e14067 Background: Tislelizumab, an investigational anti-PD-1 antibody, was engineered to minimize binding to FcγR on macrophages in order to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. Previous reports showed tislelizumab was generally well tolerated and had antitumor activity in patients (pts) with advanced solid tumors; 200 mg IV Q3W was established as the RP2D. Methods: This phase 2 clinical trial (NCT03432598) assessed tislelizumab (200 mg Q3W) with platinum (plt)-based chemotherapy (Q3W) as first-line treatment for Chinese pts with advanced lung cancer. All pts received tislelizumab + plt doublet (4–6 cycles) until disease progression. Nonsquamous (nsq) NSCLC pts received pemetrexed (PMX) + plt (4 cycles) followed by PMX maintenance; squamous (sq) NSCLC pts received A) paclitaxel (PXL) + plt or B) gemcitabine + plt; SCLC pts received etoposide + plt. Tumor response (RECIST v1.1) and safety/tolerability were evaluated. PD-L1 expression was retrospectively assessed with the VENTANA PD-L1 (SP263) assay. Results: As of 15 Oct 2018, 54 pts (median age 61 yr; 74% male; 72% current/former smokers; 31% with ≥10% PD-L1 expression on tumor cells) received tislelizumab; 24 pts remain on treatment. Confirmed PR was observed in 36 pts and most occurred within the first 2 assessments. Other efficacy estimates (eg, PFS) are maturing. Grade ≥3 AEs occurring in > 15% of pts were decreased neutrophil counts (n = 25) and anemia (n = 9); immune-related AEs occurring in ≥2 pts were decreased triiodothyronine, hyperthyroidism, hypothyroidism, and pyrexia (n = 2 each). One sq-NSCLC pt ( A) experienced fatal myocarditis/myositis after 1 cycle; other AEs resolved with tislelizumab interruption (n = 30), discontinuation (n = 4), or other appropriate treatment. Conclusions: Tislelizumab in combination with standard of care plt-based chemotherapy was generally well tolerated and demonstrated antitumor activity. Clinical trial information: NCT03432598. [Table: see text]
Corrigendum to “A phase 2 study of tislelizumab in combination with platinum-based chemotherapy as first-line treatment for advanced lung cancer in Chinese patients” [Lung Cancer 147 (2020) 259–268]
