Phase 3 results from the CONTINUUM trial demonstrated the addition of sintilimab to standard induction chemotherapy and concurrent chemoradiotherapy (IC-CCRT) resulted in improved event-free survival (EFS) and a manageable safety profile among patients with high-risk locoregionally-advanced nasopharyngeal carcinoma. 

These findings were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting by Jun Ma, MD, Sun Yat-sen University Cancer Center, Guangzhou, China.

A total of 425 patients with non-metastatic, high-risk locoregionally-advanced nasopharyngeal carcinoma were randomized on a 1-to-1 basis to either receive gemcitabine- and cisplatin induction chemotherapy plus cisplatin concurrent chemoradiotherapy with cisplatin either alone (standard arm) or plus sintilimab (sintilimab arm). In the sintilimab arm, patients received 200 mg sintilimab intravenously once every 3 weeks for up to 12 cycles (3 induction, 3 concurrent, and 6 adjuvant). The primary end point of the study was event-free survival, with secondary and exploratory endpoints including safety and biomarker (tertiary lymphoid structure, PD-L1, and gene expression) analyses.

With a median follow-up of 42 months  patients in the sintilimab had a 3-year EFS of 86.1%, compared with 76% in the standard arm (stratified HR, 0.59; 95% confidence interval [CI], 0.38 to 0.92; stratified log-rank P = 0.019). Overall, results also demonstrated that the benefit of the addition of sintilimab was observed in patients with tertiary lymphoid structure (HR 0.18; 95% CI, 0.04 to 0.81; P = 0.011) but not in patients without TLS (HR 0.94; 95% CI, 0.50 to 1.76; P = 0.85).

Grade 3/4 adverse events occurred in 155 and 140 patients, including immune-related adverse events in 20 and 2 patients, in the sintilimab and standard arms, respectively. Additionally, there were 2 grade 5 adverse events in the sintilimab arm and 1 in the standard arms. 

Dr Ma and coauthors concluded, “The addition of sintilimab to standard IC-CCRT results in significant improvement of EFS, manageable safety profile, and comparable [quality of life] in high-risk [locoregionally-advanced nasopharyngeal carcinoma].”

Source:

Ma J, Sun Y, Liu X et al. PD-1 blockade with sintilimab plus induction chemotherapy and concurrent chemoradiotherapy (IC-CCRT) versus IC-CCRT in locoregionally-advanced nasopharyngeal carcinoma (LANPC): A multicenter, phase 3, randomized controlled trial (CONTINUUM). Presented at 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. Abstract LBA6002