CrystalGenomics Releases ASCO Abstract for Licensed 'Camrelizumab'

Objective Response Rate of 81.3% Confirmed in Triple-Negative Breast Cancer Patients

[Asia Economy Reporter Hyungsoo Park] CrystalGenomics has released an abstract for a Phase 2 clinical trial of the immuno-oncology drug 'Camrelizumab,' developed and licensed domestically, targeting patients with triple-negative breast cancer at the American Society of Clinical Oncology (ASCO).

According to the abstract, the Phase 2 efficacy evaluation was conducted on a total of 48 triple-negative breast cancer patients using a combination therapy of Camrelizumab, Famitinib, and nab-paclitaxel. Drug treatment effects (CR+PR) were confirmed in 39 patients, resulting in an objective response rate (ORR) of 81.3%. The per-protocol (PP) population of 46 patients showed an ORR of 84.8%.

This result surpasses Roche's Tecentriq + nab-paclitaxel combination therapy for triple-negative breast cancer, which received FDA approval as a first-line treatment in 2019 and showed an ORR of 59%. Grade 3 to 4 adverse events included neutropenia (33.3%), anemia (10.4%), febrile neutropenia (10.4%), thrombocytopenia (8.3%), hypertension (4.2%), hypothyroidism (4.2%), proteinuria (2.1%), and sepsis (2.1%), in that order.

Two patients experienced serious treatment-related adverse events, but no treatment-related deaths were reported.

Currently, CrystalGenomics is preparing for a bridging Phase 3 clinical trial (regulatory approval trial) by translating data and reviewing submission materials for the Ministry of Food and Drug Safety to gain approval for esophageal and lung cancer treatments.

Hansoh Pharmaceutical, responsible for the presentation, plans to disclose more detailed data at the American Society of Clinical Oncology (ASCO 2021), held online from June 4 to 8.