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Cullinan Oncology’s Phase IIb study investigating CLN-081 in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutations is planned to start before the end of the year, CMO Jeff Jones says.

“We are working to rapidly expedite the initiation of that study,” Jones tells Clinical Trials Arena. It is envisioned that the study would pave the way for an accelerated approval in the US, he adds. CLN-081 was granted Breakthrough Therapy Designation by the FDA in January this year.

The single-arm Phase IIb will likely enrol at least 100 participants in the second line setting, with a primary endpoint of overall response rate (ORR) and durability of response (DoR) as a secondary measure, Jones says. Based on data from a Phase I/IIa trial (NCT04036682), the Phase IIb CLN-081 dose will be 100mg twice daily. While the Phase I/IIa recruited from 18 sites, the Phase IIb will likely have up to double the number of sites, he adds.

CLN-081 is an orally administered EGFR inhibitor. Cullinan completed a strategic collaboration agreement to jointly develop and commercialise the asset with Taiho Pharmaceuticals, according to a June 23 press release.

Clinical pipeline is set to expand

Preliminary Phase I/IIa CLN-081 trial data was presented at last month’s American Society of Clinical Oncology (ASCO) Annual Meeting. While the first two of three parts of the trial investigated CLN-081’s safety profile, the third part had a primary outcome measure of ORR.

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By GlobalData

In 39 patients in the 100mg twice daily arm, 16 (41%) had a confirmed partial response, with an estimated median DoR of greater than 21 months, as per a May 31 media release. The dose also led to a median progression-free survival (PFS) of 12 months.

As of May 2022, 73 patients were dosed in the Phase I/IIa trial, ranging from 30 to 150mg twice daily. Some 66% of these patients had received two or more prior lines of treatment, with 55% of patients previously receiving immunotherapy and 36% having prior EGFR tyrosine kinase inhibitor (TKI) treatment.

Looking at Cullinan’s other candidates, the biotech is planning to bring two pre-IND programs into the clinic, Jones says. The first is CLN-978, a trispecific extended T-cell engager targeting CD19, CD3, and HSA proteins for B-cell acute lymphoblastic leukemia and non-Hodgkin lymphoma. The other is the intratumoral injection CLN-617, a pan-cancer fusion protein that binds to cytokines interleukins 2 and 12. Both are planned to enter clinical trials by the end of the first half of 2023, Jones adds.

Most NSCLC trials in Phase II

There’s a total of 2,986 ongoing or planned Phase I–III clinical trials investigating treatments for NSLCL, according to the GlobalData’s Clinical Trial Database. Phase II trials account for 1,277 (42.77%) studies and Phase I trials corresponding to 833 (27.9%) investigations. The database shows 1,870 of ongoing trials are still recruiting, 578 have closed recruitment, while 538 studies are yet to start.

In the US, it is estimated that there will be nearly 237,000 new diagnoses of NSCLC this year. EGFR mutations is the most frequent mutation of NSCLCs, found in approximately 30% of all NSCLC patients.