FDA Grants Speedy Review for Novel NSCLC Therapy


The Food and Drug Administration will offer guidance and expedited review to CLN-081, a novel drug that is promising for the treatment of EGFR exon 20-mutated non-small cell lung cancer.

The Food and Drug Administration (FDA) granted a breakthrough therapy designation to CLN-081 for the treatment of patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 mutations, according to Cullinan Oncology, the manufacturer of the agent.

“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, Chief Executive Officer of Cullinan Oncology, in a statement.

The breakthrough therapy designation — which is given to new drugs that treat serious conditions and provides intensive FDA guidance on the drug development — is based on findings from the phase 1/2a trial (NCT04036682) that showed that CLN-081 may have a better safety profile than other drugs in the space, and is also tolerable, efficacious and leads to durable responses.

“The updated data from our ongoing phase 1/2a 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 favorable safety profile observed thus far, and we look forward to ongoing, productive regulatory discussions with the FDA, which are further enabled with this designation,” Ahmed said.

The study looked at CLN-081 in five different doses: 30, 45, 65, 100 and 150 mg twice a day. In the 36 patients on the 100 mg dose who responded to treatment, 14 (39%) achieved a partial response, with an average duration of response being longer than 15 months.

The drug proved to have a manageable side effect profile, too, with 54% and 18% of patients experiencing rash, at grades 1 and 2, respectively. It was treated with conventional supportive care. No patients had severe (grade 3 or higher) rash. Additionally, 26% of patients had grade 1 diarrhea and 8% had grade 2 diarrhea. No patients on the study experienced grade 3 or worse treatment-related diarrhea, which may have required a preventative regimen.

CLN-081 is an oral drug that targets cells that express EGFR exon 20 insertion mutations while leaving other cells unharmed. The ongoing phase 1/2a trial is testing the agent in patients with NSCLC harboring exon 20 mutations whose disease progressed on or after receiving a platinum-based chemotherapy regimen or any other standard therapy that was available for the patient.

The study is estimated to be completed by March 15, 2022.

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