The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.

开始日期2024-02-01

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+2]

NCT03820063 / Active, not recruiting临床2期IIT

Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study

This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer.

开始日期2019-02-27

申办/合作机构

Roche Pharma AG

NCT03595592 / Active, not recruiting临床3期

Atezolizumab, Pertuzumab and Trastuzumab With Chemotherapy as Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer (APTneo)

n the present study the neoadjuvant approach with the anti-HER2 trastuzumab and pertuzumab combined with carboplatin and paclitaxel will be used to compare the Event-Free Survival (EFS) in regimens with and without atezolizumab. Following the neoadjuvant part of the study, after surgery all patients will continue to receive trastuzumab and pertuzumab to complete one year of anti-HER2 therapy. Similarly, patients allocated to receive atezolizumab will continue atezolizumab to complete one year In addition, several IHC and molecular assays will be performed before and during the period of chemotherapy administration and at surgery with the goal of defining a marker of efficacy to be later validated in a larger adjuvant setting.

开始日期2018-09-07

申办/合作机构

Fondazione Child

[+1]

100 项与曲妥珠单抗生物类似药（Biocon）相关的临床结果

登录后查看更多信息

100 项与曲妥珠单抗生物类似药（Biocon）相关的转化医学

登录后查看更多信息

100 项与曲妥珠单抗生物类似药（Biocon）相关的专利（医药）

登录后查看更多信息

项与曲妥珠单抗生物类似药（Biocon）相关的文献（医药）

2023-02-01·The American journal of managed care

Evaluation of biosimilar trastuzumab MYL-1401O in HER2-positive breast cancer.

Article

作者: Kadir Eser ; Emel Sezer ; Vehbi Erçolak ; Ali İnal

OBJECTIVES:

The trastuzumab biosimilar MYL-1401O has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) as HER2 monotherapy.

STUDY DESIGN:

Here, we present the first real-world comparison of MYL-1401O vs RTZ as single/dual HER2-targeted therapy for the neoadjuvant, adjuvant, and palliative treatment of HER2-positive breast cancer in the first and second lines.

METHODS:

We retrospectively investigated medical records. We identified patients with HER2-positive early-stage breast cancer (EBC) (n = 159) who had received neoadjuvant chemotherapy with RTZ or MYL-1401O ± pertuzumab (n = 92) or adjuvant chemotherapy with RTZ or MYL-1401O plus taxane (n = 67) between January 2018 and June 2021, as well as patients with MBC (n = 53) who had received palliative first-line treatment with RTZ or MYL-1401O and docetaxel ± pertuzumab or second-line treatment with RTZ or MYL-1401O and taxane between January 2018 and June 2021.

RESULTS:

The rate of achieving pathologic complete response in patients receiving neoadjuvant chemotherapy was similar between those receiving MYL-1401O and RTZ (62.7% [37/59] and 55.9% [19/34], respectively; P = .509). Progression-free survival (PFS) at 12, 24, and 36 months was similar in the 2 cohorts of the EBC-adjuvant group: 96.3%, 84.7%, and 71.5%, respectively, in patients receiving MYL-1401O, and 100%, 88.5%, and 64.8% in patients receiving RTZ (P = .577). Median PFS was also similar in MBC, at 23.0 months (95% CI, 9.8-26.1) in patients receiving MYL-1401O and 23.0 months (95% CI, 19.9-26.0) in patients receiving RTZ (P = .270). The overall response rate, disease control rate, and cardiac safety profiles did not show significant differences in efficacy outcomes between the 2 groups.

CONCLUSIONS:

These data suggest that biosimilar trastuzumab MYL-1401O has similar effectiveness and cardiac safety to RTZ in patients with HER2-positive EBC or MBC.

2022-06-22·Immunopharmacology and immunotoxicology

Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis.

Review

作者: Tong Liu ; Duo Liu ; Yao Jin ; Mei Dong

AIM:

Breast cancer is the most frequently diagnosed cancer in women and ranks second among causes for cancer related death in women. Trastuzumab originator (Herceptin) is a monoclonal antibody used as a standard treatment for breast and metastatic gastric cancer when the cancer cells over-express human epidermal growth factor receptor type 2 (HER2). As the patent of Trastuzumab has now expired, biosimilars are moving into the market. It is still controversial to chose which trastuzumab biosimilar has the best treatment of HER2-positive breast cancer patients. We conducted this network meta-analysis to explore the best trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

METHODS:

PubMed, Cochrane library databases, China National Knowledge infrastructure (CNKI) and WanFang database up to November 2021 were systematically searched. The following search terms were used: 'trastuzumab originator', and 'trastuzumab biosimilar'. No language restriction was imposed. The reference lists of all retrieved articles were also reviewed to identify additional articles missed by using these search terms.

RESULTS:

We got 10 studies to conduct network meta-analysis to evaluate efficacy and serious adverse reactions among various trastuzumab biosimilars and trastuzumab originator. The overall response rate (ORR) and pathological complete response (pCR) of SB3 were worse than trastuzumab originator significantly, while the ORR and pCR of other trastuzumab biosimilars had not yet reached statistical differences compared with each other. The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3. The serious adverse events (SAEs) of CT-P6 were more than Herceptin and MYL-1401O significantly, while the SAEs of other trastuzumab biosimilars had not statistical differences. The SUCRA probability indicated that the SAEs from best to worst was MYL-1401O, Herceptin, PF-05280014, SB3, HLX02, BCD-22, CT-P6.

CONCLUSION:

There was no statistical difference in both ORR and pCR of various trastuzumab biosimilars and Herceptin except SB3. The ORR and pCR of SB3 were worse than Herceptin. Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.

2022-06-11·Current oncology (Toronto, Ont.)

A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab.

Review

作者: Charlie Yang ; Raida Khwaja ; Patricia Tang ; Nancy Nixon ; Karen King ; Sasha Lupichuk

The reduced cost of trastuzumab biosimilars has led to increased adoption for HER2-positive breast cancer. This review of trastuzumab biosimilars encompasses this development and real world clinical data in early breast cancer. In addition, we present a retrospective study evaluating the total pathological complete response (tpCR) rates (lack of residual invasive cancer in resected breast tissue and axillary nodes), of MYL-1401O to reference trastuzumab (TRZ) in the neoadjuvant setting for HER2+ early breast cancer (EBC) in Alberta, Canada. Neoadjuvant patients with HER2+ EBC treated with TRZ from November 2018-October 2019 and MYL-1401O from December 2019-September 2020 were identified. Logistic regression was used to control for variables potentially associated with tpCR: trastuzumab product, age, pre-operative T- and N-stage, grade, hormone receptor (HR)-status, HER2-status, chemotherapy regimen, and chemotherapy completion. tpCR was 35.6% in the MYL-1401O group (n = 59) and 40.3% in the TRZ (n = 77) group, p = 0.598. After controlling for clinically relevant variables, there was no significant difference in the odds of achieving tpCR in patients treated with TRZ versus MYL-1401O (OR 1.1, 95% CI 0.5-2.4, p = 0.850). tpCR rates were similar for patients treated with MYL-1401O compared to trastuzumab in our real world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials.

项与曲妥珠单抗生物类似药（Biocon）相关的新闻（医药）

2024-02-09

·PRNewswire

Biocon Biologics Partners with Sandoz Australia for Biosimilars Trastuzumab and Bevacizumab

BENGALURU, India, Feb. 8, 2024 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced a five-year partnership with Sandoz AG ('Sandoz') which provides Sandoz the exclusive rights to promote, sell and distribute biosimilar Trastuzumab (market value of AUD$35 million1) and biosimilar Bevacizumab (market value of AUD$45 million2) in Australia. Under the agreement, Sandoz will distribute the Biocon Biologics' brands, OGIVRI® (bTrastuzumab) and ABEVMY® (bBevacizumab), and facilitate the sustained access of these medications that were previously distributed by another pharmaceutical company to patients in Australia. Trastuzumab is a biosimilar of Herceptin® and Bevacizumab is a biosimilar of Avastin®3 – both biosimilars are available on the PBS and utilised for the treatment of various cancers. The agreement is effective from January 1, 2024 and commercialisation commenced on February 1, 2024. Matt Erick, Chief Commercial Officer of Advanced Markets, Biocon Biologics Ltd, said: "Following the recent establishment of our strategic partnership with Sandoz in Japan, our agreement with Sandoz in Australia marks another important milestone of our global partnership and growth strategy. This relationship is also a crucial step for patients in Australia, ensuring continued access to high-quality, affordable biosimilar medicines used in oncology." 1 IQVIA MAT 2023 2 IQVIA MAT 2023 3 Australian Government, Department of health; Pharmaceutical Benefits Scheme – Biosimilar Bevacizumab. Accessed 24/1/2024 from OGIVRI® and ABEVMY® are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company. All other trademarks, registered or unregistered, are the property of their respective owners. About Biocon Biologics Limited: Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., is a unique, fully integrated, global biosimilars company committed to transforming healthcare and transforming lives by enabling affordable access to high quality biosimilars for millions of patients worldwide. It is leveraging cutting-edge science, innovative tech platforms, global scale manufacturing capabilities and world-class quality systems to lower costs of biological therapeutics while improving healthcare outcomes. BBL has acquired the global biosimilars business of its long-standing partner Viatris, which is a historic milestone in its value creation journey. Biocon Biologics has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., EU, Australia, Canada, Japan. The Company has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, and other non-communicable diseases. It has many 'firsts' to its credit in the biosimilars industry. As part of its environmental, social and governance (ESG) commitment, BBL is advancing the health of patients, people, and the planet to achieve key UN Sustainable Development Goals (SDGs). Website: ; Follow us on Twitter: @BioconBiologics for company updates. Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: ; Follow us on Twitter: @bioconlimited for company updates. Forward-Looking Statements: Biocon This press release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs concerning future developments and their potential effects upon Biocon and its subsidiaries/ associates. These forward-looking statements involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from our expectations include, amongst other: general economic and business conditions in India and overseas, our ability to successfully implement our strategy, our research and development efforts, our growth and expansion plans and technological changes, changes in the value of the Rupee and other currency changes, changes in the Indian and international interest rates, change in laws and regulations that apply to the Indian and global biotechnology and pharmaceuticals industries, increasing competition in and the conditions of the Indian and global biotechnology and pharmaceuticals industries, changes in political conditions in India and changes in the foreign exchange control regulations in India. Neither Biocon, nor our Directors, or any of our subsidiaries/associates assume any obligation to update any particular forward-looking statement contained in this release. SOURCE Biocon Biologics Ltd.

引进/卖出并购免疫疗法生物类似药

2023-12-18

·美通社

Biocon Biologics 完成其在约 120 个国家/地区所收购的生物仿制药业务的整合

超过 10 个新兴市场、日本、澳大利亚和新西兰的过渡进程已进入最终阶段马来西亚吉隆坡 2023年12月18日 /美通社/ -- 作为一家独特的全球生物仿制药一体化企业， Biocon Biologics 有着广泛的胰岛素和单克隆抗体产品组合。该公司已成功完成对收购的 Viatris 生物仿制药业务的整合，其在超过 10 个新兴市场以及日本、澳大利亚及新西兰的过渡进程已进入最终阶段。 PFA the banner image 包括 Ogivri® 和 Hertraz® (bTrastuzumab)、Abevmy® (bBevacizumab)、Fulphila® (bPegfilgrastim)、Hulio® (bAdalimumab)、Nepexto® (bEtanercept)、Semglee® (bGlargine) 及 Kirsty® (bAspart) 在内的 Viatris 旗下所有生物仿制药品牌现已整合到 Biocon Biologics 在高级市场和 80 多个新兴市场的商业特许经营业务中。这些产品主要由 Biocon Biologics 开发，并在其位于印度和马来西亚的世界级工厂进行生产。目前，Biocon Biologics 在约 120 个国家/地区建立了强大的商业品牌，其直接业务覆盖美国、加拿大、欧洲，以及印度、阿联酋、沙特阿拉伯、摩洛哥、南非、巴西、马来西亚、泰国和菲律宾等 9 个主要新兴市场国家/地区。 "能够完成我们在 120 个国家/地区所收购业务的成功整合，我感到极为自豪和激动。过渡最终阶段的完成是 Biocon Biologics 向全球一体化公司转型的重大里程碑及标志。我对整个 Biocon Biologics 团队——同事、顾问及合作伙伴表示祝贺和感谢。提前完成无缝过渡，要归功于我们对患者和业务持续性的不懈关注、持续努力和坚定承诺。"—— 首席行政官兼行销总监 Shreehas Tambe 表示。 "我们的团队将借助这一重要里程碑所带来的独特机遇，将 Biocon Biologics 品牌直接推向众多市场。该自主引导的商业模式将使我们与患者、卫生部门、处方医师和付费人之间的联系更加密切。这将使我们有能力以经济实惠的价格为更多患者群体服务，同时为新兴市场的医疗保健系统大幅节约成本，从而实现高品质生物仿制药的公平获取。"—— 新兴市场首席商务官 Susheel Umesh 表示。 Biocon Biologics 已经进行了多项关键领导层任命，重新构建了新的能力和基础设施，并成立了专业化团队，利用自主经营和合作伙伴或分销商主导的商业模式，以满足患者和客户日益增长的需求，确保患者、处方医师、合作伙伴和医疗保健系统之间业务连续性。网站： www.bioconbiologics.com；Twitter： @BioconBiologics；LinkedIn： Biocon Biologics

并购

2023-12-18

·PRNewswire

Biocon Biologics Concludes Integration of Acquired Biosimilars Business in ~120 countries

10+ Emerging Markets, Japan & ANZ Transition in Final Phase DUBAI, UAE, Dec. 18, 2023 /PRNewswire/ -- Biocon Biologics, a unique, fully integrated, global biosimilars company with a rich portfolio of insulins and monoclonal antibodies, has successfully concluded the integration of the acquired Viatris biosimilars business with the transition of 10+ Emerging Markets and Japan, Australia and New Zealand in the final phase. Continue Reading PFA the banner image (PRNewsfoto/Biocon Biologics Ltd) All Viatris' biosimilars brands, including Ogivri® & Hertraz® (bTrastuzumab), Abevmy® (bBevacizumab), Fulphila® (bPegfilgrastim), Hulio® (bAdalimumab), Nepexto® (bEtanercept), Semglee® (bGlargine) and Kirsty® (bAspart) are now part of Biocon Biologics' commercial franchise in Advanced Markets and 80+ Emerging Markets. Most of these products have been developed by Biocon Biologics and are being manufactured at its world-class facilities in India and Malaysia. Biocon Biologics will now have a strong commercial footprint across ~120 countries with a direct presence in the U.S., Canada, Europe and 9 key Emerging Market countries of India, UAE, Saudi Arabia, Morocco, South Africa, Brazil, Malaysia, Thailand, and the Philippines. "I am very proud and excited that we have successfully completed the integration of the acquired business across 120 countries. The conclusion of this final wave of transition is a significant milestone and marks the beginning of Biocon Biologics' transformation to a fully integrated global company. I congratulate and thank the entire Biocon Biologics team – colleagues, advisors, and partners. This seamless transition, achieved ahead of schedule, is an outcome of relentless focus, untiring efforts and an unwavering commitment to patients and business continuity." - Shreehas Tambe, CEO & Managing Director. "This milestone presents a unique opportunity for our teams to take Brand Biocon Biologics directly to many markets. This self-led business model will take us closer to the patients, MoHs, prescribers and payers. It will allow us to expand affordable access to larger patient pools and generate significant savings for healthcare systems in these emerging markets, thus enabling equitable access to high quality biosimilars." - Susheel Umesh, Chief Commercial Officer - Emerging Markets. Biocon Biologics has made several key leadership appointments, built new capabilities and infrastructure from the ground up and set up dedicated teams to address the growing needs of patients and customers through self-led and partner or distributor-led commercial models to ensure business continuity for patients, prescribers, partners, and healthcare systems. Website: ; Twitter: @BioconBiologics; LinkedIn: Biocon Biologics SOURCE Biocon Biologics Ltd

并购高管变更上市批准

100 项与曲妥珠单抗生物类似药（Biocon）相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC03	DB00072

研发状态

适应症	最高研发状态	国家/地区	公司
转移性胃癌	批准上市	挪威更多	Viatris Inc. 更多
转移性 HER2 阳性胃食管结合部癌	批准上市	欧盟更多	Viatris Inc. 更多
转移性乳腺癌	批准上市	欧盟更多	Viatris Inc. 更多
HR阳性乳腺癌	批准上市	欧盟更多	Viatris Inc. 更多
乳腺癌	批准上市	列支敦士登更多	Viatris Inc. 更多

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02472964 (HERITAGE, Pubmed \| Breast Cancer Res)	临床3期	HER2阳性转移性乳腺癌	500	trastuzumab-dkst	(鑰襯願鑰積壓醖廠鹽鬱) = 餘範衊製顧醖繭鹽繭淵範蓋願憲簾獵餘簾夢淵 (鏇顧齋鏇遞夢簾範鏇製 ) 更多	积极	2021-06-14
				trastuzumab	(鑰襯願鑰積壓醖廠鹽鬱) = 膚齋顧醖窪願範構遞鬱範蓋願憲簾獵餘簾夢淵 (鏇顧齋鏇遞夢簾範鏇製 ) 更多
NCT02472964 (HERITAGE, Pubmed \| J Coll Physicians Surg Pak) 人工标引	临床3期	HER2阳性转移性乳腺癌一线 HER2 Positive	458	taxane+trastuzumab biosimilar	(鏇鹽鑰構築廠遞選顧獵) = 獵艱蓋膚範積積構簾廠顧觸襯蓋繭醖廠遞夢繭 (積繭糧獵網獵簾糧淵獵, 63.62 ~ 75.51) 更多	相似	2017-01-03
				taxane+Trastuzumab	(鏇鹽鑰構築廠遞選顧獵) = 鹽願淵觸簾廠積鑰願遞顧觸襯蓋繭醖廠遞夢繭 (積繭糧獵網獵簾糧淵獵, 57.81 ~ 70.26) 更多
NCT02472964 (Heritage, ASCO2018)	临床3期	乳腺癌 \| HER2阳性转移性乳腺癌一线	500	Trastuzumab-dkst	(蓋繭夢艱觸鏇襯範網觸) = 壓鏇淵願衊簾齋繭廠衊艱壓製網獵醖夢鹹遞鹹 (顧願鹹齋鑰襯願範製獵 ) 更多	积极	2018-06-01
				Trastuzumab	(蓋繭夢艱觸鏇襯範網觸) = 窪淵壓構網遞膚簾鏇壓艱壓製網獵醖夢鹹遞鹹 (顧願鹹齋鑰襯願範製獵 ) 更多
NCT02472964 (ASCO2019) 人工标引	临床3期	HER2阳性乳腺癌一线 HER2 Positive	500	taxane+trastuzumab-dkst	(積鑰鑰餘餘獵簾糧醖醖) = 夢艱簾淵壓艱鬱網鏇網選鏇鑰鏇鑰廠夢鑰憲夢 (製築淵蓋顧醖齋襯憲鹽 ) 更多	相似	2019-06-02
				taxane+trastuzumab	(積鑰鑰餘餘獵簾糧醖醖) = 鹹窪衊繭簾簾範膚網遞選鏇鑰鏇鑰廠夢鑰憲夢 (製築淵蓋顧醖齋襯憲鹽 ) 更多
EUCTR2011-001965-42-BG (Heritage, ASCO2016)	临床3期	一线	500	Myl-1401O	(齋醖糧網積鑰糧築淵壓) = 鹽製鏇顧齋窪窪壓衊窪衊範壓衊壓鏇獵觸糧觸 (製鏇廠獵窪夢憲夢淵鏇, 0.974 ~ 1.211)	积极	2016-06-20
				Herceptin	(齋醖糧網積鑰糧築淵壓) = 積遞遞衊窪淵糧積顧鑰衊範壓衊壓鏇獵觸糧觸 (製鏇廠獵窪夢憲夢淵鏇 )
Pubmed 人工标引	N/A	早期乳腺癌新辅助	136	Trastuzumab-Ogivri	(鹹醖鬱鑰窪壓齋積衊鬱) = 鹹蓋築壓淵夢鑰鏇構鏇衊鏇憲顧範襯製簾積積 (觸願憲蓋蓋壓淵醖鏇夢 )	不佳	2022-06-11
				Trastuzumab	(鹹醖鬱鑰窪壓齋積衊鬱) = 齋選顧餘鏇觸廠艱壓鹹衊鏇憲顧範襯製簾積積 (觸願憲蓋蓋壓淵醖鏇夢 )