Sintilimab Plus Pemetrexed and Platinum for NSCLC: Updated ORIENT-11 Study Results
Posted: Monday, December 6, 2021
Published in the Journal of Thoracic Oncology, Li Zhang, MD, of Sun Yat-sen University Cancer Center, Guangzhou, China, and colleagues reported their updated results from the ORIENT-11 study, focusing on overall survival data and predictive biomarkers of the monoclonal antibody sintilimab plus pemetrexed and platinum as a first-line therapy for non–small cell lung cancer (NSCLC). Patients who received sintilimab, as well as chemotherapy, demonstrated improved overall survival, and the study authors believe their findings may possibly identify a critical role of antigen-presenting cells and other pathways in cancer immunotherapy.
This phase III trial enrolled 397 patients with previously untreated, metastatic, or locally advanced nonsquamous NSCLC. Stratified by PD-L1 expression, participants were randomly assigned to receive pemetrexed and platinum plus either sintilimab (n = 266) or placebo (n = 131), followed by sintilimab or placebo plus pemetrexed for maintenance therapy. Treatment was continued until intolerable toxicity, disease progression, withdrawal of consent, or new treatment initiation, with crossover to receive sintilimab permitted (n = 60).
A total of 113 samples from the sintilimab group and 58 samples from the placebo group made up the biomarker evaluable population after the investigators accounted for quality control. The median progression-free survival for patients given sintilimab and placebo were 9.2 and 5.0 months, respectively; 58.6% of patients on combination therapy and 83.2% of those on chemotherapy experienced disease progression or death. The median overall survivals were not reached and 16.8 months, respectively, as 46.2% and 64.1% of patients from the sintilimab and placebo groups died.
Improved progression-free survival in the combination therapy group was attributed to high (P = .0057) or medium (P < .0001) cell infiltration, as well as high major histocompatibility complex class-II antigen presentation pathway expression (P < .0001). High major histocompatibility complex class-II antigen presentation pathway expression also seemed to correlate with improved overall survival (P = .0005).
Disclosure: For full disclosures of the study authors, visit jto.org.