Dr Ma on Sintilimab Plus Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Jun Ma, MD, professor, radiation oncology, deputy president, Sun Yat-sen University Cancer Center, discusses findings from the phase 3 CONTINUUM trial (NCT03700476) of sintilimab in combination with induction chemotherapy and concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma.

The CONTINUUM trial randomly assigned 425 patients with stage III to IVA nasopharyngeal carcinoma to receive standard induction chemotherapy and concurrent chemoradiotherapy with or without sintilimab. The primary end point of this trial was event-free survival (EFS), with events defined as locoregional recurrence, distant metastases, or death from any cause. Key secondary end points included overall survival (OS), locoregional recurrence–free survival (LRFS), distant metastasis–free survival (DMFS), toxicity, health-related quality of life, and biomarkers.

At a median follow-up of 41.9 months, the 3-year EFS rate was 86.1% in the patients who received sintilimab vs 76.0% in those who received standard therapy alone. In addition, the 3-year DMFS rates were 90.3% vs 82.8% in the sintilimab and standard therapy groups, respectively, with a hazard ratio (HR) of 0.57. The 3-year LRFS rates were 93.4% and 86.8%, respectively, with an HR of 0.52. The 3-year OS rates were 92.9% in the sintilimab group vs 92.8% in the standard therapy group, with an HR of 0.95.

Regarding safety, all patients in both groups experienced adverse effects (AEs) of any grade. Grade 3/4 AEs occurred in 74.2% and 65.4% of patients in the sintilimab and standard therapy groups, respectively, and grade 5 AEs were observed in 2 patients in the sintilimab group and 1 patient in the standard therapy group. The most common AEs of any grade included anemia, leukopenia, nausea, stomatitis, anorexia, dry mouth, neutropenia, dermatitis, fatigue, vomiting, weight loss, otitis, and constipation. In the sintilimab group, immune-related AEs of any grade occurred in 59.8% of patients. Grade 3/4 immune-related AEs were observed in 9.6% of patients, and 2 patients experienced grade 5 immune-related AEs. The most common immune-related AEs were rash, hypothyroidism, pruritus, hyperthyroidism, increased amylase, and allergic reaction.

Disclosures: Dr Ma reports no disclosures.