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Last update 23 Jan 2025

Pertuzumab

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

2C4 Antibody, Anti-2C4 monoclonal antibody, Monoclonal Antibody 2C4

+ [15]

Target

HER2

Mechanism

HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [7]

Active Indication

HER2 Positive Colorectal CancerEarly Stage Breast CarcinomaBreast Cancer+ [27]

Inactive Indication

Advanced breast cancerAdvanced Lung Non-Small Cell CarcinomaAdvanced Neuroendocrine Carcinoma+ [23]

Originator Organization

Genentech, Inc.

Active Organization

Roche China Holding Ltd.F. Hoffmann-La Roche Ltd.Roche Diagnostics GmbH

+ [12]

Inactive Organization

Hoffmann-La Roche Ltd.

Roche Holding AG

Eisai, Inc.

Drug Highest PhaseApproved

First Approval Date

US (08 Jun 2012),

Breast CancerHER2 Positive Breast CancerMetastatic breast cancer

RegulationAccelerated Approval (US), Orphan Drug (US)

Structure/Sequence

Sequence Code 18492L

Source: *****

Sequence Code 18505H

Source: *****

257

Clinical Trials associated with Pertuzumab

NCT04419181

/ SuspendedPhase 2IIT

A Feasibility Study of De-escalation of Chemotherapy in Patients with Early-Stage HER2 Positive Breast Cancer

The main purpose of this research study is to find out if de-escalation of chemotherapy before surgery followed by a selective escalation of adjuvant targeted therapies are efficacious and tolerable in early-stage HER2 positive breast cancer.

Start Date11 Aug 2025

Sponsor / Collaborator

University of Rochester

NCT06038539

/ Not yet recruitingPhase 3

A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer

To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in neoadjuvant treatment of patients with HR-ve and HER-2 positive early stage or locally advanced breast cancer.

Start Date31 Jan 2025

Sponsor / Collaborator

Biocon Ltd.

ChiCTR2400095009

/ SuspendedNot ApplicableIIT

A time,motion and cost assessment study of a subcutaneous (SC) pertuzumab and trastuzumab fixed-dose combination (PH FDC) for the treatment of HER2-positive early breast cancer (HER2+ EBC)

Start Date01 Jan 2025

Sponsor / Collaborator-

100 Clinical Results associated with Pertuzumab

100 Translational Medicine associated with Pertuzumab

100 Patents (Medical) associated with Pertuzumab

1,753

Literatures (Medical) associated with Pertuzumab

01 Feb 2025·ANNALS OF SURGICAL ONCOLOGY

Prognostic Value of the Baseline Systemic Immune-Inflammation Index in HER2-Positive Metastatic Breast Cancer: Exploratory Analysis of Two Prospective Trials

Article

Author: He, Xiongbin ; Ding, Nianhua ; Wang, Shouman ; Xiao, Zhi ; Zhou, Wei ; He, Yingjian ; Liu, Xuan ; Li, Yan ; Pang, Jian ; Xie, Haiqing ; Feng, Jianqi

PURPOSE:

The systemic immune-inflammation index (SII) is a hematological marker that reflects the immune status of the body. This study was designed to evaluate the prognostic significance of the baseline SII in HER2-positive metastatic breast cancer (MBC) patients receiving chemotherapy plus trastuzumab without or with pertuzumab.

METHODS:

Data were collected from 774 patients from the CLEOPATRA trial, 196 patients from the H0648G trial, and 229 patients from six clinical centers in China. Patients were divided into the low and high SII subgroups according to the median SII value. The inverse probability of treatment weighting (IPTW) method was used to control bias. Associations between the SII and progression-free survival (PFS) and overall survival (OS) were analyzed.

RESULTS:

In the CLEOPATRA trial, a lower SII was associated with better PFS (hazard ratio [HR] 1.31, 95% confidence interval [CI] 1.04-1.65, P = 0.02) and OS (HR 1.42, 95% CI 1.07-1.88, P = 0.02) in the trastuzumab and docetaxel groups, as well as improved PFS in the trastuzumab and pertuzumab and docetaxel groups (HR 1.39, 95% CI 1.10-1.77, P < 0.01) after IPTW. In the H0648G trial, a lower SII was associated with better PFS (P = 0.04) and OS (P = 0.02) in HER2-positive MBC patients receiving trastuzumab-based therapy. According to real-world data, a lower SII predicted an improvement in PFS for patients treated with docetaxel plus trastuzumab without or with pertuzumab (P = 0.02 and 0.01, respectively).

CONCLUSIONS:

A low baseline SII is associated with better survival outcomes among HER2-positive MBC patients receiving trastuzumab-based first-line therapy.

01 Feb 2025·BREAST

A multicenter retrospective study of early cardiac toxicity in operable breast cancer patients receiving concurrent dual or mono anti-HER2 therapy with postoperative radiation therapy

Article

Author: Wu, Jian-Wei ; Zhu, Qi-Wei ; Lin, Qing ; Yang, Jing ; Cai, Rong ; Zhou, Meng-Yun ; Wu, Hua-Ling ; Yao, Yuan ; Cao, Lu ; Yu, Bo ; Xie, Hua-Ying ; Chen, Jia-Yi ; Ye, Ming ; Cai, Gang ; Qi, Wei-Xiang

PURPOSE:

This study aims to assess whether dual anti-HER2 therapy with trastuzumab and pertuzumab increases early cardiac toxicity compared to trastuzumab alone in breast cancer (BC) patients receiving postoperative radiation therapy (RT).

METHODS:

Consecutive operable BC patients receiving postoperative RT and trastuzumab with or without pertuzumab between January 2017 and September 2020 at seven tertiary hospitals in China were retrospectively reviewed. Cardiac examinations included echocardiography, electrocardiogram (ECG), NT-proBNP, and cTnI at baseline before RT and during the follow-up. The cardiac event is any new-onset symptomatic heart disease or abnormality in the cardiac examination after RT.

RESULTS:

In total, 681 patients were enrolled in the analysis, of whom 567 were treated with trastuzumab-alone and 124 patients received dual anti-HER2 therapy. The median follow-up was 11 months. Multivariate analysis showed that left-sided breast cancer (HR 2.38; 95%CI 1.65-3.44, p < 0.001) and IMN RT (HR 1.47; 95 % CI 1.01-2.15, P-value = 0.047) are independent risk factors for ECG abnormalities. Age >50 years is an independent risk factor for developing LVDD (HR 5.16; 95%CI 1.17-22.73, P-value = 0.030). Dosimetric analysis showed that patients who developed subclinical cardiac events had increased mean heart dose (412.0 ± 249.6 vs. 347.2 ± 242.6 cGy, P-value = 0.010). Among right-sided patients or patients receiving anthracycline-based chemotherapy, the dual-targeted cohort had a higher risk of developing ECG abnormalities compared to the trastuzumab-only cohort.

CONCLUSION:

Compared with trastuzumab-only, dual anti-HER2 therapy does not increase early cardiac toxicity in combination with postoperative RT in BC patients. Cardiac radiation exposure remains the primary risk factor for early toxicity.

07 Jan 2025·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

Computational-aided rational mutation design of pertuzumab to overcome active HER2 mutation S310F through antibody–drug conjugates

Article

Author: Zhuang, Xinlei ; Guo, Yugang ; Chen, Shuqing ; Xu, Yingchun ; Wang, Haibin ; Bai, Xuefei ; Xu, Lingyi ; Wang, Zhe ; Sun, Yanping ; Ning, Jiangtao ; Guo, Jiangtao ; Pan, Liqiang

Recurrent missense mutations in the human epidermal growth factor receptor 2 (HER2) have been identified across various human cancers. Among these mutations, the active S310F mutation in the HER2 extracellular domain stands out as not only oncogenic but also confers resistance to pertuzumab, an antibody drug widely used in clinical cancer therapy, by impeding its binding. In this study, we have successfully employed computational-aided rational design to undertake directed evolution of pertuzumab, resulting in the creation of an evolved pertuzumab variant named Ptz-SA. This variant, with only two mutations (T30S/D31A) located on its heavy chain, effectively reinstates binding to the mutated antigen, at the expense of a 35-fold reduction in binding affinity to HER2 (S310F) compared to the wild-type pair. Subsequently, Ptz-SA demonstrates potent killing capacity through antigen-dependent cytotoxicity. Moreover, upon engineering Ptz-SA into antibody–drug conjugates, such as Ptz-SA-MMAE, it manifests notable in vitro and in vivo antitumor efficacy by efficiently delivering cytotoxic payload into tumor cells expressing HER2 (S310F). Cryoelectron microscopy studies elucidate the molecular mechanism underlying the restored binding ability of Ptz-SA toward the S310F mutation. The steric hindrance induced by the S310F mutation is efficiently circumvented by the T30S and D31A mutations, which provides adequate space to accommodate the larger phenylalanine. Additionally, Ptz-SA also exhibits binding capacity to HER2 (S310Y), another mutation occurring at the S310 site of HER2 with high frequency. The computational-aided evolution of pertuzumab provides an alternative strategy for overcoming point mutation-mediated resistance to therapeutic antibodies.

114

News (Medical) associated with Pertuzumab

12 Dec 2024

·www.accesswire.com

Significant Positive Results with Jaguar Health's Crofelemer for Cancer Therapy-Related Diarrhea (CTD) in Breast Cancer Patients Presented at San Antonio Breast Cancer Symposium (SABCS)

Adult patients with breast cancer are a prespecified subgroup of the recently conducted phase 3 OnTarget trial evaluating crofelemer for prophylaxis of CTDThe majority of patients in the OnTarget placebo group on abemaciclib and pertuzumab-based therapies required dose reduction or elimination SAN FRANCISCO, CA / ACCESSWIRE / December 12, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals ("Napo") today provided an overview of the data from the poster presentation conducted yesterday, December 11, 2024, at the San Antonio Breast Cancer Symposium (SABCS) about the recently completed analysis of the prespecified subgroup of adult patients with breast cancer from the Phase 3 OnTarget trial, which indicates that crofelemer achieved statistically significant results in this subgroup. Patients with breast cancer accounted for 183 of the 287 participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adults with solid tumors receiving targeted therapy with or without standard chemotherapy."In this responder analysis of patients with breast cancer on targeted therapies, crofelemer CTD prophylaxis resulted in a greater proportion of monthly responders of diarrhea improvement compared to placebo," said Lisa Conte, Jaguar's president and CEO. "Overall, crofelemer was significantly more effective than placebo in providing sustained response in breast cancer patients, potentially helping them stay on their cancer therapies. This research underscores the potential of crofelemer for prophylaxis of CTD.""Diarrhea is a common side effect of targeted therapies and can lead to dose changes, treatment delays, or stopping treatment altogether, all of which can impact patient outcomes," said Pablo C. Okhuysen, MD, FACP, FIDSA, the National Principal Investigator of the OnTarget trial. "The OnTarget study specifically analyzed breast cancer patients receiving crofelemer or a placebo for 12 weeks. Patients reported their diarrhea symptoms, and those with fewer than nine loose stools per week were considered ‘responders.' Breast cancer patients receiving crofelemer had significantly better control of diarrhea than those on placebo. Nearly half (47.1%) of crofelemer group patients were responders through 12 weeks, compared to 33.7% of those on placebo."Photo from the December 11, 2024 poster presentation session at SABCS. From left to right: Pravin Chaturvedi, PhD, Chair of Napo's Scientific Advisory Board (SAB) and Jaguar's Chief Scientific Officer; Lisa Conte, Jaguar's CEO; Pablo C. Okhuysen, MD, FACP, FIDSA, the lead author of both posters; Dr. Barbara Segarra-Vazquez, a patient advocate from Puerto Rico; Napo SAB member Stacey Tinianov, MPH; and Edna Pacheo, a patient advocate from Puerto Rico As announced, the content of the poster presentation will serve as the basis of the briefing package Napo plans to submit to the U.S. Food and Drug Administration to request a meeting to discuss possible pathways to make crofelemer available as efficiently as possible to breast cancer patients. Additional analyses of OnTarget prespecified subgroups are ongoing, and Jaguar believes data from additional analyses may result in future submissions to peer-reviewed forums.A second poster related to the OnTarget trial, looking at the frequency and severity of diarrhea in breast cancer patients on abemaciclib and pertuzumab-based therapies, using data from the placebo group of OnTarget, was also the subject of a poster presentation on December 11, 2024 at SABCS. In the OnTarget study, 135 patients with various cancers received a placebo, and 57% of them had breast cancer."Of the total of 183 breast cancer patients in the OnTarget trial, most received abemaciclib or pertuzumab. Among those participating patients treated with abemaciclib, more than 43% had to reduce or terminate their dosing due to diarrhea. Similarly, for patients on pertuzumab-based therapies, all required dose reduction or elimination," Conte said. "These results highlight the significant impact of diarrhea on patients undergoing cancer treatment, especially with certain breast cancer therapies. Real-time reporting from patients showed that diarrhea is often under-recognized but can severely affect treatment. More attention to managing diarrhea could improve quality of life and treatment success in breast cancer patients on targeted therapies."Pablo C. Okhuysen, MD, FACP, FIDSA, the lead author of both posters, is Professor, Department of Infectious Diseases, Infection Control and Employee Health at The University of Texas MD Anderson Cancer Center in Houston. Other key authors of both posters include Pravin Chaturvedi, PhD, Chair of Napo's Scientific Advisory Board (SAB) and Jaguar's Chief Scientific Officer; Napo SAB member Lee Schwartzberg, M.D., FACP, Chief of Medical Oncology at Renown Health in Reno, Nevada; Napo SAB member Eric Roeland, MD, FAAHPM, FASCO, Associate Professor of Medicine, Division of Hematology/Medical Oncology, School of Medicine, Oregon Health & Science University; Napo SAB member Stacey Tinianov, MPH, a Board Certified Patient Advocate; Napo SAB member Dr. Kelly Shanahan, a former clinician and a metastatic breast cancer patient who is now a full-time independent patient advocate; as well as two key advisors to Napo: Enoch Bortey and James Bolognese.Photo from the December 11, 2024 poster presentation session at SABCS. From left to right: Lisa Conte, Jaguar's CEO; Pravin Chaturvedi, PhD, Chair of Napo's Scientific Advisory Board (SAB) and Jaguar's Chief Scientific Officer; Gitte Joergensen, Ambassador for Jaguar's patient engagement program; Napo SAB member Stacey Tinianov, MPH; and Enoch Bortey, a key advisor to Napo In addition to participating in both poster presentations with its SAB members at SABCS, and in alignment with Jaguar's core focus on patient comfort, dignity, and cancer supportive care in general, Napo hosted a gathering for patient advocates during SABCS as part of the company's ongoing patient engagement program.Since 1977, SABCS has been the leading scientific conference for scientists, physicians, clinical investigators, breast care providers, and advocates seeking an exchange of new information in experimental biology, etiology, prevention, diagnosis, and therapy of premalignant breast disease and breast cancer. Based on attendance levels from 2023 SABCS, the symposium organizers anticipated more than 10,000 attendees for this year's event.About the Jaguar Health Family of CompaniesJaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications.For more information about:Jaguar Health, visit https://jaguar.healthNapo Pharmaceuticals, visit www.napopharma.comNapo Therapeutics, visit napotherapeutics.comMagdalena Biosciences, visit magdalenabiosciences.comVisit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & InstagramForward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding the potential of crofelemer for prophylaxis of CTD, Jaguar's expectations that the content of the poster about the results in breast cancer patients from the OnTarget study will serve as the basis of a briefing package Napo will submit to the U.S. Food and Drug Administration to request a meeting to discuss possible pathways to make crofelemer available as efficiently as possible to breast cancer patients, Jaguar's expectation that data from additional analyses of OnTarget prespecified subgroups may result in future submissions to peer-reviewed forums, and Jaguar's expectation that more attention to managing diarrhea could improve quality of life and treatment success in breast cancer patients on targeted therapies. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.Contact:[email protected]Jaguar-JAGXSOURCE: Jaguar Health, Inc.

Clinical ResultPhase 3

06 Dec 2024

·pipelinereview.com

China NMPA Accepts Henlius' NDA for HLX11, an Pertuzumab Biosimilar Candidate

SHANGHAI, China I December 04, 2024 I Shanghai Henlius Biotech, Inc. (2696.HK) announced that the new drug application (NDA) has been accepted by the National Medical Products Administration (NMPA) for its self-developed pertuzumab biosimilar HLX11, in combination with trastuzumab and chemotherapy, as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence, and in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive, metastatic or unresectable locally recurrent breast cancer, who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. HLX11 is a pertuzumab biosimilar developed by Henlius independently in line with relevant regulations and guidelines on biosimilars in China, the United States (U.S.) and the European Union (EU). The filing was based on data from a series of head-to-head studies of HLX11 in comparison with reference pertuzumab, including analytical studies of similarities, phase 1 clinical studies and international multicenter phase 3 clinical studies. These data demonstrated that HLX11 is highly similar to the reference pertuzumab in terms of quality, safety and efficacy. Breast cancer is the second most common tumour worldwide and the most common cancer among women globally. According to GLOBOCAN, there were 2.3 million new cases of breast cancer worldwide in 2022 [1] , including 357,200 new cases in China [2] . Among these, HER2-positive breast cancer accounts for approximately 20-25% of all breast cancer cases [3] . This type of tumour cells is characterised by high aggressiveness, high malignancy and rapid progression. Pertuzumab can specifically bind with the subdomain II of HER2 extracellular domain and inhibit the heterodimerisation of HER2 and other HER family receptors, i.e., EGFR, HER3, and HER4. This will inhibit signal transduction of relevant pathways and lead to the stop of growth and apoptosis of tumour cells. In the meantime, pertuzumab can also enhance the tumour-killing activity of immune cells via antibody-dependent cell cytotoxicity. Clinical studies have shown that the combination of pertuzumab and trastuzumab exhibits good synergy, significantly improving clinical efficacy and noticeably enhancing patient prognosis [4] . The dual-target therapy combining pertuzumab and trastuzumab has become a cornerstone in the treatment of HER2-positive breast cancer, recommended by guidelines at home and abroad, including the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Breast Cancer, the Chinese Society of Clinical Oncology (CSCO) Breast Cancer Guidelines, the Guidelines for Breast Cancer Diagnosis and Treatment by China Anti-cancer Association (CACA). Henlius has been deeply engaged in the anti-HER2 treatment field. Its comprehensive product pipeline includes multiple HER2-targeted drugs that can work synergistically to form effective treatment combinations, thereby benefiting more patients with HER2 tumours. Among them, the company’s self-developed HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac ® in Europe) is a Chinese monoclonal antibody (mAb) biosimilar approved in China, the EU and the U.S. Up to now, it has been approved for marketing in 50 countries and regions and has been licensed out to about 100 countries and regions. The company’s newly-approved small-molecule anti-tumor drug HANNAIJIA (neratinib) has rapidly entered clinical application as a sequential therapy after completion of HANQUYOU, offering a new treatment option for patients with HER2-positive early-stage breast cancer. HLX11 also has the potential to be used in combination with HANQUYOU, further strengthening Henlius’ market position and competitiveness in the HER2 breast cancer treatment field while providing patients with more comprehensive and effective treatment options. The phase 3 international multicenter clinical trial of company’s self-developed innovative anti-HER2 mAb HLX22, has recently completed its first patient dosing in China. It is expected to further improve treatment outcomes for patients with HER2-positive gastric cancer, leading to better survival benefits. Going forward, Henlius will remain dedicated to oncology, continuously enriching and optimising its product pipeline to offer patients a broader range of high-quality, accessible and affordable treatment options. Reference [1] https://www-who-int.libproxy1.nus.edu.sg/news/item/01-02-2024-global-cancer-burden-growing–amidst-mounting-need-for-services. [2] Bingfeng Han, Rongshou Zheng, Hongmei Zeng, Shaoming Wang, Kexin Sun, Ru Chen, Li Li, Wenqiang Wei, Jie He, Cancer incidence and mortality in China, 2022, Journal of the National Cancer Center, 2024. [3] Kang S,Lee SH,Lee HJ,et al.Pathological complete response,long-term outcomes,and recurrence patterns in HER2-low versus HER2-zero breast cancer after neoadjuvant chemotherapy. Eur J Cancer.2022 Sep 29;176:30-40. [4] Agus DB, Akita RW, Fox WD, et al. Targeting ligand-activated ErbB2 signaling inhibits breast and prostate tumor growth. Cancer Cell 2002; 2: 127–37 SOURCE: Henlius Biotech

Phase 3Drug ApprovalNDAPhase 1Clinical Result

05 Dec 2024

·www.prnewswire.com

MEDSIR showcases the DEMETHER Study: advancing therapeutic de-escalation and more effective treatments for advanced breast cancer

The DEMETHER trial, whose principal investigator is Dr. Javier Cortés, explores an innovative therapeutic de-escalation strategy for patients with previously untreated HER2-positive advanced breast cancer. New therapeutic perspectives for brain metastases: the PHENOMENAL and TUXEDO-4 studies in metastatic breast cancer Additionally, a total of five studies are being presented at San Antonio Breast Cancer Symposium 2024, strengthening its global leadership in oncology innovation and research. SAN ANTONIO, Dec. 5, 2024 /PRNewswire/ -- MEDSIR, a leading company dedicated to advancing independent clinical research in oncology on an international level and part of Oncoclínicas & Co, the largest oncology treatment group in Latin America with significant strength in the clinical and outpatient setting, will participate in the prestigious San Antonio Breast Cancer Symposium 2024 (SABCS) with the presentation of five innovative studies, including one of particular significance in advanced breast cancer: the DEMETHER study. These landmark studies demonstrate remarkable progress in the development of more personalized and less invasive therapies, offering the potential to enhance patients' quality of life and redefine the treatment approach for advanced breast cancer. The DEMETHER clinical trial explores an innovative treatment strategy for previously untreated HER2-positive advanced breast cancer. The study employs a dual-phase approach, beginning with an induction phase using trastuzumab deruxtecan (T-DXd), followed by a maintenance phase with subcutaneous administration of trastuzumab and pertuzumab. This strategy aims to prolong progression-free survival, improve overall survival rates at three years, and provide enhanced safety and quality of life compared to standard treatments. By offering an alternative to conventional chemotherapy and prolonged T-DXd administration, DEMETHER aims to redefine therapeutic de-escalation. This strategy seeks to minimize the side effects associated with traditional therapies, thereby significantly improving patients' quality of life. Furthermore, it underscores a commitment to making advanced breast cancer treatments more accessible, less invasive, and patient centered. 23 active centers in 4 countries and several Highly Cited Researchers 2024 The trial is currently being conducted at 23 active centers across the United States, Spain, Italy and Germany. Additionally, the study benefits from the involvement of leading international researchers renowned for their excellence. Among them are several scientists featured in the Highly Cited Researchers 2024 list by Clarivate, including Dr. Javier Cortés, Dr. Hope Rugo, Dr. Nadia Harbeck, Dr. Sara M. Tolaney, and Dr. Peter Schmid, whose expertise and contributions bring exceptional value to the project. The DEMETHER study seeks to further advance personalized medicine, exploring less invasive, safer, and potential more effective alternatives to conventional treatments. "This study reflects the collaborative efforts of international experts, leading centers, the pharmaceutical industry and MEDSIR in designing therapeutic strategies that enhance patients' quality of life through treatment de-escalation." highlights Dr. Javier Cortés, principal investigator of the DEMETHER study. New therapeutic options for patients with metastatic breast cancer: exploring advances in brain metastases with PHENOMENAL and TUXEDO-4 Both the PHENOMENAL and TUXEDO-4 studies presented at SABCS are particularly relevant as they address a critical and historically underserved population: patients with metastatic breast cancer (MBC) and brain metastases (BMs). BMs occur in up to 25% of patients with MBC 1, significantly impacting prognosis and quality of life. These studies stand out by exploring innovative therapeutic strategies tailored to overcome the unique challenges of treating brain metastases. The PHENOMENAL study focuses on nanoliposomal irinotecan, Nal-IRI, to enhance drug delivery to brain tumors while reducing systemic toxicity. Meanwhile, the TUXEDO-4 study investigates the use of T-DXd, a novel antibody-drug conjugate targeting HER2-low tumors, with the goal of achieving meaningful intracranial tumor shrinkage. An innovative therapeutic regimen with the potential to expand treatment options and improve the quality of life for patients with advanced breast cancer The Phase III ADELA study, in collaboration with the MENARINI Group, explores new perspectives in the treatment of advanced ER+ and HER2-negative breast cancer, specifically in patients with mutations in the ESR1 gene whose cancer has progressed after receiving standard first-line of therapy. This gene produces estrogen receptor proteins that can stimulate the growth of this type of breast cancer. ADELA has the potential, if successful, to pave the way for regulatory approval of this therapeutic combination, making it accessible to a broader patient population. In addition to this study, MEDSIR is presenting the PRIMED trial, which evaluates the efficacy of prophylactic administration of granulocyte colony-stimulating factor (G-CSF) and loperamide during the initial treatment cycles of sacituzumab govitecan (SG) therapy to mitigate the incidence of neutropenia and diarrhea, aiming to enhance treatment tolerability and patient safety. The presentation of these results at an event of SABCS 2024's magnitude not only positions MEDSIR as a leader in oncology research excellence but also highlights its ability to lead transformative projects addressing unmet needs in breast cancer treatment. References: Le Rhun E, et al. Ann Oncol. 2021;32(11):1332-1347 About MEDSIR   Established in 2012, MEDSIR prides itself on working closely with its strategic partners to drive innovation in oncology research. Operating in Spain and the United States, the company provides end-to-end clinical trial management, from study design to publication, with an extensive global network of experts and integrated technology to streamline the process. The company offers proof-of-concept support and a strategic approach that enables research partners to benefit from the best of both worlds: industry clinical research and investigator-driven trials.   With the aim of promoting independent research worldwide, MEDSIR has formed a strategic alliance with Oncoclínicas, the leading oncology group in Brazil, which offers outstanding research potential in South America.   For further information:     About Oncoclínicas & CO   Oncoclínicas & Co is the largest group dedicated to cancer treatment in Latin America, with a specialized and innovative model focused on the entire oncology care journey, combining operational efficiency, humanized care, and high specialization through a medical team composed of over 2,700 specialist physicians with an emphasis on oncology. With its mission to democratize cancer treatment, it offers a comprehensive system that integrates outpatient clinics with high-complexity cancer centers. The company operates 145 units across 39 Brazilian cities, allowing high-quality access in all regions it serves, aligned with world-class standards.  Focusing on technology, precision medicine, and genomics, Oncoclínicas performed approximately 635,000 treatments in 2023. It is the exclusive partner in Brazil of the Dana Farber Cancer Institute, affiliated with Harvard Medical School, one of the world's leading cancer research and treatments centers. The company also owns Boston Lighthouse Innovation, a bioinformatics firm based in Cambridge, United States, and holds shares in Medsir, a company dedicated to the development and management of clinical trials for independent cancer research, based in Barcelona, Spain. Recently, Oncoclínicas expanded its operations to Saudi Arabia through a joint venture with the Al Faisaliah Group, bringing its mission to beat cancer to a new continent and providing advanced oncology care on a global scale by combining oncological hyperspecialization with innovative treatment approaches.  The company is part of the IDIVERSA index, launched by B3, highlighting companies committed to gender and racial diversity. For more information, visit:    SOURCE MEDSIR WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

100 Deals associated with Pertuzumab

External Link

KEGG	Wiki	ATC	Drug Bank
D05446	Pertuzumab	L01XC13	DB06366

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	JP	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Early Stage Breast Carcinoma	AU	Roche Products Pty Ltd.	06 May 2013
Breast Cancer	US	Genentech, Inc.	08 Jun 2012
HER2 Positive Breast Cancer	US	Genentech, Inc.	08 Jun 2012
Metastatic breast cancer	US	Genentech, Inc.	08 Jun 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Colorectal Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Gallbladder Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Hematologic Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Lung Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Ovarian Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Pancreatic Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Prostatic Cancer	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023
Skin Neoplasms	Phase 3	GB	Hoffmann-La Roche, Inc.	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03365882 (S1613, Pubmed) Manual	Phase 2	RAS/BRAF Wild Type HER2 Positive Colorectal Cancer Second line \| Third line HER2 Positive	54	Trastuzumab plus Pertuzumab	xqklnalwmd(tmqnuqwzdg) = dcghxepbtn zkvzitsqbb (qmgvmsyozv, 1.9 - 7.6) View more	Positive	06 Jan 2025
				Cetuximab plus Irinotecan	xqklnalwmd(tmqnuqwzdg) = mfvhbeapvj zkvzitsqbb (qmgvmsyozv, 1.6 - 6.7) View more
NCT05275010 (CTgov)	Phase 1	-	151	Handheld Syringe+Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (Arm 1: PH FDC SC Using a Handheld Syringe)	dvqwzfcxiv(ggskbkbivj) = tbmbxmbyds hsyhwiyrzb (fvomwnpggt, jxntgmahfl - kwtunlnrzb) View more	-	23 Sep 2024
				On-Body Delivery System (Arm 2: PH FDC SC Using the OBDS)	dvqwzfcxiv(ggskbkbivj) = ldciaftwkh hsyhwiyrzb (fvomwnpggt, ycqonhvmnn - qqucwgcqii) View more
ESMO2024	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2	339	TCH	zzprqhqutq(wkcfcowaum) = yfyrqvqslf allvfcukba (dgcjxmdwum )	Negative	16 Sep 2024
				TCHP	zzprqhqutq(wkcfcowaum) = tnryyfhyxw allvfcukba (dgcjxmdwum )
NCT02091141 (MyPathway, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm \| Bladder Cancer \| Biliary Tract Neoplasms ... View more	673	Trastuzumab+Pertuzumab (Trastuzumab Plus Pertuzumab)	pwunoxtoak(swdaxmmdle) = dmkhjmigah rapvmkuiyp (ulmylhtnir, nuqtyznuyr - vxjbzwjeki) View more	-	23 Jul 2024
				atezolizumab (Atezolizumab)	pwunoxtoak(swdaxmmdle) = maixtdtmym rapvmkuiyp (ulmylhtnir, emtqkjpwlv - yqvferjlta) View more
NCT06136897 (CTgov)	Phase 2	Malignant Solid Neoplasm	35	Radiologic Examination+Trastuzumab+pertuzumab	nezguubepl(moovzgtgzu) = vtqaermeft sldcsgkxdi (oxjkepmwhd, bviduwhbjc - jfkftlweem) View more	-	25 Jun 2024
NCT03498521 (CUPISCO, CTgov)	Phase 2	Neoplasms	528	platinum (Molecularly-Guided Therapy MGT) Category 1)	ugwzjirbra(qawwxlkxrv) = qvwetguqqg pirjiigdjj (qrhumtthwa, hdawpznanh - vzacdrqgvk) View more	-	14 Jun 2024
				platinum (Chemotherapy Category 1)	ugwzjirbra(qawwxlkxrv) = vykdeouxqt pirjiigdjj (qrhumtthwa, itmqfovbpa - kocyglrrkg) View more
NCT05749016 (ASCO2024) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma Neoadjuvant HER2 Positive	28	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (TCbIP)	xtgdapjadk(dnbttfshkj) = wgltxposcd wfnqeygmak (mpfxemfgsb ) View more	Positive	24 May 2024
				Trastuzumab + Pertuzumab + Paclitaxel + Carboplatin (TCbHP)	xtgdapjadk(dnbttfshkj) = wuifwfraux wfnqeygmak (mpfxemfgsb ) View more
JPRN-UMIN000027938 \| JPRN-jRCTs021180027 \| NCT03264547 (EMERALD, ASCO 12024 \| ASCO 22024) Manual	Phase 3	HER2 Positive Breast Cancer First line HER2 Positive	446	Eribulin + HP	zwtvvtgdrt(xrmrdhknij) = cudxnkxraj swqeosimxn (diqawsbaoz ) View more	Positive	24 May 2024
				Docetaxel/paclitaxel + HP	zwtvvtgdrt(xrmrdhknij) = ibihnlghss swqeosimxn (diqawsbaoz ) View more
NCT04538742 (DESTINY-Breast07, ASCO2024) Manual	Phase 1/2	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2 Positive	130	T-DXd 5.4 mg/kg	cgzbxexdta(nosvthykyw) = conowupnix gptqhclmpf (icsqtymuhf ) View more	Positive	24 May 2024
				T-DXd 5.4 mg/kg + pertuzumab 420 mg	cgzbxexdta(nosvthykyw) = tyamrqymst gptqhclmpf (icsqtymuhf ) View more
NCT02693535 (TAPUR, ASCO2024)	Phase 2	Advanced Malignant Solid Neoplasm \| Multiple Myeloma ERBB2 \| ERBB3	28	Pertuzumab plus trastuzumab (P+T)	nqxhotgktc(xgbwdjhzto) = laqldybuej zrqlmzytnj (imogueucaj, 43 - 100)	Positive	24 May 2024

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