In-Depth :This was an open label, randomized, phase III study. Relevant Reading: Pembrolizumab in microsatellite instability-high advanced colorectal cancer Overall, this study demonstrated that although prior reported analysis indicated a large progression-free survival benefit and quality of life benefits, the overall survival was not different likely owing to substantial cross-over and off-label use of immunotherapy.Ĭlick to read the study in The Lancet Oncology The high cross-over rate could have contributed to an improvement in the overall survival rate in the chemotherapy group. 36% of the patients in the chemotherapy group crossed over to receive pembrolizumab and 24% received off-study anti-PD-1/anti-PD-L1 therapies. It is important to note that the crossover design could have contributed to the absence of significant overall survival benefit for pembrolizumab. Diarrhea, fatigue, and anemia were common grade 3 or higher treatment-related adverse events that were reported. At final analysis, the median overall survival as per the intention-to-treat analysis was not statistically different.
This study presents the final overall survival analysis of the KEYNOTE-177 study. Based on the initial data from the KEYNOTE-177 study, pembrolizumab showed improved progression-free survival compared to chemotherapy in patients with previously untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer. These final study findings continue to support pembrolizumab as an effective first-line therapy in patients with MSI-H/dMMR mCRC.Study Rundown:The presence of mismatch repair deficiency in colorectal cancer can help inform the surgical and systemic treatment for patients. In the final study analysis, though pembrolizumab showed robust antitumour activity and fewer treatment-related adverse events compared to chemotherapy, there was no significant difference in overall survival between the two treatment groups. Treatment-related adverse events of grade 3 or worse happened in 22% of patients in the pembrolizumab group compared to 66% of patients in the chemotherapy group. Pembrolizumab was not shown to be superior to chemotherapy for overall survival, as the findings were not statistically significant. At the final study analysis, average progression-free survival was 16.5 months for pembrolizumab versus 8.2 months with chemotherapy. 60% of patients crossed over from chemotherapy to pembrolizumab during the study. Overall survival (OS): the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.īetween February 2016 and February 2018, 307 patients were randomly assigned to pembrolizumab or chemotherapy. Progression-free survival (PFS): the amount of time during and after treatment of a disease, such as cancer, that a patients lives with the disease but it does not worsen ( National Cancer Institute)Īs part of the long-term follow-up of the KEYNOTE-177 study, the researchers aimed to understand the impact of Keytruda on the overall survival of patients in this cohort of mCRC. These study findings are what led to the Food and Drug Administration (FDA) and Health Canada approvals of pembrolizumab in this setting. Keytruda led to significantly longer progression-free survival than chemotherapy as a first-line treatment for MSI-H/dMMR mCRC, with fewer treatment-related adverse events.
KEYNOTE 177 COLORECTAL TRIAL
The KEYNOTE-177 trial is a landmark study in colorectal cancer treatment that evaluated the efficacy and safety of the immunotherapy drug, pembrolizumab (Keytruda), compared to standard of care chemotherapy for patients with microsatellite instability high (MSI-H), mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) as first-line (initial) treatment.
Overall survival associated with Pembrolizumab (Keytruda) vs.
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