Research states that atezolizumab prolongs the OS of some types of advanced NSCLC
The efficacy and safety of atezolizumab as first-line therapy for advanced NSCLC with high levels of PD-L1 expression are unclear and require additional treatment options, the authors said.
Patients were positive for PD-L1 as determined by the SP142 qualitative immunohistochemical assay in at least 1% of tumor cells or at least 1% of tumor infiltrating immune cells.
The researchers also performed a pre-specified efficacy analysis by subgroups defined by blood-based tumor mutation loading.
Patients were assigned in a 1: 1 ratio to receive atezolizumab or chemotherapy. OS was tested according to PD-L1 expression status in patients in the ITT population. In subgroup analysis EGFR And ALK Wild-type tumors were also positively evaluated for OS and progression-free survival (PFS).
The study enrolled 572 patients. 285 were assigned to atezolizumab and 287 were assigned to chemotherapy. Patients were randomized from 21 July 2015 to 20 February 2018.
Participants EGFR And ALK The number of wild-type tumors was 554, and there were 277 patients in each group.
18 patients EGFR Mutation or ALK The translocation was registered based on the original research protocol. The protocol was later modified to exclude these patients from primary analysis after suggesting that new information may not benefit from monotherapy with immune checkpoint inhibitors. They were included in the safety group.
Atezolizumab (1200 mg intravenously) or chemotherapy (4 or 6 cycles) was given once every 3 weeks. In the chemotherapy group, patients with non-squamous NSCLC received either cisplatin or carboplatin in addition to intravenous pemetrexed. Patients with squamous NSCLC received a cisplatin and gemcitabine regimen or a carboplatin and gemcitabine regimen.
In a subgroup of patients (n = 205) EGFR And ALK In the wild-type tumor with the highest PD-L1 expression, atezolizumab, median OS was extended by 7.1 months compared to the chemotherapy group (20.2 months vs. 13.1 months, HR at death, 0.59, 95% CI, 0.40 to 0.89); P = .01).
However, the patient’s OS results EGFR And ALK Wild-type tumors with high or moderate PD-L1 expression, although numerically long, did not cross the pre-specified alpha boundary (median, 18.2 months with atezolizumab, 14.9 months with chemotherapy? Month, stratified HR of death, 0.72, 95% CI, 0.52 -0.99; P = .04). The authors write that the operating system in this group was not formally tested according to a statistical analysis plan.
The median overall survival for these patients was 17.5 months with atezolizumab and 14.1 months with chemotherapy (stratified HR of death, 0.83; 95% CI, 0.65-1.07).
PFS was 8.1 months with atezolizumab and 5.0 months with chemotherapy (stratified HR of disease progression or death, 0.63; 95% CI, 0.45-0.88). In patients with EGFR and ALK wild-type tumors with high or moderate PD-L1 expression, PFS was 7.2 months with atezolizumab and 5.5 months with chemotherapy (stratified HR or disease progression or death, 0.67; 95% CI, 0.52-0.88).
View results from blood-based tumor mutation loading scores in at least 16,389 of 554 patients EGFR And ALK Wild-type tumors expressing PD-L1 can be evaluated. There, OS and PFS also endorsed atezolizumab. Median OS was 13.9 months for atezolizumab and 8.5 months for the chemotherapy group (non-stratified HR of death, 0.75; 95% CI, 0.41-1.35). Median PFS was 6.8 months in the atezolizumab group and 4.4 months in chemotherapy (non-stratified HR of disease progression or death, 0.55; 95% CI, 0.33-0.92).
Safety results showed that adverse events occurred in 90.2% of patients with atezolizumab and 94.7% of chemotherapy. The safety profile was consistent with previous studies, the authors said.
Atezolizumab Approved By the FDA in May as initial treatment for adults with this type of NSCLC. Genentech funded the exam and collaborated with the author.
Atezolizumab for first-line treatment of NSCLC patients selected with Herbst RS, Giaccone G, de Marinis F, and others PD-L1. N Engl J Med.. 2020 383: 1328-1339. 2: 10.1056 / NEJMoa1917346
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