Overall survival results from a phase II trial of anlotinib plus sintilimab in patients with recurrent advanced cervical cancer.

Authors

null

Qin Xu

Fujian Cancer Hospital, Fuzhou, China

Qin Xu , Chuan-ben Chen , Yang Sun , Zhangzhou Huang , Yibin Lin , Jing Liu , Li Li , Zirong Li , Junping Pan , Ying Chen

Organizations

Fujian Cancer Hospital, Fuzhou, China, Department of Radiation Oncology, Fuzhou, China, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, China, Department of Gynecology, Fujian Medical University Cancer Hospital, Fujian Cancer Hospital, Fuzhou, China, Longyan First Affiliated Hospital of Fujian Medical University, Fuzhou, China

Research Funding

No funding received

Background: The anlotinib (a novel multi-target TKI, inhibiting tumor angiogenesis and proliferative signaling) plus sintilimab (an antibody against PD-1) in patients with advanced cervical cancer trial was a multicenter, single-arm, phase II study (ChiCTR1900023015) that showed promising activity. The results of this trial have been previously reported and here we present updated survival data after a median follow-up of 13.0 months. Methods: Pts who have received at least once platinum-based chemotherapy, recurrent advanced cervical cancer, PD-L1 for CPS≥1, ECOG 0-1 were considered eligible for enrollment. Anlotinib was taken orally (10mg, qd, d1-14, 21 days per cycle), and sintilimab was administered intravenously (200mg, q3w, d1). The primary endpoint was objective response rate (ORR) and the secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS), safety and biomarkers. Results: Between December 2019 and December 2020, 42 patients with a median age of 53 years (range 36 to 67 years) were enrolled and received study treatment (ITT population and safety population). The data cutoff date was February 10, 2022. The patients were followed up for median duration of 13.0 months (range 0.03 to 24.8 months). In the ITT population, 2 (4.8%) patients achieved CR and 21 (50%) attained PR, the confirmed ORR was 54.8% (95% CI 38.7% to 70.2%). Fourteen (33.3%) patients had SD and the DCR was 88.1% (95% CI 74.4% to 96.0%). In the efficacy-evaluable patients (n = 39), the ORR was 59% (95% CI 42.1% to 74.4%) and the DCR was 94.9% (95% CI 82.7% to 99.4%). The median PFS was 9.46 months (95% CI 8.2 to 11.9) and the 6-month PFS rate was 73.4% (95% CI 60.6% to 89.0%). OS events occurred in 18 patients (42.9%). The median OS was 17.4 months (95% CI 12.4 to not reached). The 12-month OS rate and 24-month OS were 71.8% (95% CI 59.0% to 87.4%) and 49.1% (95% CI 34.5% to 69.9%), respectively. Conclusions: Anlotinib plus sintilimab showed a long-term survival benefit for patients with recurrent advanced cervical cancer. Additional investigations in larger randomized controlled trials are warranted in the future. Clinical trial information: ChiCTR1900023015.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Cervical Cancer

Clinical Trial Registration Number

ChiCTR1900023015

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 5536)

DOI

10.1200/JCO.2022.40.16_suppl.5536

Abstract #

5536

Poster Bd #

415

Abstract Disclosures

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