Genexine "New Cervical Cancer Drug Combination More Effective Than Chemotherapy Monotherapy"
[Asia Economy Reporter Seo So-jung] Genexine announced on the 20th that the combination therapy of 'GX-188E' (NOV1702), a new drug under development for cervical cancer treatment, and Merck (MSD)'s immune checkpoint inhibitor Keytruda (active ingredient pembrolizumab) showed improved efficacy compared to Keytruda monotherapy in the interim results of a Phase 2 clinical trial.
The interim analysis results were disclosed as an oral presentation abstract at the American Society of Clinical Oncology (ASCO) Annual Meeting on the 19th (local time). This year’s ASCO is scheduled to be held online from July 4 to 8, and Genexine plans to present more advanced research results at 9 a.m. on the 4th, compared to the time of abstract submission.
Genexine set 48 patients with advanced recurrent or progressive cervical cancer infected with human papillomavirus (HPV) types 16 or 18 as the efficacy evaluation group. Among them, 5 patients showed complete remission (CR) with disappearance of target lesions, and 10 patients showed partial remission (PR) with a reduction of 30% or more in the size of target lesions.
The objective response rate (ORR) of the combination group of GX-188E and Keytruda in all patients was 31.3%. In Keytruda monotherapy clinical trials, this rate was 12.2%.
In particular, among patients with squamous cell carcinoma, which accounts for the largest proportion of cervical cancer, who were positive for 'PD-L1' (a protein expressed on cancer cells) and had HPV type 16, the objective response rate was high at 48%. Progression-free survival (PFS) was 4.1 months, and overall survival (OS) was 16.7 months, showing improved results compared to 2.1 months and 9.4 months observed in Keytruda monotherapy trials.
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Among the 52 patients who participated in the clinical trial, only 17 experienced mild drug adverse reactions of grade 1 or 2, and 2 patients showed adverse reactions of grade 3 or 4.
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