Business Wire

MA-TAKEDA-PHARMACEUTICAL

Share
Takeda’s EXKIVITY® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC

Takeda (TSE:4502/NYSE:TAK) today announced that EXKIVITY® (mobocertinib) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China. EXKIVITY, an oral tyrosine kinase inhibitor designed to target Exon20 insertions, was reviewed as part of the NMPA’s Breakthrough Therapy program. Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

“The approval of EXKIVITY in China for patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC was only possible through dedicated collaboration and support from the NMPA and the Chinese government,” said Awny Farajallah, Head, Global Medical Affairs Oncology, Takeda. “Lung cancer is a devastating disease, and we know the discovery and delivery of precision medicines like EXKIVITY to target cancer types that are hard-to-treat have the potential to improve patient outcomes. We are thrilled to introduce EXKIVITY in China as the second lung cancer therapy from Takeda and remain committed to research and development to meet the needs of this patient community.”

Lung cancer is the most commonly diagnosed cancer in China, and NSCLC accounts for approximately 85% of all lung cancer cases in the country.1 Of those patients diagnosed with EGFR-mutated NSCLC in China, up to 10% harbor Exon20 insertions.2-7 Despite this prevalence, patients in China have lacked a targeted treatment option designed to address cancers driven by these mutations.

“Since the discovery of EGFR mutations nearly twenty years ago, patients with Exon20 insertions have been waiting for a targeted therapy to treat their disease,” said Sean Shan, President of Takeda China. “The approval of EXKIVITY in China is a remarkable breakthrough, demonstrating the strong commitment of the Chinese government to encourage and accelerate the introduction of innovative therapies. EXKIVITY offers a targeted, oral therapy to a population that has been historically underserved, and this approval brings us one step closer to defeating this complex and heterogeneous disease for patients in this region.”

This approval is based on the results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114 patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the 160 mg dose. Results demonstrated a confirmed ORR of 28% per IRC as well as a median DoR of 15.8 months per IRC, a median overall survival (OS) of 20.2 months and a median progression-free survival (PFS) of 7.3 months per IRC. The most common treatment-related adverse reactions (TRAEs) were diarrhea (92%), rash (46%), paronychia (38%) and decreased appetite (37%).

About EXKIVITY (mobocertinib)

EXKIVITY is a first-in-class, oral tyrosine kinase inhibitor (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

EXKIVITY is currently approved in the United States, Great Britain, Switzerland, South Korea, Australia and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.

For more information about EXKIVITY, visit https://www.exkivity.com/. For the Prescribing Information, including the Boxed Warning, please visit https://takeda.info/Exkivity-Prescribing-Information.

About EGFR Exon20 Insertion+ NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization.9, 10 Patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ NSCLC make up approximately 1-2% of patients with NSCLC, and the disease is more common in Asian populations compared to Western populations.2-6 This disease carries a worse prognosis than other EGFR mutations, as EGFR TKIs – which do not specifically target EGFR Exon20 insertions – and chemotherapy provide limited benefit for these patients.

Takeda is committed to continuing research and development to meet the needs of the lung cancer community through the discovery and delivery of transformative medicines.

EXKIVITY IMPORTANT SAFETY INFORMATION

QTc Interval Prolongation

Heart rate-corrected QT (QTc) interval prolongation, including resultant life-threatening arrhythmias, such as Torsades de Pointes, occurred in patients treated with mobocertinib.

A concentration-dependent QTc interval prolongation of approximately 12.7 msec (90% CI: 8.69, 16.8) was observed at the steady-state Cmax following 160 mg daily doses based on an analysis of data from 194 patients with advanced solid malignances.

Clinical trials of mobocertinib did not enroll patients with baseline QTc greater than 470 msec. Assess QTc and electrolytes at baseline and correct abnormalities in sodium, potassium, calcium, and magnesium prior to initiating mobocertinib. Monitor QTc and electrolytes periodically during treatment. Increase monitoring frequency in patients with risk factors for QTc prolongation, such as in patients with congenital long QTc syndrome, heart disease, electrolyte abnormalities, or those who are taking medicinal products known to prolong the QTc interval. Avoid concomitant use of medicinal products which are known to prolong the QTc interval. Avoid concomitant use of strong or moderate CYP3A inhibitors with mobocertinib, which may further prolong the QTc interval. Permanently discontinue mobocertinib in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Interstitial Lung Disease/Pneumonitis

Severe, life-threatening, and fatal interstitial lung disease (ILD)/pneumonitis have occurred in patients treated with mobocertinib.

Withhold mobocertinib for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever pending diagnostic evaluation and diagnosis confirmation. Permanently discontinue mobocertinib if ILD/pneumonitis is confirmed.

Cardiac Toxicity

Cardiac failure (including congestive cardiac failure, decreased ejection fraction, and cardiomyopathy) has occurred in patients treated with mobocertinib.

Mobocertinib can cause QTc prolongation resulting in Torsades de Pointes.

Atrial fibrillation (1.3%), ventricular tachycardia (0.3%), first degree atrioventricular block (0.7%), second degree atrioventricular block (0.3%), left bundle branch block (0.3%), supraventricular extrasystoles (0.3%) and ventricular extrasystoles (0.3%) also occurred in patients receiving mobocertinib. The causality of these events to mobocertinib has not been established.

Conduct cardiac monitoring, including assessment of left ventricular ejection fraction at baseline and during treatment. Patients who develop signs and symptoms consistent with cardiac failure should be treated as clinically indicated. Withhold, reduce the dose, or permanently discontinue mobocertinib based on the severity.

Diarrhea

In clinical studies, most patients experienced mild to moderate diarrhea. Diarrhea can be severe or life threatening. The median time to first onset of diarrhea was five days but could occur as soon as 24 hours after administration of mobocertinib. Diarrhea is usually transient and had a median time to resolution of three days. Prolonged diarrhea may lead to dehydration or electrolyte imbalance, with or without renal impairment.

Early and compliant diarrhea management such as prescribed anti-diarrheal medicinal products (e.g., loperamide), diet, adequate fluid intake (~2L clear liquids per day), and patient education is recommended. Instruct patients to have anti-diarrheal medicinal products (e.g., loperamide) readily available. Begin anti-diarrheal treatment at the first episode of poorly formed or loose stools or the earliest onset of bowel movements more frequent than normal. In mobocertinib clinical trials where loperamide was used as the antidiarrheal, the dosage regimen for loperamide was 4 mg at the first bout of diarrhea and then 2 mg every 2 hours until the patient is diarrhea-free for at least 12 hours; daily dose of loperamide did not exceed 16 mg. If using loperamide as the antidiarrheal treatment, refer to loperamide product labeling for additional information.

If diarrhea does not improve or additional signs or symptoms are reported, standard medical practice intervention, including other anti-diarrheal medications, are recommended. Antidiarrheal prophylaxis may be considered as needed. Monitor electrolytes and instruct patients to increase fluid and electrolyte intake as needed. No dose modification is necessary unless the patient does not tolerate mobocertinib or the symptoms recur, or the diarrhea doesn’t resolve with medical intervention. Interrupt mobocertinib and reduce subsequent doses if severe diarrhea occurs.

Embryo-Fetal Toxicity

Based on its mechanism of action and data from animal studies, mobocertinib can cause fetal harm when administered to pregnant women.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with mobocertinib and for one month following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with mobocertinib and for one week following the final dose of mobocertinib.

Takeda’s Commitment to Oncology

At Takeda Oncology, we are united by our aspiration to cure cancer and motivated every day to work harder for patients with limited or ineffective treatment options. Our agile structure and deep in-house expertise are complemented by a network of partnerships that optimize our ability to research, develop and deliver transformative medicines to people living with cancer. Building on decades of leadership in oncology and a portfolio of approved medicines for hematologic cancers and solid tumors, we are advancing a cutting-edge pipeline focused on the power of innate immunity. With inspiration from patients and innovation from everywhere, our goal is to introduce new classes of immunotherapies that can lead to deep, durable responses so that more patients can benefit from – and have access to – innovative medicines.

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 discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, 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, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; 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/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.

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Regulatory information

This indication is approved in China under conditional approval.

1 Gan J, Fang W, Zhang L. Therapy of lung cancer in China: introducing the special collection. Therapeutic Advances in Medical Oncology. 2021;13.
2 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 September 28, 2022.
3 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 September 28, 2022.
4 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
5 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
6 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
7 Yang, Guangjian et al. “EGFR exon 20 insertion mutations in Chinese advanced non-small cell lung cancer patients: Molecular heterogeneity and treatment outcome from nationwide real-world study.” Lung cancer (Amsterdam, Netherlands) vol. 145 (2020): 186-194.
8 Zhou C. Lung cancer molecular epidemiology in China: recent trends. Transl Lung Cancer Res. 2014 Oct;3(5):270-9. doi: 10.3978/j.issn.2218-6751.2014.09.01
9 Sung H. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. https://pubmed.ncbi.nlm.nih.gov/33538338/. Accessed September 28, 2022
10 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. Accessed September 28, 2022.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230111005569/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

Mainstay Medical Announces Positive Outcomes from Landmark RESTORE Clinical Trial of ReActiv8®15.1.2025 22:30:00 CET | Press release

ReActiv8® Restorative NeurostimulationTM demonstrated statistically significant and clinically meaningful superiority vs. standard of care in all primary and secondary measures of disability, pain and quality of lifeSafety profile consistent with prior ReActiv8 clinical trials and favourable to other neuromodulation proceduresReActiv8 is now supported by the most complete and robust set of clinical evidence of any neuromodulation therapy for axial back pain globally. Mainstay Medical Holdings plc today announced the publication of positive one-year primary assessment results of the RESTORE randomized clinical trial of ReActiv8 for the treatment of intractable chronic low back pain. The data show that the addition of ReActiv8 Restorative Neurostimulation therapy to current standard of care results in superior improvements in back pain-related disability, pain and quality of life compared to standard of care treatments alone. The results were published in Pain and Therapy, a leading peer

Cyble Recognized in Extended Threat Intelligence Service Providers Landscape, Q1 202515.1.2025 21:00:00 CET | Press release

Cyble, a global leader in cybersecurity solutions, has been named among notable vendors in the Q1 2025 Forrester report on Extended Threat Intelligence Service Providers (ETISPs). For Cyble, this recognition underscores its innovation and leadership in delivering actionable threat intelligence that empowers organizations to stay ahead of evolving cyber threats. The Forrester’s report highlights the critical role of extended threat intelligence service providers in enabling organizations to protect brand reputation, improve risk management, and facilitate strategic decision-making. “This recognition underscores our mission to deliver innovative threat intelligence solutions that empower organizations to mitigate risks and make informed strategic decisions,” said Beenu Arora, CEO and Co-founder of Cyble. “At Cyble, we are committed to proactive security and continuous innovation in the ever-evolving cybersecurity landscape. Our vision is to make cybersecurity seamless and integral—enabli

Sandvine Appoints Chief Ethics & Compliance Officer and Board Advisor as Part of Strengthened Commitment to Internet Freedom and Digital Rights15.1.2025 18:41:00 CET | Press release

Carol Tate will serve as CCO following her tenure as Chief Compliance Officer at IntelFormer President & CEO of Human Rights First, Michael Breen, appointed as Advisor to the Board of Directors Today, Sandvine (the “Company”), a market-leading provider of Over-the-Top (OTT) Application Classification and Quality of Experience (QoE) solutions, announced the appointments of Carol Tate as Chief Ethics & Compliance Officer, effective February 3, and Michael Breen as Advisor to the Board of Directors, effective January 1. Working closely with teams across the Company and in collaboration with its Board of Directors, Tate will spearhead compliance and due diligence initiatives to help facilitate Sandvine’s transition into a technology solution leader for democracies. Working directly with the Company’s Board of Directors, Breen is advising on human rights matters, including its engagement with non-governmental organizations to inform the Company’s human rights due diligence. With decades of

Pure Lithium and Saint-Gobain Ceramics Enter Into a Joint Development Agreement to Accelerate Production of Lithium-selective Membranes for Metal Extraction and Battery Applications15.1.2025 18:11:00 CET | Press release

Pure Lithium Corporation, a Boston-based lithium metal battery technology company, announces a joint development agreement with Saint-Gobain Ceramics, a global leader in specialty ceramic materials. The joint development agreement will accelerate the production of Pure Lithium’s patent pending lithium selective, water-blocking membranes for lithium metal anode production from brine. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250115117089/en/ Additionally, Pure Lithium invented a flexible lithium conducting membrane for next-generation lithium metal battery applications, which will serve as both a solid electrolyte and separator in a lithium metal battery. Saint-Gobain Ceramics will also scale this technology. Emilie Bodoin, Founder and CEO of Pure Lithium comments: “I am delighted to be scaling our technology with an industrial partner. Saint-Gobain Ceramics has world-class R&D expertise coupled with manufacturing and pr

Coolbrook Named on the 2025 Global Cleantech 10015.1.2025 17:01:00 CET | Press release

2025: The Year We Remember the Guardrails Coming Off Coolbrook, a transformational technology and engineering company, has been named on Cleantech Groups 2025 Global Cleantech 100. This annual list, now in its 16th year, showcases the most promising private cleantech companies making significant contributions to sustainable innovation. The complimentary report will introduce you to innovators advancing groundbreaking technologies and business models to enable us to act on the ever-increasing climate and environmental crisis. The cleantech theme is poised for pivotal milestones in 2025 as market forces intensify and innovation accelerates. Continuing trends from 2024, including policy uncertainty, groundbreaking first-of-a-kind (FOAK) projects, and the surging demand for climate adaptation technologies, will emphasize the importance of product and project economics. Companies that capitalize on organic demand—such as the growing needs of data centers—and prove their technologies in real

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye