Glecirasib Receives Orphan Drug Designation from EMA for Pancreatic Cancer
核心洞察
Jacobio Pharma (搜索)'s glecirasib, a KRAS G12C (搜索) inhibitor, has been granted orphan drug designation by the European Medicines Agency (EMA) for pancreatic cancer (搜索).
Glecirasib previously received orphan drug designation from the FDA in the United States and breakthrough therapy designation from the CDE in China for pancreatic cancer (搜索).
Clinical trial data presented at ASCO GI 2024 showed a cORR of 41.9% and a DCR of 93.5% in second-line and above KRAS G12C (搜索) mutated pancreatic cancer (搜索) patients.
Jacobio Pharma (搜索)'s glecirasib, an in-house developed KRAS G12C (搜索) inhibitor, has been granted orphan drug designation (ODD) by the European Medicines Agency (EMA) for the treatment of pancreatic cancer (搜索). This designation highlights the EMA's recognition of glecirasib's potential to address a critical unmet need in this difficult-to-treat malignancy.
Pancreatic cancer (搜索) is a highly aggressive tumor with limited effective treatment options, resulting in a five-year overall survival rate of only 3.1% for advanced cases. The EMA's decision follows a similar designation granted by the FDA in the United States, as well as breakthrough therapy designation from the CDE in China, underscoring the growing international interest in glecirasib as a potential therapeutic agent.
Promising Clinical Data in Pancreatic Cancer
Jacobio previously presented data on glecirasib in pancreatic cancer (搜索) patients at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in 2024. The results demonstrated encouraging efficacy in heavily pre-treated patients with KRAS G12C (搜索) mutated pancreatic cancer. Specifically, the confirmed objective response rate (cORR) was 41.9% (13/31), and the disease control rate (DCR) was 93.5% (29/31). The median progression-free survival (mPFS) was 5.6 months, and the median overall survival (mOS) was 10.7 months.
Ongoing Clinical Trials
A pivotal trial (NCT06008288) is currently underway across 30 sites in China to further evaluate the efficacy and safety of glecirasib in patients with advanced KRAS G12C (搜索) mutated PDAC (搜索) and other solid tumors. This trial is crucial for potentially securing regulatory approval and making glecirasib available to a broader patient population.
Glecirasib: A KRAS G12C Inhibitor
Glecirasib is a KRAS G12C (搜索) inhibitor developed by Jacobio Pharma (搜索). Several clinical trials are ongoing in China, the United States, and Europe, evaluating glecirasib in patients with advanced solid tumors harboring the KRAS G12C mutation. These trials include combination therapies with the SHP2 inhibitor JAB-3312 in non-small cell lung cancer (NSCLC) and with cetuximab in colorectal cancer. The orphan drug designation in the United States and breakthrough therapy designation in China for the pancreatic cancer (搜索) indication further highlight the drug's potential in this specific patient population.