Here is the other abstract for sarcoma... Not sure why it was presented/accepted. It seems unremarkable. Only 10 patients participated.
Abstract:
Background: The use of angiogenic and Aurora kinase inhibitors has been shown to abrogate tumor growth in STS. ENMD-2076 is an oral Aurora A and angiogenic kinase inhibitor that has demonstrated single-agent activity in STS cell lines and inhibition of sarcoma growth for a patient in a phase 1 clinical trial setting.
Methods: This is a single-center, open-labeled phase II study of ENMD-2076 in advanced STS pts treated with =1 line of prior therapy in the advanced/metastatic setting. Pts were commenced on 275mg daily dose (on a 28-day cycle. Treatment-emergent adverse events were assessed by CTCAE (4.0). Radiographic or clinical tumor measurements occurred every 2 cycles (RECIST 1.1).
Results: 10 pts were enrolled from 2/2013 – 11/2013 and evaluable for efficacy. Median age is 58 yrs (41 – 72). Male: Female 1:9. Histology: Leiomyosarcoma / pleomorphic sarcoma / angiosarcoma: 7/2/1. Pts received the following prior systemic therapies: doxorubicin/gemcitabine/others: 2/3/5.
At time of abstract submission, median follow-up is at 7 months (2-12). 3 pts continue on study. Median number of cycles administered per pt = 2 (1-8). 2 pts had confirmed partial response (PR) and 1 pt with confirmed stable disease (SD) of > 6 months. Clinical benefit rate (PR+SD >6 months) was 30%. Median OS has not been reached. Median PFS at 1.8 months (95% CI: 1.2 – not reached).
ENMD-2076 has generally been well tolerated with primarily grade 1 and 2 adverse events (AEs). Specifically, drug-induced hypertension occurred in 6 pts (grade 1-2: 4 pts, grade 3: 2 pts). Proteinuria, all grade 1-2, occurred in 6 pts. Other drug related grade 3 or 4 AEs include (pts): elevated transaminases (1), leukopenia (1), and diarrhea (1). 1 pt developed Posterior Reversible Encephalopathy Syndrome (PRES) presenting as grade 4 loss of consciousness at Cycle 1 Day 15 required ICU admission. Full neurological recovery was attained after cessation of treatment.
Conclusions: ENMD-2076 has shown activity in patients with advanced STS, with meaningful clinical benefits and a side effects profile typical of this class of agent. PRES is a rare but fully reversible side effect of ENMD-2076. Clinical trial information: NCT01719744.
