Get all your news in one place.
100’s of premium titles.
One app.
Start reading
Benzinga
Benzinga
Technology
Vandana Singh

Cullinan Oncology Lead Cancer Program Shows Confirmed ORR Of 41% In Lung Cancer Setting

Cullinan Oncology Inc (NASDAQ:CGEMannounced clinical and regulatory updates from Phase 1/2a trial of CLN-081 in a non-small cell lung cancer (NSCLC) setting.

  • The trial includes NSCLC patients harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations progressed on or after prior therapy.
  • The most recent data now include 39 patients treated at 100 mg BID following the addition of 3 patients who were reassigned to receive the 100 mg BID dose after enrollment at 150 mg BID was discontinued.
  • Of the 39 response evaluable patients, 16 achieved a confirmed partial response for a 41% confirmed overall response rate (ORR).
  • Related: Cullinan Oncology Posts Updated Data for CLN-081 in NSCLC EGFR Exon 20 Patients.
  • No patients have experienced Grade 3 or greater treatment-related diarrhea or rash.
  • Additionally, the FDA has encouraged Cullinan to explore the potential for a food effect on the clinical profile of the 150mg dose. 
  • The agency has endorsed Cullinan's plan to conduct a small food effect study (n~20) designed to evaluate food's potential impact on exposure and other pharmacokinetic (PK) parameters at 150mg. 
  • Cullinan expects to initiate a pivotal study in 2H of 2022 following the completion of this PK food effect study.
  • Price Action: CGEM shares closed 2.44% lower at $11.20 on Monday.
Sign up to read this article
Read news from 100’s of titles, curated specifically for you.
Already a member? Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member? Sign in here
Our Picks
Fourteen days free
Download the app
One app. One membership.
100+ trusted global sources.