The disease control rate (DCR) with TVB-2640 monotherapy was 42% no patient treated with monotherapy had a complete or partial response (CR or PR). Target engagement (FASN inhibition) and inhibition of lipogenesis were demonstrated with TVB-2640. One fatal case of drug-related pneumonitis occurred with TVB-2640+paclitaxel no other treatment-related deaths occurred. The most common TEAEs (n,%) with TVB-2640 monotherapy were alopecia (46 61%), PPE syndrome (35 46%), fatigue (28 37%), decreased appetite (20 26%), and dry skin (17 22%), and with TVB-2640+paclitaxel were fatigue (29 53%), alopecia (25 46%), PPE syndrome (25 46%), nausea (22 40%), and peripheral neuropathy (20 36%). DLTs with TVB-2640 were reversible skin and ocular effects. Overall, 136 patients received TVB-2640, 76 as monotherapy (weight-based doses of 60 mg/m 2 to 240 mg/m 2 and flat doses of 200 and 250 mg) and 60 in combination, (weight-based doses of 60 mg/m 2 to 100 mg/m 2 and flat dose of 200 mg) (55 paclitaxel, 5 docetaxel). The study was conducted from 21 November 2013 to 07 February 2017. The Lancet Regional Health – Western Pacific.The Lancet Regional Health – Southeast Asia.The Lancet Gastroenterology & Hepatology.
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