Tislelizumab offers improved outcomes over docetaxel in advanced NSCLC
medwireNews: The anti-PD-1 antibody tislelizumab may improve outcomes relative to docetaxel as a second- or third-line therapy for people with advanced non-small-cell lung cancer (NSCLC), regardless of histology or PD-L1 expression levels, researchers report.
In addition, “compared with docetaxel, tislelizumab was associated with a notably lower incidence of grade 3 or higher adverse events,” Caicun Zhou, from Shanghai Pulmonary Hospital in China, told delegates at the virtual AACR Annual Meeting 2021.
He presented the interim findings of the phase 3 RATIONALE 303 trial, in which individuals with locally advanced or metastatic NSCLC without oncogenic driver mutations were randomly assigned to receive intravenous tislelizumab 200 mg (n=535) or docetaxel 75 mg/m2 every 3 weeks (n=270). All of the participants had progressed during or after at least one prior platinum-doublet chemotherapy regimen and no more than two prior systemic treatments in total.
After a median 19 months of follow-up, Zhou and co-investigators found that the risk for death was a significant 36% lower with tislelizumab than with docetaxel.
Median overall survival (OS) was significantly longer in the tislelizumab arm than in the docetaxel arm, at 17.2 versus 11.9 months, while the 12- and 24-month survival rates were 61.9% and 39.4%, respectively, in the former group compared with 49.8% and 25.0%, respectively, in the latter.
Among individuals with high (≥25% tumor cell staining) PD-L1 expression (42–43% of the cohort), the risk for death was a significant 48% lower in the tislelizumab arm than in the docetaxel arm, with median OS times of 19.1 and 11.9 months, respectively.
Zhou noted that the results were similar across most subgroups studied, including squamous versus nonsquamous histology and different PD-L1 expression levels.
He also reported that the median progression-free survival time (4.1 vs 2.6 months), objective response rate (21.9 vs 7.1%), and median response duration (approximately 13.5 vs 6.2 months) were significantly better with tislelizumab than with docetaxel.
In terms of safety, 14.4% of individuals who received tislelizumab experienced a grade 3 or above treatment-related adverse event (TRAE) during a mean 10.5 cycles of treatment, compared with 66.3% of those who received docetaxel for a mean 9.4 cycles. Serious TRAEs occurred in 12.5% and 22.9%, respectively, and treatment-related deaths in 1.5% (n=8) and 1.6% (n=4), respectively.
Anemia was the most commonly reported AE of any grade with tislelizumab, occurring in 28.5% of patients, but this rate was still lower than that seen with docetaxel, at 43.4%. The most common AE in the docetaxel group was alopecia, which was reported by 47.3% of participants, compared with just 0.9% of those who received tislelizumab.
Zhou concluded that tislelizumab “produced meaningful clinical benefit” over docetaxel when given as second-or third-line monotherapy in NSCLC.
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