Regorafenib Clinically Active in Ewing Sarcoma
SARC024 study met its primary endpoint for patients with Ewing sarcoma, and enrollment is ongoing for the liposarcoma and osteosarcoma cohorts.
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Regorafenib met its primary endpoint of 8-week progression-free survival (PFS) among patients with Ewing sarcoma (EWS) in the phase 2 SARC024 (ClinicalTrials.gov Identifier: NCT02048371) trial, according to a study to be presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
The single-arm trial evaluated regorafenib among 30 patients with EWS with at least 1 prior therapy who progressed within 6 months prior to enrollment. Patients treated with prior oral kinase inhibitors were excluded. Patients received 160 mg of regorafenib once daily for 21 days of a 28-day cycle, and dose reductions were allowed for toxicities.
The median age at baseline was 32, 12 patients had EWS of the bone, and 18 of the soft tissue. The median number of prior therapies was 5.
The median PFS was 3.6 months (95% CI, 2.8-3.8 months), and the 8-week PFS was 73% (95% CI, 57-89%). The median duration of response was 5.5 months (95% CI, 2.9-8.0 months). Median overall survival was not reached.
Absence of progressive disease occurred in 18 out of 30 patients by week 8. The best responses were partial response in 3 patients, stable disease in 18, progressive disease in 7, and not evaluable in 2 according to RECIST criteria.
The most common grade 3 adverse events were hypophosphatemia, hypertension, high alanine aminotransferase, fatigue, abdominal pain, diarrhea, hypokalemia, oral mucositis, neutropenia, and rash.
No grade 4 toxicities were reported, though 13 patients required at least 1 dose reduction, most commonly due to hypophosphatemia. Regorafenib was discontinued by 2 patients due to toxicity. There was 1 death deemed not related to the study drug.
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The investigators noted that the SARC024 study met its primary endpoint, and enrollment is ongoing for the liposarcoma and osteosarcoma cohorts.
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- Attia S, Bolejack V, Ganjoo KN, et al. A phase II trial of regorafenib (REGO) in patients (pts) with advanced Ewing sarcoma and related tumors (EWS) of soft tissue and bone: SARC024 trial results. J Clin Oncol. 2017;35(suppl; abstr 11005).