Amgen Announces Sotorasib Granted Breakthrough Therapy Designation in China for KRAS G12C-Mutated Non-Small Cell Lung Cancer

Shanghai, Feb. 1, 2021 /PRNewswire/ -- Today, Amgen announced its investigational KRAS^G12CThe inhibitor sotorasib has been included in the “Breakthrough Therapy Drug” program by the Center for Drug Evaluation of the National Medical Products Administration. This designation is for its use in treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have previously received at least one systemic therapy. This marks Amgen’s first application for “Breakthrough Therapy Drug” designation in China, as well as the first such application since establishing a strategic collaboration with BeOne Medicines.

Non-small cell lung cancer, the most common type of lung cancer, accounts for approximately 80-85% of global lung cancer cases.^[1]KRAS G12C Mutation Is the Most Common Type of KRAS Mutations in Non-Small Cell Lung Cancer^[2],[3]In Chinese patients with non-small cell lung cancer (NSCLC), this mutation serves as a biomarker for poor prognosis, and G12C-specific inhibitors are expected to improve their outcomes.^[4]Studies have shown that KRAS G12C gene mutations account for approximately 3-5%, and are most common among smokers.^[4],[5]

“Being included in the ‘Breakthrough Therapy Drug’ program is a new pathway in China, so we are very pleased that sotorasib has received this designation,” said Dr. David M. Reese, Executive Vice President of Research and Development at Amgen. “Inclusion as a ‘Breakthrough Therapy Drug’ highlights the value of sotorasib. We look forward to working with Chinese regulatory authorities to bring this first targeted therapy for KRAS G12C mutations to patients with non-small cell lung cancer in China.”

Sotorasib was granted “Breakthrough Therapy” designation based on the positive results of the Phase II clinical trial named CodeBreaK 100, which enrolled patients with advanced non-small cell lung cancer (NSCLC) who had previously received chemotherapy and/or immunotherapy but still experienced disease progression. The study demonstrated that sotorasib exhibited durable anticancer activity and showed a favorable benefit-risk profile.^[6]Detailed Study ResultsAlready on 1presented at the 2020 World Conference on Lung Cancer, organized by the International Association for the Study of Lung Cancer, on Friday, [Month] 29, from 3:50 PM to 4:00 PM (Pacific Standard Time).

Review Procedures for Breakthrough Therapy Designation by the National Medical Products Administration are designed to accelerate the development and review of drugs intended for the prevention or treatment of serious life-threatening conditions or diseases that significantly impair quality of life, where no effective preventive or therapeutic options exist, or where sufficient evidence demonstrates a clear clinical advantage over existing treatments.^[7]This indicates that sotorasib is poised to become the first drug in China for the targeted treatment of KRAS G12C-mutated non-small cell lung cancer.

The development of sotorasib was one of the most formidable challenges in Amgen’s 40 years of cancer research, as it was the first KRAS inhibitor to enter clinical trials.^G12CInhibitor.^[8]Global research centers across four continents have conducted the most extensive clinical research program, with up to 10 combination therapy studies. In just over two years, the sotorasib clinical trial program has established a robust clinical dataset encompassing nearly 700 patients across 13 tumor types.

AboutCodeBreaK

CodeBreaK is the clinical development program for sotorasib, an investigational drug by Amgen. The program aims to evaluate the efficacy of sotorasib in treating patients with advanced solid tumors harboring KRAS G12C mutations, addressing the long-standing unmet therapeutic needs in this patient population. As the most advanced clinical development program targeting KRAS G12C mutations, CodeBreaK has enrolled more than 700 patients across 13 tumor types since its inception.

CodeBreaK 100 is the first-in-human, open-label, multicenter Phase I/II clinical study enrolling patients with solid tumors harboring KRAS G12C mutations. Eligible patients must have previously received systemic anticancer therapy appropriate for their tumor type and disease stage. The primary endpoint of the Phase II trial is the objective response rate assessed by central review. The Phase II clinical trial in non-small cell lung cancer enrolled 126 patients, 124 of whom had RECIST-evaluable lesions at baseline per central assessment. Patient enrollment for the Phase II clinical trial in colorectal cancer has been completed, with preliminary results expected to be announced in 2021.

CodeBreaK 200 is a global, randomized, active-controlled, Phase III clinical study comparing sotorasib with docetaxel for the treatment of non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations, and patient enrollment is currently ongoing. In addition, Amgen is concurrently conducting more than 10 Phase 1b combination studies (CodeBreaK 101) targeting various advanced solid tumors.

For more information, please visitwww.codebreaktrials.com

About Amgen Oncology

Amgen Oncology is dedicated to seeking solutions to address the complex and challenging issues of improving healthcare and enhancing quality of life for patients. Our research drives us to understand diseases from the perspective of patients’ lives, rather than focusing solely on their cancer journey, thereby empowering them to take greater control of their lives.

Over the past four decades, we have achieved numerous major breakthroughs in oncology and sought ways to alleviate the burden of cancer. Building on this legacy, Amgen will continue to strengthen the largest R&D pipeline in the company’s history and accelerate our innovation with a patient-centric approach.

At Amgen, we remain steadfast in our commitment to improving the lives of cancer patients, making it the central focus of all our work.

To learn more about Amgen’s innovative drug pipeline, please visitAmgenOncology.com

For more information, please see our Twitter account:www.twitter.com/amgenoncology

About Amgen

Amgen is dedicated to benefiting patients worldwide suffering from serious diseases by unlocking the potential of biology. To realize this vision, Amgen has long focused on the discovery, research and development, manufacturing, and sales of innovative human therapeutics, leveraging cutting-edge tools such as human genetics to elucidate the complexity of diseases and gain insights into the fundamental mechanisms of human biology.

Amgen focuses on disease areas with significant and largely unmet medical needs, leveraging its advanced expertise in biopharmaceuticals to make outstanding contributions to improving human health and quality of life. Since its founding in 1980, Amgen has become one of the world’s leading independent biotechnology companies, providing innovative medicines to millions of patients worldwide while maintaining a robust pipeline of promising investigational drugs.

For more information, please visitwww.amgen.comand followwww.twitter.com/amgen。

About Amgen China

Since entering China in 2012, Amgen has remained committed to its mission of serving patients, leveraging science and biotechnology to benefit Chinese patients and improve public health. Headquartered in Shanghai, Amgen China operates in nearly 80 cities across the country. In China, Amgen focuses on chronic disease areas with significant unmet needs, including cardiovascular disease, bone health, inflammation, and nephrology, providing patients with innovative and superior treatment options.

For more information, please visitwww.amgen.cnand follow the official corporate WeChat account of Amgen China, “Amgen.”

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References

[1] American Cancer Society. Available at https://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar. Accessed January 2021.

[2] Pakkala S, et al. JCI Insight. 2018;3:e120858. 

[3] Arbour KC, et al. Clin Cancer Res. 2018;24:334-340.

[4] Liu S, et al. Clinical characteristics and prognostic value of the KRAS G12C mutation in Chinese non-small cell lung cancer patients. Biomark Res 8, 22 (2020). https://doi.org/10.1186/s40364-020-00199-z.

[5] Loong, et al. Transl Lung Cancer Res. 2020 Oct; 9(5): 1759–1769.

[6] AMGEN, 2020. Retrieved January 20, 2021, from https://www.amgen.com/newsroom/press-releases/2020/10/amgen-announces-positive-topline-phase-2-results-for-investigational-kras-g12c-inhibitor-sotorasib-in-advanced-non-small-cell-lung-cancer.

[7] China Drug Registration Regulation: http://www.gov.cn/gongbao/content/2020/content_5512563.htm

[8] Kim D, et al. Cell. 2020. doi:10.1016/j.cell.2020.09.044.