LBA44 Camrelizumab plus famitinib versus camrelizumab alone and investigator’s choice of chemotherapy in women with recurrent or metastatic cervical cancer

Combining immunotherapy and anti-angiogenic agents may enhance immune response by reversing the immunosuppressive microenvironment. We conducted a randomized, open-label, phase 2 trial to assess camrelizumab (CAM, an anti-PD-1 antibody) plus famitinib (FAM, a multi-targeted TKI against VEGFR2/3) versus CAM alone and investigator’s choice of chemotherapy (chemo) for recurrent or metastatic cervical cancer (R/M CC). Patients (pts) with R/M CC who failed prior platinum-based chemo were enrolled. Prior anti-PD-1/PD-L1/CTLA-4 treatment was not allowed. Pts were randomized to receive CAM 200 mg IV Q3W with (cohort A) or without (cohort B) FAM 20 mg PO QD, or investigator’s choice of chemo (cohort C) every 3-week cycle. The primary endpoint was ORR per RECIST v1.1 assessed by blinded independent central review (BICR). At data cutoff on April 21, 2023, 194 pts were randomized (cohort A n=105, cohort B n=54, cohort C n=35), and 46 pts (23.7%) remained on treatment. 77.8% of pts had squamous CC, 63.9% were PD-L1 positive, 31.4% received prior targeted therapy. The median follow-up duration was 9.9 months (IQR 7.3-15.1). Antitumor activities are shown in the table. Treatment-related adverse events (TRAEs) occurred in 100%, 94.3%, and 100% of pts, respectively. Grade ≥3 TRAEs were reported in 84.8%, 15.1%, and 60.0% of pts, respectively, with the most common ones being decreased neutrophil count (23.8%, 1.9%, 30.0%), hypertension (22.9%, 0, 0), decreased white blood cell count (20.0%, 0, 33.3%), and anemia (20.0%, 1.9%, 13.3%). Dose discontinuation due to AEs occurred in 19.0%, 5.7%, and 0 pts, respectively. Treatment-related death was reported in two pts (1.9%) in cohort A (acute coronary syndrome, infection and sepsis).Table: LBA44Summary of efficacyCohort A (n=105)Cohort B (n=54)Cohort C (n=35)BICR-assessedCR9 (8.6)3 (5.6)—PR34 (32.4)10 (18.5)—ORR41.0 (31.5-51.0)24.1 (13.5-37.6)—DCR75.2 (65.9-83.1)55.6 (41.4-69.1)—PFS (mo)7.2 (6.1-12.4)4.0 (2.1-6.1)—Investigator-assessedCR4 (3.8)2 (3.7)1 (2.9)PR41 (39.0)10 (18.5)4 (11.4)ORR42.9 (33.2-52.9)22.2 (12.0-35.6)14.3 (4.8-30.3)DCR74.3 (64.8-82.3)53.7 (39.6-67.4)42.9 (26.3-60.7)PFS (mo)8.1 (6.2-12.4)4.1 (2.1-5.1)2.9 (2.0-6.2)12-months OS rate80.3 (70.7-87.0)71.9 (55.8-83.0)59.7 (40.9-74.3) Open table in a new tab CAM plus FAM showed improved antitumor activity than CAM alone or investigator’s choice of chemo in pts with R/M CC, with a tolerable safety profile.