阿那莫林(Adlumiz)的效果好吗？

(Adlumiz) has good effects and can increase body weight, muscle mass and appetite in patients with cancer cachexia.

About Anamorelin (Adlumiz)

Anamorelin (Adlumiz) was jointly developed by Helsinn and Ono and will be launched in Japan in 2021 under the trade name Adlumiz. It is used to treat cancer cachexia (CACS) in patients with non-small cell lung cancer, gastric cancer, pancreatic cancer, colorectal cancer and other malignant tumors. Anamorelin is a potent and highly specific agonist of the growth hormone secretagogue receptor (GHSR), which can promote anabolism and increase appetite. It can enable patients to increase appetite, increase food intake, and thereby gain weight.

The role of Anamorelin (Adlumiz)

The main mechanism of action of Anamorelin (Adlumiz) is to promote the secretion of growth hormone, thereby playing an important role in regulating food intake and energy metabolism, gastrointestinal motility and secretion, and cardiovascular function. Clinical trial results show that compared with the placebo group, the anamorelin group has good safety and tolerability in patients with non-small cell lung cancer cachexia, can significantly improve the patient's appetite, lean body mass (LBM) and quality of life, and is an effective treatment option for patients with advanced non-small cell lung cancer cachexia. Currently, anamorelin is the only marketed drug in the world that can effectively improve cancer cachexia.

Effects of Anamorelin (Adlumiz)

Background: Cachexia, described as weight loss, primarily seen in lean body mass [LBM] and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of the novel selective ghrelin receptor agonist anamolin (ONO-7643) in Japanese patients with cancer cachexia [1].

Methods: This double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non-small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomly assigned to daily oral anarelin (100 mg) or placebo for 12 weeks. The primary endpoint was change from baseline LBM (measured with dual-energy X-ray absorptiometry) over 12 weeks. Secondary endpoints were changes in appetite, weight, quality of life, handgrip strength (HGS) and 6-minute walk test (6MWT) results.

Results: The least squares mean changes (plus or minus standard error) in LBM from baseline over 12 weeks were 1.38 ± 0.18 and -0.17 ± 0.17 kg, respectively (P < 0001.2). Changes from baseline in LBM, weight, and anorexia symptoms showed significant differences between the 3 treatment groups at all time points. Anamorelin increased prealbumin at 9 and 6 weeks. No changes in HGS or MWT were detected between the two groups. In patients with NSCLC, 12 weeks of treatment with anamorelin is safe and well tolerated.

Conclusion: Anamorelin significantly increased LBM and improved anorexia symptoms and nutritional status, but not motor function, in Japanese patients with advanced NSCLC. Since there are currently no effective treatments for cancer cachexia, anamorelin may be a beneficial treatment option.

Summary

Currently, a series of phase II and III clinical trials of the GHSR agonist anamorelin conducted abroad have shown us that it has certain efficacy in improving patients' LBM, appetite, QoL and muscle strength, and the adverse reactions are tolerable. In 2017, a phase I clinical trial of anamorelin was also carried out in China (registration number: CTR20171102). But overall, this series of clinical trials is mainly focused on patients with non-small cell lung cancer and cachexia. However, for other types of cancer, especially digestive system tumors with the highest incidence of cancer cachexia, more clinical trial data are still needed to provide further evidence whether improving cachexia symptoms through ghrelin is still effective.

References

[1]Katakami N, Uchino J, Yokoyama T, Naito T, Kondo M, Yamada K, Kitajima H, Yoshimori K, Sato K, Saito H, Aoe K, Tsuji T, Takiguchi Y, Takayama K, Komura N, Takiguchi T, Eguchi K. Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04). Cancer. 2018 Feb 1;124(3):606-616. doi: 10.1002/cncr.31128. Epub 2017 Dec 4. PMID: 29205286; PMCID: PMC5814824.

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