On July 14, 2021, the official website of the China National Medical Products Administration (NMPA) showed that the PD-L1 inhibitor durvalumab injection was approved for the new indication marketing application, and etoposide combined with platinum (EP, Carboplatin or cisplatin ) chemotherapy regimen for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC).
Previously, on March 30, 2020, the US FDA approved durvalumab in combination with chemotherapy (etoposide + carboplatin/cisplatin) for the treatment of patients with extensive-stage small cell lung cancer who have not received systemic therapy.
Duvalumab is a -selective , high-affinity human IgG1 monoclonal antibody that blocks programmed cell death ligand 1 (PD-L1) and programmed death receptor 1 (PD-1) -1) Binding to CD-80 stimulates anti-tumor T cell activity.
商品名：Imfinzi（英飞凡）
通用名：durvalumab（德瓦鲁单抗、度伐利尤单抗注射液）
靶点：PD-L1
美国首次获批：2017年5月
中国首次Approved: December 2019
Approved indications in the United States: urothelial carcinoma, non-small cell lung cancer (China), small cell lung cancer (China)
Approved indications in China: non-small cell lung cancer
lung cancer Recommended dose: 10mg/kg intravenously every two weeks.
Clinical Data
The approval is reportedly based on positive results from the Phase III clinical study of CASPIAN.The study used a fixed dose of 1500 mg of durvalumab in combination with chemotherapy administered once every three weeks for 4 cycles; then the single agent was maintained once every 4 weeks until disease progression.
Between March 27, 2017, and May 29, 2018, a total of 805 patients were included in the study, of which 268 received durvalumab plus EP and 269 received EP chemotherapy.
The data cutoff date is January 27, 2020, and the median survival (OS) of durvalumab + EP group VS EP group was 12.9 months VS 10.5 months ; 2-year OS rate 22 .2% vs 14.4% ; median progression-free survival (PFS) was 5.1 months vs 5.4 months , 6-month PFS rate 45.6% vs 45.8% , 12-month PFS The rate of PFS at 24 months was 17.9% VS 5.3%, the 24-month PFS rate was 11% VS 2.9%; the objective response rate (ORR) was 67.9% VS 58%; the duration of response (DOR) was 24 Monthly patient ratio was 13.5% vs 3.9%.
Legend: Clinical data of durvalumab combined with EP chemotherapy regimen in the treatment of small cell lung cancer
Focusing on the data of the Asian population of the CASPIAN study, the exploratory OS analysis showed: Asian population subgroups, brain metastases subgroups, liver metastases subgroups All groups showed a consistent benefit trend with the overall population. At the same time, in the exploratory subgroup analysis, the OS rate of 24 months in patients with PFS over 12 months reached 77%.
In the brain metastases subgroup patients, the median OS of durvalumab + EP group vs EP group was 12 months vs 8.8 months .
The EP group had a controllable safety , which was consistent with the general population. The incidence of adverse events (AEs) leading to discontinuation of treatment and AEs leading to death was numerically lower than that of the general population.
Chart: Summary of approved indications for immunosuppressants that have been marketed in China
Conclusions
According to the above CAPSIAN test results, combined chemotherapy showed significant survival benefits and improved efficiency, which is a significant improvement in the treatment of this devastating disease An important step forward. This time, the new indication of durvalumab has been approved in China to bring new treatment options to lung cancer patients, which will undoubtedly benefit more patients.
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