DAIICHI-SANKYO
3.11.2021 08:02:14 CET | Business Wire | Press release
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Type II Variation Application for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN), for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen.
Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). This application is based on the positive results from the DESTINY-Gastric01 pivotal phase 2 trial published in The New England Journal of Medicine and the DESTINY-Gastric02 phase 2 trial recently presented at the 2021 European Society for Medical Oncology (ESMO) Congress.
“After progression on initial therapy, patients with HER2 positive advanced gastric cancer are faced with limited options in Europe, so there is a significant unmet need for new therapeutic options,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “We look forward to working with the EMA on its review of this application and to potentially bring trastuzumab deruxtecan to physicians and patients in Europe, as it offers the potential to provide an important new treatment option to patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen.”
About HER2 Positive Gastric Cancer
Gastric (stomach) cancer is the fifth most common cancer worldwide and the fourth highest leading cause of cancer mortality, with a five-year global survival rate of 5% to 10% for advanced or metastatic disease.1,2,3 There were approximately one million new cases of gastric cancer and 768,000 deaths reported worldwide in 2020.4 In Europe, approximately 136,000 cases of gastric cancer are diagnosed annually, and Eastern Europe has the second highest incidence of gastric cancer worldwide after Eastern Asia.3,4 Gastric cancer is the sixth leading cause of cancer death in Europe, and is typically diagnosed in the advanced stage but even when diagnosed in earlier stages of the disease the survival rate remains modest.3,5,6,7
Approximately one in five gastric cancers are HER2 positive.8,9 HER2 is a tyrosine kinase receptor growth promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers.9 HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification.9
Recommended first-line treatment for HER2 positive advanced or metastatic gastric cancer is combination chemotherapy plus trastuzumab, an anti-HER2 medicine, which has been shown to improve survival outcomes when added to chemotherapy.10 For patients with metastatic gastric cancer that progress following initial treatment with a trastuzumab-based regimen, treatment options are limited, and in many regions in the world there are no additional HER2 directed medicines available.1,5,11
About DESTINY-Gastric01
DESTINY-Gastric01 is a pivotal, randomized, open-label, multi-center phase 2 trial assessing the safety and efficacy of trastuzumab deruxtecan (6.4 mg/kg) in patients from Japan and South Korea with HER2 positive (defined as IHC3+ or IHC2+/ISH+) advanced gastric cancer or gastroesophageal junction adenocarcinoma who have progressed on two or more prior treatment regimens including fluoropyrimidine (5-FU), platinum chemotherapy and trastuzumab. Patients were randomized 2:1 to receive trastuzumab deruxtecan or physician’s choice of chemotherapy (paclitaxel or irinotecan monotherapy). The primary endpoint of DESTINY-Gastric01 is objective response rate (ORR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response (DoR), disease control rate and time to treatment failure as well as pharmacokinetic and safety endpoints. DESTINY-Gastric01 enrolled 189 patients at multiple sites in Japan and South Korea. For more information about the trial, visit ClinicalTrials.gov .
About DESTINY-Gastric02
DESTINY-Gastric02 is an open-label, single-arm, phase 2 trial in Western patients evaluating the safety and efficacy of trastuzumab deruxtecan (6.4 mg/kg) in patients with HER2 positive metastatic and/or unresectable gastric or GEJ adenocarcinoma with disease progression on or after a trastuzumab-containing regimen. The primary endpoint of DESTINY-Gastric02 is confirmed ORR based on independent central review. Secondary endpoints include PFS, OS, DoR and safety. DESTINY-Gastric02 enrolled 79 patients at multiple sites in North America and Europe. For more information about the trial, visit ClinicalTrials.gov .
About Trastuzumab Deruxtecan
Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Trastuzumab deruxtecan consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.
Trastuzumab deruxtecan (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens based on the results from the DESTINY-Breast01 trial.
Trastuzumab deruxtecan (6.4 mg/kg) is approved in Israel, Japan, Singapore, and U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.
About the Trastuzumab Deruxtecan Clinical Development Program
A comprehensive global development program is underway evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.
Trastuzumab deruxtecan was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the “ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers,” based on data from both the DESTINY-Gastric01 and DESTINY-CRC01 trials, as well as one of the targeted therapy advances of the year in non-small cell lung cancer (NSCLC) based on the interim results of the HER2 mutated cohort of the DESTINY-Lung01 trial.
Trastuzumab deruxtecan recently received its fourth Breakthrough Therapy Designation (BTD) in the U.S., which was for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.
About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize trastuzumab deruxtecan in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.
About Daiichi Sankyo in Oncology
The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc ., our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.
About Daiichi Sankyo
Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.” For more information, please visit: www.daiichisankyo.com .
___________________________________
References
1 Casamayor M, et al. Ecancermedicalscience . 2018;12:883.
2 SEER Survival rates: Stomach 2004-2017 . Accessed: October 2021.
3 Sung H, et al. Ca Cancer J Clin . 2021;71:209–249.
4 WHO. International Agency of Cancer Research. Cancer Today . Accessed October 2021.
5 Thuss-Patience PC, et al. Lancet Oncol . 2017;18(5):640-653.
6 Cancer Research UK. Stomach Cancer Survival Statistics . Accessed October 2021.
7 SEER Cancer Stat Facts: Stomach Cancer . Accessed October 2021.
8 Iqbal N, et al. Mol Biol Int . 2014;2014:852748.
9 Abrahao-Machado LF, et al. World J Gastroenterol . 2016;22(19):4619-4625.
10 Oditura M, et al. World J Gastroenterol . 2014 Feb 21;20(7):1635-49.
11 Satoh T, et al. J Clin Oncol . 2014;32(19):2039‐2049.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211103005102/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
International Human Rights Lawyer Jared Genser and Former White House Counsel Lanny J. Davis Join Legal and Advocacy Team Supporting Cambodian Businessman Yim Leak, Seiden Law LLP Announces18.9.2026 19:52:00 CEST | Press release
Jared Genser, one of the world's most recognized international human rights lawyers, and Lanny J. Davis, an adviser to former presidents George W. Bush and Bill Clinton, join the legal and advocacy team for Cambodian businessman Yim Leak and challenge what they call a coordinated smear campaign in Thailand. International human rights lawyer Jared Genser and Lanny J. Davis, who has close ties to two former US presidents and a worldwide reputation for defending those under attack with lies and smears, and for repairing the damage done to their reputations, have joined the legal and advocacy team supporting Cambodian businessman Yim Leak, Seiden Law LLP, which serves as Yim Leak's chief global counsel, announced today. Their first move is to hold the Thai government accountable, framing its conduct as either complicit in or willfully blind to a sustained smear campaign against Yim. Genser is Managing Director of Perseus Strategies, an international law firm. Over more than two decades, he
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 17:38:00 CEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom