Patients with advanced lung squamous cell carcinoma (SCC) have very limited second-line treatment options after platinum doublet treatment failure
ORIENT-3 (NCT03150875), a phase III, randomized, open-label and multicenter trial was presented in this first week of the American Association for Cancer Research (AACR) Annual Meeting 2021. The trial compared the efficacy and safety of sintilimab (an anti-PD-1 antibody) versus docetaxel in second-line treatment in patients with advanced lung SCC.
Participants with phase IIIB/IIIC disease (ineligible for chemoradiotherapy) or IV who experienced disease progression during or after first-line platinum-based chemotherapy were enrolled and randomized 1:1 to receive 200mg of sintilimab or docetaxel 75mg/m2 EV every three weeks until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS).
Findings
On July 31, 2020, 290 participants were enrolled. The efficacy analysis (n = 280) was based on FAS (Full Analysis Set, i.e., the closest possible method to the intent-to-treat principle) and the security analysis was based on the safety set (n = 274). Baseline characteristics were well balanced between groups and most patients in the efficacy analysis (75.9% in the sintilimab arm and 77% in the docetaxel arm) had n ECOG PS score of 1. The median of sintilimab treatment cycles was eight (range 1 to 45) and two with docetaxel (range 1 to 15).
With a mean follow-up of 23.56 months, sintilimab showed a statistically significant improvement in OS versus docetaxel, reaching a median of 11.79 versus 8.25 months (HR 0.74; IC 95%: 0.56 – 0.96; P = 0.02489), respectively. The median PFS was also higher: 4.30 versus 2.79 months (HR 0.52; IC95%: 0.39 – 0.68; P < 0.00001). The confirmed objective response rate was 25.5% in the sintilimab arm and 2.2% in the docetaxel arm.
Treatment-related adverse events (TRAEs) occurred in 84.7% of patients undergoing treatment with sintilimab and 83.1% with docetaxel, the most common being hypothyroidism (18.1%) and alopecia (34.6%), respectively. TRAEs ≥ grade 3 were less frequent in the immunotherapy arm (18.1%) than chemotherapy (36.2%). Five participants died related to sintilimab and one patient died from docetaxel-related adverse effects.
Researchers concluded that sintilimab as a 2nd-line treatment for advanced/metastatic SCC of the lung demonstrated superiority in OS, PFS, and response rate compared to docetaxel.
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