Sintilimab provided superior clinical benefit compared to docetaxel in patients with previously treated, advanced and/or metastatic squamous non–small cell lung cancer (NSCLC), according to phase III study findings presented by Shi et al at the European Society for Medical Oncology (ESMO) Immuno-Oncology Virtual Congress 2020 (Abstract 30MO).
The phase III ORIENT-3 study evaluated the efficacy and safety of sintilimab, an anti–PD-1 monoclonal antibody, compared with docetaxel as second-line treatment in squamous NSCLC.
The study enrolled patients with stage IIIB/IIIC or IV squamous NSCLC who were ineligible for radical chemoradiotherapy and had failed first-line platinum-based chemotherapy. Following 1:1 random assignment, 145 patients received sintilimab at 200 mg and 145 received docetaxel at 75 mg/m2; both agents were delivered intravenously every 3 weeks until disease progression or intolerable toxicity.
In addition, patients were stratified according to Eastern Cooperative Oncology Group (ECOG) performance score of 0 vs 1. The patients’ baseline characteristics were well-balanced between treatment groups, with the majority (75.9% vs 77.0% in the sintilimab and docetaxel arms, respectively) having an ECOG performance score of 1.
Overall survival was the primary study endpoint.
As of July 31, 2020, a median of 8.0 cycles of sintilimab (range = 1–45) and 2.0 cycles of docetaxel (range = 1–15) had been administered. The efficacy analysis comprised 280 patients in the full analysis set; 10 patients in the docetaxel arm were excluded from the full analysis set due to initiation of immunotherapy before receiving docetaxel treatment or before radiographic disease progression on study treatment.
With a median of 23.56 months, the patients treated with sintilimab demonstrated improved overall survival compared to those treated with docetaxel; median overall survival was 11.79 months (95% confidence interval [CI] = 10.28–15.57) vs 8.25 months (95% CI = 6.47–9.82) (hazard ratio [HR] = 0.74, 95% CI = 0.56–0.96, P = .02489).
The median progression-free survival was significantly prolonged—4.30 months (95% CI = 4.04–5.78) in the sintilimab group compared to 2.79 months (95% CI = 1.91–3.19) in the docetaxel group (HR = 0.52, 95% CI = 0.39–0.68, P < .00001).
The response was more than fivefold higher with sintilimab, with an objective response rate of 27.6 % (95% CI = 20.5–35.6) compared to 5.2% (95% CI = 2.1–10.4) with docetaxel.
The safety analysis was done in the safety set of 274 patients (n = 144 in sintiliamb arm, n = 130 in docetaxel arm); 84.7% of patients receiving sintilimab and 83.1% of patients receiving docetaxel reported treatment-related adverse events. Treatment-related adverse events of at least grade 3 occurred at half the frequency with sintilimab vs docetaxel (18.1% vs 36.2%, respectively).
Based on these findings, the authors were able to conclude that sintilimab as second-line treatment for advanced/metastatic squamous NSCLC provided superior overall and progression-free survival compared to docetaxel.
Disclosure: Funding for this study was reported from Innovent Biologics, Inc, and Eli Lilly and Company. For full disclosures of the study authors, visit annalsofoncology.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.