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Health-related quality of life (HRQoL) in patients (pts) treated with pembrolizumab (pembro) vs chemotherapy as first-line treatment in microsatellite instability-high (MSI-H) and/or deficient mismatch repair (dMMR) metastatic colorectal cancer (mCRC): Phase III KEYNOTE-177 study
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KEYNOTE-177 approves pembrolizumab as SoC and an obvious choice for 1L patients MSI-H/dMMR mCRC
Abstract No : Abstract #396O
Indication : Colorectal Cancer
Intervention : Pembrolizumab
Company : Merck & Co.
Technology : Immune Checkpoint Inhibitor (ICI)
Results:
Pts with confirmed MSI-H/dMMR mCRC with no prior systemic therapy for mCRC were randomized 1:1 to pembro 200 mg Q3W for up to 2 y or investigator’s SOC choice of mFOLFOX6 or FOLFIRI Q2W ± bevacizumab or cetuximab. EORTC QLQ-C30, EORTC QLQ-CR29, and EQ-5D-3L were administered at baseline and at various time points up to 1 y or end of treatment, whichever came first, and at 30 days after treatment discontinuation. Data from pts receiving ≥1 dose of study treatment and completing ≥1 HRQoL assessment were analyzed. Least-squares mean (LSM) score change from baseline to prespecified wk 18, 95% CI, and nominal 2-sided P values were calculated. Time to deterioration (TTD; ≥10-point decline from baseline) was assessed by Kaplan-Meier method and Cox regression model. HRs, 95% CIs, and nominal 1-sided P values are provided.
Conclusion:
Pembro monotherapy demonstrated clinically meaningful improvements in HRQoL vs SOC chemotherapy in pts with previously untreated MSI-H/dMMR mCRC.
Executive Summary
Pembrolizumab monotherapy provided clinically meaningful improvement in HRQoL compared to chemo ± Bevacizumab or cetuximab in patients with previously untreated MSI-H/dMMR mCRC. It had earlier demonstrated higher PFS and lower treatment related adverse events. These findings supports the use of pembrolizumab as SoC in 1L patients and can be considered best upfront option for patients with MSI-H/dMMR mCRC. OS data is still awaited.