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TAS-115 shows preliminary antitumor activity for osteosarcoma
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WAILEA, Hawaii — TAS-115 induced stable disease among patients with osteosarcoma and rare soft tissue sarcoma subtypes, according to results from the expansion cohort of a phase 1 study presented at the Connective Tissue Oncology Society Annual Meeting.
TAS-115 (Taiho Pharmaceutical) is a novel multitargeted kinase inhibitor that mainly targets MET, VEGFR and macrophage colony-stimulating factor 1 receptor, which is essential for the differentiation of osteoclasts.
Yoichi Naito , MD, of National Cancer Center Hospital East in Kashiwa, Japan, and colleagues assessed the tolerability and preliminary efficacy of the 650-mg daily recommended dose of TAS-115 in 15 patients (median age, 33 years; 53.3% men) with various cancer types, including osteosarcoma (n = 8) and rare subtypes of soft tissue sarcoma known to overexpress MET. These included alveolar soft part sarcoma (n = 2), clear cell sarcoma (n = 2) and epithelioid sarcoma (n = 3).
All patients were refractory to standard treatment.
Patients received the recommended dose for 5 days, followed by 2 days off, up to 21 days per cycle.
Five patients achieved stable disease as best overall response per RECIST criteria. This included one patient with osteosarcoma who showed stable disease for longer than 10 months, whereas they had only achieved stable disease for 3.2 months with prior gemcitabine-docetaxel.
One patient with epithelioid sarcoma experienced significant response per bone scintigraphy.
Further, one patient with osteosarcoma showed marked reduction of 18F-fluorodeoxyglucose uptake on bone metastases by PET scan imaging.
The most common all-grade adverse events associated with therapy included increased alanine transaminase and aspartate transaminase, anorexia, fatigue, nausea, hypophosphatemia and leukopenia.
Grade 3 or worse adverse events occurred among 20.2% of patients, and 73.3% of patients required therapy interruptions, most commonly due to rash and pyrexia. However, all adverse events resolved following therapy interruption.
“TAS-115 was generally tolerated well by patients with osteosarcoma and rare subtypes of soft tissue sarcoma,” Naito said during his presentation. “Preliminary antitumor activity was observed in both osteosarcoma and rare soft tissue sarcoma subtypes.”
The ongoing expansion cohort of this phase 1 study will continue to explore TAS-115 in patients with osteosarcoma, he added. – by Alexandra Todak
Reference:
Naito Y, et al. Abstract 043. Presented at: CTOS Annual Meeting; Nov. 8-11, 2017; Maui, Hawaii.
Disclosures: Naito reports speakers bureau roles with Eisai, Chugai, Novartis, Pfizer and Roche, and research support from AstraZeneca, Eisai, Eli Lilly, Merck Serono and Nippon Kayaku.