Exhibit 99.1
![LOGO](https://capedge.com/proxy/8-K/0001193125-21-358521/g237379dsp001.jpg)
Cullinan Oncology Announces Updated Phase 1/2a Data for
CLN-081 in NSCLC EGFR Exon 20 Patients
CLN-081 continues to demonstrate a differentiated clinical profile at the recommended Phase 2 dose of 100mg BID
Continued high response rate with favorable safety and tolerability profile observed in heavily pre-treated patients at 100mg BID
Encouraging durable responses and progression free survival at 100mg BID
Cambridge, MA, December 16, 2021 – Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients, today reported updated data from the Company’s ongoing Phase 1/2a trial of CLN-081 in non-small cell lung cancer (NSCLC) patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations that have progressed on or after prior therapy.
“The updated data from our ongoing Phase 1/2a study in a larger number of patients further reinforce CLN-081’s differentiated clinical profile. CLN-081 has demonstrated both a high response rate and durable responses in heavily pre-treated patients,” said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. “For many lung cancer patients currently receiving EGFR inhibitors, treatment related side effects can significantly impact their daily lives. In this regard, we are encouraged by CLN-081’s favorable safety profile at the 100mg BID dose.”
The current analysis of the ongoing trial included a total of 73 NSCLC patients with EGFR exon 20 insertion mutations who received at least one dose of CLN-081 and were evaluable for safety as of the data cutoff. CLN-081 was administered orally, at dose levels including 30, 45, 65, 100 and 150 mg twice daily (BID). Based on prespecified safety and efficacy criteria, enrollment at the Phase 2a cohort for 100mg BID was expanded up to the planned maximum of 36 patients. Additional patients were also enrolled at the 150mg BID dose level, although enrollment was subsequently discontinued after a total of 11 patients based on overall assessment of the clinical profile at this dose level. Guided by these data,100mg BID was nominated as the Recommended Phase 2 Dose (RP2D) for CLN-081.
Efficacy Highlights:
Efficacy data from patients enrolled in the 100mg BID cohort:
| • | | Of 36 response evaluable patients, 14 achieved a confirmed PR for a 39% confirmed response rate and one additional patient had a PR that was pending confirmation at the time of the data cut-off. |
| • | | The median duration of response was >15 months and the median progression free survival was 12 months in the initial cohort of phase 1 patients (N=13). |