Business Wire

Takeda Presents Positive Results For Mobocertinib in Patients with EGFR Exon20 insertion+ mNSCLC Who Received Prior Platinum-based Chemotherapy

Share

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:

Parameter

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.

Important Notice

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.

Forward-Looking Statements

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

Contact information

Media Contacts:
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media outside Japan
Lauren Padovan
lauren.padovan@takeda.com
+1 (617) 444-1419

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Temenos and Canadian Western Bank Break the Boundaries of SME Banking with an Explainable AI Digital Banking Solution4.3.2021 16:00:00 EETPress release

Temenos (SIX: TEMN), the banking software company, today announced that it is partnering with Canadian Western Bank (CWB) on a pioneering innovation to support small- and medium-sized enterprises (SMEs) with financial decision-making and growing their businesses. The new solution, Temenos Virtual COO, is built on Temenos Infinity, the leading omnichannel digital banking product, and leverages Temenos Analytics and Explainable AI (XAI), API-first, cloud-native technology. Temenos Virtual COO will offer relevant insights to accelerate the growth of small businesses and put business owners in control of their companies’ financial destiny. SME owners will be able to simulate different business scenarios with XAI-driven modeling enabling them to identify the best course of action for their business. The new solution will aggregate financial banking and business data to provide a consolidated real-time view of an SME’s financial health, and lighten the administrative burden so that business

Data Presented at the Miami Breast Cancer Conference Show MammaPrint® and BluePrint® Accurately Predict Pathologic Complete Response Rate Regardless of Age4.3.2021 16:00:00 EETPress release

Agendia, Inc., a world leader in precision oncology for breast cancer, announced new data from the prospective Neoadjuvant Breast Symphony Trial (NBRST) which demonstrate the predictive and prognostic abilities of MammaPrint® and BluePrint®, and underpin both assays’ pre-operative utility in pre-and post-menopausal patients. A poster highlighting these findings will be presented at the 38th Annual Miami Breast Cancer Conference. The poster, entitled Pathologic Complete Response (pCR) Rates According to MammaPrint and BluePrint Results are Consistent Among Pre- and Post-Menopausal Patients, outlines the first age-based analyses of MammaPrint and BluePrint assays in the pre-operative setting. As expected, the data show that pCR rates varied according to molecular subtype, with MammaPrint and BluePrint accurately predicting pCR in patients of all subtypes, regardless of age. This analysis reinforces both tests’ use to better tailor pre-operative treatment and in determining the best timin

Square, Inc. Announces Plans to Acquire Majority Ownership Stake in Tidal4.3.2021 16:00:00 EETPress release

Square, Inc. (NYSE: SQ) announced today that it has entered into a definitive agreement to acquire a majority ownership stake in TIDAL, the global music and entertainment platform that brings fans and artists together through unique music, content, and experiences. Square expects to pay a mix of cash and stock of $297 million for a significant majority ownership stake, and existing artist shareholders will be the remaining stakeholders. TIDAL will operate independently within Square, alongside the Seller and Cash App ecosystems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304005346/en/ Photo (from left to right): Shawn “JAY-Z” Carter, Jack Dorsey. Photo credit (from left to right): Raven Varona, Hermione Hodgson. The acquisition extends Square’s purpose of economic empowerment to a new vertical: musicians. Artists are entrepreneurs with a dream and deserve access to systems, tools, and financial freedom to reach those

Wipro to acquire Capco, a global management and technology consultancy to banking and financial services industry, for $ 1.45 billion4.3.2021 15:40:00 EETPress release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has signed an agreement to acquire Capco, a global management and technology consultancy providing digital, consulting and technology services to financial institutions in the Americas, Europe and the Asia Pacific. London-headquartered Capco’s clients include many marquee names in the global financial services industry. Over the past 20 years, the company has worked closely with business leaders, including Boards and C-Suites in the banking, capital markets, wealth, asset management and insurance sectors and is widely acknowledged for its deep domain and consulting expertise, risk and regulatory offerings and thought leadership around key industry technology challenges and opportunities. In addition, Capco services clients in the energy and commodities trading sector. Capco has an experienced executive team and over 5,000

Hopin Raises $400 Million to Scale Innovation for Hybrid Experiences4.3.2021 15:30:00 EETPress release

Hopin, a leading virtual events provider, announced today that it has raised $400M in Series C funding co-led by new investors Andreessen Horowitz and General Catalyst, and existing investor IVP, with participation from returning investors Coatue, DFJ Growth, Northzone, Salesforce Ventures and Tiger Global. The funding follows Hopin’s $125 million Series B funding announced in November 2020. Since then, Hopin has added 30,000 customers including Poshmark, American Express, Hewlett Packard, The Financial Times, and YMCA. Since February of last year, Hopin has raised more than $565 million. Johnny Boufarhat, CEO and Founder of Hopin said: “We are creating a portfolio of products to build the future of live video collaboration and remote community. As we’ve seen, the importance of providing unparalleled virtual and hybrid event experiences has never been greater and this latest funding is a reflection of how critical it is as brands look for ways to connect with people and avenues of grow

New Research Reveals More CROs Taking Action to Meet Urgent Need for Faster Clinical Trials4.3.2021 15:03:00 EETPress release

Contract research organizations (CROs) are making significant advancements to modernize and speed clinical trials, according to the latest Veeva Unified Clinical Operations Survey: Annual CRO Report. COVID-19 dramatically accelerated the need to execute faster and with greater precision than ever before. Findings from Veeva Systems (NYSE: VEEV) show CROs have taken decisive action to streamline trial execution by adopting new digital strategies and technologies that eliminate information siloes, replace manual processes, and enable trial collaboration. Nearly all CROs surveyed (90%) have major initiatives underway to unify clinical operations, a lynchpin to faster, more efficient research. The efforts to unify extended beyond CROs’ internal systems and processes. Streamlining collaboration and information sharing with research sites and sponsors was consistently cited by CROs as one of the highest priority areas overall and a key driver for the modernization efforts underway. In additi

DeepGreen, Developer of the World's Largest Estimated Resource of Battery Metals for EVs, to Combine with Sustainable Opportunities Acquisition Corporation4.3.2021 15:00:00 EETPress release

DeepGreen Metals Inc., a developer of lower-impact battery metals from unattached seafloor polymetallic nodules, today announced that it has entered into a definitive business combination agreement with Sustainable Opportunities Acquisition Corporation (NYSE: SOAC), a special purpose acquisition company with a dedicated ESG focus and deep operational and capital market capabilities in the energy and resource sectors. The transaction represents a pro forma equity value of US$2.9 billion (assuming no redemptions) for the combined company, which will be renamed “TMC the metals company Inc.” and operate as The Metals Company upon closing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210304005510/en/ Responsibly Sourcing Battery Metals to Address Looming Critical Shortage for EV Supply Chain DeepGreen is developing a new, scalable source of EV battery metals in the form of polymetallic nodules found unattached on the seafloor i

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