Avelumab in Patients With Metastatic Colorectal Cancer

Area of Science:

• Oncology
• Immunotherapy
• Clinical Trials

Background:

• Metastatic colorectal cancer (mCRC) has a poor prognosis, with limited survival benefits from current treatments.
• While PD-1/PD-L1 inhibitors are effective in specific tumor types (microsatellite unstable/mismatch repair deficient), most patients with microsatellite stable/mismatch repair proficient mCRC do not benefit.
• This study investigates the efficacy of avelumab, an anti-PD-L1 antibody, in patients with mCRC.

Purpose of the Study:

• To evaluate the objective response rate of avelumab in patients with metastatic colorectal cancer (mCRC).
• To assess the safety and efficacy of avelumab in an unselected mCRC patient population.

Main Methods:

• A phase I, open-label, dose-escalation trial with a consecutive parallel-group expansion was conducted.
• Twenty-two patients with measurable mCRC, having received at least one prior systemic therapy for metastatic disease, were enrolled.
• Patients received avelumab 10 mg/kg intravenously every two weeks; prior immune checkpoint inhibitor treatment was an exclusion criterion.

Main Results:

• No objective responses were observed in the 22 participants treated with avelumab.
• Median progression-free survival was 2.1 months (95% CI: 1.4-5.5 months).
• Five grade 3 treatment-related adverse events were reported, including GGT elevation, PRESS, lymphopenia, and asymptomatic amylase/lipase elevation.

Conclusions:

• Avelumab demonstrated no activity in unselected patients with metastatic colorectal cancer (mCRC).
• These findings are consistent with previous studies of anti-PD-1/PD-L1 antibodies in similar patient populations.
• Further research may be needed to identify specific subgroups of mCRC patients who could benefit from PD-L1 blockade.