Efficacy and safety of QL1706, a novel dual immune checkpoint blockade containing a mixture of anti-PD1 IgG4 and anti-CTLA4 IgG1 antibodies, for advanced cervical cancer: Cohort data from a phase 1b trial.

• DOI: 10.1200/jco.2022.40.16_suppl.5535
• Publication Date: 2022-06-06T16:32:21Z
• Authors: Jihong Liu; Naifu Liu; Danbo Wang; Dapeng Li; Cheng Fang
• Keywords: Clinical endpoint; Regimen

5535 Background: Anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) and anti-programmed cell death 1 (PD-1) antibodies have synergistic effect. QL1706 is a novel dual immune checkpoint blockade containing mixture of anti-PD-1 IgG4 anti-CTLA4 IgG1 produced by single line. showed promising anti-tumor activity in multiple solid tumors. Here we reported the cervical cancer cohort data from phase 1b trial (NCT05171790). Methods: Eligible patients had pathologically confirmed diagnosis squamous carcinoma, adenosquamous or adenocarcinoma cervix, with recurrent metastatic, immunotherapy-naive disease at time enrollment. Patients were required to ≥one lesion measurable RECIST v1.1 that relapsed after first-line, platinum-based regimen. included regardless PD-L1 expression status baseline. received intravenous 5.0 mg/kg q3w (i.e., recommended 2 dose, defined 1a trial), for up 24 months. The primary endpoint was overall response rate (ORR) per investigator. secondary endpoints control rate, duration (DoR), progression-free survival (PFS), (OS), safety, etc. Results: As Dec 31, 2021, totally 53 enrolled (median age, 52 years [range 33-72]). Median follow-up 5.6 Most (45 [85%]) ECOG performance 1. Histological breakdown carcinoma (44 [83%]) (nine [17%]). 33 (62%) one prior chemotherapy, 20(38%) ≥two chemotherapy. ORR 28% (95% CI 17%-42%; 15 patients), including (2%) complete 14 (26%) partial response, median not reached 2.8 months-not estimable). Disease observed 29 (55%; 95% 40%-68%) patients. PFS 4.2 months 1.7-6.9), 6-month estimated as 37% 24%-51%). Treatment-related adverse events (TRAE) 40 (75%) Nine (17%) experienced grade ≥3 TRAE. most common TRAE rash (eight [15%]), hyperthyroidism pyrexia (seven [13%]). Three (6%) suffered leading dose discontinuation. immune-related serious 28 (53%) eight (15%) patients, respectively. Conclusions: demonstrated durable clinical activity, favorable tolerability and/or metastatic cancer. Further investigations this setting are continuing. Clinical information: NCT05171790.