PD-L1 inhibitor Atezolizumab has received FDA priority review qualification!
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PD-L1 inhibitor Atezolizumab has received FDA priority review qualification!
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PD-L1 inhibitor Atezolizumab has received FDA priority review qualification!
On August 3, 2021, Genentech, a subsidiary of Roche Group, announced that FDA has granted the PD-L1 inhibitor Tecentriq (atezolizumab) supplementary biological product license application (sBLA) priority review as a non-small cell Adjuvant treatment for patients with lung cancer (NSCLC) after surgery and platinum-containing chemotherapy.
The press release on its official website pointed out that this is the first tumor immunotherapy with positive results in a Phase 3 clinical trial of adjuvant treatment of early lung cancer. The FDA is expected to make an approval decision before December 1, 2021.
Prior to this, Tecentriq (atezolizumab) has been approved by the European Commission and the FDA for the first-line treatment of patients with metastatic NSCLC with high PD-L1 expression and without abnormal EGFR and ALK mutations.
The IMpower010 phase 3 results released at this year’s ASCO meeting showed that compared with the best supportive treatment, PD-L1-positive early lung cancer surgery and platinum-based chemotherapy followed by atezolizumab treatment can increase the risk of disease recurrence or death (DFS) in stage II patients Reduced by 34% (hazard ratio [HR] = 0.66, 95% CI: 0.50-0.88).
IMpower010 is a phase III, global, multicenter, open-label, randomized study designed to evaluate patients with stage IB-IIIA NSCLC whose tumors express PD-L1 after undergoing surgical resection and up to 4 cycles of platinum-containing chemotherapy. Compared with the best standard treatment (BSC), Atezo’s efficacy and safety.
The study included patients eligible for complete resection (4-12 weeks before enrollment) stage IB (≥ 4 cm)-IIIA non-small cell lung cancer (AJCC/UICC v7) and ECOG PS 0-1.
A total of 1280 patients were enrolled, and 1269 patients received 4 21-day cycles of cisplatin chemotherapy (combined with pemetrexed, docetaxel, gemcitabine or vinorelbine). Among these pts (n = 1269), 1005 patients were subsequently randomly assigned 1:1 to the group taking 1200 mg Q3W for 16 cycles or the BSC group.
The investigators performed a stratified test on the primary endpoint of DFS assessed and the secondary endpoint of overall survival (OS): first, DFS in the PD-L1 TC ≥ 1% (SP263) subgroup of stage II-IIIA disease, and then It is the DFS of all random pts of stage II-IIIA disease, then the DFS of the ITT population (stage IB-IIIA), and finally the OS of the ITT population. Efficacy evaluation is based on random pts.
At the data cutoff date (January 21, 2021), the median follow-up time for the ITT population was 32.2 months. In PD-L1 TC ≥ 1% stage II-IIIA and all randomized stage II-IIIA populations, Atezo showed a statistically significant DFS benefit from BSC; DFS in the ITT population did not cross the significance boundary.
The median dose of Atezo received by Pts in the Atezo group was 16 (range 1-16).
Adverse events of any level occurred in 92.7% (atezo) and 70.7% (BSC). The event level is 3/4, accounting for 21.8% and 11.5% respectively. 0.8% of patients in the Atezo group had grade 5 treatment-related adverse events.
The incidence of adverse events leading to the discontinuation of Atezo was 18.2%.
At a median follow-up time of 32.8 months, the median DFS in the Atezo group had not been reached, and the DFS in the BSC group was 35.3 months.
The safety data obtained in the test is consistent with the known safety characteristics of the drug, and no new safety signals have been found.
IMpower010 reached its primary endpoint, indicating that in the removal of stage II-IIIA NSCLC pts, the use of adjuvant Atezo and BSC after adjuvant chemotherapy is beneficial for DFS, and it has a clear benefit in the PD-L1 TC ≥ 1% subgroup.
Atezolizumab is a monoclonal antibody designed to bind to a protein called PD-L1 and block its interaction with PD-1 and B7.1 receptors. By inhibiting PD-L1, Atezolizumab can be reactivated T cells to kill tumor cells.
PD-L1 inhibitor Atezolizumab has received FDA priority review qualification!
(source:internet, reference only)
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