KEY TAKEAWAYS
- The phase 2 trial aimed to investigate the efficacy of CAM plus FAM vs CAM alone or chemo in improving OS for pts with R/M CC.
- Researchers noticed that the improved OS with CAM plus FAM supports its potential as a novel treatment option for pts with R/M CC.
The prognosis of recurrent or metastatic cervical cancer (R/M CC) remains dismal, given the paucity of effective treatment options. The randomized, open-label, phase 2 trial showed that (CAM, an anti-PD-1 antibody) plus famitinib (FAM, a multi-targeted TKI against VEGFR2/3) improved antitumor activity compared with CAM alone or the investigator’s choice of chemotherapy (INV chemo) in patients (pts) with recurrent or metastatic cervical cancer (R/M CC) (2023 ESMO LBA44).
Xiaohua Wu and the team aimed to assess the survival outcomes of pts with R/M CC treated with CAM plus FAM, CAM alone, or INV chemo.
They performed an inclusive analysis, enrolling 194 pts with R/M CC who had experienced relapse or progression after platinum-based chemotherapy. Patients were randomized to receive CAM (200 mg IV Q3W) with (n=105) or without (n=54) FAM (20 mg PO QD) or INV chemo (n=35) every 3 weeks. The randomization was stratified by histologic subtyping (squamous cell carcinoma vs. non-squamous cell carcinoma) and PD-L1 expression (CPS ≥1 vs. <1).
About 77.8% of enrolled pts had squamous cell carcinoma (SCC), 63.9% were PD-L1 positive, and 31.4% received prior targeted therapy. With a median follow-up of 9.9 months, CAM + FAM achieved improved ORR and prolonged PFS compared with CAM and INV chemo (ORR per INV, 42.9% vs 22.2% and 14.3%; median PFS per INV, 8.1 vs 4.1 and 2.9 months); however, OS data were immature.
As of the data cutoff on Sep 25, 2023, for the current analysis, the median follow-up was 13.6 months (IQR, 9.3–18.0). A total of 91 deaths were recorded, including 43 (41.0%) in the CAM + FAM cohort, 27 (50.0%) in the CAM cohort, and 21 (60.0%) in the INV chemo cohort.
The median OS was 20.6 months (95% CI: 15.7–not reached [NR]) in CAM + FAM cohort, 14.9 months (95% CI: 12.6–NR) in CAM cohort, and 13.9 months (95% CI: 7.4–20.0) in INV chemo cohort. The risk of death in the CAM + FAM cohort was reduced by 33% compared with CAM cohort (HR = 0.67 [95% CI: 0.41–1.10]) and by 45% compared with the INV chemo cohort (HR = 0.55 [95% CI: 0.32–0.95]). OS rate at 12 months was 76.1% (95% CI: 66.7–83.2), 67.2% (95% CI: 52.6–78.2), and 58.4% (95% CI: 39.3–73.4) with CAM + FAM, CAM, and INV chemo, respectively. No new safety signals were observed.
The study concluded that these results further support the regimen of CAM plus FAM as a novel treatment option for pts with R/M CC.
The trial was sponsored by Jiangsu HengRui Medicine Co., Ltd.
Source: https://sgo.planion.com/Web.User/AbstractDet?ACCOUNT=SGO&ABSID=582268&CONF=AM2024&CKEY=
Clinical Trial: https://clinicaltrials.gov/study/NCT04680988
Wu X, Xia L, Zhang K, et al. (2024) “Overall survival with camrelizumab plus famitinib versus camrelizumab alone and investigator’s choice of chemotherapy for recurrent or metastatic cervical cancer.” Presented at Society of Gynecologic Oncology Annual Meeting on Women’s Cancers; March 16-18, 2024. San Diego, California. (11)
