Last update 14 Dec 2024

Pertuzumab

Last update 14 Dec 2024

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

NeoplasmsSkin and Musculoskeletal DiseasesDigestive System Disorders+ [4]

Active Indication

HER2 Positive Colorectal CancerEarly Stage Breast CarcinomaBreast Cancer+ [19]

Inactive Indication

Advanced breast cancerAdvanced Lung Non-Small Cell CarcinomaAdvanced Neuroendocrine Carcinoma+ [17]

Originator Organization

Genentech, Inc.

Active Organization

Hoffmann-La Roche, Inc.Roche Diagnostics GmbH

Shanghai Roche Pharmaceuticals Ltd.

+ [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)

Gene Sequence

Sequence Code 18492L

Source: *****

Sequence Code 18505H

Source: *****

259

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

NCT06348134 / Not yet recruitingPhase 2IIT

Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer

Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.

Start Date01 Jan 2025

Sponsor / Collaborator

The University of Chicago

NCT06686394 / Not yet recruitingPhase 1/2

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:
* About the safety and how well people tolerate of patritumab deruxtecan
* How many people have the cancer respond (get smaller or go away) to treatment

Start Date19 Dec 2024

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

[+1]

100 Clinical Results associated with Pertuzumab

100 Translational Medicine associated with Pertuzumab

100 Patents (Medical) associated with Pertuzumab

1,681

Literatures (Medical) associated with Pertuzumab

01 Jan 2025·CLINICAL ONCOLOGY

Switching to a Fixed-dose Combined Pertuzumab and Trastuzumab With Recombinant Human Hyaluronidase Subcutaneous Injection to Treat Human Epidermal Growth Factor Receptor 2-positive Breast Cancer in Real-world UK Clinical Practice

Article

Author: Borley, Annabel ; Harding, S ; Borley, A. ; Borley, A ; Harding, Sophie ; Harding, S.

AIM:

A UK cancer centre set out to switch all patients currently receiving IV infusion of pertuzumab and trastuzumab over to the combined SC injection in a safe and timely manner and to initiate all future patients on the combined SC injection.

MATERIALS AND METHODS:

Organisational governance approval was obtained before a novel project model approach was used to implement the treatment switch which incorporated aspects such as education and multidisciplinary team collaboration.

RESULTS:

Of the 97 eligible patients, 99% were switched to the combined SC injection safely and effectively over a 4-week period. Between 1st April 2021 and 30th September 2022, 3062 hours of pharmacy aseptic preparation time and 6764 hours of day unit chair time were saved. The number of aseptic unit operation days above the maximum capacity was reduced post-switch.

CONCLUSION:

This initiative demonstrated the ability to rapidly and effectively transition >95% of eligible breast cancer patients from separate IV trastuzumab and pertuzumab to a fixed combined SC formulation. Patient benefits included shorter administration appointments and a less invasive form of treatment, whereas healthcare system benefits included substantial savings in aseptic preparation time and chair time, and a meaningful increase in clinic capacity. The reported treatment-switch process provides a model that can be adopted by other centres wishing to implement similar treatment switches.

31 Dec 2024·mAbs

Anti-HER2 biparatopic antibody KJ015 has near-native structure, functional balanced high affinity, and synergistic efficacy with anti-PD-1 treatment in vivo

Article

Author: Liu, Yu ; Wu, Peican ; Liu, Chendan ; Fang, Xin ; Lou, Junwen ; Tang, Yao ; Xu, Yunxia ; Wang, Zheng ; Lu, Lin ; Hu, Ying ; Liu, Yanjun ; Wang, Jinhua ; Lv, Baojie ; Zhu, Zhen ; Xu, Qing ; Zeng, Xin ; Cheng, Yu

Currently approved human epidermal growth factor receptor 2 (HER2)-targeted antibody therapies are largely derived from trastuzumab, including trastuzumab-chemotherapy combinations, fixed-dose trastuzumab-pertuzumab combinations, and trastuzumab antibody-drug conjugates. To expand the options, bispecific antibodies, which may better utilize the benefits of combination therapy, are being developed. Among them, biparatopic antibodies (bpAbs) have shown improved efficacy compared to monoclonal antibody (mAb) combinations in HER2-positive patients. BpAbs bind two independent epitopes on the same antigen, which allows fine-tuning of mechanisms of action, including enhancement of on-target specificity and induction of strong antigen clustering due to the unique binding mode. To fully utilize the potential of bpAbs for anti-HER2 drug development, it is crucial to consider formats that offer stability and high-yield production, along with a functional balance between the two epitopes. In this study, we rationally designed a bpAb, KJ015, that shares a common light chain with two Fab arms and exhibits functionally balanced high affinity for two HER2 non-overlapping epitopes. KJ015 demonstrated high-expression titers over 7 g/L and stable physicochemical properties at elevated concentrations, facilitating subcutaneous administration with hyaluronidase. Moreover, KJ015 maintained comparable antibody-dependent cytotoxicity, phagocytosis, and complement-dependent cytotoxicity with trastuzumab plus pertuzumab. It exhibited enhanced synergy when administered subcutaneously with hyaluronidase and anti-PD-1 mAb in a mouse tumor model, suggesting promising clinical prospects for this combination.

01 Dec 2024·Clinical Breast Cancer

Why Do You Treat pCR Patient With Pertuzumab and Trastuzumab?

Article

Author: Staropoli, Nicoletta ; Sanò, Maria Vita

113

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
Solid tumor	Phase 3	CN	Hoffmann-La Roche, Inc.	02 Feb 2015
Solid tumor	Phase 3	JP	Roche China Holding Ltd.	02 Feb 2015
Solid tumor	Phase 3	JP	Hoffmann-La Roche, Inc.	02 Feb 2015
Solid tumor	Phase 3	BR	Hoffmann-La Roche, Inc.	02 Feb 2015
Solid tumor	Phase 3	BR	Roche China Holding Ltd.	02 Feb 2015
Solid tumor	Phase 3	CR	Hoffmann-La Roche, Inc.	02 Feb 2015
Solid tumor	Phase 3	CR	Roche China Holding Ltd.	02 Feb 2015
Solid tumor	Phase 3	FR	Roche China Holding Ltd.	02 Feb 2015
Solid tumor	Phase 3	FR	Hoffmann-La Roche, Inc.	02 Feb 2015
Solid tumor	Phase 3	DE	Roche China Holding Ltd.	02 Feb 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05275010 (CTgov)	Phase 1	-	151	Handheld Syringe+Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (Arm 1: PH FDC SC Using a Handheld Syringe)	aweicxfhbd(yzkizudirp) = bertjzkgru zmwbxuwarm (vrwjuteaiz, hxheximvtw - vsbxloqiuy) View more	-	23 Sep 2024
				On-Body Delivery System (Arm 2: PH FDC SC Using the OBDS)	aweicxfhbd(yzkizudirp) = iwyzqmovrb zmwbxuwarm (vrwjuteaiz, ixmltcuxoz - qgcnzqfcwd) View more
ESMO2024	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2	339	TCH	fnmcjqoxly(bbiyoqbwuv) = dgtgjukhhc wvfqgqkmzo (ijmbkgliby )	Negative	16 Sep 2024
				TCHP	fnmcjqoxly(bbiyoqbwuv) = uazzfnpibt wvfqgqkmzo (ijmbkgliby )
NCT02091141 (MyPathway, CTgov)	Phase 2	Advanced Malignant Solid Neoplasm \| Bladder Cancer \| Biliary Tract Neoplasms ... View more	673	Trastuzumab+Pertuzumab (Trastuzumab Plus Pertuzumab)	qqtcvhntpi(lduaazfqge) = ehosrrqgvt dcbronavkm (qszzynwmhs, rxjgmzzjtu - gnlxusjyys) View more	-	23 Jul 2024
				atezolizumab (Atezolizumab)	qqtcvhntpi(lduaazfqge) = xztnnjbcpp dcbronavkm (qszzynwmhs, apvgirmouk - zwruoelftg) View more
NCT03498521 (CUPISCO, CTgov)	Phase 2	Neoplasms	528	platinum (Molecularly-Guided Therapy MGT) Category 1)	nlzscdfrsy(obrqtibjfk) = xmemcwsfln tiysttbhgx (hjrumjvrmc, xlcmriyjkl - oqdyrifsie) View more	-	14 Jun 2024
				platinum (Chemotherapy Category 1)	nlzscdfrsy(obrqtibjfk) = sruumuzrwi tiysttbhgx (hjrumjvrmc, sklcsittjp - mkqfqkjwrx) View more
NCT03716180 (DAPHNe, ASCO2024)	Phase 2	HER2 Positive Breast Cancer Neoadjuvant ctDNA+	98	Neoadjuvant THP	wdpnxejkuu(mscbrtvfuk) = dmyobqmlbj gskupsgglv (sqngzmksoa )	Positive	24 May 2024
JPRN-UMIN000030783 (JCOG1607 HERB TEA, ASCO2024)	Phase 3	Advanced HER2-Positive Breast Carcinoma First line	148	Trastuzumab emtansine (T-DM1)	rmlozaorcw(fzrnkhswqo) = zspakllvhi bfndwuozbr (ghdjdohyvt, 0.310 - 1.808)	Negative	24 May 2024
ASCO2024	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 positive \| estrogen receptor \| progesterone receptor	-	Pertuzumab, Docetaxel, and Trastuzumab (PTH) regimen	cswjnkkyhy(kiqmxlvjcf) = ldagkwnklv vmfiyuqgwh (sypmencenj ) View more	Positive	24 May 2024
NCT03417544 (CTgov)	Phase 2	Neoplasm Metastasis \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	19	Trastuzumab+Pertuzumab+atezolizumab	arzboupuyy(ozhaoyvqif) = qjcpdcuxez yggkewhkyw (lvjcrmhhwx, vrutgxiucu - hiroxjvmsu) View more	-	07 May 2024
NCT03161353 (PHERGain, AACR2024) Manual	Phase 2	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	14	trastuzumabPerjetauHerceptin (HER2DX low-risk in RD)	akelfkbgmm(bunrnoqsyf) = dpxmqslimp pnyksivjos (ifmoxiluqf )	Positive	22 Mar 2024
				Perjeta+Herceptin+Endocrine therapy (developed distant recurrences)	mocuussesg(ookyqgqkdn) = qkpvcjxppw qltxymzaqp (gwryojsfqf ) View more
NCT05749016 (ESMO2023) Manual	Phase 2	Locally advanced breast cancer Neoadjuvant HER2-positive	23	Inetetamab + Pertuzumab + Paclitaxel + Carboplatin	mbtsyuzokz(durtbvdzgr) = cvhnpsrpcr pphywhpttl (qrnzksjhlz )	Positive	21 Oct 2023
				Inetetamab + Pertuzumab + Paclitaxel + Carboplatin (completed the study treatment and surgery)	dmxyrtervz(ryxuglqfki) = gakmlhuqdt ccesarctwf (wjtfapcian ) View more

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