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Ref Type abstract
PMID
Authors R. Dziadziuszko,S. Damian, S. Gadgeel, E. Garralda, A. Italiano, J.E. Kim, M. Krzakowski,C-C. Lin, A. Popovtzer, D. Thomas, W. Kirschbrown, S. Patel, T. Pham, M. Sbirnac, F. Wu, F. Barlesi
Title 624P Belvarafenib in patients (pts) with BRAF class II or III alteration-positive tumours: TAPISTRY study
URL https://www.annalsofoncology.org/article/S0923-7534(24)02210-5/fulltext
Abstract Text Background BRAF class II and III alterations are found in a range of cancers and are resistant to approved type 1 BRAF inhibitors. We present efficacy and safety data for the potent and selective RAF inhibitor belvarafenib in pts with BRAF class II or III alteration-positive solid tumours from Cohorts I and J of the TAPISTRY study. Methods The TAPISTRY phase II, open-label study (NCT04589845) is evaluating the efficacy and safety of various therapies in pts with advanced/metastatic solid tumours. Pts were aged ≥12 years, with measurable disease by RECIST v1.1 and BRAF class II mutant/fusion positive/intragenic deletion (Cohort I) or class III mutant tumours (Cohort J), identified by next-generation sequencing. Pts received 400 mg oral belvarafenib twice daily in 28-day cycles. Tumour assessments were performed at screening, every 8 weeks for 1 year, and every 12 weeks after. Primary endpoint: objective response rate (ORR) by independent review committee (IRC). Key secondary endpoints: ORR by investigator; clinical benefit rate; progression-free survival; overall survival; safety. Results At data cutoff, 30 pts in Cohort I and 24 in Cohort J were evaluable for safety. In the efficacy-evaluable population there were 26 pts in Cohort I (12 tumour types; most common: colorectal and NSCLC [15% each]) and 23 in Cohort J (8 tumour types; most common: colorectal [39%]). After a median follow-up of 4.4 mos in Cohort I and 5.6 mos in Cohort J, there were no confirmed responses by IRC in either cohort (Table). Most common treatment-related adverse event was dermatitis acneiform (Cohort I: 43%; Cohort J: 25%). No new safety signals were identified. Conclusions In this study belvarafenib did not demonstrate antitumour activity in pts whose tumours had class II or III BRAF alterations. However, a number of pts had stable disease. Further studies are needed to understand the value of BRAF inhibition in the tumour-agnostic setting. The safety profile of belvarafenib was consistent with the known safety profile of the drug.

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