A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects

Start Date28 Feb 2025

Sponsor / Collaborator

Celltrion, Inc.

NCT04817540

/ RecruitingPhase 2IIT

Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study)

In this study, we prospectively analyzed molecular subtyping through the PAM 50 test in HER2-negative (IHC1+ or 2+ (FISH/SISH-)) breast cancer patients. A phase 2 single arm study was designed to determine whether the addition of HER2-targeted treatment with treatment increases the pathologic remission rate.

Start Date01 Sep 2021

Sponsor / Collaborator

Gangnam Severance Hospital

NCT04722133

/ CompletedPhase 2IIT

A Phase II Trial of Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy

Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer. The recent study showed that HER2 overexpression or amplification is noted about 5-15% of total biliary tract cancer patients and have shown efficacy in small basket trials. The aim of this study is to evaluate the efficacy and safety of trastuzumab in the combination of mFOLFOX for gemcitabine+cisplatin refractory biliary tract cancer patients.

Start Date23 Jun 2020

Sponsor / Collaborator

Yonsei University

100 Clinical Results associated with Trastuzumab-PKRB(Celltrion)

100 Translational Medicine associated with Trastuzumab-PKRB(Celltrion)

100 Patents (Medical) associated with Trastuzumab-PKRB(Celltrion)

Literatures (Medical) associated with Trastuzumab-PKRB(Celltrion)

01 Feb 2025·International Journal of Pharmaceutics

Challenges with effective removal of surfactants from monoclonal antibody formulations

Article

Author: Kamel, Eman ; Suryanarayanan, Raj ; Refaat, Hesham ; Gurvich, Vadim J ; Ahmad, Aziz ; Nejadnik, Reza ; Rathore, Anurag S

Buffer exchange is a critical step in biologics development, playing a pivotal role in removing contaminants, adjusting sample conditions, and facilitating compatibility studies. The efficiency of centrifugal concentrators for polysorbate removal was compared to a two-step approach involving a surfactant removal column followed by buffer exchange. Trastuzumab-pkrb from Herzuma® was used. While a 30 kDa centrifugal concentrator was ineffective in polysorbate removal, a 50 kDa concentrator caused partial removal. Surfactant removal column proved more effective in removing polysorbates. Buffer exchange using polysorbate-containing formulation buffer, even with a 50 kDa concentrator, accumulated polysorbate, revealing the need for a different approach in small-scale formulation. Adding polysorbate in a separate step after buffer exchange appeared to be a good strategy to prevent this problem. The two approaches did not reveal any differences in the protein aggregation behavior.

01 Jan 2025·Gastric Cancer

Correction: Real-world effectiveness and safety of trastuzumab-deruxtecan in Japanese patients with HER2-positive advanced gastric cancer (EN-DEAVOR study)

Author: Konishi, Hirotaka ; Narita, Yukiya ; Kawakami, Hisato ; Makiyama, Akitaka ; Minashi, Keiko ; Muro, Kei ; Morita, Satoshi ; Kodera, Yasuhiro ; Imano, Motohiro ; Hashimoto, Wataru ; Sugimoto, Naotoshi ; Kume, Hiroki ; Nakanishi, Koki ; Inamoto, Rin ; Yamaguchi, Keita

01 Jan 2025·The Lancet Oncology

De-escalated neoadjuvant weekly nab-paclitaxel with trastuzumab and pertuzumab versus docetaxel, carboplatin, trastuzumab, and pertuzumab in patients with HER2-positive early breast cancer (HELEN-006): a multicentre, randomised, phase 3 trial

Article

Author: Chen, Bo ; Plichta, Jennifer K ; Yan, Min ; Lu, Zhen-Duo ; Jiao, De-Chuang ; Ma, Ming-De ; Deng, Miao ; Zhang, Chong-Jian ; Qiao, Jiang-Hua ; He, You-Wen ; Liu, Zhen-Zhen ; Feng, Yue-Qing ; Sun, Xian-Fu ; Wang, Cheng-Zheng ; Chen, Xiu-Chun ; Li, Lian-Fang ; Wei, Ya

BACKGROUNDA previous phase 2 trial showed promising outcomes for patients with HER2-positive early-stage breast cancer using neoadjuvant de-escalation chemotherapy with paclitaxel, trastuzumab, and pertuzumab. We aimed to evaluate the efficacy of weekly nab-paclitaxel compared with the standard regimen of docetaxel plus carboplatin, both with trastuzumab and pertuzumab, as neoadjuvant therapies for patients with HER2-positive breast cancer.METHODSHELEN-006 was a multicentre, randomised, phase 3 trial done at six hospitals in China. We enrolled patients aged 18-70 years with untreated, histologically confirmed stage II-III invasive HER2-positive breast cancer and an Eastern Cooperative Oncology Group performance status of 0 or 1. Using an interactive response system, patients were randomly assigned (1:1) under a permuted block randomisation scheme (block size of four), stratified by tumour stage, nodal status, and hormone receptor status. Patients received either intravenous nab-paclitaxel (125 mg/m² on days 1, 8, and 15) for six 3-week cycles, or intravenous docetaxel (75 mg/m² on day 1) plus intravenous carboplatin (area under the concentration-time curve 6 mg/mL per min on day 1) for six 3-week cycles. Both groups also received concurrent intravenous trastuzumab, with an initial loading dose of 8 mg/kg and a maintenance dose of 6 mg/kg on day 1, as well as intravenous pertuzumab with a loading dose of 840 mg and a maintenance dose of 420 mg on day 1. This report is the final analysis of the primary endpoint, pathological complete response (ypT0/is ypN0), analysed in all patients who started treatment (modified intention to treat). The trial is registered with ClinicalTrials.gov, NCT04547907, and follow-up of the adjuvant phase is ongoing.FINDINGSBetween Sept 20, 2020, and March 1, 2023, 789 patients were screened for eligibility, 689 of whom were randomly assigned (343 to the nab-paclitaxel group and 346 to the docetaxel plus carboplatin group). All 689 patients were Asian women. 669 patients received at least one dose of the study treatment and were included in the full analysis set (332 in the nab-paclitaxel group and 337 in the docetaxel plus carboplatin group). Median age of the patients was 50 years (IQR 43-55). Median follow-up time was 26 months (IQR 19-32). 220 (66·3% [95% CI 61·2-71·4]) patients in the nab-paclitaxel group had a pathological complete response, compared with 194 (57·6% [52·3-62·9]) in the docetaxel plus carboplatin group (combined odds ratio 1·54 [95% CI 1·10-2·14]; stratified p=0·011). 100 (30%) patients in the nab-paclitaxel group and 128 (38%) in the docetaxel plus carboplatin group had grade 3-4 adverse events. The most common grade 3-4 adverse events were nausea (22 [7%] in the nab-paclitaxel group vs 76 [23%] in the docetaxel plus carboplatin group), diarrhoea (25 [8%] vs 55 [16%]), and neuropathy (43 [13%] vs eight [2%]). Serious drug-related adverse events were reported in three (1%) patients in the nab-paclitaxel group and five (2%) in the docetaxel plus carboplatin group. No treatment-related deaths were reported in either group.INTERPRETATIONThese findings might suggest a potential advantage of nab-paclitaxel combined with trastuzumab and pertuzumab compared with the standard regimen in neoadjuvant therapy for patients with HER2-positive early breast cancer, suggesting that this new combination might establish a new standard for neoadjuvant treatment in this patient population.FUNDINGNational Natural Science Foundation of China, and Science and Technology Research Projects of Henan Province, China.TRANSLATIONFor the Chinese translation of the abstract see Supplementary Materials section.

News (Medical) associated with Trastuzumab-PKRB(Celltrion)

15 Dec 2024

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Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union

INCHEON, South Korea--( BUSINESS WIRE )--Celltrion today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions and recommended marketing authorisations for three biosimilar candidates: Eydenzelt ® (CT-P42, aflibercept), Stoboclo ® and Osenvelt ® (CT-P41, denosumab), and Avtozma ® (CT-P47, tocilizumab). This significant milestone reflects the company’s leadership in biosimilar innovation and commitment to expanding access to biologic treatments across Europe. Eydenzelt (40 mg/mL solution for injection in vial and pre-filled syringe), a biosimilar to Eylea ® (aflibercept), is recommended for approval to treat multiple retinal disorders, including neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO, branch RVO or central RVO), diabetic macular edema (DME) and myopic choroidal neovascularisation (myopic CNV). In a Phase III study of Eydenzelt, the efficacy, safety, pharmacokinetics and immunogenicity of Eydenzelt was compared to Eylea in patients with diabetic macular edema (DME), demonstrating therapeutic equivalence to Eylea by meeting the predefined equivalence criteria. 1 If marketing authorisation is granted by the European Commission (EC), Eydenzelt would be one of the first-wave aflibercept biosimilars in Europe. Stoboclo (60 mg solution for injection in pre-filled syringe) and Osenvelt (120 mg solution for injection in vial) have been recommended for approval for all indications of the reference products Prolia ® and Xgeva ® , respectively. The positive CHMP opinion was based on the totality of evidence including results from a Phase III clinical trial in postmenopausal osteoporosis (PMO), and the results showed that CT-P41 had equivalent efficacy and pharmacodynamics (PD) to reference denosumab, with similar pharmacokinetics (PK) and comparable safety and immunogenicity profiles. 2 Avtozma , a biosimilar referencing RoActemra ® (tocilizumab), has been recommended for all indications of its reference product, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA) and giant cell arteritis (GCA). The positive CHMP opinion for Avtozma was supported by a comprehensive data package and totality of evidence demonstrating Avtozma’s biosimilarity to RoActemra, with no clinically meaningful differences in efficacy, PK equivalence, safety or immunogenicity. 3,4 “ With CHMP approvals for Eydenzelt, Avtozma, and Prolia/Xgeva biosimilars, Celltrion solidifies its leadership in the European biosimilar market, offering one of the most extensive antibody biosimilar portfolios. Our vertically integrated model ensures supply chain stability while addressing the specific challenges faced by European healthcare professionals and patients. These approvals underscore our commitment to supporting European healthcare systems by improving access to high-quality, affordable treatments,” said Taehun Ha, Vice President and Head of Europe. “ Our focus remains on empowering clinicians with the tools and solutions they need, as we aim to transition from a pioneer to a frontier leader in European healthcare.” The CHMP’s recommendations will now be referred to the EC, which will decide whether to grant a marketing authorisation for Eydenzelt, Stoboclo and Osenvelt, and Avtozma. If marketing authorisations are granted, the three biosimilars will be made available across EU member states, furthering Celltrion’s commitment to delivering innovative and accessible healthcare solutions. About CT-P41 Phase III Clinical Trial The Phase III study randomised 479 patients to receive 60 mg of CT-P41 or reference product every six months (Weeks 0 and 26; treatment period [TP] I). Before dosing at Week 52, patients initially assigned to reference product in TP I were re-randomised in a 1:1 ratio to continue with the reference product or switch to CT-P41 in TP. All patients initially randomly assigned to CT-P41 in TP I continued their treatment with CT-P41 in TP II. In TP II, 422 patients were randomised in Week 52 (CT-P41 maintenance group: 221, reference product maintenance group: 100, switched to CT-P41 group: 101). The primary efficacy endpoint was met in terms of percent change from baseline in bone mineral density (BMD) for lumbar spine (L1-L4) by dual-energy X-ray absorptiometry (DXA) at Week 52, and the primary pharmacodynamics (PD) endpoint was met in terms of area under the effect curve (AUEC) of serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) over the initial six months. Results of the study showed that CT-P41 had equivalent efficacy and PD to reference denosumab, with similar PK and comparable safety and immunogenicity profiles. 2 About CT-P42 Phase III Clinical Trial In a randomised, double-masked, parallel-group, multi-centre Phase III study of Eydenzelt ® (CT-P42), the efficacy, safety, pharmacokinetics, usability and immunogenicity of Eydenzelt was compared to Eylea ® (aflibercept) in patients with diabetic macular edema (DME). The primary endpoint was the change from baseline in best corrected visual acuity (BCVA) measured at Week 8, comparing Eydenzelt and Eylea. Results of the study showed that Eydenzelt met the predefined equivalence criteria, and secondary endpoints of efficacy, safety, and immunogenicity also showed trends similar to Eylea. 1,5 About CT-P47 Phase III Clinical Trial This was a Phase III, randomised, active-controlled, double-blind trial to compare the efficacy and safety of Avtozma ® (CT-P47) and RoAtemra ® (tocilizumab) in patients with moderate to severely active rheumatoid arthritis (RA). The Phase III study randomised 479 patients to receive 8mg/kg of CT-P47 or reference tocilizumab every 4 weeks (Week 0 and 24; treatment period [TP] I). Before dosing at Week 24, patients initially assigned to tocilizumab in TP I were re-randomised in a 1:1 ratio to continue with tocilizumab or switch to CT-P47 in TP II up to Week 52. In TP II, 444 patients were randomised in Week 24 (CT-P47 maintenance group: 225, tocilizumab maintenance group: 109, switched to CT-P47 group: 110). The primary endpoint was mean change from baseline in Disease Activity score in 28 joints (DAS28; erythrocyte sedimentation rate [ESR]) at week 12. Efficacy equivalence was determined if confidence intervals (CIs) for the treatment difference was within the predefined equivalence margin: (95% CI: -0.6, +0.6 (analysis of covariance [ANCOVA]) at week 12). Therapeutic equivalence of CT-P47 and reference tocilizumab in treating RA was demonstrated and supported by comparable and sustained efficacy results up to Week 52. CT-P47 was also well tolerated with a safety profile comparable to reference tocilizumab, and no notable safety issue was identified following the single transition from reference tocilizumab to CT-P47 compared with maintenance groups up to Week 52. 3,4 About Stoboclo ® (CT-P41, biosimilar candidate of denosumab) Stoboclo ® (denosumab), a receptor activator of NF-κb ligand (RANKL) inhibitor, is a treatment developed as a biosimilar to reference product Prolia ® (denosumab). In Europe, Stoboclo has been recommended for approval to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. About Osenvelt ® (CT-P41, biosimilar candidate of denosumab) Osenvelt ® (denosumab) is a receptor activator of NF-κb ligand (RANKL) inhibitor developed as a biosimilar referencing Xgeva ® (denosumab). Osenvelt has been recommended for approval in Europe to prevent skeletal-related events in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. About Eydenzelt ® (CT-P42, biosimilar candidate of aflibercept) Eydenzelt ® (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor referencing Eylea ® . Based on comprehensive data from a Phase III clinical trial confirming therapeutic equivalence to Eylea 1 , Eydenzelt was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in June and November 2023, respectively. About Avtozma ® (CT-P47, biosimilar candidate of tocilizumab) CT-P47, containing the active ingredient tocilizumab, is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial, designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to the reference product RoActemra ®4 , CT-P47 was filed for regulatory approval with the U.S. FDA and EMA in January and February 2024, respectively. About Celltrion Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specialises in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as Remsima ® , Truxima ® and Herzuma ® , providing broader patient access globally. Celltrion has also received U.S. FDA and EC approval for Vegzelma ® and Yuflyma ® , FDA approval for Zymfentra ® , and EC approval for Remsima ® SC, Omlyclo ® , SteQeyma ® . To learn more, please visit www.celltrion.com/en-us . FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business, and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as “prepares,” “hopes to,” “upcoming,” ”plans to,” “aims to,” “to be launched,” “is preparing,” “once gained,” “could,” “with the aim of,” “may,” “once identified,” “will,” “working towards,” “is due,” “become available,” “has potential to,” the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. Trademark Stoboclo ® and Osenvelt ® are registered trademarks of Celltrion Inc. Prolia ® and Xgeva ® are registered trademarks of Amgen Inc. Eydenzelt ® is a registered trademark of Celltrion Inc. Eylea ® is a registered trademark of Bayer AG. Avtozma ® is a registered trademark of Celltrion, Inc., used under license. RoActemra ® is a registered trademark of Chugai Pharmaceutical Co., Ltd. References 1 Sebastian Wolf et al., Long-term efficacy and Safety of CT-P42 compared to Reference Aflibercept in Diabetic Macular Edema: 52-Week Results from the Phase 3 CT-P42 3.1. [EURETINA 2024, Abstract #CA24-2257-8397]. Available at: https://abstracts.euretina.org/2024/ca24-2257-8397/r/recxUD7DqYfFfjC7s [Last accessed December 2024]. 2 Reginster JY et al. Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis. Osteoporos Int. 2024 Nov;35(11):1919-1930. doi: 10.1007/s00198-024-07161-x. Epub 2024 Jul 23. PMID: 39042292; PMCID: PMC11499533. Available at: https://pubmed.ncbi.nlm.nih.gov/39042292/ [Last accessed December 2024]. 3 Smolen JS et al., Efficacy and safety of CT-P47 versus reference tocilizumab: 32-week results of a randomised, active-controlled, double-blind, phase III study in patients with rheumatoid arthritis, including 8 weeks of switching data from reference tocilizumab to CT-P47. RMD Open. 2024;10(4), e004514. Available at: https://rmdopen.bmj.com/content/10/4/e004514.abstract [Last accessed December 2024]. 4 Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. Available at: https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/ [Last accessed December 2024]. 5 Sebastian Wolf et al., Biosimilar Candidate CT-P42 in Diabetic Macular Edema: 24-Week Results from a Randomized, Active-Controlled, Phase III Study. Available at: https://www.sciencedirect.com/science/article/pii/S2468653024003063 [Last accessed December 2024].

Phase 3Clinical ResultDrug Approval

02 Dec 2024

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Daiichi Sankyo Highlights Progress Across Oncology Portfolio in Multiple Solid and Blood Cancers at ESMO Asia, SABCS and ASH

BASKING RIDGE, N.J.--( BUSINESS WIRE )--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 45 abstracts in multiple types of solid and blood cancers at the 2024 ESMO Asia Congress (#ESMOAsia24), San Antonio Breast Cancer Symposium (#SABCS24) and American Society of Hematology (#ASH24) Annual Meeting prior to its Science & Technology Day. Data at ESMO Asia, SABCS and ASH will showcase Daiichi Sankyo’s progress towards its goal of creating new standards of care for patients with cancer. Highlights include three late-breaking presentations, including a pooled analysis of data from the TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials of datopotamab deruxtecan (Dato-DXd) in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC) at ESMO Asia, as well as a subgroup analysis from the DESTINY-Breast06 phase 3 trial of ENHERTU ® (trastuzumab deruxtecan) in patients with unresectable or metastatic HR positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer and the primary analysis from the VALENTINE phase 2 trial of patritumab deruxtecan (HER3-DXd) in patients with early HR positive, HER2 negative breast cancer at SABCS. “ Important updates in difficult-to-treat cancers including lung, breast, gastric and biliary tract cancer as well as acute myeloid leukemia and peripheral T-cell lymphoma will be highlighted at these upcoming meetings,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “ We continue to make important progress with our approved and pipeline medicines with the goal of changing the standard of care across a wide range of cancers.” Innovation in Lung, Breast, Gastric and Biliary Tract Cancer at ESMO Asia Late-breaking data at ESMO Asia will highlight a pooled analysis of results from the TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials of datopotamab deruxtecan in patients with previously treated EGFR-mutated advanced NSCLC during a proffered paper session. Two mini oral presentations will feature results of the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan in Chinese patients with previously treated metastatic HR positive, HER2 low or negative breast cancer and the final results of the DESTINY-Gastric06 phase 2 trial of ENHERTU in Chinese patients with previously treated HER2 positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Results of DESTINY-Gastric06 led to the recent conditional approval in China of ENHERTU as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received two or more prior treatment regimens. Trials-in-progress posters also will feature the trial designs of three ongoing ENHERTU clinical trials, including the DESTINY-BTC01 phase 3 trial that will evaluate ENHERTU with rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, versus standard of care in patients with previously untreated HER2 expressing, locally advanced or metastatic biliary tract cancer, and the DESTINY-Gastric03 phase 1b/2 trial where a new arm has been added to evaluate ENHERTU in combination with rilvegostomig and chemotherapy in patients with HER2 positive or HER2 low gastric or GEJ adenocarcinoma. A second part of the DESTINY-PanTumor02 phase 2 trial of ENHERTU also will be presented where patients with previously treated HER2 expressing metastatic solid tumors will be enrolled into one of five new cohorts: patients with any tumor expressing HER2 IHC 3+ (excluding breast, gastric and colorectal cancer); patients with any tumor expressing HER2 IHC 2+/ISH+ (excluding breast, gastric and colorectal cancer); patients with HER2 IHC 2+/1+ endometrial cancer; patients with HER2 IHC 2+/1+ ovarian cancer; and patients with HER2 IHC 2+/1+ cervical cancer. Continued Progress in Breast Cancer at SABCS Late-breaking presentations in breast cancer at SABCS will include two oral presentations featuring a subgroup analysis of the DESTINY-Breast06 phase 3 trial reporting on the impact of response to prior endocrine-based therapy on outcomes in patients with unresectable or metastatic HR positive, HER2 low or HER2 ultralow breast cancer who failed at least one line of endocrine therapy receiving ENHERTU compared to chemotherapy, and the primary results from the VALENTINE phase 2 trial evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) alone or in combination with letrozole in patients with high-risk HR positive, HER2 negative early breast cancer. Other data at SABCS includes two spotlight poster presentations highlighting the first exploratory biomarker analysis assessing the impact of genomic alterations on the efficacy of ENHERTU compared to ado-trastuzumab emtansine (T-DM1) in patients with HER2 positive metastatic breast cancer from the DESTINY-Breast03 phase 3 trial, and the effects of ENHERTU on health-related quality of life and neurological function from the DESTINY-Breast12 phase 3b/4 trial in patients with previously treated HER2 positive metastatic breast cancer with or without brain metastases. Final results from the dose expansion portion of the DESTINY-Breast08 phase 1b trial evaluating ENHERTU in combination with capecitabine or capivasertib in patients with HER2 low metastatic breast cancer also will be presented as a poster presentation. Trial-in-progress posters will feature the trial designs from a sub-protocol of a phase 1b master protocol trial evaluating ENHERTU in combination with valemetostat, a dual EZH1 and EZH2 inhibitor, in patients with previously treated HER2 low unresectable or metastatic breast cancer as well as a phase 1b trial evaluating the combination in patients with previously treated HER2 low, HER2 ultralow or HER2 null metastatic breast cancer. Updates in Hematology Portfolio in Certain Leukemias and Lymphomas At ASH, several sub-analyses of the QuANTUM-First phase 3 trial of VANFLYTA ® (quizartinib) in patients with newly diagnosed FLT3 -ITD positive acute myeloid leukemia (AML) will be presented. An oral presentation will highlight data on the frequency of co-mutations in trial patients and their impact on remission rate, overall survival and relapse-free survival. Three poster presentations will report new data, including the impact of continuation therapy on the efficacy of VANFLYTA, focusing on measurable residual disease status; a concordance between utilizing a FLT3 -ITD mutation detection clinical trial assay and a next-generation sequencing measurable residual disease assay; and a matching adjusted indirect comparison analysis of VANFLYTA compared to midostaurin in patients with newly diagnosed FLT3 -ITD AML. Additionally, several poster presentations will report on the QUIWI phase 2 trial that evaluated VANFLYTA in combination with standard chemotherapy in patients with newly diagnosed FLT3 -ITD negative AML, including the final results of QUIWI and sub-analyses of the trial by mutational status, including FLT3 -TKD and NPM1, and ELN risk categorization. The QUIWI phase 2 trial formed the basis of the QuANTUM-Wild phase 3 trial that is further evaluating the addition of VANFLYTA to standard chemotherapy in this patient population. The design of the QuANTUM-Wild phase 3 trial will be highlighted as a trial-in-progress poster. Other data at ASH includes two poster presentations reporting the primary results of the VALYM phase 2 trial of valemetostat in patients with relapsed or refractory large B-cell lymphoma and an exploratory analysis of circulating tumor DNA, a novel biomarker, to potentially predict clinical response to valemetostat from the VALENTINE-PTCL01 phase 2 trial in patients with relapsed or refractory peripheral T-cell lymphoma, which was recently published in The Lancet Oncology . Science & Technology Day Daiichi Sankyo will hold “Science & Technology Day,” formerly called R&D Day, for investors on Monday, December 16, 2024 from 5:30 to 7:30 pm EST / Tuesday, December 17 from 7:30 to 9:30 am JST. Executives from Daiichi Sankyo will provide an overview of the ESMO Asia, SABCS and ASH research data and provide updates on R&D strategy. ESMO Asia, SABCS and ASH Data Highlights Highlights of data from Daiichi Sankyo’s DXd ADC portfolio at ESMO Asia 2024 include: Presentation Title Author Abstract Presentation (SGT) Datopotamab Deruxtecan (Dato-DXd) Lung Cancer Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients with previously treated EGFR-mutated advanced non-small cell lung cancer: a pooled analysis of TROPION-Lung01 and TROPION-Lung05 M. Ahn LBA7 Proffered Paper Session Friday, December 6 10:15 - 11:45 am Breast Cancer Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with pre-treated inoperable/metastatic hormone receptor positive, HER2 negative breast cancer: results from TROPION-Breast01 China cohort S. Wang 38MO Mini Oral Session Saturday, December 7 2:30 - 3:40 pm ENHERTU (trastuzumab deruxtecan; T-DXd) Gastric Cancer Trastuzumab deruxtecan (T-DXd) in Chinese patients with previously treated HER2 positive advanced gastric or gastroesophageal junction adenocarcinoma: DESTINY-Gastric06 final analysis Z. Peng 129MO Mini Oral Session Saturday, December 7 9:00 - 10:40 am A phase 1b/2 open-label study evaluating trastuzumab deruxtecan (T-DXd) in combination with rilvegostomig and chemotherapy in patients with HER2 positive and HER2 low gastric or gastroesophageal junction adenocarcinoma: DESTINY-Gastric03 part 4 Y. Janjigian 264TiP Poster Session December 7, 2024 5:50 - 6:45 pm PanTumor Randomized, open-label, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) with rilvegostomig vs standard of care in first-line HER2 expressing, locally advanced or metastatic biliary tract cancer: DESTINY-BTC01 M. Ikeda 261TiP Poster Session December 7, 2024 5:50 – 6:45 pm An open-label, multicenter, phase 2 study of trastuzumab deruxtecan (T-DXd) in patients with HER2 expressing solid tumors: DESTINY-PanTumor02 part 2 J. Lee 400TiP Poster Session December 7, 2024 5:50 – 6:45 pm Highlights of data from Daiichi Sankyo’s DXd ADC portfolio at SABCS 2024 include: Presentation Title Author Abstract Presentation (CST) ENHERTU (trastuzumab deruxtecan; T-DXd) HER2 Low & HER2 Ultralow Breast Cancer Efficacy and safety of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy by pace of disease progression on prior endocrine-based therapy: an additional analysis from DESTINY-Breast06 A Bardia LB1-04 Oral Session Tuesday, December 10 6:00 – 7:00 pm Trastuzumab deruxtecan in combination with capecitabine or capivasertib in patients with HER2 low metastatic breast cancer: a phase 1b, multicenter, open-label study (DESTINY-Breast08) K. Jhaveri P3-09-17 Poster Session Thursday, December 12 12:30 - 2:00 pm A real-world study of the effectiveness and safety of trastuzumab deruxtecan in HER2 low metastatic breast cancer among racial and ethnic minorities and older populations in the United States M. Henderson P2-12-20 Poster Session Wednesday, December 11 5:30 - 7:00 pm Agreement between the DESTINY-Breast04/06 VENTANA 4B5 HER2 IHC clinical trial assay and other comparator assays for HER2 low breast cancer: overall results of a large-scale, multicenter global ring study G. Viale P1-03-28 Poster Session Wednesday, December 11 12:30 - 2:00 pm Trastuzumab deruxtecan in HER2 low metastatic breast cancer patients with newly diagnosed or progressing brain metastases: the TUXEDO-4 phase II trial M. Marhold P3-08-21 Poster Session Thursday, December 12 12:30 - 2:00 pm Re-evaluation of human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) 0 or 1+ in metastatic breast cancer samples to characterize the proportion of HER2 ultralow (IHC 0 with membrane staining) S. Krishnamurthy P3-09-20 Poster Session Thursday, December 12 12:30 – 2:00 pm Valemetostat and trastuzumab deruxtecan in patients with HER2 low, previously treated, unresectable or metastatic breast cancer S. Tolaney P3-08-24 Poster Session Thursday, December 12 12:30 - 2:00 pm Phase 1b study of EZH1/2 inhibitor valemetostat in combination with trastuzumab deruxtecan in subjects with HER2 low/ultra-low/null metastatic breast cancer T. Iwase P3-12-28 Poster Session Thursday, December 12 12:30 - 02:00 pm HER2 Positive Breast Cancer Exploratory biomarker analysis of trastuzumab deruxtecan vs trastuzumab emtansine efficacy in human epidermal growth factor receptor 2-positive metastatic breast cancer in DESTINY-Breast03 W. Jacot PS8-03 Spotlight Poster Session Thursday, December 12 7:00 - 8:30 am Effects of trastuzumab deruxtecan (T-DXd) on health-related quality of life and neurological function in patients with HER2+ advanced/metastatic breast cancer with or without brain metastases: DESTINY-Breast12 results N. Harbeck PS14-10 Spotlight Poster Session Friday, December 13 7:00 – 8:30 am Real-world analysis of interstitial lung disease in patients with HER2-positive unresectable or recurrent breast cancer treated with trastuzumab deruxtecan: all-patient post-marketing surveillance study in Japan J. Tsurutani P1-02-10 Poster Session Wednesday, December 11 12:30 – 2:00 pm HER2 Expressing Breast Cancer Trastuzumab deruxtecan with pembrolizumab in previously treated HER2 expressing advanced or metastatic breast cancer: interim analyses of the breast cohorts from the open-label, multicenter, phase 1b study DS8201-A-U106 H. Rugo P5-07-29 Poster Session Friday, December 13 12:30 - 2:00 pm Patritumab Deruxtecan (HER3-DXd) HR Positive, HER2 Negative Breast Cancer Primary results of SOLTI VALENTINE: neoadjuvant randomized phase II trial of HER3-DXd alone or in combination with letrozole for high-risk hormone receptor positive/HER2-negative early breast cancer M. Oliveira LBA1-06 Oral Presentation Tuesday, December 10 6:00 - 7:00 pm ICARUS-BREAST02: safety, tolerability, and anti-tumor activity of patritumab deruxtecan (HER3-DXd) monotherapy and combinations in patients with inoperable advanced breast cancer following progression on trastuzumab deruxtecan (T-DXd) B. Pistilli P2-08-27 Poster Presentation Wednesday, December 11 5:30 - 7:00 pm Highlights of data from Daiichi Sankyo’s hematology portfolio at ASH 2024 include: Presentation Title Author Abstract Presentation (PST) VANFLYTA (quizartinib) FTL3 -ITD Positive AML Correlation of baseline gene mutations with quizartinib efficacy in patients with FLT3 -ITD positive newly diagnosed acute myeloid leukemia in the phase 3 QuANTUM-First trial M. Levis 848 Oral Presentation Monday, December 9 3:00 - 3:15 pm QuANTUM-First: effects of quizartinib on RFS, OS, CIR, and MRD in newly diagnosed patients with FMS-like tyrosine kinase 3-internal tandem duplication positive ( FLT3 -ITD+) acute myeloid leukemia who received continuation therapy M. Levis 2890 Poster Presentation Sunday, December 8 6:00 - 8:00 pm QuANTUM-First: deep-dive analysis of FMS-like tyrosine kinase 3-internal tandem duplication ( FLT3 -ITD) detection methods utilized for enrollment and longitudinal MRD detection in newly diagnosed patients with FLT3 -ITD+ acute myeloid leukemia J. Rohrbach 4278 Poster Session Monday, December 9 6:00 - 8:00 pm Anchored matching adjusted indirect treatment comparison of quizartinib vs midostaurin in newly diagnosed patients with FLT3 -ITD positive acute myeloid leukemia S. Unni 1509 Poster Session Saturday, December 7 5:30 - 7:30 pm FLT3 -ITD Negative AML Trial in progress: the phase 3, randomized, double-blind, placebo-controlled QuANTUM-Wild study of quizartinib in combination with chemotherapy and as single-agent maintenance in newly diagnosed FLT3 -ITD negative acute myeloid leukemia P. Montesinos 1504.3 Poster Session Saturday, December 7 5:30 – 7:30 pm Final results of QUIWI: a double blinded, randomized PETHEMA trial comparing standard chemotherapy plus quizartinib versus placebo in adult patients with newly diagnosed FLT3 -ITD negative AML P. Montesinos 1512 Poster Session Saturday, December 7 5:30 - 7:30 pm Enhanced validation of the FLT3 -like gene expression signature as a predictive biomarker for quizartinib response in FLT3 -ITD negative acute myeloid leukemia: expanded cohort and extended follow-up from the PETHEMA QUIWI trial A. Mosquera Orgueira 1552 Poster Session Saturday, December 7 5:30 - 7:30 pm Correlation of ELN-risk and gene mutations with quizartinib efficacy in patients with FLT3 -ITD negative newly diagnosed acute myeloid leukemia in the phase 2 QUIWI PETHEMA trial R. Rodriguez- Viega 2895 Poster Session Sunday, December 8 6:00 - 8:00 pm Valemetostat (EZHARMIA in Japan only) B-Cell & T-Cell Lymphomas Valemetostat monotherapy in patients with relapsed or refractory large B-cell lymphoma: primary results of the phase 2 VALYM study from the LYSA E. Bachy 4479 Poster Session Monday, December 9 6:00 - 8:00 pm Prediction of clinical response by phased variants in circulating tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of patients with relapsed or refractory peripheral T-cell lymphoma N. Mehta-Shah 4342 Poster Session Monday, December 9 6:00 - 8:00 pm 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 (Dato-DXd), 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, 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. 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 needs. For more information, please visit www.daiichisankyo.com .

Phase 2Phase 3Clinical ResultPhase 1ASH

26 Nov 2024

·www.globenewswire.com

Greenwich LifeSciences Partners with GIM in Italy

STAFFORD, Texas, Nov. 26, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced its partnership with clinical sites in Italy. The Company has partnered with "Gruppo Italiano Mammella" (GIM), the largest academic cooperative breast cancer research group in Italy, including over 150 participating centers and approximately 500 investigators, with 28 clinical trials on-going today. GIM conducts independent research in innovative technologies and overall, more than 16,000 patients have been involved in approximately 30 studies conducted by the group so far. According to the latest data collected by the European Cancer Information System (click here), a total of 58,160 new cases of breast cancer were diagnosed in Italy in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Italy with 15,455 deaths in 2022. Nine of the top enrolling institutions belonging to GIM have agreed to participate in FLAMINGO-01. These sites were approved by Italian authorities, which has led to in-person training and start-up activities with all sites. At the annual national GIM conference in September 2024, updates on the FLAMINGO trial and new research proposals of interest to the entire group were discussed. Professor Grazia Arpino commented, "The FLAMINGO-01 trial is of great interest to me and to my patients. I originally served on the Data Safety Monitory Board of FLAMINGO-01. As I became more familiar with the potential of GLSI-100, I felt that it was important to give the opportunity to patients in Italy to participate in the trial. I therefore presented the FLAMINGO-01 to my colleagues in GIM, and they also enthusiastically agreed to participate. My institution was the first site in Italy to be activated, and we have already started enrollment and treatment of patients." Grazia Arpino, Professor in Oncology and head of the Breast Cancer Group at the University of Naples Federico II is an expert in mechanism of resistance to endocrine therapy and anti-HER2 therapies in breast cancer. Her research mainly focuses on the development of novel medical strategies to overcome mechanisms of resistance to current anticancer therapies, with more than 137 published articles and an h-index of 39. She is the Principal Investigator in several national and international clinical trials, she is a member of the scientific committee of GIM, and she serves as the Italian National Principal Investigator for FLAMINGO-01. Professor Sabino De Placido, head of the GIM group, commented, "In the past, HER2-positive breast cancer had a very bad prognosis. Today, with novel anti-HER2 targeting therapies, the relapse rate in patients with early disease has improved, but there is still room for amelioration, particularly in high-risk patients. The vaccine being tested in the FLAMINGO-01 study offers an excellent, innovative opportunity to reduce these relapses without increasing the side effects of treatment." CEO Snehal Patel commented, "Italy is the first country where we have personally visited and trained all of the sites participating in FLAMINGO-01. These sites are well located near large cities that will provide convenient access to patients. We are truly grateful for the time and commitment from our Italian colleagues." “The team of trial sites, clinical investigators, and support personnel in Italy has exceeded our expectations, and we are encouraged that FLAMINGO-01 is off to an excellent start in Italy,” added Jaye Thompson, VP of Clinical and Regulatory Affairs. Some of the most important Italian breast cancer units are participating in the trial: NCI Pascale of Naples with Professor Michelino De Laurentiis, San Martino Hospital in Genova with Professor Lucia Del Mastro, Maggiore Hospital in Novara with Professor Alessandra Gennari, IOV in Padova with Professor Valentina Guarneri, Saint Orsola Hospital in Bologna with Professor Claudio Zamagni, Humanitas Cancer Centre in Rozzano (MI) with Professor Alberto Zambelli, Maugeri Institute in Pavia with Professor Laura Locati, and Gemelli Foundation with Professor Alessandra Fabi. The full list of participating centers is shown below and listed on clinicaltrials.gov here, where an interactive map can be used by patients to locate a hospital to contact regarding potential participation in the clinical trial. Bologna Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Genova Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Milan Humanitas Research Hospital Naples (2) Azienda Ospedaliera Universitaria Federico II Di NapoliIstituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Novara Azienda Ospedaliero Universitaria Maggiore della Carità di Novara Padova Istituto Oncologico Veneto Pavia Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) Rome Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico) About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

Phase 3ImmunotherapyVaccine

100 Deals associated with Trastuzumab-PKRB(Celltrion)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Early Stage Breast Carcinoma	LI	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	NO	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	EU	Celltrion Healthcare Hungary Kft	09 Feb 2018
Early Stage Breast Carcinoma	IS	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	NO	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	IS	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	LI	Celltrion Healthcare Hungary Kft	09 Feb 2018
HER2-positive gastric cancer	EU	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	NO	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	IS	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	LI	Celltrion Healthcare Hungary Kft	09 Feb 2018
Hormone receptor positive breast cancer	EU	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic Gastric Carcinoma	IS	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic Gastric Carcinoma	LI	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic Gastric Carcinoma	EU	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic Gastric Carcinoma	NO	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic HER2 positive gastroesophageal junction cancer	NO	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic HER2 positive gastroesophageal junction cancer	IS	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic HER2 positive gastroesophageal junction cancer	EU	Celltrion Healthcare Hungary Kft	09 Feb 2018
Metastatic HER2 positive gastroesophageal junction cancer	LI	Celltrion Healthcare Hungary Kft	09 Feb 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Gastroesophageal Junction Adenocarcinoma	Preclinical	KR	Celltrion, Inc.	10 Jun 2018
HER2-positive gastric cancer	Preclinical	KR	Celltrion, Inc.	10 Jun 2018
Neoplasm Metastasis	Preclinical	KR	Celltrion, Inc.	10 Jun 2018
Metastatic breast cancer	Preclinical	KR	Celltrion, Inc.	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2023	Not Applicable	BREAST CANCER, EARLY-ONSET \| Breast Cancer \| Metastatic Gastric Carcinoma	642	CT-P6	(thjewrmplh) = ooxkoirbge cvdnkvcpuh (baggwvwcqj )	Positive	31 May 2023
NCT03755141 (KCSG BR 18-14/KM10B, Pubmed) Manual	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	128	treatment of physician's choice +Herzuma	(aibvqzidaq) = cgcsluelse kqknwwodza (lhsdrcnzww, 2.8 - 7.2) View more	Positive	17 Aug 2022
NCT03614364 (KCSG HN18-08/KM11, ASCO2022) Manual	Phase 2	Salivary duct carcinoma HER2 Positive	43	Nanoxel+Herzuma	(wantpclyyj) = helssqpuun seudjmfbkb (hwtbrziffn, 52 - 81) Met View more	Positive	02 Jun 2022
NCT02162667 (Pubmed \| Breast Cancer Res Treat)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant human epidermal growth factor receptor-2 (HER2)-positive	-	CT-P6	(bfsrzswlcq): HR = 1.23 (95% CI, 0.78 - 1.93) View more	-	01 Aug 2021
				Trastuzumab
NCT02162667 (Phase III trial comparing neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer, CTgov)	Phase 3	HER2 Positive Breast Cancer	562	Trastuzumab	iczezldfok(hqhfcbcinc) = diatlwucyt ucddudmrio (lzhgpxxfth, pqnfshufzh - exybkqczpz) View more	-	29 Oct 2019
NCT02162667 (Pubmed \| Cancer Chemother Pharmacol)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant	562	CT-P6	(kgqylywgsh) = kcgcqsnfhm krsamlfhqa (ebpzqkdjgi )	Positive	01 Oct 2019
				Trastuzumab	(kgqylywgsh) = auqolgwlmc krsamlfhqa (ebpzqkdjgi )
NCT02162667 (Phase III trial comparing neoadjuvant then adjuvant trastuzumab and its biosimilar candidate CT-P6 in HER2 positive early breast cancer, SABCS2019)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant HER2 positive	549	CT-P6	(iomtwkqvvu) = nwoqazulqy iqrwtcwlzg (ykmxnebihv, 80% - 90%) View more	Positive	15 Feb 2019
				Reference Trastuzumab (RTZ)	(iomtwkqvvu) = dmqcxnztnr iqrwtcwlzg (ykmxnebihv, 85% - 93%) View more
NCT02162667 (SABCS2018)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant HER2 positive	549	CT-P6	(svnebvceci) = Grade 3 of Adams-Stokes syndrome occurring 5 months after the completion of 1-year treatment orgrinndrn (tdcsodubwm ) View more	Positive	15 Feb 2018
				Reference Trastuzumab
NCT02162667 (Pubmed \| Lancet Oncol) Manual	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	549	Trastuzumab-PKRB	(qqqxhurzhy) = jfrkctxuzw vxezobegyy (qwhdebnhze, 40.4 - 53.2) View more	Similar	01 Jul 2017
				trastuzumab	(qqqxhurzhy) = omkogcvjlz vxezobegyy (qwhdebnhze, 44.1 - 56.7) View more
NCT02162667 (ASCO2017)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant	549	CT-P6	(umlcowmnre) = mlekikmpyp ouydocnfvc (izwzemboeb, 0.74 - 1.35)	Positive	30 May 2017
				Trastuzumab	(umlcowmnre) = qukgtmiwax ouydocnfvc (izwzemboeb, 0.74 - 1.35)

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