Qilu Pharmaceutical's Panitumumab Biosimilar (QL1203) Becomes China's First Approved for RAS Wild-Type Metastatic Colorectal Cancer
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
Source: PharmaCube Info
December 9,The official website of the National Medical Products Administration (NMPA) shows that Qilu PharmaceuticalQilu Pharmaceutical's Panitumumab Biosimilar (QL1203) Approved for Marketing in China, for combinationmFOLFOX as First-line Treatment for RAS Wild-type Metastatic Colorectal Cancer (mCRC) Patients.
The original research Panitumumab isTakeda and Amgen's collaboration in developmentA monoclonal antibody targeting the epidermal growth factor receptor (EGFR),Not yet approved for marketing in China.EGFR is an important proto-oncogene, and panitumumab can target the abnormal EGFR cell signaling pathway to inhibit tumor growth.
Qilu Pharmaceutical Co., Ltd. has launched a Phase III registrational clinical study aimed at evaluatingQL1203 Combined with mFOLFOX6 Versus Placebo Combined with mFOLFOX6 as First-Line Treatment for RAS Wild-TypemCRCEfficacy and safety of patients.
The study enrolled RAS/BRAF wild-type mCRC patients who had not previously received anti-EGFR therapy and randomly assigned them (2:1) Receive QL1203 (6mg/kg) once every 2 weeks in combination with mFOLFOX6 (oxaliplatin 85mg/m2+Calcium Levofolinate 200mg/m2+Fluorouracil 2400mg/m2) or placebo combined with mFOLFOX6 until disease progression, intolerable toxicity, or other discontinuation events. The primary endpoint is progression-free survival (PFS) assessed by BICR, and secondary endpoints include PFS assessed by investigators, overall survival (OS), objective response rate (ORR), disease control rate (DCR), radical resection rate, safety, etc.
This study enrolled a total of 641 patients. As of March 22, 2024, the median follow-up time was 23.8 months. The median overall survival (OS) in the QL1203 group was 27.66 months, compared to 24.54 months in the placebo group. The objective response rate (ORR) assessed by BICR in the QL1203 group was 68.31%, including 4 cases (0.9%) of complete response (CR) and 287 cases (67.4%) of partial response (PR). The ORR in the placebo group was 47.91%. The disease control rates (DCR) were 93.43% and 89.30%, respectively, with median progression-free survival (PFS) of 11.20 months and 8.34 months (HR=0.61, p<0.01).
Figure 2. Progression-Free Survival (FAS) Assessed by BICR
Figure 3. Overall Survival (FAS)
In terms of safety, the study results showed that in RAS/BRAF wild-type mCRC patients who had not previously received anti-EGFR therapy, QL1203 combined with mFOLFOX6 significantly improved PFS and achieved a higher ORR compared to placebo combined with mFOLFOX6. The combination of QL1203 and mFOLFOX6 demonstrated good tolerability and safety. In the study of QL1203 combined with chemotherapy for first-line treatment of colorectal cancer patients, it exhibited favorable safety and tolerability, with a safety profile similar to the original drug.
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