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KEYNOTE-042 is a phase III randomized trial with initial results showing that pembrolizumab monotherapy significantly prolongs overall survival (OS) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a previously untreated PD-L1 tumor proportion score (TPS)
of ≥1% compared with platinum-based chemotherapy.
Prognosis results
at approximately 5 years of follow-up of the trial are reported here.
In this trial, participants who did not carry the EGFR/ALK variant and PD-L1 TPS ≥1% of locally advanced or metastatic non-small cell lung cancer were given pembrolizumab 200 mg/3 weeks for 35 courses or chemotherapy (carboplatin + paclitaxel or pemetrexed) for 4 to 6 sessions, followed by pemetrexed maintenance therapy
.
The primary endpoint was overall survival in patients with PD-L1 TPS ≥ 1%, ≥ 20%, ≥
50%.
Patients who have completed 35 courses of pembrolizumab and are ≥ stable may start the second phase of pembrolizumab after progression
.
Key prognosis for both groups
A total of 1274 patients were randomized to pembrolizumab (n=637) or chemotherapy (n=637).
The median follow-up was 61.
1 months
.
Regardless of PD-L1 TPS score, the prognosis of OS in the pembrolizumab group was better than that in the chemotherapy group: risk ratio, TPS ≥ 50%: 0.
68; TPS ≥20%: 0.
75; TPS≥1%: 0.
79; and the estimated 5-year overall survival in the pembrolizumab group was 21.
9%, 19.
4%, and 16.
6%,
respectively.
No new toxic reactions
were observed.
The objective response rate was as high as 84.
3% in 102 patients who completed 35 courses of pembrolizumab and 15.
2%
in 33 patients treated with pembrolizumab in the second stage.
In summary, after 5 years of follow-up, pembrolizumab monotherapy continued to show clinical benefits
over chemotherapy in PD-L1-positive patients with locally advanced or metastatic NSCLC without EGFR/ALK variants.
Original source:
Gilberto de Castro Jr, et al.
Five-Year Outcomes With Pembrolizumab Versus Chemotherapy as First-Line Therapy in Patients With Non–Small-Cell Lung Cancer and Programmed Death Ligand-1 Tumor Proportion Score ≥ 1% in the KEYNOTE-042 Study.
Journal of Clinical Oncology.
October 28, 2022.
https://ascopubs.
org/doi/full/10.
1200/JCO.
21.
02885
