Sintilimab, a PD-1 inhibitor, in combination with chemotherapy continues to demonstrate a significant overall survival (OS) advantage in patients with metastatic non-small cell lung cancer (NSCLC), according to an updated analysis of the PERLA trial. This Phase 3 trial's findings, presented recently, reinforce the potential of this combination as a first-line treatment option for a subset of NSCLC patients.
The PERLA trial is a randomized, double-blind, Phase 3 study evaluating the efficacy and safety of sintilimab plus chemotherapy (pemetrexed and platinum-based chemotherapy) versus placebo plus chemotherapy in patients with advanced NSCLC who have not received prior systemic therapy for advanced disease. The primary endpoint of the trial was progression-free survival (PFS), with overall survival (OS) as a key secondary endpoint.
The updated OS analysis revealed a statistically significant and clinically meaningful improvement in overall survival for patients treated with sintilimab plus chemotherapy compared to those treated with chemotherapy alone. The median OS was significantly longer in the sintilimab arm, and the hazard ratio favored the combination therapy, indicating a reduced risk of death. Detailed data, including median OS and hazard ratios with confidence intervals, are expected to be published in a peer-reviewed journal.
"These updated results from the PERLA trial provide further evidence supporting the use of sintilimab in combination with chemotherapy as a valuable treatment strategy for patients with advanced NSCLC," said a lead investigator of the study. "The sustained survival benefit observed with this combination is encouraging and warrants further investigation to identify predictive biomarkers and optimize its use in diverse patient populations."
NSCLC accounts for approximately 85% of all lung cancer cases, and a significant proportion of patients are diagnosed with advanced or metastatic disease. The current treatment landscape for advanced NSCLC includes chemotherapy, targeted therapies, and immunotherapy. However, there remains a significant unmet need for more effective and durable treatment options, particularly for patients who are not eligible for targeted therapies or who develop resistance to existing treatments.
The PERLA trial enrolled patients with histologically or cytologically confirmed Stage IIIB or IV NSCLC who had not received prior systemic therapy for advanced disease, had measurable disease according to RECIST v1.1, and had an ECOG performance status of 0 or 1. Patients were randomized 1:1 to receive either sintilimab plus chemotherapy or placebo plus chemotherapy. Treatment was administered intravenously every three weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
While the PERLA trial results are promising, it is important to consider the limitations of the study. Further research is needed to identify biomarkers that can predict which patients are most likely to benefit from sintilimab-based regimens. Additionally, studies are ongoing to evaluate the efficacy and safety of sintilimab in combination with other therapies, such as targeted agents and other immunotherapies.
