184MO - Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial

Background

The KEYNOTE 826 study has demonstrated significant survival benefits with first-line pembrolizumab (anti PD-1) plus chemotherapy for recurrent/metastatic cervical cancer (CC). This phase II study aims to evaluate the efficacy and safety of Sintilimab (anti PD-1) plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced CC.

Methods

This is a single arm, phase II study (NCT04799639). Pts with newly confirmed locally advanced CC (stage IB3 or IIA2) received neoadjuvant chemotherapy with paclitaxel (150mg/m², iv) and cisplatin (70mg/m², iv) plus Sintilimab (200mg, iv) Q3W for 3 cycles, followed by radical surgery. For Pts evaluated PD without distant metastases after 2 cycles of neoadjuvant therapy underwent surgery immediately. The primary endpoint was pathological complete response (pCR) rate. Key secondary endpoints included ORR, PFS, 2y PFS rate and adverse events (CTCAE 5.0) and biomarkers.

Results

As of data cutoff on Jun 16, 2022, 21 eligible pts were enrolled, all pts received 3 cycles of neoadjuvant therapy. 20 pts underwent radical surgery and were evaluable. The primary endpoint of pCR rate was 35% (7/20). Except for one patient with SD, 19 pts had objective responses (95%), including 4 CR and 8 PR. At the date cutoff, the median follow-up time was 5 months (range 1-11), no patient recurred. In terms of hematological toxicity, 4 patients presented with grade 3-4 neutropenia and no other grade 3-4 adverse events. Possible immune-related side effects included skin rash (8/20, G1-2), alanine aminotransferase increased (7/20, G1), creatinine increased (3/20, G1), hyperlipidemia (1/20, G1), and hypothyroidism (3/20, G1-2). No treatment-related death were observed.

Conclusions

Sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy had encouraging antitumor activity with 35% pCR rate and manageable toxicities in patients with locally advanced CC. The study is ongoing and more data will be reported in the future.

Clinical trial identification

NCT04799639.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Innoventbio.

Disclosure

All authors have declared no conflicts of interest.