(Singapore Embargoed for 7:23 pm EST on January 29, 2021 to coincide with publication in the Journal of Clinical Oncology) – Addition of ipilimumab to pembrolizumab does not improve efficacy and is associated to more toxic than pembrolizumab alone as a first-line treatment for metastases. non-small cell lung cancer (NSCLC) for patients with a PD-L1 tumor dose score greater than or equal to 50% and no targeted EGFR or ALK disorders, according to a study presented today at International Society for the Study of Lung Cancer World Conference on Lung Cancer.
The research was presented by Dr. Michael Boyer, clinical professor of medicine at Chris O’Brien Life and Central University Clinical School, Sydney, Sydney, Australia.
Previously, KEYNOTE-024 study showed that pembrolizumab monotherapy significantly improved survival against platinum-doublet chemotherapy for patients with metastatic NSCLC, TPS PD-L1 greater than or equal to 50%, and no EGFR targets or ALK targeted.
Boyer and his research group, which included centers in Europe, Asia, and North America, conducted the randomized, double-blind, phase III study KEYNOTE-598 (NCT03302234) to determine whether ipilimumab added pembrolizumab better efficacy than pembrolizumab alone in this population.
The trial enrolled 568 participants – 284 received a combination of pembrolizumab and ipilimumab and 284 were randomly assigned to receive pembrolizumab and placebo.
Patients were randomly assigned 1: 1 to ipilimumab at 1 mg / kg every six weeks or to saline placebo for up to 18 cycles. Patients in each arm received 200 mg of pembrolizumab every three weeks for up to 35 cycles. Random assignment was confirmed by the European Collaborative Oncology Group score of (0 vs 1), region (East Asia vs non-East Asia), and histology (squamous vs nonsquamous). Treatment differences in key endpoints of overall survival and non-progressive survival were assessed by the serial log status test in the treatment-targeting population.
The first protocol-assigned interim study (IA1) was expected to occur in approximately 255 deaths and approximately 12 months had elapsed since the last participant was randomly assigned. Non-binding income criteria at IA1 were the differences in the limited average survival time between ipilimumab / pembrolizumab and placebo / pembrolizumab of less than or equal to 0.2 at peak observation time and above. less than or equal to 0.1 at 24 months of follow-up.
With 272 deaths, the overall survival rate was 21.4 months for patients receiving ipilimumab / pembrolizumab compared with 21.9 months for placebo / pembrolizumab (HR, 1.08; 95% CI: 0.85–1.37; p = 0.74). Limited survival time differences were -0.56 at peak observation time and -0.52 at 24 months, which met the futures criteria, according to Dr. Boyer.
With 372 events, median survival was no improvement at 8.2 months for the ipilimumab / pembrolizumab group compared with 8.4 months for placebo / pembrolizumab (HR, 1.06; 95% CI: 0.86–1.30; p = 0.72). The target response rate was 45.4% in each arm; the median duration of response was 16.1 months for the ipilimumab / pembrolizumab group vs. 17.3 months for placebo / pembrolizumab. Treatment-related adverse events occurred in 76.2% of patients in the ipilimumab / pembrolizumab group versus 68.3% for the placebo group.
Dr Boyer said that, based on the observed efficiencies and safety, the external data review committee recommended that the study be discontinued due to revenue and that participants stop both ipilimumab and placebo.
“As a result of the results of this study, monotherapy with pembrolizumab remains the standard of care for this population of patients. Despite the benefits of this type of treatment, nearly 50% of all patients Those patients die from their disease within two years, so in the future research will focus on other ways to improve outcomes, “he said.
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About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association’s membership includes more than 8,000 lung cancer specialists across all disciplines in more than 100 countries, creating a global network working together to overcome lung and thoracic cancer all over the world. The association also publishes the Journal of Thoracic Oncology, the leading educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancy. Visit http: // www.
About the WCLC:
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting nearly 7,500 researchers, physicians and experts from more than 100 countries. The goal is to increase awareness, collaboration, and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of topics and highlight a number of research studies and clinical trial results. For more information, visit wclc2020.iaslc.org.
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