This trend continued for Grade 3 to 5 adverse events - 41% in the chemo arm compared to 17.8%.īut a similar number of patients discontinued treatment to due treatment-related AEs: 58 patients in the chemo arm, and 57 in the pembrolizumab arm. Treatment-related adverse events (AEs) were higher in the chemotherapy arm - seen in 89.9% of patients compared to 62.7%. At 18 months, 53.4% of those patients continued to show a response, compared to 30.4% in the chemo group. 27.3%, which was significantly different (p=.017).ĭuration of response, across all patients, was greater for those treated with pembrolizumab. The one-year PFS for those with PD-L1 expression of 50% or more was 37.4% vs. Overall, PFS at one year was 28% in the pembrolizumab group and 26.6% in the chemotherapy group, which was not a statistically significant difference. About a third of patients had a TPS of 1 to 19% in each arm.Īt 2 years, the overall survival for all patients was 39.3% in the pembrolizumab group and 28% in the chemotherapy group (p=.0018).īut the greatest difference was seen among patients with PD-L1 expression of 50% or higher - with a 2-year overall survival of 44.7% in the pembrolizumab arm and 30.1% in the chemotherapy arm (p=.0003). The portion of patients with the highest levels of PD-L1 expression - 50% TPS or greater - was balanced, with 299 such patients in the pembrolizumab arm and 300 in the chemotherapy arm, Dr. Patients included those with untreated locally advanced or metastatic NSCLC of any histology, a PD-L1 expression of at least 1%, an ECOG performance status of 0 or 1, no untreated or unstable central nervous system metastases, and no history of pneumonitis that required systemic corticosteroids.Ī total of 637 patients were enrolled in the pembrolizumab arm and 637 in the chemotherapy arm, which included carboplatin and paclitaxel treatment for up to 6 cycles, with patients with non-squamous cancer strongly encouraged to get pemetrexed therapy as maintenance. An independent expert said that this lack of crossover was crucial in interpreting the results. Patients with sensitizing EGFR and ALK alterations were not enrolled, and no crossover was allowed. No significant, cohort-wide progression-free survival (PFS) difference was seen between the arms. “KEYNOTE-042 is the first study with a primary endpoint of overall survival to demonstrate superiority of pembrolizumab over platinum-based chemotherapy in previously untreated locally advanced or metastatic non-small cell lung cancer,” said presenter Dr Gilberto Lopez, Associate professor of medicine at the University of Miami. First-line treatment with the PD-1 inhibitor pembrolizumab showed an overall survival benefit compared to platinum-based chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer and a PD-L1 tumour proportion score of at least 1…ĭr Riyaz Shah (Maidstone) and Dr Jason Lester (Velindre NHS Trust, Cardiff) discuss how the data from KEYNOTE-042, KEYNOTE-407 and KEYNOTE-189 will guide UK practice.įirst-line treatment with the PD-1 inhibitor pembrolizumab showed an overall survival (OS) benefit compared to platinum-based chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and a PD-L1 tumour proportion score (TPS) of at least 1, according to findings presented here at the annual meeting of the American Society of Clinical Oncology.

Keynote 042 update