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ORAL 29 - MASCC-IASLC Joint Session: Palliative and Supportive Care (ID 136)
- Event: WCLC 2015
- Type: Oral Session
- Track: Palliative and Supportive Care
- Presentations: 1
ORAL29.02 - ONO-7643/Anamorelin for the Treatment of Cancer Cachexia in Advanced NSCLC Patients: Results From the Phase 2 Study in Japan (ID 1375)
16:45 - 18:15 | Author(s): Y. Takeda
Cancer cachexia is characterized by decreased body weight (BW), mainly lean body mass (LBM) and negatively impacts quality of life (QOL) and prognosis. ONO-7643/anamorelin (ANAM) is a novel selective ghrelin receptor agonist with appetite-enhancing and anabolic activity.
ONO-7643-03 was a double-blind, exploratory Phase 2 trial assessing ANAM efficacy and safety in Japanese non-small cell lung cancer (NSCLC) patients with unresectable stage III/IV NSCLC, ECOG performance status (ECOG PS) 1-2 and cachexia (main criteria: ≥5% weight loss within prior 6 months). Patients were randomized to ANAM at 100 or 50 mg, or placebo, given daily orally for 12 weeks. Co-primary endpoints were change from baseline over 12 weeks in LBM (measured by DXA) and handgrip strength (HGS). Secondary endpoints included change in BW, ECOG PS, Karnofsky performance scale (KPS) and QOL assessment (QOL-ACD).
Demographics were balanced (N=180); median age=66 yr, male (68.9%), ECOG PS=1 (77.5%) and stage IV (76.1%). Treatment effects: the change in LBM over 12 weeks was 0.55 kg in the placebo arm and 1.15 kg in the ANAM 100 mg arm, and the change in LBM at both Weeks 8 and 12 showed significant differences between ANAM 100 mg and placebo (p<0.05). However, the change in HGS was similar between arms at both time points. The change in BW to Weeks 12 was -0.93 kg in the placebo arm vs +0.54 kg in the 50 mg arm and +1.77 kg in the 100 mg arm, and was significantly different between the 100 or 50 mg arms and the placebo arm at all time points (p<0.05). The cumulative rate of deterioration of ECOG PS was lowest in the 100 mg arm, and ANAM 100mg significantly improved KPS and QOL-ACD compared to placebo at Weeks 4 and 12 (p<0.05). Regarding safety, ANAM treatment for 12 weeks was well tolerated. While median survival time (MST) was not significantly different between active treatment arms and placebo, MST of patients with BW loss was significantly shorter than those without (215 vs 327 days; p=0.0055).
This phase 2 study demonstrated that ANAM has promising potential in improving body composition, performance status and QOL in patients with cancer cachexia.
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