Please use this identifier to cite or link to this item:
https://repository.monashhealth.org/monashhealthjspui/handle/1/36462
Conference/Presentation Title: | Safety and antitumor activity of sitravatinib in combination with tislelizumab in patients with advanced solid tumors: Ovarian cancer cohort data. | Authors: | Qiu J.;Xiang X.;Xu Y.;Millward M.;Yang L.;Gao B.;Goh J.;Markman B.;Voskoboynik M.;Gan H.K.;Coward J.;Palmieri D.;So J.;Meniawy T.;Chen C. | Monash Health Department(s): | Oncology | Institution: | (Gao, Palmieri) Oncology, Blacktown Cancer and Haematology Centre, Blacktown, Australia (Goh, Coward) Oncology, ICON Research, University of Queensland, St Lucia, Australia (Markman, So) Oncology, Monash Health and Monash University, Melbourne, Australia (Voskoboynik) Oncology, Nucleus Network, Melbourne, Australia (Gan) Medical Oncology, Austin Hospital, Heidelberg, Australia (Meniawy, Millward) Medical Oncology, University of Western Australia, Crawley, Australia (Meniawy) Linear Clinical Research, Perth, Australia (Chen, Xu, Yang) Oncology, BeiGene (Shanghai) Co., Ltd., Shanghai, China (Xiang, Qiu) Oncology, BeiGene (Beijing) Co., Ltd., Beijing, China | Presentation/Conference Date: | 31-Jan-2020 | Copyright year: | 2019 | Publisher: | Oxford University Press | Publication information: | Annals of Oncology. Conference: ESMO Immuno Oncology Congress 2019. Geneva Switzerland. 30 (Supplement 11) (pp xi34-xi35), 2019. Date of Publication: December 2019. | Journal: | Annals of Oncology | Abstract: | Background: Sitravatinib is an investigational, orally bioavailable, receptor tyrosinekinase inhibitor with immune modulatory and potential antitumor activity. Tislelizumab is an investigational, humanized IgG4 monoclonal antibody with high affinity and binding specificity for programmed cell death receptor-1 (PD-1). We assessed the safety and antitumor activity of sitravatinib plus tislelizumab in patients with advanced solid tumors. Method(s): This is an open-label, multicenter, non-randomized, phase Ib study (NCT03666143). This cohort evaluated anti-PD-(L)1 antibody-naive patients with recurrent, platinum-resistant, epithelial ovarian cancer who were treated with 120 mg of sitravatinib once daily in combination with 200 mg tislelizumab every 3 weeks until disease progression, unacceptable toxicity, death, withdrawal of consent, or study termination. The primary objective was to assess the safety and tolerability of this combination therapy. Overall response rate, duration of response (DOR), disease control rate, and progression-free survival (PFS) were assessed as secondary endpoints. Result(s): As of 17 July 2019, 20 patients (median age, 66.0 years) were enrolled; median number of prior regimens was 5 (range, 2-12). All 20 patients received study drugs and were included in the safety analysis. Common (frequency >=10%) grade>=3 treatmentemergent adverse events (TEAEs) assessed as related to sitravatinib by investigators were hypertension (25%) and fatigue (10%). Six patients had AEs that led to sitravatinib discontinuation. The common (frequency >=10%) grade>=3 TEAE assessed as related to tislelizumab by investigators was increased transaminases (10%). Three patients had AEs that led to tislelizumab discontinuation. Of 17 efficacy-evaluable patients, 4 achieved confirmed partial response, 11 had stable disease, and 2 had progressive disease per RECIST version 1.1. Median PFS was 18.0 weeks; median DOR was not reached (NR) (both ranges, 12.29 weeks-NR). Conclusion(s): Combination treatment with sitravatinib and tislelizumab was manageable and showed promising antitumor activity in patients with ovarian cancer. | Conference Start Date: | 2019-12-11 | Conference End Date: | 2019-12-14 | DOI: | http://monash.idm.oclc.org/login?url=http://dx.doi.org/10.1093/annonc/mdz451.003 | ISSN: | 1569-8041 | URI: | https://repository.monashhealth.org/monashhealthjspui/handle/1/36462 | Type: | Conference Abstract | Subjects: | gene frequency hypertension ovary carcinoma pharmacokinetics phase 1 progression free survival fatigue aminotransferase antineoplastic activity platinum adverse drug reaction advanced cancer response evaluation criteria in solid tumors disease control drug efficacy drug safety drug withdrawal aged programmed 1 ligand 1 sitravatinib tislelizumab cancer patient cancer recurrence cancer survival |
Type of Clinical Study or Trial: | Clinical trial |
Appears in Collections: | Conferences |
Show full item record
Items in Monash Health Research Repository are protected by copyright, with all rights reserved, unless otherwise indicated.