Addition of Sintilimab to Pemetrexed, Platinum Improves Progression-Free Survival in Patients with Lung Cancer

An interim analysis of the ORIENT-11 trial has found that the addition of sintilimab to pemetrexed and a platinum-based chemotherapy can have a significant effect on progression-free survival (PFS) in patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic aberrations.

The combination of sintilimab, pemetrexed, and a platinum-based chemotherapy had previously shown promise for nonsquamous NSCLC in a phase 1b study, according to a press release. The new findings were presented at the International Association for the Study of Lung Cancer Virtual Presidential Symposium and were published in the Journal of Thoracic Oncology.

Investigators in China enrolled 397 patients in the study, 266 of whom were randomly assigned to receive the sintilimab combination therapy and 131 of whom received the placebo combination. Patients with all ranges of PD-L1 expression were included.

According to a press release, the study found that the median PFS reached 8.9 months, significantly longer than the placebo group, which had a median PFS of 5 months. The sintilimab-combination group also showed a nominally significant improvement in overall survival compared with the placebo combination group (51.9% vs 29%, respectively).

Notably, the safety signal for the sintilimab combination was similar to what was observed in previous studies, but rates of occurrence of grade 3 or higher adverse events were slightly higher in the sintilimab-combination group.

“This study demonstrated that the addition of sintilimab to chemotherapy significantly improved progression-free survival and a nominally improved overall survival, with an acceptable safety profile in [patients with] first-line non-squamous non-small cell lung cancer,” said investigator Li Zhang, MD, in a statement.

Zhang added that the team’s future work will focus on biomarker explanation using RNA sequencing of tumor samples, in an effort to predict the survival benefit of PD-1 combination with chemotherapy.

REFERENCE

Addition of sintilimab to pemetrexed and platinum improved progression-free survival [news release]. EurekAlert; August 8, 2020. https://www.eurekalert.org/pub_releases/2020-08/iaft-aos080520.php. Accessed August 11, 2020.