763P - Penpulimab + anlotinib plus chemo-less therapy in first-line treatment for persistent, recurrent, or metastatic cervical cancer: A single-arm, phase II study (ALTN-AK105-II-06)

Background

Anlotinib is a novel multi-target tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. Penpulimab is a novel human immunoglobulin G1 (IgG1) anti-programmed cell death-1 (PD-1) antibody. ALTN-AK105-II-06 (ChiCTR2200062897) aimed to assess the effiacy and safety of penpulimab + anlotinib plus chemo-less therapy as fist-line therapy for persistent, recurrent, or metastatic cervical cancer.

Methods

Eligible adults with persistent, recurrent, or metastatic cervical cancer not previously treated with systemic chemotherapy and not amenable curative treatment, with CPS more than 1% PD-L1 expression, and ECOG 0-1 were considered eligible for enrolment. Patients received 2 cycles of chemotherapy (paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 or carboplatin AUC 5) + penpulimab 200mg Q3W + anlotinib 10mg, following with penpulimab and anlotinib for maintenance therapy. Patients were treated on continuous 3 weeks of penpulimab for up to 2 years, until disease progression, or unacceptable toxicities. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), 6-month PFS, safety and quality of life.

Results

From Sep 2022 to May 2023, 15 patients were recruited with a median age of 47 years (range: 44-66), FIGO histopathological stage IIB (26.7%), III (46.7%) and IV (26.7%) were enrolled. 46.7% patients had ECOG PS 1. At data cutoff date (May 08, 2023), 14 patients had at least one post treatment anti-tumor assessment. 1 (7.1%) patient achieved CR, 11 (78.6 %) patients achieved PR, 1 (7.1%) SD and 1 (7.1%) patient NE. The ORR was 85.7%. Median PFS and OS were not reached. Grade ≥3 TRAEs incidence was 42.86% (hypertension: 21.43%, neutropenia: 21.43% leukopenia: 14.29%, and hypertriglyceridemia: 7.14%).

Conclusions

This chemo-less therapy of only 2 cycles of chemotherapy + penpulimab + anlotinib in first-line treatment, maintaining with penpulimab and anlotinib showed promising efficacy with a favourable toxicity profile for patients with persistent, recurrent, or metastatic cervical cancer.

Clinical trial identification

ChiCTR2200062897 (China Clinical Trial Registry).

Editorial acknowledgement

Legal entity responsible for the study

Q. Xu.

Funding

ChiaTai Tianqing Pharmaceutical Group Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.