723P - A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy

Background

Recurrent/ metastatic (R/M) cervical cancer (CC) patients who failed previous therapy has limited treatment options, especially in those progressed on previous immunotherapy. Cadonilimab (AK104, a PD-1/CTLA-4 bi-specific antibody) has showed promising anti-tumor activity in R/M CC in those failed standard platinum-based chemotherapy. This study explored the efficacy and safety of AK104 plus chemotherapy to enhance tumor control in persistent R/M CC patients who failed previous immuno/chemotherapy.

Methods

This phase II study recruited patients with histologically confirmed CC who had failed previous immuno/chemotherapy for R/M disease. All patients received AK104 (10mg/kg, Q3W) with 4-6 cycles of investigator's choice of chemotherapy. The primary endpoint is ORR and PFS per RECIST1.1. The secondary endpoints includes DCR, OS and AE (CTCAE 5.0).

Results

By April 1, 2024, 21 patients were enrolled (median age: 52). All had history of radiotherapy (postoperative adjuvant or radical radiotherapy). For R/M disease, all patients had received previous platinum-based chemotherapy, and eight of them were treated with PD-1 inhibitors. The median follow-up was 9.4 months (range: 2.4-14.1). Of 21 patients, the ORR and DCR was 52.4% (11/21) and 95.2% (20/21), respectively. The mPFS was 6.2 months (95%CI[2.6-9.8]), the mPFS of 2^nd and ≥ 3^rd line treatment was 6.2 and 4.8 months, respectively. Median OS was not mature. In patients progressed on previous PD-1 inhibitors, 2 achieved partial response and 5 had stable disease, with the ORR of 25% (2/8) and DCR of 87.5% (7/8). 28.6% (6/21) of the patients had grade 3 AEs (4 leukocyte reduction, 1 anemia, 1 rash).

Conclusions

This study evaluated the efficacy and safety of AK104 plus chemotherapy on R/M CC patients who had failed previous immuno/chemotherapy. Our results showed preliminary improved efficacy comparing to previous monotherapy (COMPASSION-03 study, ORR of 32.3%). This demonstrated the promising anti-tumor effectiveness of AK104 in patients who failed previous immunotherapy, the potential of reversing drug resistance and good safety. Further studies in larger populations are warranted.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

X.

Disclosure

All authors have declared no conflicts of interest.