LEAP regimen: A phase II study of sintilimab + pegaspargase + anlotinib for advanced-stage NKTCL

Results from a prospective, multicenter, single-arm, phase II study (NCT04004572), evaluating the LEAP regimen (sintilimab + pegaspargase + anlotinib) in 37 patients with newly diagnosed Stage IV extranodal natural killer / T-cell lymphoma (NKTCL) ineligible for high-dose methotrexate (HD-MTX), were published in Blood Advances by Li et al. The primary endpoint was complete remission (CR).

Key data: At Week 24, the CR rate was 72.9% (95% confidence interval [CI], 58.7–87.3), surpassing the prespecified 55% threshold; the overall response rate (ORR) was 83.8%, including four patients with partial response (PR) and six with progressive disease (PD). At a median follow-up of 48 months, 4‑year progression-free survival (PFS) and overall survival (OS) were 56.6% (95% CI, 39.2–70.7) and 75.2% (95% CI, 57.7–86.3), respectively. Patients who underwent autologous hematopoietic stem cell transplantation (auto-HSCT) after achieving CR had lower relapse rates (17.6% vs 60.0%) and improved PFS (hazard ratio [HR], 0.23; p < 0.05) vs observation. All patients experienced treatment-emergent adverse events (TEAEs), with no patients discontinuing therapy due to adverse events.

Key learning: The LEAP regimen demonstrated high CR rates and durable survival with a manageable safety profile in advanced-stage NKTCL unsuitable for HD‑MTX induction, with consolidative auto-HSCT further improving outcomes.