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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
Journal Vol Issue Date Pages Journal Short Title
Annals of Oncology 35 Supplement 2 2024
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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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRAF class 3 Advanced Solid Tumor no benefit Belvarafenib Phase II Actionable In a Phase II trial (TAPISTRY), Belvarafenib (HM95573) treatment did not result in any confirmed objective responses in patients with advanced solid tumors harboring BRAF class III alterations, with a clinical benefit rate of 8.7% (2/23), 34.8% (8/23) with stable disease, a median progression-free survival of 2.0 months, and a median overall survival of 8.2 months (Ann Oncol (2024) 35 (Suppl_2): S498-S499; NCT04589845). detail...
BRAF class 2 Advanced Solid Tumor no benefit Belvarafenib Phase II Actionable In a Phase II trial (TAPISTRY), Belvarafenib (HM95573) treatment did not result in any confirmed objective responses in patients with advanced solid tumors harboring BRAF class II alterations (including mutations, fusion positive, or intragenic deletions), with a clinical benefit rate of 3.8% (1/26), 42.3% (11/26) with stable disease, a median progression-free survival of 2.1 months, and a median overall survival of 4.8 months (Ann Oncol (2024) 35 (Suppl_2): S498-S499; NCT04589845). detail...