Keynote 042 trial#

The primary end point of the trial was OS, and secondary end points included progression-free survival (PFS) and overall response rate (ORR) as assessed by RECIST v 1.1, plus safety and tolerability of patients with a PD-L1 TPS of at least to 50%, 20%, and 1%. Patients who completed 35 cycles of pembrolizumab were also eligible to receive a second course of 200 mg pembrolizumab every 3 weeks for up to 1 year. In China, 262 eligible patients were randomized 1:1 to receive either 200 mg pembrolizumab for no more than to 35 cycles (n = 128) or carboplatin area under the curve (AUC) 5 or 6 and paclitaxel 200 mg/m2 or carboplatin AUC 5 or 6 and pemetrexed 500 mg/m2 every 3 weeks for up to 6 cycles (n = 134). Patients were stratified by ECOG performance status, squamous vs non-squamous disease, and PD-L1 TPS of 1%-49% or ≥ 50%.

Exclusion criteria included untreated or unstable central nervous system metastases and a histology of pneumonitis that required corticosteroids. Moreover, patients could not have sensitizing EGFR or ALKalterations and must have had ECOG performance status of 0 or 1. Key eligibility criteria for patients on the study included untreated locally advanced or metastatic NSCLC of any histology and a PD-L1 TPS at least 1%. In addition to providing updated safety and efficacy outcomes of the KEYNOTE-042 China trial, study authors aimed to provide updated efficacy and safety outcomes of patients with additional 14 months of follow up of Chinese patients. Prior data from KEYNOTE-042 trial at a median follow-up of 33 months (range, 25.6-41.9) showed pembrolizumab elicited significantly improved OS rates vs chemotherapy in the patients with a PD-L1 TPS of at least 50% (HR, 0.63 95% CI, 0.43- 0.94), at least 20% (HR, 0.66 95% CI, 0.47- 0.92), and at least 1% (HR, 0.67 95% CI, 0.50-0.89).

“Pembrolizumab monotherapy remains a standard of care treatment for Chinese patients with previously untreated, locally advanced or metastatic NSCLC with PD-L1 TPS greater than or equal to 1 and without sensitizing EGFR or ALK alterations,” lead study author, Yi-Long Wu, MD, said in the poster presentation. Results showed that patients with PD-L1 tumor proportion score (TPS) of at least 50% achieved a 4-year OS rate of 23.4% and a median OS of 24.5 months (95% CI, 17.4-34.3) with pembrolizumab, compared with 13.6% and 13.8 months (95% CI, 10.1-18.3) with chemotherapy (HR, 0.66 95% CI, 0.45-0.95). Mok, Yi‐Long Wu, +248 authors A.First-line pembrolizumab (Keytruda) monotherapy continued to elicit an overall survival (OS) benefit and durable tumor response vs standard-of-care platinum-based chemotherapy in Chinese patients with untreated PD-L1–positive, advanced or metastatic non–small cell lung cancer (NSCLC) without sensitizing EGFR or ALKmutations, according to results of a 4-year follow-up from the phase 3 KEYNOTE-042 trial (NCT02220894) and phase 3 China extension KEYNOTE-042 trial (NCT03850444) presented at the 2022 AACR Annual Meeting. Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial},Īuthor=,

Keynote 042