RegulationBreakthrough Therapy (US), Orphan Drug (US), Breakthrough Therapy (CN), Conditional marketing approval (CN), Orphan Drug (AU), Priority Review (AU), SAKIGAKE (JP), Priority Review (US), Accelerated Approval (US), Priority Review (CN), Fast Track (US), Orphan Drug (JP)

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Gene Sequence

Sequence Code 18481L

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Sequence Code 44772H

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138

Clinical Trials associated with Fam-trastuzumab deruxtecan-NXKI

NCT06364410 / RecruitingPhase 1IIT

Phase 1 Study of Trastuzumab Deruxtecan (DS-8201a) in Combination With Azenosertib (ZN-c3) in HER2-Expressing/Amplified Cyclin E-Amplified Gastric/Gastroesophageal Junction Cancer and Other Solid Tumors With HER2 Expression

This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.

Start Date07 Jul 2025

Sponsor / Collaborator

National Cancer Institute

NCT06585969 / Not yet recruitingPhase 3IIT

A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer

Start Date01 May 2025

Sponsor / Collaborator

Danish Breast Cancer Cooperative Group

NCT06533826 / Not yet recruitingPhase 2IIT

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy

The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-low metastatic breast cancer.
The names of the study drugs involved in this study are:
* Datopotamab deruxtecan (a type of antibody drug conjugate)
* Trastuzumab deruxtecan (a type of antibody drug conjugate)

Start Date01 Jan 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

100 Clinical Results associated with Fam-trastuzumab deruxtecan-NXKI

100 Translational Medicine associated with Fam-trastuzumab deruxtecan-NXKI

100 Patents (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

663

Literatures (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

01 Jan 2025·Current cancer drug targets

Twenty-four-month Progression-free Survival in HER2-amplified Advanced Gastric Cancer with Brain Metastases after Trastuzumab Deruxtecan Treatment: A Case Report and Literature Review

Author: Xu, Min ; Zhang, Haibo

Background::

Trastuzumab deruxtecan (T-DXd) has shown promising outcomes as a second or subsequent-line treatment for human epidermal growth factor-2 (HER2)-positive advanced gastric or gastroesophageal junction cancer.

Case Presentation::

We reported a 49-year-old male patient with stage IV HER2-amplified gastric cancer. Despite extensive pretreatments, including first-line trastuzumab plus FOLFOX, second-- line trastuzumab plus FOLFOX, followed by traditional Chinese medicine, third-line nivolumab plus trastuzumab, fourth-line pyrotinib plus paclitaxel and five hepatic arterial chemoembolization procedures, and fifth-line pembrolizumab plus nab-paclitaxel and thoracic radiotherapy, the patient experienced disease progression. In April 2021, T-DXd was initiated as the sixth-line therapy in combination with radiotherapy for brain metastases. After one treatment cycle, the patient achieved a partial response. T-DXd was discontinued in August 2022 due to recurrent anemia attributed to cardiac stenosis-related bleeding.

Conclusion::

The condition of the patient remained stable until May 2023, indicating a progression- free survival of over 24 months. This case suggests that T-DXd may offer long-term clinical benefits in patients with HER2-amplified advanced gastric cancer with brain metastases.

01 Dec 2024·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Prevalence of treatment-related adverse events (TRAEs) with antibody-drug conjugates in metastatic breast cancer patients: A systematic review and meta-analysis

Review

Author: Magon, Arianna ; Tiberio, Paola ; Arrigoni, Cristina ; Santoro, Armando ; Sanctis, Rita De ; Zambelli, Alberto ; Caruso, Rosario ; Belloni, Silvia

Antibody-drug conjugates (ADCs) are revolutionizing metastatic breast cancer treatment, resulting in a better prognosis and a higher safety profile than chemotherapy. Nevertheless, treatment-related adverse events (TRAE) have been extensively documented. We searched five databases for articles published up to December 2023 and conducted a meta-analysis on 23 clinical trials to estimate TRAE prevalence related to currently approved ADCs. The prevalence of the most common TRAEs ranged from 12% to 33%, depending on the ADC type and study design. Gastrointestinal disorders were highly prevalent during Trastuzumab Deruxtecan, general disorders were extremely common during Trastuzumab Emtansine, and blood system disorders and gastrointestinal disorders were the most prevalent during Sacituzumab Govitecan. This study provides an estimate of ADC-related TRAEs for each treatment based on study design. Despite each ADC having specific toxicities, gastrointestinal symptoms were highly prevalent in all treatments. This study lays the groundwork for developing personalized risk-stratified care pathways.

01 Dec 2024·CANCER TREATMENT REVIEWS

Safety and efficacy of antibody-drug conjugates plus immunotherapy in solid tumours: A systematic review and meta-analysis

Review

Author: Cresta Morgado, Pablo ; Pascual, Tomas ; Carità, Lorenzo ; Villacampa, Guillermo ; Dienstmann, Rodrigo ; Navarro, Victor

BACKGROUND:

Combining antibody-drug conjugate (ADCs) with immune checkpoint inhibitors (ICIs) is emerging as a promising treatment option to increase efficacy outcomes. However, concerns arise regarding the safety of these combinations, as some toxicities may overlap. Currently, there is still limited information about the safety profiles of this strategy.

METHODS:

A systematic review and meta-analysis was conducted to identify clinical trials investigating FDA-approved ADCs in combination with ICI drugs in the metastatic setting across all solid tumors. The primary endpoint of this study was the percentage of adverse events (AEs) of any grade and grade ≥ 3. Secondary endpoints include the percentage of patients with AEs leading to death, treatment discontinuation, proportion of complete responses (CR) and overall response rate (ORR). A parallel search was conducted to quantify the safety profile of ADCs and ICIs in monotherapy. Random effects models were used to estimate pooled outcomes.

RESULTS:

Sixteen trials involving 1,133 patients treated with ADC plus ICI met the inclusion criteria with six different ADCs evaluated. Overall, 55.3 % of patients developed grade ≥ 3 AEs, 30.0 % of patients had treatment discontinuation, and 3.0 % experienced AEs leading to death. When compared to trials evaluating ADC or ICI as monotherapy, the combination results in similar rates of the most common AEs. However, it increases the risk of specific toxicities, such as ILD/pneumonitis (15.0 % with T-DXd plus ICI vs. 11.5 % with T-DXd alone). The pooled ORR was 48.8 % (95 %CI 39.4 % - 58.4 %) and the CR rate was 9.0 % (95 %CI 5.5 - 14.5). PD-L1-positive tumors showed numerically better efficacy outcomes.

CONCLUSIONS:

This meta-analysis shows that the safety profile of the ADC plus ICI is comparable to that of ADC monotherapy. However, it increases the risk of certain toxicities of special interest, such as ILD/pneumonitis, highlighting the need for careful monitoring.

603

News (Medical) associated with Fam-trastuzumab deruxtecan-NXKI

31 Oct 2024

·pipelinereview.com

Three Phase 3 Trials of Datopotamab Deruxtecan-Based Combinations Initiated in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer

TOKYO, Japan & BASKING RIDGE, NJ, USA I October 30, 2024 I The first patients have been dosed in three global, randomized phase 3 trials evaluating the efficacy and safety of datopotamab deruxtecan (Dato-DXd)-based combinations in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC). Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). TROPION-Lung10 is evaluating datopotamab deruxtecan plus rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, or rilvegostomig alone versus pembrolizumab in patients with previously untreated locally advanced or metastatic nonsquamous NSCLC with high PD-L1 expression (tumor cells [TC] ≥ 50%) and without actionable genomic alterations. TROPION-Lung14 is evaluating datopotamab deruxtecan plus osimertinib, AstraZeneca’s EGFR tyrosine kinase inhibitor (TKI), versus osimertinib alone in patients with previously untreated locally advanced or metastatic EGFR mutated nonsquamous NSCLC. TROPION-Lung15 is evaluating datopotamab deruxtecan with or without osimertinib versus platinum-based doublet chemotherapy in patients with locally advanced or metastatic nonsquamous EGFR mutated NSCLC whose disease progressed on prior treatment with osimertinib. “These three trials in either high PD-L1 expressing or EGFR mutated nonsquamous non-small cell lung cancer are critical to helping us understand the potential role of datopotamab deruxtecan in treating patients across different lines and types of lung cancer,” said Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo. “Our growing TROPION clinical program, which now consists of seven phase 3 trials demonstrates our commitment to understanding the full potential of datopotamab deruxtecan in lung cancer.” “Clinical research suggests that combining an antibody drug conjugate with a targeted treatment or a bispecific immunotherapy may drive stronger and more durable tumor responses in patients with a variety of cancers including lung cancer,” said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. “The initiation of these additional three phase 3 trials of datopotamab deruxtecan in combination with our agents, osimertinib and rilvegostomig illustrates our commitment to exploring potential synergies within our oncology pipeline as well as the full potential and combinability of this TROP2 directed antibody drug conjugate across multiple segments and settings of non-small cell lung cancer.” About TROPION-Lung10 TROPION-Lung10 is a global, multicenter, open-label, three-arm phase 3 trial where patients will be randomized in a 2:1:2 ratio to evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) in combination with rilvegostomig (750 mg) or rilvegostomig (750 mg) monotherapy versus pembrolizumab (200 mg) monotherapy in adult patients with previously untreated locally advanced or metastatic nonsquamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations. The dual primary endpoints of TROPION-Lung10 are progression-free survival (PFS) as assessed by blinded independent central review (BICR) and overall survival (OS) in patients with TROP2 positive tumors receiving datopotamab deruxtecan in combination with rilvegostomig versus the pembrolizumab arm. A pre-specified retrospective analysis from tumor biopsies collected pretreatment will be conducted following validation of a potential TROP2 biomarker determined by quantitative continuous scoring, a computational pathology approach. Key secondary endpoints for all arms of the trial include PFS as assessed by BICR and investigator and OS in the intention-to-treat (ITT) population, objective response rate (ORR) as assessed by BICR and duration of response (DoR) as assessed by BICR and investigator in both TROP2 biomarker positive and the ITT populations. The safety and tolerability of datopotamab deruxtecan in combination with rilvegostomig and rilvegostomig monotherapy as compared with pembrolizumab also will be assessed. TROPION-Lung10 will enroll approximately 675 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov . The TIGIT component of rilvegostomig is derived from the clinical-stage anti-TIGIT antibody, COM902, developed by Compugen Ltd. (Nasdaq/TASE: CGEN). About TROPION-Lung14 TROPION-Lung14 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) in combination with osimertinib (80 mg) versus osimertinib (80 mg) monotherapy in adult patients with previously untreated locally advanced or metastatic nonsquamous NSCLC with an EGFR mutation (Exon 19 deletion and/or L858R). The randomized period of the trial is preceded by a single-arm safety run-in period which will enroll approximately 20 patients to evaluate the combination therapy. The primary endpoint of TROPION-Lung14 is PFS as assessed by BICR. Key secondary endpoints include central nervous system (CNS) PFS as assessed by CNS BICR, PFS as assessed by investigator, ORR as assessed by BICR and investigator, OS and safety. TROPION-Lung14 will enroll approximately 580 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov . About TROPION-Lung15 TROPION-Lung15 is a global, multicenter, open-label, three-arm phase 3 trial where patients will be randomized in a 1:1:1 ratio to evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) as monotherapy or in combination with osimertinib (80 mg) versus platinum-based doublet chemotherapy (pemetrexed in combination with carboplatin or cisplatin followed by pemetrexed maintenance) in adult patients with locally advanced or metastatic nonsquamous NSCLC with at least one EGFR mutation (G719X, Ex19del, S768I, L858R, and/or L861Q) and with disease progression following prior treatment with osimertinib. The dual primary PFS endpoints of TROPION-Lung15 are PFS as assessed by BICR for datopotamab deruxtecan monotherapy versus chemotherapy and datopotamab deruxtecan in combination with osimertinib versus chemotherapy. Key secondary endpoints include investigator-assessed CNS PFS as assessed by CNS BICR, ORR and DoR as assessed by BICR, OS and safety. TROPION-Lung15 will enroll approximately 630 patients in Asia, Europe, North America, Oceania and South America. For more information visit ClinicalTrials.gov . About Advanced Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. 1 NSCLC is the most common type of lung cancer, accounting for about 85% of cases. 2 Approximately 75% and 25% of NSCLC tumors are of nonsquamous or squamous histology, respectively, with EGFR mutations occurring in 14% to 38% of all NSCLC tumors worldwide. 3,4 A majority of EGFR mutations occur in tumors with nonsquamous histology. 5 For patients with tumors that do not express a known actionable genomic alteration (e.g., EGFR, ALK, ROS1, NTRK, BRAF, RET or MET), the current first-line standard of care in the metastatic setting is an immune checkpoint inhibitor and/or platinum-based chemotherapy based on PD-L1 expression. 6,7,8 For certain patients with tumors that have EGFR mutations, the established first-line treatment in the metastatic setting is an EGFR TKI. 9 While these treatment strategies have improved outcomes in the first-line metastatic setting, most patients eventually experience disease progression. 10,11,12 TROP2 is a protein broadly expressed in the majority of NSCLC tumors. 13 There is currently no TROP2 directed ADC approved for the treatment of lung cancer. 8,9 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. 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 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 (Dato-DXd) 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 (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. 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 October 2024. 2 Economopoulou P, et al. Ann Transl Med . 2018; 6(8):138 3 National Cancer Institute. SEER Cancer Statistics Factsheets: Lung and Bronchus Cancer, CSR 1975-2017 . Accessed October 2024. 4 Pretelli G, et al. Int J Mol Sci . 2023; 24, 8878. 5 Prabhakar C. Translational Lung Cancer Research . 2015; 4(2), 110-118. 6 Mok TSK, et al. Lancet . 2019 May 4;393(10183):1819-1830. 7 Brahmer J.R. et al. KEYNOTE-024 5-year OS update . ESMO 2021 Virtual Congress. 2021 Sept 16 – 20; Abstract LBA51. 8 Rodríguez-Abreau D, et al. Ann Onc . 2021 Jul;32(7):881-895. 9 American Cancer Society. Targeted Drug Therapy for Non-Small Cell Lung Cancer . Accessed October 2024. 10 Chen R, et al. J Hematol Oncol . 2020:13(1):58. 11 Majeed U, et al. J Hematol Oncol . 2021;14(1):108. 12 Pircher A, et al. Anticancer Research . 2020;70(5):287-294. 13 Mito R, et al. Pathol Int . 2020;70(5):287-294. SOURCE: Daiichi Sankyo

Phase 3ImmunotherapyADCLicense out/in

31 Oct 2024

·medcitynews.com

Precision Oncology Startup Kivu Unveils $92M for More Stable & Durable ADC Cancer Drugs - MedCity News

It doesn’t matter how well a drug kills cancer cells if the patient doesn’t stay on treatment. Side effects lead many patients to interrupt dosing of a drug regimen, allowing cancer to advance, said Mohit Trikha, president and chief operating officer of Kivu Bioscience. Kivu is developing therapies intended to offer better tolerability and efficacy. The startup emerged from stealth this week, revealing $92 million in financing and plans to bring its lead program into the clinic in 2025. San Francisco-based Kivu is developing antibody drug conjugates (ADCs), a type of drug comprised of a targeting antibody linked to a potent cancer-killing payload. While the ability to deliver a powerful, targeted strike to cancer cells has made this class of drugs a hot areas of research and dealmaking, ADCs still have limitations, Trikha said. Sometimes the toxic drug payload falls off the antibody, leading to adverse effects elsewhere in the body. Severe lung and eye toxicity are known complications of currently available ADCs. Off-target toxicity happens when an ADC is unstable, said Trikha, whose 25 years of experience in cancer research includes serving as an oncology executive at AbbVie. Kivu aims to improve stability with technology licensed from Synaffix, an Amsterdam-based company whose ADC technologies are used by many biotech companies. Last year, contract drug and manufacturing organization giant Lonza acquired Synaffix for €100 million (about $107 million) up front in a move to strengthen its ADC service offerings to its customers. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech When it comes to designing an ADC, where the drug payload links to the antibody matters, Trikha said. The Synaffix technology enables linking at specific sites that improve the stability of the overall molecule. This approach is intended to widen the therapeutic window, the dose range that balances safety and efficacy. Kivu aims to deliver the highest dose possible with an ADC drug payload that is released only in the tumor microenvironment. Doing so should maximize the toxic effect to the tumor while limiting that effect elsewhere in the body so a patient does not have to reduce or interrupt dosing. “In my mind, precision oncology is bringing the right drug to the right patient at the right time, with the right schedule,” Trikha said. “Cancer medicines, whether it’s an ADC or something else, has a benefit to risk profile. Not only do we want to have efficacious drugs, we want to reduce toxicity, improve tolerability, so patients stay on treatment.” Kivu aims for each of its drugs to achieve single-agent activity. That’s important because with combination treatments, patients often reduce dosing to manage the regimen’s toxic effects, Trikha said. Another benefit Kivu aims to show is overcoming drug resistance. Cancers have a mechanism for kicking out a drug after it’s been internalized by the cell, which makes the cancer resistant to treatment. Trikha said the drug payload employed by Kivu’s ADC is not acted upon by a membrane protein cancer cells use to pump out a drug, so the drug remains in the cell to carry out its cancer-killing effects. Kivu’s pipeline lists three programs. The most advanced of them, KIVU-107, is undergoing the preclinical research that could support an investigational new drug application (IND), laying the groundwork for a Phase 1 study expected to begin next year. Trikha declined to specify the types of cancers this ADC could treat other than to say they are solid tumors with unmet medical need. But he did say the biotech’s drugs are designed to inhibit topoisomerases, enzymes that support cancer growth. Trodelvy, from Gilead Sciences, and Enhertu, from AstraZeneca and Daiichi Sankyo, are examples of topoisomerase inhibitor ADCs. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum Kivu takes its name from Lake Kivu, which is located on the border of the Democratic Republic of Congo and Rwanda. Volcanic activity has led to the buildup of dissolved gasses in the lower levels of the lake. A disturbance to the lake could lead to a deadly explosion of those gasses. Trikha said the time between IND-enabling studies and proof-of-concept data is referred by some as “the valley of death” due to the many failures in this stage of drug development. Kivu, the startup, aims to avoid these deadly pitfalls. “The meaning of Kivu — we’re here to conquer cancer,” Trikha said. Kivu’s Series A financing was led by Novo Holdings. Other participants in the round include Gimv, Red Tree, HealthCap, BioGeneration Ventures, M Ventures, and Innovatiefonds Brabant. Photo by Flickr user Josep Casas via a Creative Commons license

AcquisitionADC

22 Oct 2024

·www.globenewswire.com

BriaCell Reports Outperforming Metastatic Breast Cancer Patients and Standard-Beating Survival Data

55% of BriaCell patients1 remained alive one year since enrollment in BriaCell’s Phase 2 study, markedly exceeding the survival rate of current standard of care for similar patientsMultiple outperforming patients with overall survival of over 2 yearsSurvival benefit observed even in heavily pre-treated patients who failed treatment with checkpoint inhibitors (CPIs) and/or antibody-drug conjugates (ADCs) Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive No Bria-IMT™ related discontinuations reported to date PHILADELPHIA and VANCOUVER, British Columbia, Oct. 22, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, announces new positive survival data, outperforming patients, and survival rates in its Phase 2 metastatic breast cancer (MBC) study. In BriaCell’s Phase 2 clinical study, patients treated with the same Bria-IMT™ regimen formulation being used in the ongoing Phase 3 pivotal trial experienced a one-year survival rate of 55% (i.e. 55% of patients remain alive at least one year after starting on the study). This rate exceeds the survival data of the current standard of care for similar patients (see Table 1). Notably, 4 of 13 patients recruited in 2022 remain in survival follow-up as well, including: Patient 01-009: Overall survival (OS) of 25 months has been reported in a patient who had failed 6 prior treatments prior to the BriaCell regimen. Stable disease and lymph node shrinkage has been recorded during 13 cycles of therapy.Patient 07-001: OS of 24 months. She had stable disease and received 8 cycles of BriaCell’s therapy.Patient 16-003: OS of 15 months and received 8 cycles of therapy with stable disease. Prior to the BriaCell regimen, she had 7 lines of therapy, which included the progression of disease while on the antibody-drug conjugate (ADC) Enhertu.Patient 11-018: OS of 14 months. This previously-reported responder with 100% resolution of her brain metastasis has recently completed her 19th cycle of therapy. “With over 40,000 deaths each year in the US alone, late-stage MBC remains an important unmet medical need for many patients and their families. Approved treatments are restricted by poor survival and harsh side effects,” stated Adam M. Brufsky, MD, PhD, FACP, Professor of Medicine at the University of Pittsburgh School of Medicine and Medical Director of the Magee-Women's Cancer Program. “We are impressed with BriaCell’s promising randomized Phase 2 survival data indicating robust survival and a preferred tolerability profile for Bria-IMT™ and look forward to seeing the data being replicated in BriaCell’s pivotal Phase 3 study.” “A number of patients with metastatic breast cancer have disease progression on currently approved drugs, including CPIs and ADCs, with limited overall survival,” remarked Dr. Aditya Bardia, Program Director of Breast Medical Oncology at UCLA, who was not involved with the BriaCell Phase 2 clinical trial. “BriaCell’s clinical data is interesting and highlights the role of the combination of Bria-IMT™ with CPIs in MBC.” “Significant numbers of patients with metastatic breast cancer do not respond to currently approved drugs, including CPIs and ADCs, and have a very limited lifespan of weeks to a few months,” said Dr. William V. Williams, BriaCell’s President and CEO. “BriaCell’s clinical data supports our hypothesis that our regimen has prolonged survival in patients with metastatic breast cancer who otherwise have not responded to currently available treatments. We look forward to further confirming these impressive data in our ongoing pivotal Phase 3 study, with interim results expected in the second half of 2025. Overall survival is the primary endpoint in our pivotal Phase 3 study.” Table 1: Comparable Analysis of 1 year survival for the BriaCell Phase 2 studyReferenceBreast Cancer TypeMedian prior lines of therapyMedian OS (months)Percent Survival at 1 yearBria-IMT™ plus CPIAll types61% HR+33% TNBC6% HER2+613.4* 15.6**55%Cortes et al.1All types 57% HR+ 18-19% TNBC18-20% HER2+49.1-9.3~38-40%Kazmi et al.2 All types 51-52% HR+ 25-29% TNBC9-24% HER2+27.2-9.830-38%Bardia et al. (TPC arm)3TNBC2-36.9~23% Rugo et al (TPC arm)4HR+ HER2-211.247%* Patients treated with the Phase 3 formulation** Patients treated with the Phase 3 formulation since 2022 1. Cortes J, et al. Annals of Oncology 20182. Kazmi S, et al. Breast Cancer Res Treat. 20203. Bardia A, et al. J Clin Oncol. 20244. Rugo HS, et al. The Lancet. 2023 Abbreviations: HR+: hormone receptor-positiveTNBC: Triple-negative breast cancer (lacks or has low levels of the estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2))HER2+: Human epidermal growth factor receptor 2 positiveHR+ HER2-: hormone receptor-positive and human epidermal growth factor receptor 2 negativeTPC: Treatment of Physicians Choice The Phase 2 study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT™ regimen plus checkpoint inhibitor. Of these 54 patients, 37 were treated with the formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612). Final median overall survival calculation for the Phase 2 study is pending, as many patients remain alive. No Bria-IMT™ related discontinuations have been reported to date. About BriaCell Therapeutics Corp. BriaCell is a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care. More information is available at https://briacell.com/. Safe Harbor This press release contains “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, including statements about: the impact of Bria-IMT™ on patients with metastatic breast cancer; BriaCell’s further clinical development of Bria-IMT™; the Company’s beliefs regarding the results of BriaCell’s pivotal Phase 3 study; and the efficacy of immune check point inhibitors, are based on BriaCell’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. 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 under the heading “Risks and Uncertainties” in the Company’s most recent Management’s Discussion and Analysis, under the heading “Risk Factors” in the Company’s most recent Annual Information Form, and under “Risks and Uncertainties” in the Company’s other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company’s profiles on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law. Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.Contact Information Company Contact: William V. Williams, MDPresident & CEO 1-888-485-6340 info@briacell.com Media Relations: Jules Abraham CORE IR julesa@coreir.com Investor Relations Contact: CORE IR investors@briacell.com 1 Patients treated with the Bria-IMT™ formulation being used in the phase 3 study.

Phase 2Phase 3ImmunotherapyClinical ResultADC

100 Deals associated with Fam-trastuzumab deruxtecan-NXKI

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KEGG	Wiki	ATC	Drug Bank
-	Fam-trastuzumab deruxtecan-NXKI	L01XC	DB14962

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Stomach Adenocarcinoma	KR	Daiichi Sankyo Co., Ltd.	19 Sep 2022
Hormone receptor positive HER2 positive breast cancer	KR	Daiichi Sankyo Co., Ltd.	19 Sep 2022
HER2 mutant non-small cell lung cancer	US	Daiichi Sankyo, Inc.	11 Aug 2022
HER2-Low Breast Carcinoma	AU	AstraZeneca Pty Ltd.	08 Oct 2021
Metastatic breast cancer	CA	AstraZeneca Canada, Inc.	15 Apr 2021
HER2 positive Gastroesophageal Junction Adenocarcinoma	US	Daiichi Sankyo, Inc.	15 Jan 2021
HER2-positive gastric cancer	JP	Daiichi Sankyo Co., Ltd.	25 Sep 2020
HER2 Positive Breast Cancer	US	Daiichi Sankyo, Inc.	20 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Solid Tumors	NDA/BLA	US	Daiichi Sankyo Co., Ltd.	29 Jan 2024
HER2 Positive Solid Tumors	NDA/BLA	US	AstraZeneca Pharmaceuticals LP	29 Jan 2024
Advanced biliary tract cancer	Phase 3	US	AstraZeneca PLC	12 Aug 2024
Advanced biliary tract cancer	Phase 3	JP	AstraZeneca PLC	12 Aug 2024
Advanced biliary tract cancer	Phase 3	AU	AstraZeneca PLC	12 Aug 2024
Advanced biliary tract cancer	Phase 3	AT	AstraZeneca PLC	12 Aug 2024
Advanced biliary tract cancer	Phase 3	BE	AstraZeneca PLC	12 Aug 2024
Advanced biliary tract cancer	Phase 3	BR	AstraZeneca PLC	12 Aug 2024
Advanced biliary tract cancer	Phase 3	CA	AstraZeneca PLC	12 Aug 2024
Advanced biliary tract cancer	Phase 3	CZ	AstraZeneca PLC	12 Aug 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO2024	Not Applicable	Lung Diseases, Interstitial	-	Trastuzumab-deruxtecan	ffmvsrbgow(jpfscrvtch) = 29 (16%) developed ILD (18-G1, 7-G2, 1-G3, 1-G4, 2-G5) zxwefhwfgl (yhhsjjpjeg ) View more	-	16 Sep 2024
ESMO2024	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast	-	Trastuzumab deruxtecan (T-DXd)	ykwunofsez(lzxfgeexfm) = lnznshmyez nvbmwuqugm (pmrspeyxpm, 50 - 67) View more	-	16 Sep 2024
				Treatment of physician’s choice (TPC)	ykwunofsez(lzxfgeexfm) = gceyfmqevz nvbmwuqugm (pmrspeyxpm, 8 - 27) View more
NCT04494425 (DESTINY-Breast06, Pubmed \| N Engl J Med) Manual	Phase 3	Hormone receptor positive breast cancer Hormone Receptor Positive	866	Trastuzumab deruxtecan	oohcejbhna(enepyixczp) = ctyzcdhbkz zftxkxpxll (uytejcmhgj, 11.4 - 15.2) View more	Positive	14 Sep 2024
				Physician's choice of chemotherapy	oohcejbhna(enepyixczp) = thrrgxypqy zftxkxpxll (uytejcmhgj, 7.0 - 9.0) View more
NCT04739761 (DESTINYBreast-12, ESMO2024) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 Positive	504	Trastuzumab deruxtecan 5.4 mg/kg (BM)	jiapjundki(drzjuwpwor) = vehbuovvlj wwqqyigvrp (hknmsomoiz, 54.9 - 67.6) View more	Positive	13 Sep 2024
				Trastuzumab deruxtecan 5.4 mg/kg (non-BM)	kyusjndebi(zjipoopfyo) = bzyvptgaoi ckjdmzqais (irnurckmti ) View more
NCT04686305 (DESTINY-Lung03, WCLC2024) Manual	Phase 1	Non-Small Cell Lung Cancer HER2 Overexpression	36	Trastuzumab deruxtecan	kgcnzbcdgm(epmjddbsuf) = tpfcxrlqce ebpimemooj (blgwxmxieo, 20.1 - 50.6) View more	Positive	10 Sep 2024
NCT04420598 (DEBBRAH, Pubmed \| Med) Manual	Phase 2	HER2-Low Breast Carcinoma \| HER2 Positive Breast Cancer \| Meningeal Carcinomatosis First line HER2 Positive	7	Trastuzumab deruxtecan 5.4 mg/kg	vweqmsbsnx(cepzlvfcck) = cemsncntbf iruijsjufw (okhepcngxc, 5.7 - NA) View more	Positive	01 Sep 2024
NCT03505710 (DESTINY-Lung01, Pubmed)	Phase 2	HER2 mutant non-small cell lung cancer HER2-mutant	181	Trastuzumab deruxtecan (T-DXd)	vqwqtiwhox(liznzmitae) = During the study, 97% of participants had drug-related adverse events, with nausea being the most common huhzljnpep (sarppyzidk ) View more	Positive	16 Jul 2024
NCT03529110 (DESTINY-Breast03, Pubmed) Manual	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	309	Trastuzumab deruxtecan (T-DXd)	tpmodluisu(iaopunbhqz) = mfovayahyb txcnjydueg (kngyekkflc ) View more	Positive	09 Jul 2024
				Trastuzumab emtansine (T-DM1)	tpmodluisu(iaopunbhqz) = zdbagsvunv txcnjydueg (kngyekkflc ) View more
NCT03734029 (DESTINY-Breast04, Pubmed)	Phase 3	HER2-Low Breast Carcinoma HER2-low	213	Trastuzumab deruxtecan (T-DXd)	rcdbkarrzz(cnbuoqbwla) = 12.9% yveqeirfev (deoqmyhhxp ) View more	Positive	17 Jun 2024
				Treatment of physician's choice (TPC)
NCT03529110 (DESTINY-Breast03, Pubmed)	Phase 3	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-positive	-	Trastuzumab deruxtecan (T-DXd)	xehtwjnimk(cknyoghdsg) = qpamuaogub oirudjfdfr (hidgvpoyiu ) View more	Positive	02 Jun 2024
				Trastuzumab emtansine (T-DM1)	xehtwjnimk(cknyoghdsg) = sdsukxbhqi oirudjfdfr (hidgvpoyiu ) View more

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