Abstract 644P
Background
Tifcemalimab, a humanized IgG4 monoclonal antibody against B and T lymphocyte attenuator (BTLA), has shown preliminary anti-tumor activities in combination with toripalimab (anti-PD-1) as a later line treatment for patients with lung cancer. We further conducted a multi-cohort phase Ib/II study (NCT05664971) to evaluate the safety and efficacy of tifcemalimab combined with toripalimab and chemotherapy in patients with advanced lung cancer. Here, we report the preliminary results from the Sq-NSCLC cohort.
Methods
Patients with Sq-NSCLC who failed on 1st line platinum-contained chemotherapy and immunotherapy were enrolled to receive tifcemalimab 200 mg plus toripalimab 240 mg and docetaxel intravenously every 3 weeks until disease progression, intolerable toxicity, or completion of 2 years treatment of tifcemalimab and toripalimab. Primary endpoints included safety and objective response rate (ORR) by investigators per RECIST v1.1.
Results
From Feb 9, 2023 to Nov 3, 2023, a total of 41 patients were enrolled and 34 received docetaxel 75 mg/m2. As of Jun 25, 2024, the median follow-up was 8.7 months. The median age of the patients was 65 (range 53-80) years, and 90.2% were males. Forty (97.6%) patients reported treatment-emergent adverse events (TEAEs). Grade ≥3 TEAEs occurred in 34 (82.9%) patients with the most common ones being neutropenia (70.7%), and leukopenia (63.4%) which was considered related to chemotherapy. Two (4.9%) patients discontinued tifcemalimab or toripalimab due to TEAE. Twelve (29.3%) patients reported immune-related AE (irAEs), and 5 (12.2%) reported grade ≥3 irAEs. Among 33 efficacy evaluable patients, ORR and disease control rate were 24.2% and 84.8%, respectively. Median progression-free survival was 5.7 (95% CI 3.8, 6.9) months. Median overall survival (OS) was not reached. The 6- month and 9-month OS rates were 85.3% and 70.1%, respectively.
Conclusions
Tifcemalimab in combination with toripalimab and docetaxel showed a promising antitumor activity with a manageable safety profile as a 2nd line treatment for immunotherapy-treated Sq-NSCLC patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Shanghai Junshi Biosciences.
Funding
Shanghai Junshi Biosciences.
Disclosure
S. Lu: Financial Interests, Personal and Institutional, Leadership Role: Innovent Biologics, INC; Financial Interests, Personal and Institutional, Advisory Role: AstraZeneca; Boehringer Ingelheim; GenomiCare; Hutchison MediPharma; InventisBio Co. Ltd; Menarini; Pfizer; Roche; Simcere; Yuhan; Zai Lab; Financial Interests, Personal and Institutional, Speaker’s Bureau: AstraZeneca; Hansoh Pharma; Hengrui Therapeutics; Roche; Financial Interests, Institutional, Research Funding: AstraZeneca (Inst); BeiGene (Inst); BMS (Inst); Hansoh (Inst); Hengrui Therapeutics (Inst); Hutchison MediPharma (Inst); Lilly Suzhou Pharmaceutical Co. (Inst); Roche (Inst). All other authors have declared no conflicts of interest.