Sintilimab could be a viable second-line option for advanced squamous NSCLC
medwireNews: Patients with advanced squamous non-small-cell lung cancer (NSCLC) derive a significant overall survival (OS) benefit from second-line treatment with sintilimab versus docetaxel, suggest results from the Chinese ORIENT-3 trial.
The risk for death was a significant 26% lower for participants who received the PD-1 inhibitor than those given docetaxel, presenting author Yuankai Shi (Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing) told delegates of the virtual AACR Annual Meeting 2021.
Sintilimab also had “a favorable safety profile,” and therefore could be “an alternative second-line treatment option” for this patient population, he said.
The phase 3 trial investigators recruited 280 Chinese patients who had progressed during or after first-line platinum-based chemotherapy for locally advanced or metastatic disease and randomly assigned them to receive either intravenous sintilimab 200 mg or docetaxel 75 mg/m2 every 3 weeks.
After a median follow-up of 23.56 months, the primary endpoint of OS was significantly improved among the 145 sintilimab-treated patients compared with the 135 patients instead given docetaxel, at a median of 11.79 versus 8.25 months, and a hazard ratio (HR) for death of 0.74.
Median progression-free survival was also significantly longer in the sintilimab than docetaxel group, at 4.30 versus 2.79 months (HR=0.52); the objective response rate was higher, at 25.5% versus 2.2%, and responses lasted longer, at a median of 12.45 and 4.14 months, respectively.
Reporting on the toxicity profile, Shi noted that treatment-related adverse events (TRAEs) of at least grade 3 occurred at a lower rate in the sintilimab than docetaxel study arm, at 18.1% versus 36.2%. The most common of these events in the sintilimab group were elevations in liver enzymes and rash (each in 1.4% of patients), whereas decreases in neutrophil count and white blood cell count were most frequent in the docetaxel group (23.8% and 19.2%, respectively).
However, a higher proportion of sintilimab- than docetaxel-treated patients discontinued due to TRAEs (12.5 vs 5.4%), and the rate of death attributable to TRAEs was also higher (3.5 vs 0.8%).
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