Chicago, Illinois-based Ellipses Pharma has announced its intention to accelerate the global clinical development of its selective RET inhibitor EP0031/A400.
Following the publication of clinical data from its Phase I study of the inhibitor at the American Society of Clinical Oncology (ASCO) conference, Ellipses was motivated to accelerate clinical development due to what it believes are “very encouraging” results. The ASCO Annual Meeting is being held 2–6 June in Chicago.
According to the company, RET mutations and fusions may be responsible for roughly 2% of all solid tumours. This includes 2% of non-small cell lung cancer (NSCLC) and 60-80% of medullary thyroid cancers.
Ellipses reported preliminary efficacy and safety data for the 109 patients enrolled in the trial. For the RET-altered tumour population, patients receiving doses of 40-120mg had an objective response rate (ORR) of 60%, and a disease control rate of 90%.
Two patient cohorts were highlighted in particular. The first, patients, with previously untreated RET-fusion positive advanced NSCLC, had an ORR of 80.8%. Another cohort of patients with RET-fusion positive NSCLC who had received treatment like chemo-immunotherapy, had an ORR of 69.7%. In both cases, DCR of over 96% were reported.
Dr. Tobias Arkenau, Global Head of Drug Development & CMO at Ellipses, said the data gives Ellipses the backing to advance their pipeline.
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The company was also eager to highlight observed evidence of clinical activity in patients with brain metastases. It also saw similar for patients who had previously been treated with first-generation SRIs, who currently have limited available treatment options.
The cohorts were part of a global, modular phase I/II trial in patients with advanced RET-altered tumours (add NCT). Data released at this point will be augmented by the results of ongoing trials in the US, EU, and UK
Kelun-Biotech, Ellipses’ partner in developing the RET inhibitor, is conducting clinical investigations in China for patients with RET-altered cancers.