Sintilimab Granted National Reimbursement for EGFR-Mutated Non-Squamous NSCLC Following TKI Failure

Lung CancerPatients Receive Good News Again

ShanghaiDecember 13, 2023PR Newswire -- Today, the latest announcement from the National Healthcare Security Administration and the Ministry of Human Resources and Social Security showed that the innovative PD-1 inhibitor Tyvyt, jointly developed by Eli Lilly and Company and Innovent Bio^®(General name: Sintilimab Injection) On the basis of the original medical insurance, the seventh new indication has been included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2023)" (hereinafter referred to as the Medical Insurance Catalog), for the treatment of patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who are positive for epidermal growth factor receptor (EGFR) gene mutations and have failed treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). The new version of the Medical Insurance Catalog is expected to be implemented starting from January 1, 2024. Reimbursement procedures and timelines in various regions will be subject to local government announcements.

Tyvyt^®(Tyvyt, sintilimab injection) is the world's first and only PD-1 inhibitor approved for this indication, and also becomes the only PD-1 inhibitor in China included in the National Reimbursement Drug List (NRDL) for the treatment of EGFR-mutant lung cancer after TKI resistance. Meanwhile, Tyvyt^®(Tyvyt, sintilimab injection) successfully renewed for other indications, achieving national medical insurance coverage for all seven indications, including squamous and non-squamous non-small cell lung cancer, hepatocellular carcinoma, gastric adenocarcinoma, esophageal squamous cell carcinoma, and classical Hodgkin's lymphoma.

In China, the incidence and mortality rates of lung cancer have ranked first among malignant tumors for many years. According to the "2022 National Cancer Report" released by the National Cancer Center, the number of new lung cancer patients in China reached 828,000 in 2022.^[1]Among all lung cancer patients, NSCLC accounts for about 80% to 85%, of which the proportion of EGFR mutation-positive patients reaches 40% to 55%.^[2]For such patients, EGFR-TKI has long been the standard first-line treatment regimen.^[3]。

However, EGFR-TKI resistance has long been a major challenge in the treatment of EGFR mutation-positive advanced NSCLC. Although the issue of EGFR-TKI resistance has been alleviated to some extent with the iteration of EGFR-TKIs, the vast majority of patients still develop resistance.^[3]Previously, the main subsequent treatment for these patients was platinum-based doublet chemotherapy, with a progression-free survival of only 4-5 months.^[4],[5], therefore, there is an urgent clinical need for innovative treatment methods.

In May this year, based on the results of the ORIENT-31 study^[4]Sintilimab officially approved for EGFR-TKI treatment-failed EGFR mutation-positive non-squamous non-small cell lung cancer. The approval of this new indication represents a "zero breakthrough" in the field of immunotherapy for EGFR mutation-positive lung cancer globally, and also brings new treatment options and the possibility of longer survival for such patients with EGFR-TKI resistance.

Breakthrough Progress in Innovative Drug Research and Approval of New Indications Bring New Treatment Options to Patients. However, the majority of cancer patients still face significant financial pressure during their treatment journey. After the availability of effective drugs, affordability becomes another crucial prerequisite for patients to benefit from innovative therapies. With the inclusion of sintilimab’s new indication in the National Reimbursement Drug List (NRDL), a broad population of EGFR mutation-positive NSCLC patients who develop resistance to EGFR-TKIs may now access innovative immunotherapy with reduced financial burden. Additionally, the incorporation of this new indication into the NRDL means that all seven indications approved for this drug in China are now covered by medical insurance. The enhanced clinical accessibility will enable more patients to receive continuous and effective treatment, extending life expectancy and improving quality of life.

About Sintilimab

Sintilimab, Chinese trade name: Tyvyt^®(Sintilimab Injection) is an innovative PD-1 inhibitor with international quality co-developed by Eli Lilly and Company and Innovent Bio. Sintilimab is a humanized immunoglobulin G4 (IgG4) monoclonal antibody that specifically binds to the PD-1 molecule on the surface of T cells, thereby blocking the PD-1/Programmed Death-Ligand 1 (PD-L1) pathway responsible for tumor immune tolerance, reactivating the anti-tumor activity of lymphocytes, and achieving the purpose of treating tumors.^[6]Currently, more than twenty clinical studies (including over 10 registered clinical trials) are ongoing to evaluate the anti-tumor effects of Sintilimab in various solid tumors and hematological malignancies.

Sintilimab has been approved for seven indications in China, all of which have now been included in the National Reimbursement Drug List (NRDL). The restricted payment scope described within the NRDL during the agreement period includes:

[1] National Cancer Center. 2022 China Cancer Report

[2] Song X, et al. Tumor Research and Clinical Practice. 2019, 31(8): 551-553

[3] Non-Small Cell Lung Cancer Expert Committee of Chinese Society of Clinical Oncology (CSCO). Chinese Journal of Lung Cancer. 2022, 25(9): 627-641

[4]Shun Lu, et al. Lancet Respir Med. 2023 May 5:S2213-2600(23)00135-2

[5]Mok TSK, et al. ESMO Asia Congress 2022, LBA8

[6]Wang J, Fei K, Jing H, et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451.