FDA grants breakthrough therapy designation to novel EGFR inhibitor
pharmafile | January 5, 2022 | News story | Research and Development |
The FDA has granted a breakthrough therapy designation to Cullian Oncology’s CLN-081, in certain patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). CLN-081 is an orally available, irreversible EGFR inhibitor, and has been shown to target cells that express EGFR exon 20 exertion mutations, while simultaneously bypassing cells that express wild-type EGFR.
The agent is currently being investigated in a Phase I/IIa, open-label, multi-centre trial, in patients following treatment with platinum-based systemic chemotherapy. In approximately 80 patients, the study will explore the safety and preliminary efficacy. The study will assess the rate and severity of treatment-emergent adverse events (AEs) and dose-limiting toxicities, the incidence of laboratory assessment abnormalities, and the overall response rate (ORR) in patients treated in the Phase IIa dose-expansion cohorts.
“We are extremely pleased that Cullinan has received breakthrough therapy designation from the FDA for CLN-081, a distinction that underscores the urgent need to bring improved targeted treatments to this patient population and further supports the differentiated clinical profile of CLN-081,” Nadim Ahmed, chief executive officer of Cullinan Oncology, shared.
The secondary end points of the study include ORR, duration of response, disease control rate, progression-free survival, overall survival, assessment of maximum concentration, area under the curve, time to maximum concentration, terminal half-life, and mean residence time.
“The updated data from our ongoing Phase I/IIa study in a larger number of patients have demonstrated a high response rate with durable responses and encouraging progression-free survival in heavily pre-treated patients. We are also encouraged by the favourable safety profile observed thus far, and we look forward to ongoing, productive regulatory discussions with the FDA, which are further enabled with this designation, said Ahmed, in the press release.
CLN-081 is an orally available, irreversible EGFR inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR.
Ana Ovey
