Tislelizumab, Bevacizumab, and Chemo in Cervical Cancer

Patients (pts) with persistent, recurrent, or metastatic cervical cancer face a heightened risk of progression post-standard first-line treatment involving platinum-doublet chemotherapy (chemo) ± bevacizumab. Incorporating a PD-1 inhibitor has shown enhanced survival benefits for PD-L1+ pts. Preliminary findings revealed a promising efficacy objective response rate (ORR) of 78.4% (29/37, 95% CI, 61.8%-90.2%) for tislelizumab, bevacizumab, and platinum-based chemotherapy, irrespective of PD-L1 expression (J Zhu, et al., JCO 2023 41:16_suppl).

Jianqing Zhu and his team aimed to assess the efficacy and safety of tislelizumab in combination with bevacizumab and platinum-based chemo as a 1L treatment for cervical cancer pts.

The study performed an inclusive analysis involving eligible pts with persistent, recurrent, or metastatic cervical cancer. These pts were administered tislelizumab (200 mg, Q3W), bevacizumab (7.5 mg/kg, Q3W), and platinum-based chemotherapy. PD-L1 expression was assessed using the VENTANA PD-L1(SP263) assay. The primary endpoint for evaluation was progression-free survival (PFS), with secondary endpoints encompassing ORR, disease control rate (DCR), duration of response (DOR), and an assessment of safety parameters.

About 50 pts with persistent, recurrent, or metastatic cervical cancer were enrolled in the study, with 46 (92.0%) presenting squamous cell carcinoma (SCC). PD-L1 expression was detected in 41 pts, where 35 (85.4%) were PD-L1+, and 6 (14.6%) were PD-L1–. As of August 10, 2023, the median follow-up duration was 7.8 months (range 0.8-14.6). Within the efficacy analysis set comprising 47 pts, the confirmed ORR was 72.3% (34/47, 95% CI 57.4%-84.4%), including a complete response (CR) rate of 14.9% (6/47).

Subgroup analysis demonstrated an ORR of 72.7% (32/44) for pts with SCC and 66.7% (2/3) for those with adenocarcinoma. Additionally, the ORR for PD-L1+ and PD-L1– tumors were 70.6% (24/34) and 100% (5/5), respectively. The DCR reached 100% (95% CI 92.4%-100.0%). Median DOR and PFS were not reached. After a median treatment duration of 6.8 months, 48.0% of pts experienced grade ≥3 treatment-related adverse events (AEs). Immune-related adverse events (irAE) were reported in 32.0% of pts, with no grade ≥3 irAE reported. Serious (AEs) occurred in 20.0% of pts.

The study concluded that the updated results affirm the sustained efficacy and tolerability of tislelizumab when combined with bevacizumab and chemo to treat persistent, recurrent, or metastatic cervical cancer. Notably, the observed increase in the CR rate over an extended treatment duration underscores the potential of this therapeutic combination in enhancing treatment outcomes for these pts.

The study is sponsored by Zhejiang Cancer Hospital

Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/34

Clinical Trial: https://clinicaltrials.gov/study/NCT05247619

Zhu J, et al. (2023). “Phase II trial of tislelizumab plus bevacizumab and chemotherapy as the first-line therapy for persistent, recurrent, or metastatic cervical cancer: updated efficacy and safety results” Presented at ESMO IO 2023 (Abstract 100 P).