Hello, I am Professor Igor Bondarenko from the Department of Oncology and Medical Radiology at the Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Today I would like to share the results of subgroup analysis focusing on the patients with locally advanced non-small cell lung cancer from the Phase 3 Empower Lung 1 study. Here are my disclosures and acknowledgements. One third of non-small cell lung cancer diagnoses are classified as locally advanced and there is an unmet need for novel therapies with improved treatment benefits and acceptable safety profiles for this patient group. There have been limited prospective clinical data on the use of PD-1 inhibitors in treating locally advanced disease. In Empower Lung 1, first-line semi-plumar monotherapy demonstrated superior survival benefits compared with chemo in patients with advanced non-small cell lung cancer without driver mutations and with PD-L1 expression of 50% or more. The safety profile of semi-plumar was comparable to other PD-1 inhibitors in non-small cell lung cancer. Here we provide subgroup analysis of patients with locally advanced non-small cell lung cancer from the PD-L1 of 50% or more population from Empower Lung 1. In Empower Lung 1, patients were randomized one-to-one to receive either semi-plumar 350 milligrams intravenously every three weeks for 108 weeks or until disease progression or four to six cycles of chemo. Patients with locally advanced disease were defined as those with stage 3b-3c disease who were not candidates for definitive concurrent chemoradiotherapy or whose disease had recurred after initial treatment with concurrent chemoradiotherapy. Overall, 60% of patients enrolled in this study had locally advanced disease, 45 patients in semi-plumar arm and 42 patients in chemo arm. The baseline characteristics were generally consistent between the two arms. The median duration of exposure was shorter in chemo arm at 17.7 weeks versus 30.7 weeks in semi-plumar arm. The median duration of follow-up were similar between the two arms. Median overall survival was not yet reached in the semi-plumar group versus 15.5 months for chemo. Semi-plumar demonstrated a numerically longer overall survival resulting in a hazard ratio of 0.48. The overall survival at 12 months was 79 for semi-plumar versus 58 for chemo. For progression-free survival, there was statistically significant improvement associated with semi-plumar with a median PFS of 8.4 months versus 6.2 months for chemo. The hazard ratio was 0.49. The objective response rate was numerically higher with semi-plumar versus chemo, 44 versus 31%. More patients experienced a partial response at their best overall response with semi-plumar. Duration of response was also numerically longer with semi-plumar with an estimated median duration of response of 12.5 months versus 6.2 months for chemo. In summary, in this subgroup, analysis from Empower Land 1, patient with locally advanced non-small cell lung cancer and with PD-L1 expression of 50% or more without driver mutation, first-line semi-plumar monotherapy demonstrated a significant improvement in progression-free survival, numerically longer overall survival, numerically better objective response rate, and numerically longer duration of response versus chemo. This result supports the clinical benefit of first-line semi-plumar monotherapy in this patient population. Thank you so much for your kind attention.

subgroup analysis

semi-plumab monotherapy

survival benefits

PD-L1 expression

patient population