Xinhua News Agency, March 11th: The website of the National Medical Products Administration showed that AstraZeneca's Imfinzi (generic name: Durvalumab Injection) has been approved for a new indication. It is to be used in combination with platinum-based chemotherapy as neoadjuvant therapy, followed by continued use of this product as monotherapy adjuvant treatment after surgery. It is intended for treating adult patients with resectable stage Ⅱ, ⅢA, and ⅢB non-small cell lung cancer (NSCLC) who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This makes it the first PD-L1 inhibitor approved in China for perioperative treatment of lung cancer.
The "2022 China Cancer Incidence and Mortality" report released by the National Cancer Center shows that in 2022, the number of new lung cancer cases in China reached 1.0606 million, with 733,300 deaths due to lung cancer. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, with approximately 25%-30% of patients diagnosed early and eligible for surgery with curative intent. However, 52%-75% of stage II-III NSCLC patients will experience recurrence or metastasis within five years post-surgery, representing a significant unmet treatment need in this patient population.
This approval marks the fourth indication for durvalumab in China, based on the pivotal AEGEAN Phase III clinical trial results previously published in The New England Journal of Medicine. The pre-specified interim analysis of event-free survival (EFS) showed that, compared with neoadjuvant chemotherapy alone, the perioperative treatment regimen based on durvalumab reduced the risk of recurrence, progression, or death by 32%.
Hao Jie, an academician of the Chinese Academy of Sciences and president of the Cancer Hospital of the Chinese Academy of Medical Sciences, stated that immunotherapy has gradually become an important means to improve the survival prognosis of patients with operable NSCLC. "The AEGEAN study was conducted across 28 countries and regions, with China enrolling the highest number of patients globally. We are pleased to see that perioperative treatment based on durvalumab significantly reduced the risk of recurrence, progression, or death in patients with operable stage IIA-IIIB NSCLC, marking a new chapter for PD-L1 inhibitors in the field of perioperative lung cancer treatment and providing a new therapeutic strategy to improve survival outcomes for these patients."
Proofread by Baoqing Liu