Tagrisso® (Osimertinib) Adjuvant Therapy Indication for Early-Stage EGFR-Mutated NSCLC Included in China's 2023 National Reimbursement Drug List

Helping Early- and Mid-Stage Lung Cancer Patients Achieve Long-Term Survival

ShanghaiDecember 13, 2023PR Newswire -- Today, the National Healthcare Security Administration announced the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2023)", in which AstraZeneca's third-generation EGFR-TKI targeted lung cancer drug Tagrisso® (generic name: Osimertinib Mesylate Tablets, hereinafter referred to as "Osimertinib") adjuvant treatment indication has successfully been included in the medical insurance catalog. It is indicated for the treatment of patients with non-small cell lung cancer (NSCLC) at stages IB-IIIA who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Patients must have previously undergone surgical resection and may or may not receive adjuvant chemotherapy as determined by their physician.

According to the 2022 edition of "Global Health Estimates 2020" released by the World Health Organization: Lung cancer has become the malignant tumor with the "double highest" incidence and mortality rate in China.^[1], and about 45.9% of non-small cell lung cancer patients in China have EGFR mutations.^[2]Osimertinib, as the world's first third-generation EGFR-TKI targeted drug^[3], since entering China in 2017, it has successively been approved for second-line and first-line treatment indications for adult patients with locally advanced or metastatic non-small cell lung cancer, both of which have been included in the medical insurance directory. The adjuvant treatment indication after early surgery was approved in China in 2021. After being included in the national medical insurance this time, Osimertinib is not only the only one^[*^1]A third-generation EGFR-TKI targeted drug covered by the medical insurance directory for adjuvant treatment after surgery in patients with Stage IB-IIIA early-stage lung cancer signifies that osimertinib, from early to advanced stages, continues to reduce the financial burden of medication for Chinese patients with EGFR mutation-positive non-small cell lung cancer.

Ultra50% of patients with early- and mid-stage lung cancer experience recurrence or metastasis within 5 years.

Based on the size of the primary tumor, whether tumor cells have infiltrated, invaded, metastasized, and the distance of metastasis, lung cancer can be divided into Stage Ⅰ, Stage Ⅱ, Stage Ⅲ, and Stage Ⅳ.^[4], among which stage ⅠA-ⅢA is considered early to intermediate lung cancer. The survival rates of patients vary significantly across different stages. For instance, even if early-stage lung cancer patients undergo complete surgical resection, there remains a risk of recurrence and metastasis, with the level of risk increasing as the stage advances.^[5]Data show that the 5-year recurrence rate for stage IB lung cancer patients is 45%, for stage II it is 62%, and for stage IIIA it is as high as 76%.^[2,4]If postoperative adjuvant therapy is not received, more than 50% of lung cancer patients will experience recurrence or metastasis within five years, and approximately 74% of patients will develop distant metastases after surgery, primarily brain metastases (CNS).^[6], and once distant metastasis occurs after surgery, it will have an even worse impact on the patient's prognosis and 5-year survival rate, making subsequent treatment even more challenging. Currently, the 5-year survival rate for patients with stage IB-IIIA lung cancer in China is between 36% and 68%.^[7,8], there is still significant room for improvement towards the goal of "cure," making adjuvant therapy after surgical resection particularly crucial.

Currently, adjuvant therapy after lung cancer surgery mainly includes postoperative adjuvant chemotherapy, radiotherapy, targeted therapy, and immunotherapy. Although postoperative adjuvant chemotherapy can improve overall survival (OS) and disease-free survival (DFS), its benefits for patients with early- to mid-stage non-small cell lung cancer are limited, increasing the 5-year OS rate by only about 5%.^[9], and the incidence of chemotherapy adverse reactions is high, which patients can hardly tolerate, also seriously affecting their quality of life.^[8]。

Adjuvant Targeted Therapy Post-Surgery Can Extend Overall Survival(OS), Included in Medical Insurance to Benefit More Early- and Mid-stage Lung Cancer Patients

As a targeted precision treatment, adjuvant targeted therapy differs from adjuvant chemoradiotherapy in that it specifically acts on certain precise sites of tumor cells, highly selectively killing tumor cells without harming or causing minimal harm to normal cells. Due to its significant clinical benefits, it is a treatment method prioritized and recommended by authoritative guidelines both in China and internationally.^[10]Osimertinib not only breaks the previous dilemma of no IB stage postoperative adjuvant treatment indications in the medical insurance directory, but is also the only one.^[*^2]With significant overall survival benefits, the third-generation EGFR-TKI notably improves the 5-year survival rate, alleviating the psychological and financial pressures on patients and their families caused by disease progression, and bringing "cure" hope to patients with early- and mid-stage lung cancer.

However, not all NSCLC patients can benefit from postoperative targeted adjuvant therapy. The premise of precise diagnosis and treatment is precise testing. As recommended by major authoritative guidelines, EGFR gene mutation testing should be performed simultaneously on postoperative pathological specimens for early- and mid-stage non-small cell lung cancer. For patients who are EGFR mutation-positive, adjuvant targeted therapy can be initiated as soon as possible after surgery to achieve early benefits.^[11,12]。

Mr. Chen Kangwei, General Manager of AstraZeneca China Oncology Business UnitSaid: "Since pioneering the era of targeted lung cancer treatment in China, AstraZeneca has always adhered to its patient-centered mission, continuously introducing innovative drugs for Chinese lung cancer patients and improving drug accessibility. We are grateful to the Chinese government for including the third indication of osimertinib—adjuvant treatment for early- and mid-stage lung cancer after surgery—in the medical insurance coverage. We hope this will help more patients with early- and mid-stage lung cancer achieve the hope of 'cure' and assist them in reintegrating into society. In the future, we will continue to address the unmet clinical treatment needs of a large number of lung cancer patients in China, constantly bringing innovative treatment solutions to help them achieve high-quality long-term survival and contribute to the realization of the 'Healthy China 2030' strategic goals."

^*1As of2023Year12Month13National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Directory (2023Year)
^*2 As of2023Year12Month8Day, use postoperative targeted adjuvant therapy keywords inPubMedDatabase retrieval within ten yearsRCTResearch

About AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a science-led global biopharmaceutical company focused on the research, development, manufacturing, and marketing of prescription medicines. Key areas of focus include oncology, biopharmaceuticals such as cardiovascular, renal, and metabolic diseases, respiratory and immunology, vaccines and infectious diseases, as well as rare diseases. AstraZeneca’s global headquarters is located in Cambridge, UK, with operations in over 100 countries worldwide, delivering innovative medicines to millions of patients globally. For more information, please visitwww.astrazeneca.com。

About AstraZeneca China

Since entering China in 1993, AstraZeneca has adhered to the principle of science first, focusing on innovation to meet the growing health needs of China and to realize the grand vision of "pioneering innovation for the benefit of patients and becoming the most trusted healthcare partner in China." The headquarters of AstraZeneca's Chinese branch is located in Shanghai, with regional headquarters established in Beijing, Guangzhou, Wuxi, Hangzhou, and Chengdu. The company has production bases in Wuxi and Taizhou, Jiangsu Province, and a logistics center in Wuxi, China. In China, AstraZeneca focuses its business on therapeutic areas with the most urgent needs for Chinese patients, including oncology, cardiovascular, metabolism, renal, respiratory, gastroenterology, vaccines and antibodies, autoimmune diseases, and rare diseases. In 2017, the China Health Internet of Things Innovation Center was established in Wuxi to explore innovative integrated solutions for the entire disease management process through the Internet of Things. In the same year, AstraZeneca formed Dizal (Jiangsu) Pharmaceutical Co., Ltd. as a joint venture with SDIC Innovation to accelerate local new drug development. In 2019, AstraZeneca announced a collaboration with Wuxi to build the Wuxi International Life Science Innovation Park, gathering global intelligence to benefit Chinese patients. In 2020, AstraZeneca announced its support for the "Internet Hospital" project. In 2021, AstraZeneca officially upgraded its Global R&D China Center in Shanghai and jointly initiated the AstraZeneca CICC Healthcare Industry Fund with CICC Capital.

Disclaimer: This material is not intended for any promotional purposes, and the relevant information should not be used as advice for treatment or use. If you have any related questions, please consult a healthcare professional.

[1] Sung H., et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249.

[2] Liu SY, et al. J Thorac Oncol. 2016 Sep;11(9):1503-10

[3] Non-Small Cell Lung Cancer Expert Committee of Chinese Society of Clinical Oncology (CSCO), Expert Committee on Safety Management of Antineoplastic Drugs, Zhou Caicun, et al. Expert Consensus on the Application of Third-Generation EGFR-TKI in the Treatment of EGFR-Mutated NSCLC (2022 Edition) [J]. Chinese Journal of Lung Cancer, 2022(009):025.

[4] 2023 Chinese Society of Clinical Oncology (CSCO) Non-Small Cell Lung Cancer Diagnosis and Treatment Guidelines

[5] Chinese Society of Clinical Oncology, Lung Cancer Professional Committee of Chinese Anti-Cancer Association. Evidence-Based Medicine, 2019; 19(4): 193-199

[6] Chouaid C, Danson S, Andreas S, et al,. Lung Cancer. 2018;124:310-316

[7] Pignon J, et al,. LACE collaborative group. J Clin Oncol. 2008;26(21):3552

[8] Uramoto H, Tanaka F. Recurrence after surgery in patients with NSCLC. Transl Lung Cancer Res. 2014;3(4):242-249.

[9] Pignon JP, et al. J Clin Oncol. 2008 Jul 20;26(21):3552-9.

[10] NCCN Guidelines: Non-Small Cell Lung Cancer (Version 3.2021-February 16, 2021) / Chinese Medical Association Oncology Branch Lung Cancer Clinical Diagnosis and Treatment Guidelines (2021 Edition)

[11] NCCN, Clinical Practice Guidelines NSCLC, 2023 Version 5.

[12] CSCO, Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer, 2023.