Name:
Outcomes of first-line pembrolizumab monotherapy for PD-L1–positive (TPS ≥50%) metastatic NSCLC at US oncology practices
Description:
Outcomes of first-line pembrolizumab monotherapy for PD-L1–positive (TPS ≥50%) metastatic NSCLC at US oncology practices
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Duration:
T00H07M30S
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Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/307df5b9-ae6b-4cc0-b2f7-8cd033d1e54b/Velcheti_VJ_V6_05.02.20.mp4?sv=2019-02-02&sr=c&sig=4faFaJh63rg3hxoKmpQ16rrVd0up22ogcJsLLxbhAg8%3D&st=2025-06-30T21%3A36%3A09Z&se=2025-06-30T23%3A41%3A09Z&sp=r
Upload Date:
2020-04-28T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 Outcomes of first-line pembrolizumab monotherapy for PD-L1–positive (TPS ≥50%) metastatic NSCLC at US oncology practices.
[MUSIC PLAYING]
VAMSIDHAR VELCHETI: I'm Dr. Vamsidhar Velcheti. I'm An Associate Professor and the Director for the Thoracic Medical Oncology Program at NYU Perlmutter Cancer Center. I am going to be giving a summary of our article entitled "Outcomes of First-line Pembrolizumab Monotherapy for PD-L1-positive Metastatic Non-small Cell Lung Cancer at US Oncology Practices" that was recently published in the journal Immunotherapy.
Segment:2 What was the purpose of this study?.
VAMSIDHAR VELCHETI: [MUSIC PLAYING] The aim of the study was to describe clinical outcomes of first-line pembrolizumab monotherapy administered at US oncology practices for high PD-L1 expressing-- that is, tumor proportion score of at least 50% metastatic non-small cell lung cancer without EGFR, ALK, ROS aberrations and good performance status of 0 to 1.
VAMSIDHAR VELCHETI: This retrospective study has examined real-world clinical outcomes in patient populations that are clinically similar to that enrolled in KEYNOTE-024 trial and the subpopulation in KEYNOTE-042 trial.
Segment:3 How was the study undertaken?.
VAMSIDHAR VELCHETI: [MUSIC PLAYING] We conducted a retrospective analysis of data sets arising from Flatiron Longitudinal Health Database, comprising of electronic health record data from 280 participating cancer clinics in the United States.
VAMSIDHAR VELCHETI: De-identified patient-level data was collected through technology-enabled electronic chart abstraction of structured and unstructured data from the EHR. We included adult patients who received at least one dose of pembrolizumab at first-line therapy after pathologic confirmation of stage IV or recurrent metastatic non-small cell lung cancer with PD-L1 tumor proportionate score of at least 50% and no documented evidence of EGFR mutation or ALK and ROS1 rearrangements.
VAMSIDHAR VELCHETI: We restricted all analysis to patients with ECOG performance status of 0 or 1 and those with at least six months of follow-up after pembrolizumab initiation. Two data sets were used. The EHR cohort included patients who initiated pembrolizumab between October 26 of 2016 and September 30, 2018. The data cutoff used was March 31, 2019.
VAMSIDHAR VELCHETI: The Spotlight cohort included a random sample of patients in data sets who initiated pembrolizumab between December 1, 2016 and November 30, 2017. Data cutoff was September 30, 2018. These patients were selected for enhanced manual chart review to collect real-world progression data, response data, and reason for discontinuation. The study endpoints included overall survival for both the EHR and Spotlight cohorts.
VAMSIDHAR VELCHETI: In addition to real-world progression-free survival, real-world tumor response and reason for pembrolizumab discontinuation were evaluated in the Spotlight cohort. To provide context to these results, we also report overall survival and investigator-assessed progression-free survival and tumor response results from similar patients in the pivotal phase III trials, including KEYNOTE-042 and KEYNOTE-024 with patients PD-L1 expression of at least 50%.
VAMSIDHAR VELCHETI: [MUSIC PLAYING]
Segment:4 What were the results?.
VAMSIDHAR VELCHETI: The study included 423 patients in the EHR cohort and 188 patients in the Spotlight cohort that met selection criteria. The median age in both studies was 72 years. And almost 3/4 of the patients in both cohorts were 65 years or older. The EHR cohort included a greater percentage of men-- 54% versus 48% in the Spotlight cohort-- and a greater percentage of patients with ECOG performance status 1-- 65% versus 57%.
VAMSIDHAR VELCHETI: So for outcome, survival rates in the two real-world cohorts at 12 months was 59.1% versus 60.4%, was similar to that of a KEYNOTE-042 subpopulation with locally advanced or metastatic non-small cell lung cancer with PD-L1 TPS score of 50% or more. While median overall survival of approximately 19 months in EHR and Spotlight cohorts was shorter than the KEYNOTE-024 trial, which was 30 months, it was similar to that of the KEYNOTE-042 subpopulation, which was 20 months.
VAMSIDHAR VELCHETI: Real-world progression-free survival, which was median 6.8 months, was similar to progression-free survival as assessed by investigators in KEYNOTE-024 and KEYNOTE-042 subpopulation with PD-L1 TPS score of at least 50% with progression-free median survivals of 7.6 and 6.1 months. The real-world tumor response of 48% was also similar to investigator-assessed tumor response as part of the pivotal trials, which were 45% in KEYNOTE-024 and 40% in KEYNOTE-042.
Segment:5 What is the significance of these findings?.
VAMSIDHAR VELCHETI: [MUSIC PLAYING] In real-world oncology practices, patients prescribed first-line pembrolizumab monotherapy for PD-L1-high-- that is TPS score of greater than 50%-- metastatic non-small cell lung cancer tend to be older and include fewer men than in clinical trials even after limiting to key trial eligibility criteria, such as good performance status.
VAMSIDHAR VELCHETI: The outcomes observed in this retrospective study-- including overall survival, real-world progression-free survival, and real-world tumor response rate-- were consistent with pivotal trial findings, supporting the effectiveness of first-line pembrolizumab monotherapy in a real-world setting. Continued research is needed to investigate short-term and long-term outcomes of anti-PD-1/PD-L1 treatments as monotherapy or in combination for the heterogeneous patient populations with non-small cell lung cancer requiring care in clinical practice.
VAMSIDHAR VELCHETI: [MUSIC PLAYING]
