5-Year Study Finds Treatment To Improve Overall Survival In Advanced NSCLC
Exciting news for some patients with NSCLC: a new study has found that treatment with the PD-1 inhibitor pembrolizumab improved overall survival in patients with advanced PD-L1-positive non-small cell lung cancer (NSCLC). These results were the findings from a 5-year analysis.
“Pembrolizumab provides long-term OS benefit and durable responses with tolerable safety for treatment-naive and previously treated patients with advanced PD-L1-expressing NSCLC, based on this analysis of 5-year outcomes from the KEYNOTE-001 study. Because the 5-year survival for advanced NSCLC has historically been very low, the data demonstrate the potential of pembrolizumab to improve long-term outcomes for patients with advanced NSCLC.”
At SURVIVEiT, we believe there is a huge difference between deferred decision-making and informed decision-making. The more solid your understanding of treatment options for your unique cancer, the better. After you read more about this study, take a look at our Start Here Guide to help you!
Here’s a deeper look at the study.
KEYNOTE-001: Landmark Study Reports Favorable 5-Year OS Rates in Advanced NSCLC
Source: medpagetoday.org
As far back as more than a century ago, researchers realized the potential of the immune system to produce cancer regression. In the 1990s and 2000s, they laid the groundwork for today’s immune checkpoint inhibitors by — among other discoveries — identifying proteins carried on the surface of many cancer cells, such as programmed death ligand 1 (PD-L1), which helped these cells to multiply and masked them from harassment by the immune system. Six PD-1/L1 immunotherapies have thus far been approved by the FDA for 14 different types of cancer, and are being evaluated in more than 2,250 clinical trials.
Edward B. Garon, MD, of the University of California Los Angeles, and colleagues, reported long-awaited updated outcomes data from KEYNOTE-001 for patients with advanced NSCLC treated with single-agent pembrolizumab in the Journal of Clinical Oncology (and presented earlier at the 2019 ASCO annual meeting).
Unlike the traditional drug development pathway, KEYNOTE-001 was composed of nested phase II-like studies assessing the anti-PD-1 agent pembrolizumab in two oncologic indications — melanoma and NSCLC — with six randomized dose/schedule comparison sub-studies involving both patient populations, as well as training and validation sets for the development of the PD-L1 immunohistochemistry (IHC) companion diagnostic assay. Its unique adaptive design and evolution to include NSCLC-specific (and melanoma-specific) expansion cohorts led to interim findings that showed that the PD-L1 tumor proportion score (TPS), using the IHC kit, was a useful biomarker for patient selection. Moreover, patients with tumor PD-L1 TPS ≥50% experienced the highest objective response rate (ORR) and progression-free survival (PFS), at 45.2% and 6.3 months, respectively.
Median OS was 22.3 months and 10.5 months, respectively, for the 101 treatment-naive and 449 previously treated patients with advanced NSCLC who were included in the current analysis. Given that the 5-year survival for metastatic lung cancer is only 5%, the 2-, 3-, 4-, and 5-year OS rates of 49%, 37%, 31.0%, and 23.2% for treatment-naive patients represented compelling data. Similarly, the 2-, 3-, 4-, and 5-year OS rates of 30.1%, 20.9%, 18.2%, and 15.5% for previously treated patients with advanced NSCLC represented higher proportions than historical 5-year survival rates for the disease.
Notably, for patients with a PD-L1 TPS ≥50%, the 5-year OS rates were 29% and 25% for treatment-naive and previously treated patients, respectively.
In 2015, interim KEYNOTE-001 findings formed the basis for the FDA’s accelerated approval of pembrolizumab for use in patients with previously treated advanced NSCLC and PD-L1 TPS ≥50%.
Pertinent study characteristics included the enrollment of 550 patients with confirmed locally advanced/metastatic NSCLC, who provided a contemporaneous tumor sample for PD-L1 evaluation by IHC. Treatment-naive patients deemed eligible for one of the study cohorts had no systemic treatment for advanced disease or adjuvant treatment in the previous year, no EGFR mutation and/or ALK translocation (with selected exceptions), and a PD-L1 TPS ≥1%.
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