Efficacy and safety of anamorelin in patients with cancer cachexia: Post‐hoc subgroup analyses of a placebo‐controlled study

Abstract

Background Cachexia, a disorder associated with anorexia, inflammation, and muscle wasting, is frequent in cancer patients. We performed post‐hoc analyses of the ONO‐7643‐04 study to investigate the efficacy and safety of anamorelin in subgroups of Japanese patients with non‐small cell lung cancer (NSCLC). Methods The patients were divided into subgroups by baseline characteristics, including sex, age, body mass index, prior weight loss, performance status (PS), concomitant anticancer therapy, and number of previous chemotherapy regimens. The changes from baseline through to 12 weeks for lean body mass (LBM), body weight, and appetite were calculated. Appetite was evaluated using the quality of life questionnaire for cancer patients treated with anticancer drugs (QOL‐ACD) item 8 score. Responder rates were defined as the maintenance/improvement of LBM (≥0 kg), body weight (≥0 kg), or QOL‐ACD item 8 score (≥0) from baseline to all evaluation time points. Safety was evaluated in patients subgrouped by age and PS. Results Anamorelin resulted in greater improvements versus placebo in LBM, body weight, and appetite in most subgroups. Anamorelin was also associated with greater LBM, body weight, and appetite responder rates than placebo in nearly all subgroups. Among anamorelin‐treated patients, adverse drug reactions (ADRs) tended to be more frequent with increasing age (<65 years, 19.2%; ≥65 to <75 years, 45.9%; ≥75 years, 60.0%) and PS score (PS 0–1, 38.4%; PS 2, 60.0%). The frequency of serious ADRs was 2.7% and 0% in the PS 0–1 and PS 2 subgroups, respectively. Conclusion This study of NSCLC patients with cancer cachexia revealed consistent improvements in LBM, body weight, and appetite across most subgroups of anamorelin‐treated patients. This study also demonstrated the tolerability of anamorelin regardless of age and PS, with a low incidence of serious ADRs in each subgroup.

Real‐world safety and effectiveness of anamorelin for cancer cachexia: Interim analysis of post‐marketing surveillance in Japan

“…According to the subgroup effectiveness analysis by patient background characteristics, most of the subgroups showed tendencies towards increases in BW and appetite from baseline (Table S6 , S7 ), although patients with a BMI <20 kg/m 2 showed a greater BW gain than patients with a BMI ≥20 kg/m 2 . Post hoc subgroup analyses of the ONO‐7643‐04 trial revealed that the odds ratio for BW improvement in the anamorelin arm vs. placebo arm tended to be greater in patients with a BMI of <20 kg/m 2 at baseline than in those with a BMI of ≥20 kg/m 2 , 22 consistent with the current results. Although an increased appetite was observed regardless of baseline BMI, a baseline BMI of <20 kg/m 2 may be useful as a predictor of BW gain in patients treated with anamorelin.…”

Loss of appetite in patients with cancer: an update on characterization, mechanisms, and palliative therapeutics

“…Takayama and others conducted secondary analyses of trial ONO-7643-04, a study in lung cancer patients. These analyses showed that, among 81 anamorelin-treated patients and 90 placebo-exposed patients, anamorelin resulted in appetite improvement compared to baseline, even in various subgroups based on age, gender, and other baseline demographic factors [14]. Although some of these subgroups might have been represented with small patient numbers and hence might have led to underpowered analyses, overall, it appears that anamorelin seems uniform across patients in its ability to promote appetite in patients with non-small-cell lung cancer.…”

Vitamin and Mineral Supplementation, Weight Gain, and Poor Appetite in Patients With Cancer: Many Questions and Fewer Answers

“…Furthermore, anamorelin was well tolerated. Recently, Takayama et al 32 showed that, among 81 anamorelin-treated patients and 90 placebo-exposed patients, anamorelin resulted in appetite improvement from baseline, even in age- and sex-based subgroups, observations that suggest this agent has the potential of helping a broad swath of patients with advanced cancer, if prescribed.…”