Tesaro reports initial data from AMBER trial of TSR-022, TSR-042 combo

TESARO presented initial data from the Phase 1 AMBER trial of TSR-022 in combination with TSR-042 in patients who have progressed following anti-PD-1 therapy treatment, in an oral session during the 2018 Annual Meeting of the Society for Immunotherapy of Cancer, or SITC, Conference in Washington, D.C. Data presented at SITC included safety and efficacy data from the combination dose-escalation and two expansion cohorts: NSCLC patients that had progressed following anti-PD-1 treatment and melanoma patients that had progressed following anti-PD-1 treatment. At the time of data cutoff, 39 patients with NSCLC who had progressed following anti-PD-1 treatment had received treatment with the TSR-022 and TSR-042 combination, including 14 patients at the 100 milligram dose and 25 patients at the 300 milligram dose of TSR-022. Among the 11 evaluable patients treated with the 100 milligram dose of TSR-022, 1 had a confirmed partial response by immune related RECIST criteria and 3 had stable disease. Among the 20 evaluable patients treated with the 300 milligram dose of TSR-022, 3 had confirmed partial responses and 8 had stable disease. “The initial AMBER data featured at this year’s SITC conference are the first clinical data to be presented for an anti-TIM-3 antibody in combination with an anti-PD-1 antibody and demonstrated that the combination of TSR-022 and TSR-042 is active and generally well tolerated in NSCLC and melanoma patients who have progressed following anti-PD-1 treatment. Additionally, updated results from the GARNET trial demonstrated robust clinical activity of TSR-042 in previously treated, anti-PD-1 naive patients with recurrent or advanced NSCLC, the vast majority of which had TPS less than50%. We look forward to presenting additional data from these studies in 2019,” said COO Mary Lynne Hedley. Additionally, Phase 1 GARNET data of TSR-042 in patients with previously treated recurrent/advanced non-small cell lung cancer and Phase 1 monotherapy dose-escalation data for TSR-033 in a broad range of solid tumors were also highlighted in poster presentations.
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