Camrelizumab
Overview
Camrelizumab (ingredient name: camrelizumab, product name: Camrelizumab Injection) is a targeted anticancer drug for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations. This drug selectively inhibits EGFR mutations through a dual mechanism of action, offering a new treatment option for patients who have developed resistance to existing therapies. It received domestic approval from the Ministry of Food and Drug Safety in December 2024, demonstrating significant objective response rates and improvements in progression-free survival in global clinical trials.
Main Content
Mechanism of Action
Camrelizumab is a humanized IgG1 monoclonal antibody that binds to the extracellular domain of EGFR, blocking ligand binding and inhibiting receptor dimerization. In particular, EGFR exon 20 insertion mutations often show resistance to conventional EGFR tyrosine kinase inhibitors (TKIs), and camrelizumab recognizes the structural changes in these mutant proteins to effectively block signal transduction pathways. It also induces antibody-dependent cellular cytotoxicity (ADCC), activating the immune system through a dual mechanism.
Clinical Trial Results
In a global phase 2 clinical trial (Cohort A), camrelizumab monotherapy was evaluated in 114 NSCLC patients with EGFR exon 20 insertion mutations who had previously received platinum-based chemotherapy. The objective response rate (ORR) was 40.4% (95% CI: 31.4-49.9), and the disease control rate (DCR) reached 78.9%. The median progression-free survival (PFS) was 8.2 months (95% CI: 6.3-10.5), and the median overall survival (OS) was 22.5 months (95% CI: 17.1-not reached). The most common grade 3 or higher adverse events were hypoalbuminemia (8.8%), anemia (7.0%), and fatigue (5.3%).
Approval and Indications
On December 20, 2024, the Ministry of Food and Drug Safety approved camrelizumab for "the treatment of patients with locally advanced or metastatic non-small cell lung cancer with confirmed EGFR exon 20 insertion mutations." This is the first targeted anticancer drug approved in South Korea for EGFR exon 20 insertion mutations, where previously platinum-based chemotherapy or immune checkpoint inhibitors were mainly used but with limited efficacy. The approved dose is 1050 mg administered intravenously every two weeks, continued until disease progression or unacceptable toxicity.
Safety Profile
The safety profile of camrelizumab is similar to other EGFR-targeted antibodies. Notable adverse events include infusion-related reactions (10-15%), skin toxicity (rash, dry skin, pruritus, 30-40%), diarrhea (20-25%), and elevated liver enzymes (ALT/AST elevation, 15-20%). The incidence of interstitial lung disease (ILD) is low at 2-3%, but it can be fatal if it occurs, requiring caution. Patients should undergo liver function tests and hematological assessments before starting treatment, and regular monitoring during treatment is recommended.
Drug Interactions and Contraindications
Camrelizumab is not metabolized through CYP450 enzymes, so the potential for drug-drug interactions is low. However, caution is needed when used concomitantly with immunosuppressants or corticosteroids, as immune modulation effects may be counteracted. It is contraindicated in pregnant or breastfeeding women and patients with severe hepatic impairment. Women of childbearing potential should use effective contraception during treatment and for at least 6 months after the last dose.
Latest Trends
As of 2024-2025, camrelizumab is establishing itself as a new standard therapy for EGFR exon 20 insertion mutation NSCLC. In January 2025, the U.S. FDA is reviewing additional clinical trial data to expand approval of camrelizumab as a first-line treatment. In South Korea, discussions on health insurance coverage began in February 2025, with expectations for improved patient access. Additionally, a phase 3 clinical trial (Cohort B) of camrelizumab in combination with chemotherapy (carboplatin + pemetrexed) is ongoing, with results expected in the second half of 2025. Concurrently, advances in liquid biopsy-based detection technology for EGFR exon 20 insertion mutations are improving diagnostic accuracy, enabling more patients to receive timely treatment.
Related Topics
- [[Non-small cell lung cancer]]
- [[EGFR mutation]]
- [[Targeted anticancer drug]]
- [[Monoclonal antibody]]