Takeda Presents Positive Results For Mobocertinib in Patients with EGFR Exon20 insertion+ mNSCLC Who Received Prior Platinum-based Chemotherapy
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced new data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in previously treated patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) will be presented as a late-breaking oral session at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) on Friday, January 29 SGT.
“Results show mobocertinib demonstrated clinically meaningful responses and a noteworthy duration of response in patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum-based therapy,” said Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute. “These data are promising and provide further evidence for mobocertinib as a potential oral treatment for patients with EGFR Exon20 insertion+ mNSCLC, who are in critical need of targeted treatment options.”
The analysis of platinum-pretreated patients included patients with EGFR Exon20 insertion+ mNSCLC who received prior platinum therapy from the Phase 1/2 trial. All patients were treated at the 160 mg once daily oral dose. Key findings from this population include:
Results in Platinum-Pretreated Population (N=114)
Confirmed objective response rate (ORR) per investigator
35% (40/114; 95% CI 26-45)
Confirmed ORR per IRC
28% (32/114; 95% CI 20-37)
Median duration of response (DoR) per IRC
17.5 months (95% CI 7.4-20.3)
Median progression-free survival (PFS) per IRC
7.3 months (95% CI 5.5-9.2)
Disease control rate (DCR) per IRC
78% (89/114; 95% CI 69-85)
The safety profile observed was manageable. The most common treatment-related adverse events (TRAEs; ≥ 20%) in platinum-pretreated patients from the May data cutoff were diarrhea (90%), rash (45%), paronychia (34%), nausea (32%), decreased appetite (32%), dry skin (30%) and vomiting (30%). Grade ≥3 TRAEs (≥5%) included diarrhea (21%). Nineteen patients (17%) discontinued due to AEs, most commonly diarrhea (4%) and nausea (4%). The safety profile from the November data cutoff was consistent with that of the May data cutoff.
“The importance of advancing research for people living with EGFR Exon20 insertion+ mNSCLC – a complex and devastating disease with no approved targeted therapies – cannot be overstated, as existing treatment options provide limited benefit and patients often have poor survival outcomes,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “We’re proud of these positive results from mobocertinib, the first oral therapy designed to selectively target their disease, and we look forward to submitting data from the platinum-pretreated population analysis to the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the globe.”
Mobocertinib is currently not approved for EGFR Exon20 insertion+ mNSCLC.
Takeda will host a briefing for analysts and investors on Friday, January 29, at 5:00 p.m. ET to discuss these data and the mobocertinib program.Please contact TakedaRandDEvents@fticonsulting.com for further details. Presentation slides and an archived replay of the webcast will be available at https://www.takeda.com/investors/reports/ir-events/.
About the Phase 1/2 Trial
The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). The trial is comprised of a Phase 1 dose-escalation, evaluating mobocertinib as a monotherapy and in combination with chemotherapy, and a Phase 2 expansion, which includes seven different cohorts, as well as an extension cohort, investigating the anti-tumor activity of mobocertinib in various trial populations.
The platinum-pretreated population analysis investigated 114 patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) who received prior platinum-based therapy from the escalation and expansion phases of the Phase 1/2 trial and were treated with mobocertinib at the 160 mg once daily dose.
The Phase 2 extension cohort, known as EXCLAIM, investigated 96 previously treated patients with EGFR Exon20 insertion+ mNSCLC who were treated with mobocertinib at the 160 mg once daily dose.
About Mobocertinib (TAK-788)
Mobocertinib, an oral therapy, is a potent, small-molecule tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with human EGFR 2 (HER2) mutations or EGFR mutations including Exon20 insertion mutations. In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC) whose disease has progressed on or after platinum-based chemotherapy. In October 2020, mobocertinib was designated as a Breakthrough Therapy in China by the Drug Review Center (CDE) for the same indication.
About EGFR Exon20 Insertion+ mNSCLC
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.1,2 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC) make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.3-7 This disease carries a worse prognosis than other EGFR mutations because there are currently no FDA-approved therapies that target Exon20 insertions, and current EGFR TKIs and chemotherapy provide limited benefit for these patients.
Takeda is committed to continuing research and development in EGFR Exon20 insertion+ mNSCLC with the hope of introducing a targeted treatment option for the approximately 30,000 patients diagnosed with the disease worldwide each year.3,4
Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
1 World Health Organization. Latest Global Cancer Data. https://www.who.int/cancer/PRGlobocanFinal.pdf. Accessed May 11, 2019.
2 American Cancer Society. What is Non-Small Cell Lung Cancer? https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.
3 Riess, Jonathan W. Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC. https://www.jto.org/article/S1556-0864(18)30770-6/fulltext. Accessed April 7, 2020.
4 Fang, Wenfeng. BMC Cancer. EGFR exon 20 insertion mutations and response to osimertinib in non-small-cell lung cancer. https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5820-0. Accessed April 7, 2020.
5 Kobayashi Y, Mitsudomi T. Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy. Cancer Sci. 2016;107(9):1179-1186. doi:10.1111/cas.12996
6 Yatabe Y, Kerr KM, Utomo A, et al. EGFR mutation testing practices within the Asia Pacific region: results of a multicenter diagnostic survey. J Thorac Oncol. 2015;10(3):438-445. doi:10.1097/JTO.0000000000000422
7 Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006. doi:10.1001/jama.2014.3741
+81 (0) 3-3278-2095
Media outside Japan
+1 (617) 444-1419
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Seglan Payments Solution Provider Turns to Verimatrix for Efficient, Time-Tested Security24.2.2021 17:45:00 CET | Press release
Regulatory News: Verimatrix, (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced that Seglan, an existing Verimatrix Code Protection customer and leading provider of secure payment solutions, recently selected the Verimatrix Mobile Payments technology to provide global banks and processors with time-trusted security. Seglan previously developed their own mobile payment Software Developer Kit (SDK) for implementation across its customer base. It’s now in the process of deploying Verimatrix’s mobile payments SDK that offers existing certifications for streamlining Seglan’s go-to-market capabilities aimed at some of the largest financial institutions in Europe and South America. The Verimatrix security tool will continue to be used for Seglan’s 3DSecure SDKs (certification included) while also aiming to provide their customers a full HCE and 3DSecure solution all contained within a single server. “Having successfully relied upon Ve
EnTrust Global’s Julian Proctor to Present at Economist’s World Ocean Summit24.2.2021 17:02:00 CET | Press release
Julian Proctor, Portfolio Manager of EnTrust Global’s Blue Ocean 4Impact Fund (“BO 4Impact”), will join Elisabeth Munck af Rosenschöld, Head of Supply Chain and Sustainability at IKEA, Sadan Kaptanoglu, President of BIMCO, Jeremy Nixon, Chief Executive of Ocean Network Express Co., and Craig Jasienski, Group Chief Executive at Wallenius Wilhelmsen at The Economist’ World Ocean Summit panel entitled “Shipping: Collaborating across industry and supply chains to reduce emissions.” Blue Ocean 4Impact is part of EnTrust Global’s $2+ billion maritime investment platform and is launching one of the first companies that will own and lease environmentally-advanced vessels and other marine infrastructure assets to large corporate operators and end-users, in order to help reduce carbon emissions and other pollution generated by the ocean economy. The Summit is the pre-eminent global event bringing together the widest cross-section of ocean stakeholders each year, from business to government to ci
New Study Finds Zio by iRhythm 10x More Effective in Proactively Identifying Atrial Fibrillation and Increasing Detection24.2.2021 17:00:00 CET | Press release
iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced the results of a brand new “SCREEN-AF” study, led by researchers at Sunnybrook Health Sciences Centre in Toronto, Canada and University Hospital in Leipzig, Germany, which was published in JAMA Cardiology. The transatlantic clinical trial found that Zio by iRhythm, an ambulatory cardiac monitoring solution, led to a tenfold increase in the detection of atrial fibrillation (AF) versus patients receiving standard clinical care. One out of every 20 patients in the heart monitoring group was found to have a new diagnosis of atrial fibrillation and, as a result, 75 percent of those patients were subsequently prescribed a blood thinner medication for protection against strokes. The study results lend support for Zio as a screening tool for early detection of AF. The results have important implications for stroke prevention, especially as the pre
Jamestown Expands European Presence With More Than $1 Billion in Assets Under Management24.2.2021 16:22:00 CET | Press release
Global real estate and investment company Jamestown today announced it has significantly expanded its global presence and now has more than $1 billion in European assets under management with the acquisition of another two buildings in Amsterdam, and a mandate to manage a portfolio of properties across Europe on behalf of one of its institutional investment partners and co-investors, E.ON Pension Trust. This latest news about its European portfolio comes on the heels of Jamestown’s recent purchase of three office buildings in Cologne, Germany, and just over a year after purchasing the iconic Groot Handelsgebouw in Rotterdam, one of the largest mixed-use buildings in the Netherlands, which currently houses more than 450 businesses. “After entering the European market just over a year ago, Jamestown has grown its platform with $1 billion in assets under management and a knowledgeable real estate team headquartered in Cologne, Germany and offices in Amsterdam, London, and Madrid,” said Ja
Saint-Gobain Life Sciences Introduces Highly Efficient Cell Culture Bags for T Cell Expansion24.2.2021 16:00:00 CET | Press release
Saint-Gobain Life Sciences, an industry leader in material science-based solutions for cell and gene therapy manufacturing, today launched a new cell culture bag designed specifically for T cell derived therapies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210224005014/en/ VueLife® "HP" Series Bag cell culture testing in Saint-Gobain Life Sciences Laboratory. (Photo: Business Wire) T cell based therapies are revolutionizing the approach to treating cancer. Harnessing the patient’s own immune system by isolating their T cells and engineering them to elicit an immune response is emerging as a preferred manufacturing practice. As the industry continues the advancement of these therapies, process efficiency becomes paramount to the success of delivering affordable therapies to patients. Building upon the VueLife® family of fluorinated ethylene propylene (FEP) based cell culture bags, VueLife® “HP” (high permeability) incorpo
KA Imaging to Present Poster on Unprecedented Lateral Dual-Energy X-ray Views at ECR 202124.2.2021 15:17:00 CET | Press release
KA Imaging, a company that develops innovative X-ray imaging solutions, announced that a poster reporting on results from a study examining the feasibility of lateral chest dual-energy subtraction radiography using a stacked single-exposure multi-layer x-ray detectorwill be presented by Sebastian Maurino, a medical physicist at KA Imaging, at this year’s European Congress of Radiology (ECR). As highlighted in the poster, KA Imaging’s novel approach allows radiologists to take full advantage of lateral dual-energy images by obtaining both conventional and dual-energy subtraction lateral images simultaneously, thereby making it considerably easier to differentiate between materials behind the heart. Quoting directly from the poster, “The DE lateral image also visualizes calcified joints and masses behind the heart that are not visible in the [Posterior-Anterior (PA)] image. Multi-layer detectors were shown to provide DE PA and lateral images of the chest at conventional patient dose leve
OAG and IATA Strengthen Data Partnership to Combat Market and Schedule Volatility24.2.2021 15:00:00 CET | Press release
OAG, the world’s leading provider of travel data and insight has agreed a partnership with International Air Transport Association (IATA), to provide schedule and reference data via its new cloud platform. As part of the strengthened partnership between the two aviation leaders, OAG will also provide IATA with a customized version of its market-leading Analyzer tool which will be offered as part of a bundle alongside Airport IS and other existing tools in the future. Built on the Snowflake cloud platform, the supply of reference and schedules data provides customers with the richest and freshest version of schedules data available in the market. “COVID-19’s ongoing impact on traffic volatility has made it critical to power our products with the most up-to-date data available,” said Charles de Gheldere, Director Aviation Data at IATA. “Our strengthened partnership with OAG supplies our airport customers with fresh and accurate data and a highly-innovative, modern and flexible cloud-base