Dataset Information

Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study.

ABSTRACT:

Purpose

Immune checkpoint inhibitors (ICI) have been a potential treatment option for patients with cervical cancer in several clinical studies. We investigated the safety and efficacy of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, plus standard therapy for the first-line treatment of R/M CC (recurrent and/or metastatic cervical cancer).

Patients and methods

Eligible patients were assigned to 3 cohorts: cohort A-15 (cadonilimab 15 mg/kg every 3 weeks (Q3W) plus chemotherapy), cohort A-10 (cadonilimb 10 mg/kg Q3W plus chemotherapy), and cohort B-10 (cadonilimab 10 mg/kg Q3W plus chemotherapy and bevacizumab). They received the corresponding treatments until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. The primary objective was safety; the secondary endpoints included objective overall response (ORR), duration of response, disease control rate, progression-free survival, and overall survival. This study is registered with ClinicalTrials.gov (NCT04868708).

Results

As of February 13, 2023, treatment-related adverse events (TRAE) occurred in 45 (100.0%) patients. Grade ≥3 TRAEs were reported in 33 (73.3%) patients. Immune-related adverse events (irAE) occurred in 29 (64.4%) patients and grade ≥3 irAEs were observed in 9 (20.0%) patients. Seven (15.6%) of 45 patients permanently discontinued cadonilimab treatment due to TRAEs. One death due to hemorrhagic shock occurred in cohort B-10. Among 44 patients who underwent at least one post-baseline tumor assessment, the ORR was 66.7% in cohort A-15, 68.8% in cohort A-10, 92.3% in cohort B-10, and 79.3% in cohorts A-10 and B-10 combined.

Conclusions

Cadonilimab combined with standard therapy was acceptable, with encouraging antitumor activity in patients with R/M CC.

SUBMITTER: Lou H

PROVIDER: S-EPMC11016896 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature

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Publications

Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study.

Lou Hanmei H Cai Hongbing H Huang Xin X Li Guiling G Wang Li L Liu Fei F Qin Wenjing W Liu Ting T Liu Wei W Wang Zhongmin Maxwell ZM Li Baiyong B Xia Yu Y Wang Jing J

Clinical cancer research : an official journal of the American Association for Cancer Research 20240401 8

<h4>Purpose</h4>Immune checkpoint inhibitors (ICI) have been a potential treatment option for patients with cervical cancer in several clinical studies. We investigated the safety and efficacy of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, plus standard therapy for the first-line treatment of R/M CC (recurrent and/or metastatic cervical cancer).<h4>Patients and methods</h4>Eligible patients were assigned to 3 cohorts: cohort A-15 (cadonilimab 15 mg/kg every 3 weeks (Q3W) plus c ...[more]

PMID: 38372727

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Project description:BackgroundThe addition of cadonilimab to first-line platinum-based chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in patients with persistent, recurrent, or metastatic cervical cancer. However, the economic value of using this novel therapy for this indication is currently unknown. The aim of this study is to evaluate the cost-effectiveness of the addition of cadonilimab to first-line standard chemotherapy for patients with persistent, recurrent, or metastatic cervical cancer from the perspective of Chinese healthcare system.MethodsA partitioned survival model was constructed to compare the cost-effectiveness of cadonilimab versus placebo in patients enrolled in the COMPASSION-16 trial. Cost, life-year, quality-adjusted life-year (QALY), incremental cost-effectiveness ratio (ICER), incremental net health benefit (INHB), and incremental net monetary benefit (INMB) were calculated for 2 treatment strategies. Sensitivity, scenario, and subgroup analyses, and value of information analysis (EVPI) were performed.ResultsCadonilimab provided an additional 1.18 QALYs and $89,528.64 compared with placebo, which resulted in an ICER of $75,944.56/QALY. At the willingness-to-pay threshold of $38,042.49/QALY, INHB was estimated to be -1.17 QALYs, while INMB amounted to -$44,681.55 and EVPI was calculated as $71.40/person. Sensitivity analyses revealed that the model was most sensitive to hazard ratio (HR) for OS and PFS, and the probability of cadonilimab being cost-effective was 0.70%. To achieve cost-effectiveness, the price of cadonilimab must be reduced by approximately 50%. Subgroup analysis found that all subgroups unfavored cadonilimab by varying the HR for OS and PFS. Scenario analyses showed using life-year as effectiveness, altering time horizon and selection of survival analysis did not reverse results.ConclusionsAlthough the use of cadonilimab resulted in clinical benefit, it was not deemed cost-effective as a first-line therapy for persistent, recurrent, or metastatic cervical cancer in China. Lowering the price of cadonilimab may enhance its cost-effectiveness.

Project description:ObjectiveDespite advances in cervical cancer prevention and diagnosis, outcomes for patients given a diagnosis of advanced and recurrent disease are poor. In the GOG240 trial, the addition of bevacizumab to paclitaxel-topotecan or paclitaxel-cisplatin has been shown to prolong survival compared with paclitaxel-topotecan or paclitaxel-cisplatin in patients with persistent, recurrent, or metastatic disease. However, standards of care vary between regions and countries. The purpose of this systematic review and network meta-analysis was to enable a comparison between bevacizumab + chemotherapy with multiple monotherapy or combination chemotherapy regimens in the treatment for women with advanced, recurrent, or persistent cervical cancer.Methods/materialsA systematic literature review was conducted to identify randomized or nonrandomized controlled trials of patients with recurrent, persistent, or metastatic cervical cancer published in English from 1999 to 2015. A feasibility study was performed to assess the heterogeneity of the trials, and a network meta-analysis was conducted. Fixed- and random-effects models were fitted to calculate the hazard ratio for overall survival (OS) for all pairwise comparisons and ranking of all interventions.ResultsTwenty-three studies (19 trials) met inclusion criteria and were included in the review. Sample sizes ranged from 69 to 452, and median patient age ranged from 45 to 53 years. There was a trend toward prolonged OS with cisplatin-paclitaxel-bevacizumab and topotecan-paclitaxel-bevacizumab compared with all non-bevacizumab-containing therapies. Cisplatin-paclitaxel-bevacizumab had the highest probability of being the most efficacious compared with all regimens (68.1%), and cisplatin monotherapy had the lowest (0%).ConclusionsThe results of this network meta-analysis show that bevacizumab in combination with paclitaxel-topotecan or paclitaxel-cisplatin is likely to prolong OS over other non-bevacizumab-containing chemotherapies (eg, paclitaxel-carboplatin), which were not included in the GOG240 trial. In patients with advanced, persistent, and recurrent cervical cancer, cisplatin-paclitaxel-bevacizumab and topotecan-paclitaxel-bevacizumab showed the highest efficacy in all regimens investigated in this analysis.

Dataset Information

Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study.

Purpose

Patients and methods

Results

Conclusions

Publications

Cadonilimab Combined with Chemotherapy with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Cervical Cancer (COMPASSION-13): A Phase 2 Study.

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