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• W4382811263 abstract "Immune-checkpoint inhibitors (ICIs) showed limited efficacy in mismatch repair proficient (MMRp) metastatic colorectal cancer (mCRC) to date. Many RAS/BRAF wildtype mCRCs respond to EGFR antibodies (cetuximab/panitumumab) and we previously showed that acquired resistance to these is characterised by an inflamed phenotype and PD-L1 and LAG3 upregulation. The single arm phase 2 iSCORE trial investigated whether RAS/BRAF wildtype MMRp mCRCs that had acquired resistance to prior chemotherapy and an EGFR antibody benefit from nivolumab (anti-PD1) and relatlimab (anti-LAG3) ICIs. Patients (pts) with RAS/BRAF wildtype MMRp mCRC that had responded to chemotherapy + EGFR antibody and subsequently progressed were recruited for treatment with nivolumab (480mg iv) and relatlimab (160mg iv) every 4 weeks. The primary endpoint was disease control rate at 6 months (DCR6) from treatment initiation. To detect an increase in DCR6 from 10% to 30%, with a two-sided 5% significance and power of 80%, 25 pts were needed. Secondary endpoints included duration of disease control, best objective response (ORR) during 6 months, progression free survival (PFS), overall survival (OS) and safety. Pre-treatment and on-treatment biopsies were obtained for biomarker analyses. 32 pts were registered. 25pts who received at least one dose of nivolumab/relatlimab were included in the primary endpoint analysis. 24% of pts had received ≥2 prior lines of systemic therapy. The median number of cycles administered was 2 (range: 1-12). 1pt remained on treatment (cycle 11) at the time of data cut-off (30/01/2023). Among 25 evaluable pts, best objective responses during 6 months by RECIST 1.1 were one CR, one PR, two SD and 20 PD; 1pt died without a follow-up scan. One PR and one SD were reported during treatment in two additional pts by iRECIST after pseudoprogression. Median duration of disease control for pts with clinical benefit (CR, PR, SD) by iRECIST was 9.0mo [range:1.8-11.1]. 4/7pts [57.1%] without liver metastases and 2/18pts [11.1%] with liver metastases achieved clinical benefit by iRECIST. The best ORR during 6 months was 8% [95% CI:1.0-26.0] by both RECIST 1.1 and iRECIST. DCR6 was 12% [95% CI:2.5-31.2] by RECIST 1.1 and 16% [95% CI:4.5-36.1] by iRECIST in all 25pts. At data cut-off, median PFS and OS were 1.6mo [95% CI:1.6-1.8] and 15.2mo [95% CI:6.4-18.5], respectively. Five grade 3 treatment related adverse events (TRAE) were reported across 5pts; no grade 4/5 TRAEs occurred. The most common TRAEs (any grade) were fatigue (24%) and acneiform rash (12%). In pre-treatment biopsies, the median PD-L1 combined positive score (CPS) was 0 [range:0-3] for pts without liver metastases and PD-L1 CPS was 0 for all four of these with clinical benefit. The median PD-L1 CPS was 1.5 [range:0-65] for pts with liver metastases, with PD-L1 CPS 6 and 12 in the 2pts with clinical benefit. The prespecified endpoint of 25% DCR6 was not met with nivolumab/relatlimab. However, the clinical benefit rate in pts without liver metastases and prolonged disease control in two pts with liver metastases are encouraging. Nivolumab/relatlimab was well tolerated. Biomarker analyses, including TMB and T-cell quantification, are ongoing and will be presented." @default.
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• W4382811263 date "2023-06-01" @default.
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• W4382811263 title "P-111 PD1 and LAG3 inhibition as second+ line treatment after EGFR antibody-containing therapy in RAS/BRAF wildtype, MMRp metastatic colorectal cancer" @default.
• W4382811263 doi "https://doi.org/10.1016/j.annonc.2023.04.167" @default.
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