On September 24, 2022, the online journal of OncLive Medical released the 5-year data of the Phase III KEYNOTE-407 trial (NCT02775435). In this trial, we aim to evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in patients with metastatic squamous lung cell carcinoma (NSCLC) who were initially treated with .
Non-small cell lung cancer has entered the era of precise treatment, and patients with negative driver genes are currently difficult to treat clinical treatment. In recent years, immunotherapy has developed rapidly, providing a new treatment strategy for non-small cell lung cancer, which has attracted much attention and expectations.
1 pembrolizumab is a humanized anti-PD-1 monoclonal antibody that can block the binding of PD-1 with its ligands PD-L1 and PD-L2, and then activate T lymphocytes . This effect may affect tumors and normal cells. can enhance the immune system in the body to detect and resist tumor cells .
Trade name: KEYTRUDA (Kerida)
Generic name: pembrolizumab (Pembrolizumab) html l2
Specification: 100mg/4ml
First time approved in the United States: September 2014
First time approved in China: 1 September 2014
First time approved in China: ml2 July 2018
approved indications: Non-small cell lung cancer (China), small cell lung cancer , liver cancer , kidney cancer , gastric cancer , cervical cancer , endometrial cancer, esophageal cancer (China), melanoma (China), head and neck Squamous cell carcinoma (China), Hodgkin's lymphoma , urothelial carcinoma, primary mediastinal large B-cell lymphoma, MSI-H solid tumor, Merck's cell carcinoma, TMB-H solid tumor, skin squamous cell carcinoma , MSI-H/dMMR colorectal cancer (China), triple-negative breast cancer
recommended dosage of lung cancer: 200 mg, intravenous injection for more than 30 minutes, once every 3 weeks. Continue to take medication until the disease progresses, an intolerable toxic reaction or no disease progresses within 24 months.
Give medicine plan: For low-income patients, the drug policy is 3+3 (buy 3 courses and get 3 courses); for patients with low-income patients, it can be used for 24 months for free.
Storage conditions: 2°C to 8°C Refrigerate
Clinical data
In this phase III KEYNOTE-407 trial, patients who met the conditions were randomly divided into pembrolizumab combined with chemotherapy (n=278) or placebo combined with chemotherapy (n=281). The main endpoints of the trial were overall survival (OS) and progression-free survival (PFS).
Over approximately 5 years, 50.9% (n=117) of the placebo patients were transferred to pembolizumab monotherapy in the study, and another 26 patients received anti-PD-(L)1 treatment after the study. The results of the
trial showed that when the median follow-up time was 56.9 months, the median overall survival (OS) of pembrolizumab combined with chemotherapy group VS placebo group was 17.2 months VS 11.6 months ; the 5-year OS rate was 18.4% VS 9.7% . The median progression-free survival (PFS) was 8.0 months VS 5.1 months ; the 5-year PFS rate was 10.8% VS 3.5% .
In the intention-to-treat population, the objective response rate (ORR) of pembrolizumab combined with chemotherapy group VS placebo group was 62.2% VS 38.8% ; the median persistent response time (DOR) was 9.0 months VS 4.9 months .
Other results show that patients can benefit from pembrolizumab regardless of whether the PD-L1 expression level is less than 1%, between 1% and 49%, or above 50%.When
PD-L1 expression is less than 1%, the ORR is 67.4% VS 41.4% ; when PD-L1 expression is 1%~49%, the ORR is 54.4% VS 43.3% ; when PD-L1 expression is 50% or higher, the ORR is 64.4% VS 30.1% . In addition, in each PD-L1 subset, the use of pembrolizumab also extended the median DOR.
It is worth noting that patients who completed all 35 pembolizumab treatment cycles (n=55) had a lasting response and long-term OS. In this population, the ORR was 90.9%, including 9 (16.4%) complete remission (CR) and 41 (74.5%) partial remission (PR). But the median DOR in this population has not reached (NR).
In addition, after completing 35 cycles of pembolizumab treatment, the 3-year OS rate was 69.5% , and 43.6% (n=24) of patients survived without progressive disease or follow-up treatment.
Adverse reactions
In terms of safety, 98.6% of patients in the pembrolizumab group (n=278), while 98.2% of patients in the placebo group (n=280) had adverse reactions; 74.8% of grades 3-5 adverse reactions were 70.0%. The incidence of immune-mediated toxic reaction was 35.6% vs 9.3%; the incidence of immune-mediated toxic reactions at grades 3 to 5 was 13.3% vs 3.2%.
Summary
Pembrolizumab combined with chemotherapy continues to significantly improve OS and PFS in patients with metastatic pulmonary squamous cell carcinoma. Therefore, long-term data continue to support pembrolizumab combined with chemotherapy as a standard first-line treatment option for metastatic lung squamous cell carcinoma.
Reference source:
https://www.onclive.com
[Important reminder] This official account [Global Good Medicine Information] All article information is for reference only. For specific treatment , please follow the doctor's advice !
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-