Phase 2 trial of tislelizumab plus anlotinib as first-line treatment in advanced pulmonary sarcomatoid carcinoma

Pulmonary sarcomatoid carcinoma (PSC) is associated with a poor prognosis. A phase 2 trial at the Second Affiliated Hospital of Nanchang University (China) evaluated the combination of tislelizumab and anlotinib as first-line therapy in patients with advanced PSC without EGFR or ALK mutations. The trial enrolled 29 patients (median age 71 years; range 39-79) who received the combination until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR). Two patients (6.90%) achieve complete response and 14 achieved partial response, for an ORR of 55.2% (95% CI 35.7-73.6), while the disease control rate was 96.6% (82.2-99.9). After a median follow-up of 16.7 months, the median progression-free survival was 9.4 months (95% CI 3.7-13.3) and the median overall survival was 14.4 months (9.0-17.5). Grade 3 or 4 treatment-related adverse events occurred in 8 patients (27.6%), with no treatment-related deaths. The authors conclude that the combination of tislelizumab and anlotinib demonstrated promising antitumor activity with a manageable safety profile as first-line therapy in patients with advanced PSC.