|The following article features coverage from the Society of Gynecologic Oncology’s 50th Annual Meeting on Women’s Cancer. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Preliminary results from the phase 1/2 GARNET study (ClinicalTrial.gov Identifier: NCT02715284) showed that TSR-042, a PD-1 inhibitor under development, had antitumor activity in women with recurrent or advanced endometrial cancer. The findings of this study were presented at the Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer.
TSR-042 is an investigational immune checkpoint blocker that is a humanized, monoclonal antibody against the programmed cell death-1 (PD-1) receptor. It is currently being studied in adult patients with advanced solid tumors in the ongoing GARNET trial.
Of the 110 patients with previously treated recurrent or advanced endometrial cancer who received at least 1 dose of TSR-042 (recommended phase 2 dose of 500 mg every 3 weeks for the first 4 cycles and 1000 mg every 6 weeks thereafter), the median age was 66 years and the median number of prior regimens for advanced disease was 1.
The overall response rate by immune-related RECIST criteria in the 94 patients who received at least 1 dose of study drug (79 patients) or discontinued treatment prior to week 12 (15 patients) was 27.7% and included confirmed and unconfirmed responses. This included response rates of 50.0% and 19.1% in patients with disease characterized as having microsatellite instability (MSI) or as being microsatellite stable (MMS). The disease-control rate was 48.9%, and responses were ongoing in 88.4% at data cutoff.
Pharmacokinetic data obtained from analysis of serum and blood mononuclear cells revealed linear and dose-proportional pharmacokinetic characteristics, with maximal receptor occupancy at the recommended phase 2 dose.
At least 1 treatment-related adverse event was observed in 61.8% of patients who received TSR-042, with grade 3 or higher adverse events reported in 11.8% of patients.
Read more of Cancer Therapy Advisor‘s coverage of SGO’s annual meeting by visiting the conference page.
- Oaknin A, Duska LR, , Sullivan RJ, et al. Preliminary safety, efficacy, and pharmacokinetic/pharmacodynamic characterization from GARNET, a phase I/II clinical trial of the anti–PD-1 monoclonal antibody, TSR-042, in patients with recurrent or advanced MSI-h and MSS endometrial cancer. Presented at: The Society of Gynecologic Oncology (SGO)’s 50th Annual Meeting on Women’s Cancer; Honolulu, Hawaii; March 16-19, 2019. Abstract 33.