ISOFOL 12.84 SEK (-0.16) 03 Dec 2021 17:29 005 STUDY DATA EXTENDED POWER AND SAFETY DATA Extension cohorts I and II (31 patients): Tumor shrinkage after 16 weeks of treatment with arfolitixorin In September 2020, Isofol presented data on the two extension cohorts (31 patients) treated for 16 weeks or longer. Data showed a "best overall response rate" (best ORR) of 55%. These patients were treated with 120 mg / m 2 arfolitixorin and 5-fluorouracil (5-FU) with either irinotecan or oxaliplatin (ARFIRI / ARFOX). Of these 31 patients, 17 were treated with an ARFOX regimen, which is the experimental regimen in the current AGENT study. En ”best ORR” om 59% observerades i ARFOX regimgruppen jämfört med 50% i ARFIRI regimgruppen, trots att 53% av patienterna hade högersidig tumörplacering och 24% uppvisade BRAF-mutation 4,5. I den allmänna CRC-populationen och i historiska kontroller av fas III-studier i första linjens mCRC har cirka 30-40% 1,2,3 högersidig tumörplacering uppvisats och 10% har visat BRAF-mutation 4,5. Både högersidig tumörplacering och BRAF-mutationer är historiskt kända som svaga prognostiska faktorer 4,5,6,7,8 och ”best ORR” i dessa patientpopulationer i första linjens mCRC, behandlade med antingen FOLFOX eller FOLFIRI, har historiskt genererat ”best ORR” om ~ 40% 1,2 respektive 15-20% 9,10. Mean ORR based on pivotal phase III studies considered in a recently published meta-analysis / review by Giuliani & Bonetti (2018) 11 indicates that FOLFOX regimens generate 45% “best ORR” and FOLFIRI regimens generate 40% “best ORR” in historical first-line mCRC non-selected patient populations (all-comers). The extension cohorts included a total of 43 patients. Of these, 12 patients were not evaluated after 8 weeks (not included in the group per protocol) or longer with computed tomography (follow-up after 8 weeks was not mandatory) and thus were not followed to the "best ORR". References 1. Saltz et al. JCO.2008 26: 2013-2019 2. Loupakis F. et al 2018 119:1451-145 3. Hanna D & Lenz H-J, Clin Advanc in Hematology & Oncology. 2020 May; 18(5):253-257 4. Caputo et al Int J Mol Sci. 2019 Nov; 20(21): 5369 5. Clarke C & Kopetz S, J Gastrointest Oncol. 2015 Dec; 6(6): 660-667 6. Tejpar S. et al JAMA Oncol. 2016 Oct 10 7. Arnold D. et al Ann Oncol. 2017 Aug 1;28(8):1713-1729 8. Loupakis F. et al J Natl Cancer Inst. 2015 Feb 24;107(3) 9. Van Cutsem E. et al. J.Clin Oncol. (2015) 33:692-700 10. Tveit KM. et al J.Clin Oncol. (2012) 30(15):1755-1762 11. Giuliani & Bonetti, Int J Colorectal Dis. 2018 Nov; 33(11): 1505-1516 Pressmeddelanden 2020-09-30 PM, Isofol reports 55% objective tumor response at… >> 2019-05-08 PM, Isofol reports 58% Overall Response Rate… >> 2019-01-17 PM, Isofol reports tumor shrinkage at… >> Read more Clinicaltrials.gov - ISO-CC-005 (NCT02244632) >> Clinical studies AGENT Study (Phase III) 005 study (phase I / IIa) 005 study data Further studies Compilation of clinical studies Clinical development plan About Isofol Isofol Medical AB (publ) is a biotech company active in oncology that develops the cancer drug arfolitixorin. Arfolitixorin is a new drug candidate that is primarily intended for the treatment of colorectal cancer (CRC), one of the most common forms of cancer. Isofol also develops arfolitixorin for so-called rescue treatment after high-dose treatment with the cytotoxic methotrexate in osteosarcoma (bone cancer). Contact Isofol Medical AB (publ) Biotech Center, Arvid Wallgrens Backe 20 413 46 Gothenburg Sweden Phone: +46 (0) 31 7972280 E-mail: info@isofolmedical.com Newsletter and privacy policy Sign up here to receive news, press releases & information and consent to Isofol's processing of your personal data in accordance with the company's privacy policy. Isofol's privacy policy (general) Isofol's privacy policy (clinical trials) © 2018 Isofol Medical AB (publ) Biotech Cente, Arvid Wallgrens Backe 20, SE-413 46 Gothenburg, Sweden Isofol´s Glossary Isofol's website uses cookies to improve and customize your visit. By continuing you accept this.Accept Read More