CLN-081 Receives Breakthrough Therapy Designation for NSCLC

Cullinan Oncology’s CLN-081 today received a Breakthrough Therapy Designation from the FDA for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC).

Cullinan Oncology’s CLN-081, an orally available, irreversible epidermal growth factor receptor (EGFR) inhibitor, today received a Breakthrough Therapy Designation from the FDA for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) in patients harboring EGFR exon 20 insertion mutations and who have previously received platinum-based systemic chemotherapy.

CLN-081 functions by selectively targeting cells expressing EGFR exon 20 insertion mutations while sparing cells expressing wild type EGFR, according to a company statement. A phase 1/2 trial is underway to evaluate various doses in patients whose NSCLC has progressed on or after prior therapy.

The designation, which serves to expedite the development and review of drugs intended to treat a serious condition, is based off updated phase 1/2a data that showed CLN-081 led to a high response rate and durable response among heavily pretreated patients.

That data, which were released in December 2021, revealed that of the 36 patients enrolled in the 100-mg BID cohort 14 achieved a confirmed PR for a 39% confirmed response rate, with a median duration of response of greater than 15 months. In the initial cohort of phase 1 patients (n = 13), median progression-free survival was 12 months.

When it comes to safety and tolerability, both diarrhea and rash have been limited to grade 1 and 2 events.

“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,” said Nadim Ahmed, CEO of Cullinan Oncology.

“We look forward to ongoing, productive regulatory discussions with the FDA, which are further enabled with this designation,” he added.