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• W4206185909 abstract "15 Background: Immune check point inhibitors (ICI) are ineffective in MSSCRC. Combination of ICI with targeted agents has the potential to alter the tumor microenvironment and render these tumors vulnerable to ICI. We report the results of the multicenter study of rego and pembro in a diverse patient population with advanced MSSCRC. Methods: This was an investigator-initiated study and enrolled patients (pts) who had failed/were intolerant of chemotherapy at 3 sites. A 3+3 design was used for phase I to evaluate escalating doses of rego (80,120,160, days 1-14/21) in combination with pembro (200m/q3weeks). The primary endpoint was dose limiting toxicities during the first cycle. For phase II, pts received rego at the recommended phase II dose (RP2D) with pembro. The primary endpoint was progression free survival (PFS). Secondary endpoints were overall survival (OS) and objective response rate (ORR). The study was powered to show an improvement in PFS from 1.9 months (CORRECT data) to 2.85 months. Estimated sample size for phase II was 63 pts. Results: Study started in 7/2019 and accrual completed in 7/2021. Of 73 pts, 10 enrolled in phase I and 63 in phase II. RP2D of rego was 80 mg, days 1-14/21, and 70 pts treated at that dose. As of Sep 14, 11 pts remain on treatment. At baseline, median age was 54 years (23-81), 51% female, 53% white, 19% Asian, 12% black, and 11% Hispanic, median prior lines of therapy 2 (1-5), primary tumor location rectosigmoid/rectal 13%, KRAS mutated 68%, BRAF mutated 5%. Liver metastases was present in 78% of the pts. There was no grade 4 toxicity. The most common grade 3 toxicities were rash (20%), followed by hand-foot syndrome and HTN (7%). Dose modification was required in 14%. The most common reason for discontinuation was disease progression (85%), followed by withdrawal of consent (12%). With a median follow up of 5.3 (range:0.6-24.4) months, median PFS was 2.0 (1.8 -3.5) months, and median OS was 10.9 (5.3-NR) months. In 16 pts (23%), with non-liver metastatic disease PFS was 4.3 (1.9-8.4) months. No objective response was observed. Stable disease was observed in 49% of pts, median duration of stable disease was 2 (0.2-18.8) months. Conclusions: This is the largest trial of combination of ICI + rego in MSSCRC reported to date. The trial didn’t meet its primary endpoint, though the median OS is provocative. Analysis of biomarkers for identification of pts with longer duration of benefit is ongoing. Clinical trial information: NCT03657641." @default.
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• W4206185909 date "2022-02-01" @default.
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• W4206185909 title "Phase I/II study of regorafenib (rego) and pembrolizumab (pembro) in refractory microsatellite stable colorectal cancer (MSSCRC)." @default.
• W4206185909 doi "https://doi.org/10.1200/jco.2022.40.4_suppl.015" @default.
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