Tevimbra(tislelizumab)

Tevimbra (tislelizumab) is indicated for the first-line treatment of adult patients with recurrent, not amenable to curative surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC). It is also proposed for use in combination with etoposide and platinum chemotherapy for the first-line treatment of adult patients with extensive-stage SCLC. The Marketing Authorisation Application for Tevimbra was submitted on 3 March 2022, following an Orphan medicinal product designation on 13 November 2020.

In a Phase 3, randomised, double-blind, placebo-controlled study (BGB-A317-309), Tevimbra combined with gemcitabine plus cisplatin (GC) demonstrated a median PFS2 of 13.1 months. The PFS2 stratified Hazard Ratio was 0.71 (0.57, 0.89). The 12-month survival rate was 75%, and the 18-month survival rate was 38%. The confirmed INV-DCR was 88.5%, with a confirmed INV-DOR of 3.7 months.

Regarding safety, the incidence of treatment-emergent ADA in monotherapy was 16.3%, and in combination therapy, it was 24.0%. Neutralizing antibodies incidence in monotherapy was 0.6%. Grade ≥ 3 AEs in Blood and lymphatic system disorders for ADA-positive patients was 9.9%.