Two-year clinical trial of KEYNOTE-024 showed that non-small cells with high expression of PD-L1 using the first-line drug pembrolizumab (Keytruda) The overall survival level (OS) of patients with lung cancer (NSCLC) is more than double that of standard chemotherapy.
At the 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan, based on a previously reported 6-month analysis of results, the median value of OS was longer in patients with PD-1 than in the chemotherapy group (30.2). Months vs 14.2 months), the risk of death was reduced by 37% (risk factor: 0.63; 95% confidence interval: 0.47 – 0.86; P= 0.002).
“In this continually updated study of non-small cell lung cancer, practitioners have seen the long-term clinical benefit of this drug,” said Dr. Martin, a research reporter. Among the prognostic patients, the important findings of OS in the KEYNOTE-024 trial reinforce the first-line use of the drug.”
In the open trial, untreated patients with advanced NSCLC were randomly assigned to pembrolizumab The monotherapy group (n=154) or the standard treatment group based on platinum chemotherapy (n=151). The selected cases had tumors, no systemic chemotherapy, no EGFR-sensitive mutations or ALK translocations. According to FDA-approved tests, the high expression of tumor PD-L1 was defined as the tumor proportion score ≥50%.
Pembrolizumab patients received 200 mg of Pembrolizumab intravenously on the first day of each cycle (21 days duration) until the 35th cycle or disease progression. Patients in the chemotherapy group were given paclitaxel plus cisplatin, gemcitabine plus carboplatin, or gemcitabine plus cisplatin daily. Pemetrexed in patients with non-squamous NSCLC. The primary endpoint of the trial was PFS, and the second outcome was OS and overall response rate (ORR).
The data provided by WCLC was based on a median follow-up of 25.2 months. The follow-up included 82 patients who were switched from chemotherapy to pembrolizumab and 12 patients who received anti-PD-1 therapy. .
Pembrolizumab group and chemotherapy group, the OS in July was 51.5% and 34.5%, respectively, and the OS in December was 70.3% and 54.8%, respectively. The ORR of the two groups was 45.5% (95% CI, 37.4-53.7) and 29.8% (95% CI, 22.6-37.8). The Pembrolizumab group did not reach an average response time (1.8+ to 20.6+ months), and the response time of the chemotherapy group was 7.1 months (2.1+ to 18.1+ months).
The safety results are consistent with the experimental results of the previous metabolic NSCLC. In the Pembrolizumab group, 31.2% of patients experienced ≥3 treatment-related adverse events (TRAEs). The most common TAREs are diarrhea, fatigue, fever, itching, nausea, loss of appetite, and rash. The most common immune-related adverse events are hypothyroidism, pneumonia, hyperthyroidism, severe skin toxicity, and infusion reactions. There was one treatment-related death.
From the results released in 2016, the proportion of patients with ≥3 grades of TRAEs in the chemotherapy group was twice that of the Pembrolizumab group (53.3% vs. 26.6%). The proportion of patients with severe TAEs was similar (20.7% vs 21.4%).
The proportion of patients in the Pemblerizumab group who gave up treatment due to TAREs was 7.1%, and that in the chemotherapy group was 10.7%. One person in the Pembrolizumab group died of TRAEs: died on the second day for unknown reasons. Three people in the chemotherapy group died of TRAEs: one died of pulmonary sepsis on the 25th day, one died of alveolar hemorrhage on the 112th day, and one died on the 8th day for unknown reasons.
Based on preliminary results of KEYNOTE-024, the US FDA approved the use of pembrolizumab for the treatment of metabolic NSCLC in October 2016, FDA approved patients with PD-L1 expression ≥50%, and no EGFR or ALK aberrations use.
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