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy based on results from the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer, and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU® in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP-2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References: 1 World Health Organization. Global Cancer Observatory: Japan. Accessed December 2024. 2 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed December 2024. 3 Bray F, et al. CA Cancer J Clin. 2024; 10.3322/caac.21834. 4 Manohar P, et al. Cancer Biol Med. 2022 Feb 15; 19(2):202–212. 5 Cortes J, et al. Lancet. 2011;377:914-923. 6 Yuan P, et al. Eur J Cancer. 2019;112:57-65. 7 Jerusalem G, et al. JAMA Oncol. 2018;4(10):1367–1374. SOURCE: Daiichi Sankyo

Phase 3Drug ApprovalADCClinical Result

24 Dec 2024

·pipelinereview.com

Datopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn

TOKYO, Japan & MUNICH, Germany I December 24, 2024 I Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase 3 trial. The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Daiichi Sankyo and AstraZeneca will continue to work to bring datopotamab deruxtecan to patients with lung cancer in the EU who can benefit and are committed to unlocking the potential of this medicine in lung cancer through our robust clinical development program which includes seven pivotal trials in various lung cancer settings. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. Daiichi Sankyo and AstraZeneca’s application in the EU for datopotamab deruxtecan for the treatment of hormone receptor (HR) positive, HER2 negative metastatic breast cancer based on the TROPION-Breast01 phase 3 trial remains under review. About TROPION-Lung01 TROPION-Lung01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan versus docetaxel in adult patients with locally advanced or metastatic NSCLC with and without actionable genomic alterations who require systemic therapy following prior treatment. Patients with actionable genomic alterations were previously treated with an approved targeted therapy and platinum-based chemotherapy. Patients without known actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. The dual primary endpoints of TROPION-Lung01 are progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS). Key secondary endpoints include investigator-assessed PFS, objective response rate, duration of response, time to response, and disease control rate as assessed by both BICR and investigator, and safety. TROPION-Lung01 enrolled approximately 600 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov . Primary PFS results and interim OS results from TROPION-Lung01 were presented at the 2023 ESMO (#ESMO23) Congress. Final OS results were presented at IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC24) and simultaneously published in the Journal of Clinical Oncology in September 2024. About Advanced Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. 1 In Europe, nearly 500,000 lung cancer cases were diagnosed in 2022. 1 Lung cancer is broadly split into small or non-small cell lung cancer, the latter accounting for about 80% of cases. 2 While immunotherapy and targeted therapies have improved outcomes in the first-line setting, most patients eventually experience disease progression and receive chemotherapy. 3,4,5 For decades, chemotherapy has been the last treatment available for patients with advanced NSCLC, despite limited effectiveness and known side effects. 3,4,5 TROP2 is a protein broadly expressed in the majority of NSCLC tumors. 6 There is currently no TROP2 directed ADC approved for the treatment of lung cancer. 7,8 About Datopotamab Deruxtecan (Dato-DXd) Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datopotamab deruxtecan is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Additional regulatory submissions in breast cancer are under review in China, Japan, the U.S. and other regions. Datopotamab deruxtecan has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) NSCLC with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. Daiichi Sankyo and AstraZeneca have submitted a Biologics License Application for datopotamab deruxtecan for this potential indication. About the Datopotamab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of datopotamab deruxtecan across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 low or negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating datopotamab deruxtecan as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc., Rahway, N.J. USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References 1 World Health Organization. Global Cancer Observatory: Lung. Accessed December 2024. 2 American Cancer Society. Key Statistics for Lung Cancer . Accessed December 2024. 3 Chen R, et al. J Hematol Oncol . 2020:13(1):58. 4 Majeed U, et al. J Hematol Oncol . 2021;14(1):108. 5 Pircher A, et al. Anticancer Research . 2020;70(5):287-294. 6 Mito R, et al. Pathol Int . 2020;70(5):287-294. 7 American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer . Accessed December 2024. 8 Rodríguez-Abreau D, et al. Ann Onc . 2021 Jul;32(7): 881-895. SOURCE: Daiichi Sankyo

Phase 3Clinical ResultDrug ApprovalLicense out/inBreakthrough Therapy

09 Dec 2024

·endpts.com

Merck's Keytruda combo misses overall survival in Phase 3 trial in ovarian cancer

Merck said a Keytruda regimen hit the primary endpoint of progression-free survival in a Phase 3 study that enrolled certain patients with ovarian cancer, but it failed to hit the secondary endpoint of overall survival. The KEYLYNK-001 trial investigated Keytruda plus chemotherapy followed by maintenance with AstraZeneca and Merck’s Lynparza either with or without bevacizumab in patients with BRCA non-mutated advanced epithelial ovarian cancer. While patients saw a statistically significant improvement in progression-free survival compared to chemotherapy alone, overall survival wasn’t met, with Merck saying the “role of Keytruda in the intention-to-treat population remains uncertain at this time.” Merck plans to present detailed data at a future medical meeting and discuss the results with regulatory agencies. The safety profiles of Keytruda and Lynparza were consistent with previous trials. Merck and AstraZeneca have been working together on Lynparza, a PARP inhibitor, since 2017. Lynparza was first approved to treat ovarian cancer in 2014, the same year that the FDA initially approved Keytruda. Merck has other ovarian cancer treatment prospects in its pipeline, including a combination of Keytruda and vibostolimab, a TIGIT inhibitor, that’s in Phase 2. It also has ifinatamab deruxtecan, raludotatug deruxtecan and patritumab deruxtecan — all antibody-drug conjugates — in Phase 2 trials.

Phase 3Clinical ResultDrug ApprovalPhase 2ADC

100 Deals associated with Patritumab

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KEGG	Wiki	ATC	Drug Bank
-	Patritumab	-	DB12090

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Phase 3	US	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	BE	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	CA	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	CZ	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	DE	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	HU	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	IT	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	PL	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	ES	Daiichi Sankyo, Inc.	01 Mar 2014
metastatic non-small cell lung cancer	Phase 3	GB	Daiichi Sankyo, Inc.	01 Mar 2014

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01211483 (HERALD, CTgov)	Phase 1/2	Advanced Lung Non-Small Cell Carcinoma	222	Erlotinib+U3-1287 (Phase 2: U3-1287 18 mg/kg + Erlotinib)	rwanaookxm(nvhjtabfoc) = cvqaewhlni scpulnayyb (wveuplabtv, qnotjtqjor - jzodhnaunl) View more	-	16 Jun 2021
				Erlotinib+U3-1287 (Phase 2: U3-1287 9 mg/kg + Erlotinib)	rwanaookxm(nvhjtabfoc) = xgjijnymyo scpulnayyb (wveuplabtv, vchhkrwbhh - dznfjkwfzl) View more
NCT02350712 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Squamous Cell Carcinoma of Head and Neck First line	15	Cetuximab+cisplatin+carboplatin+Patritumab	gircwlvpuf(xksczehroq) = lkqhhjynic sqgdpnebzu (fcvmzqizff ) View more	Positive	15 Jan 2019
NCT02633800 (CTgov)	Phase 2	Squamous cell carcinoma of head and neck metastatic	87	Cetuximab+Patritumab+carboplatin+cisplatin (Patritumab)	isqvzabpcr(qvmcdqowtg) = cqyvlayosc imjvowykwz (fvesflnoey, rbxwhigkpp - bbikaeicya) View more	-	07 Jan 2019
				Placebo+Cetuximab+carboplatin+cisplatin (Placebo)	isqvzabpcr(qvmcdqowtg) = tkwqqkumms imjvowykwz (fvesflnoey, geihgmgsqh - wzwpppmogz) View more
NCT02134015 (HER3-Lung, CTgov)	Phase 3	metastatic non-small cell lung cancer	145	Placebo+Erlotinib (Placebo + Erlotinib)	wqsbunnjkz(gicwfagpfy) = yekvhldfta fdyftzeual (sxupxntzcq, hdzhprmiwx - gmajlkmcyj) View more	-	23 Jan 2018
				Erlotinib+Patritumab (Patritumab + Erlotinib)	wqsbunnjkz(gicwfagpfy) = kosknmjeda fdyftzeual (sxupxntzcq, fvwosyxxfg - fkayrqyuhh) View more
NCT01211483 (HERALD, ASCO2016)	Phase 2	Non-Small Cell Lung Cancer	212	Patritumab + Erlotinib	wanjyqfwfe(knkuuxckxz): HR = 0.41 (95% CI, 0.18 - 0.9), P-Value = 0.02	Positive	20 May 2016
				Placebo + Erlotinib
NCT01211483 (ASCO2014)	Phase 1/2	Advanced Lung Non-Small Cell Carcinoma	145	Patritumab 18 mg/kg every three weeks	raoaujlogc(nvaaivkdac) = dieptnctsv tgsmtjmpuq (pogukgxzpo ) View more	-	20 May 2014
				Patritumab 9 mg/kg every three weeks	raoaujlogc(nvaaivkdac) = ehpkfeajlo tgsmtjmpuq (pogukgxzpo ) View more
NCT01211483 (HERALD, ASCO2014)	Phase 2	Non-Small Cell Lung Cancer	215	High Dose Patritumab	jhusnntpyp(ieiwoktzfx) = wmbplixmar fzytslhgcz (ugyjzrduor )	-	20 May 2014
				Low Dose Patritumab	jhusnntpyp(ieiwoktzfx) = ljqjbozang fzytslhgcz (ugyjzrduor )

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