Dr Wu on SAFFRON-301 Data in Advanced or Metastatic NSCLC

Yi-Long Wu, MD, PhD, professor of oncology at the Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, discusses findings from the phase 3 SAFFRON-301 trial (NCT04921358), which examined tislelizumab-jsgr (Tevimbra) plus sitravatinib vs chemotherapy with docetaxel in patients with advanced or metastatic non–small cell lung cancer (NSCLC) following disease progression with platinum-based chemotherapy and an anti–PD-(L)1 agent.

Prior data from the phase 1b SAFFRON-103 study (NCT03666143) demonstrated that tislelizumab plus sitravatinib displayed promising efficacy in patients with metastatic NSCLC who experienced disease progression following treatment with an anti–PD-(L)1 agent.

During the2024 IASLC World Conference on Lung Cancer data from SAFFRON-301 showed that patients who received tislelizumab in combination with sitravatinib (n = 187) did not achieve a significant overall survival (OS) benefit vs docetaxel (n = 190), Wu explains; the median OS was 11.5 months (95% CI, 9.4-14.6) vs 11.4 months (95% CI, 9.9-15.0), respectively (HR, 1.02; 95% CI, 0.75-1.39). Additionally, the median progression-free survival (PFS) per independent review committee assessment was 4.4 months (95% CI, 4.0-5.7) vs 2.9 months (95% CI, 2.6-4.2), respectively (HR, 0.82; 95% CI, 0.62-1.07). There were also higher rates of grade 3 or higher treatment-emergent adverse effects (TEAEs), serious TEAEs, and TEAEs leading to treatment discontinuation and death in the combination arm compared with docetaxel.

The study was terminated in September 2023 due to an imbalanced rate of serious/fatal pulmonary hemorrhage and an unfavorable risk-benefit assessment in the investigational arm, Wu concludes.