Abstract No : Abstract #396O
Indication : Colorectal Cancer
Intervention : Pembrolizumab
Company : Merck & Co.
Technology : Immune Checkpoint Inhibitor (ICI)
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.
Pembro monotherapy demonstrated clinically meaningful improvements in HRQoL vs SOC chemotherapy in pts with previously untreated MSI-H/dMMR mCRC.