The appetite enhancing drug anamorelin has shown superiority over placebo in reversing weight loss in people with lung cancer, in late-stage data presented at ESMO 2023 that has spotlighted a potential new option for supportive care.
The meeting heard that the ghrelin receptor agonist promotes GH secretion to increases appetite and is used in patients with cancer cachexia, although it is currently only approved in Japan.
It is hoped that data from the international SCALA-1 and -2 trials, which took place in non small cell lung cancer (NSCLC) treatment centres across Australasia, North America and Europe will underpin its regulatory approval, giving clinicians the first option for managing the key element of the condition, ESMO delegates heard.
Highlighting the current unmet need in this area, Professor David Currow, Deputy Vice-Chancellor (Research and Sustainable Futures) at the University of Wollongong, Australia, emphasised that the lack of registered treatments for cancer cachexia was driving many clinicians to use glucocorticoids as an approach, which are associated with accelerated muscle loss.
Results from the SCALA trials show that anamorelin is “an incredibly safe and well tolerated therapy for participants with NSCLC undergoing systemic therapy,” which “has great importance for [clinicians] as we think about supportive care of people with cancer”, he said.
The SCALA trials collectively included 636 adults with advanced NSCLC, who had an ECOG performance status of 0-2, BMI of less than 20 kg/m2, and unintentional weight loss more than 2% in the previous six months.
Participants were randomised to receive either 100mg of anamorelin or a placebo orally once daily for 24 weeks.
The data showed significantly increase body weight over 12 weeks in patients taking the drug versus placebo (p<0.0001), with an increase of 1.4kg in SCALA-1 and 1.3kg in SCALA-2, which Prof Currow described as both “statistically and clinically highly significant”.
On the downside, the data showed no difference between the two arms with regard to improvement in anorexia symptoms as assessed by the 5-domain IASS.
However, researchers reported that there was a very large effect in the placebo arm in patients who levels below or equal to the median value at baseline, and that there was a low correlation between 5-IASS and body weight at each visit during the study.
The drug fared well on the safety side, with the proportion of patients who experienced treatment-related adverse events similar between the anamorelin group (71.2%) and placebo (73.4%), while just two patients in the treatment arm experienced severe hypoglycaemia.
The study authors concluded that the positive benefit-risk profile “strongly emphasises the therapeutic potential of anamorelin for treating unintended weight loss in patients with advanced NSCLC and cachexia”.
The SCALA programme is funded by Helsinn Healthcare.