Combination of cemiplimab and ISA101b vaccine for the treatment of recurrent/metastatic HPV16 cervical cancer.

• DOI: 10.1200/jco.2024.42.16_suppl.5522
• Publication Date: 2024-06-06T19:11:49Z
• Authors: Domenica Lorusso; Ana Oaknin; Giuliano Santos B...; Fernanda Damian; P. B. Ottevanger; Toon Van Gorp; Carlos Eduardo Paiva; Judith R. Kroep; Yong Man Kim; Hee Seung Kim; Jae-Kwan Lee; Cornelis JM Melief; Leon Hooftman; Shaheda Jamil Jamil; Suk-Young Yoo; Frank A. Seebach; Israel Lowy; Matthew G. Fury; Melissa Divya Mat...; Nicoletta Colombo
• Keywords: 03 medical and health sciences; 0302 clinical medicine

5522 Background: Cemiplimab + ISA101b vaccine is being studied in HPV16-positive cancers several phase 2 clinical trials. Here, we present the efficacy and safety results of a study cemiplimab patients with recurrent HPV16 cervical cancer who had disease progression after first-line chemotherapy (NCT04646005). Methods: Patients received 350 mg administered intravenously every 3 weeks doses 100 µg/peptide by subcutaneous injection on Days 1, 29, 50. The primary endpoint was objective response rate (ORR) as measured RECIST version 1.1. Secondary endpoints included duration (DOR), overall survival (OS), progression-free (PFS), safety. Efficacy were assessed full analysis set (patients ≥1 dose). Baseline PD-L1 expression immunohistochemistry using anti–PD-L1 clone SP263. Results: This single arm 113 (Table). Median follow-up 4.9 months (interquartile range [IQR]: 3.0–7.5); median treatment exposure 10.0 (IQR: 9.7–10.3) for 18.2 9.0–27.6) cemiplimab. At data cutoff (May 22, 2023), 90 discontinued reasons including (66.4%), death (7.1%), an adverse event (AE; 3.5%) 20.4% still treatment. ORR (95% CI) 16.8% (9.9–23.7). tumor cells 12.5% <1% 22.4% ≥1%, per investigator assessment. DOR 5.6 (3.5–not estimable) months. OS PFS 13.3 (10.8–16.3) 3.0 (1.7–4.0) months, respectively. 6 12 estimated probabilities 80.5% (71.7–86.9) 54.5% (42.1–65.3), respectively, OS, 20.5% (13.4–28.6) 7.8% (3.3–15.0), PFS. Treatment-emergent AEs occurred 92.9% patients, most common injection-site reaction (38.9%), anemia (25.7%) nausea (22.1%). Six (5.3%) died due to treatment-emergent AE. Conclusions: Results from this show benefit, especially high expression, no unexpected signals, supporting further research. Clinical trial information: NCT04646005 . [Table: see text]