Reference Detail

Ref Type

Journal Article

PMID

(31204078)

Authors

Liu JF, Gordon M, Veneris J, Braiteh F, Balmanoukian A, Eder JP, Oaknin A, Hamilton E, Wang Y, Sarkar I, Molinero L, Fassò M, O'Hear C, Lin YG, Emens LA

Title

Safety, clinical activity and biomarker assessments of atezolizumab from a Phase I study in advanced/recurrent ovarian and uterine cancers.

Journal	Vol	Issue	Date	Pages	Journal Short Title
Gynecologic oncology	154	2	2019 08	314-322	Gynecol Oncol

URL

Abstract Text

Patients with advanced/recurrent epithelial ovarian and uterine cancers have limited treatment options beyond platinum chemotherapy. Both tumor types can express programmed death-ligand 1 (PD-L1), providing a potential therapeutic target for these patients. Here we present data from the ovarian and uterine cancer cohorts of the Phase I atezolizumab monotherapy study (PCD4989g).This Phase I, multi-center, first-in-human, open-label, dose-escalation/expansion clinical trial investigated single-agent atezolizumab in cohorts of patients with recurrent epithelial ovarian or uterine cancer. The primary objective was to evaluate the safety and tolerability of single-agent atezolizumab. Anti-tumor activity and preliminary assessment of potential biomarkers were evaluated as secondary and exploratory objectives, respectively.The ovarian and uterine cancer cohorts enrolled 12 and 15 patients, respectively (10 [83%] and 5 [33%], respectively, had PD-L1 ≥ 5% on tumor-infiltrating immune cells). Atezolizumab was generally well tolerated with no new safety signals identified. The safety profiles in both cohorts were consistent with the known profile of atezolizumab monotherapy. Treatment-related adverse events (AEs) were mostly Grade ≤ 2, with no treatment-related Grade ≥ 4 AEs reported. Preliminary anti-tumor activity, with long durations of response, was observed in 2 patients from each cohort (ovarian cancer, 8.1 and 30.6+ months; uterine cancer, 7.3 and 16.6+ months). High microsatellite instability and tumor mutational burden were noted in the responders from the uterine cancer cohort.Atezolizumab monotherapy was well tolerated in patients with epithelial ovarian or uterine cancer and may have clinical activity warranting further investigation.ClinicalTrials.gov identifier: NCT01375842.

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
CD274 positive	uterine cancer	predicted - sensitive	Atezolizumab	Case Reports/Case Series	Actionable	In a Phase I trial, Tecentriq (atezolizumab) treatment resulted in an objective response rate (ORR) of 13.3% (2/15, 2 partial responses) and a median progression-free survival of 1.4 months in patients with advanced or recurrent uterine cancer, ORR was 40% (2/5) in patients with tumor CD274 (PD-L1) expression of 5% or higher and 0% (0/10) in patients with tumor CD274 (PD-L1) expression below 5% (PMID: 31204078; NCT01375842).	31204078
CD274 positive	ovary epithelial cancer	predicted - sensitive	Atezolizumab	Case Reports/Case Series	Actionable	In a Phase I trial, Tecentriq (atezolizumab) treatment resulted in an objective response rate (ORR) of 22.2% (2/9, 1 complete response, 1 partial response) and a median progression-free survival of 2.9 months in patients with advanced or recurrent ovarian epithelial cancer, ORR was 25% (2/8) in patients with tumor CD274 (PD-L1) expression of 5% or higher and 0% (0/1) in patients with tumor CD274 (PD-L1) expression below 5% (PMID: 31204078; NCT01375842).	31204078