- Initial data from AMBER trial of TSR-022 (anti-TIM-3) in combination with TSR-042 (anti-PD-1) demonstrated clinical activity in patients who have progressed following anti-PD-1 treatment
- TSR-042 monotherapy demonstrated significant activity in patients with previously treated recurrent/advanced NSCLC across all PD-L1 TPS categories
- Investor webcast to highlight
SITCdata presentations and TESARO’s immuno-oncology portfolio on November 12
“The initial AMBER data featured at this year’s
A Phase 1 study of TSR-022, an anti-TIM-3 monoclonal antibody, in combination with TSR-042, an anti-PD-1 antibody (AMBER) [Oral presentation; Abstract: 10877; Poster: O21]
AMBER is an ongoing, open-label, Phase 1 study of TSR-022, an anti-TIM-3 antibody, in monotherapy or in combination with TSR-042, an anti-PD-1 antibody. The TSR-022 and TSR-042 combination portion of the study consists of dose-escalation and expansion cohorts. Data presented at
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 (irRECIST) 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. All objective responses were in PD-L1 positive (TPS ≥ 1%) patients, indicating potential for biomarker enrichment. Sixteen patients had known PD-L1 positive tumors. Among the 12 evaluable patients with PD-L1 positive tumors treated with either the 100 or 300 milligram dose of TSR-022, 4 patients had confirmed partial responses (3 responses ongoing) and 6 had stable disease.
Preliminary safety findings indicate that the combination of TSR-022 and TSR-042 was generally well-tolerated. Pharmacokinetic analysis showed that a 300 mg dose is not sufficient to maintain maximal pharmacodynamic effect and suggests that a 900 milligram dose of TSR-022 should maintain a maximal effect in the vast majority of patients for the duration of the Q3W dosing interval. Patients with NSCLC who have progressed following anti-PD-1 treatment are currently being enrolled in the NSCLC expansion cohort at the 900 milligram dose of TSR-022 in combination with TSR-042. Additional data from this cohort (900 milligram dose) and the melanoma cohort (100 and 300 milligram doses) are expected in 2019.
GARNET: Preliminary safety, efficacy, pharmacokinetic, and biomarker characterization from a Phase 1 clinical trial of TSR-042 (anti-PD-1 monoclonal antibody) in patients with previously treated recurrent/advanced NSCLC [Poster: P326; Abstract: 10853]
GARNET is an ongoing Phase 1 study evaluating TSR-042 as a monotherapy in patients with advanced solid tumors. The ongoing cohort expansion portion of GARNET is evaluating TSR-042 at a dose of 500 milligrams every 3 weeks for the first 4 cycles and 1,000 milligrams every 6 weeks thereafter in four cohorts: MSI (microsatellite instability)-high endometrial cancer, MSI-high non-endometrial cancer, MSS (microsatellite-stable) endometrial cancer and previously treated recurrent / advanced anti-PD-1 naïve NSCLC. Data presented at
At the time of data cutoff, 67 patients with previously treated recurrent / advanced anti-PD-1 naive NSCLC had received treatment with TSR-042, and 47 patients had at least one post-baseline tumor assessment or had discontinued treatment prior to first baseline assessment. Among these 47 patients, 15 had partial responses (including 2 unconfirmed responses that have not yet progressed) by irRECIST criteria for an overall response rate (ORR) of 31.9%; 14 additional patients (29.8%) had stable disease. Responses were durable and nine of the 15 responses are ongoing (60%).
The majority of patients (32 of 34; 94%) with available PD-L1 status had TPS <50% and clinical activity of TSR-042 was observed across all PD-L1 TPS categories. Among the 32 patients with low PD-L1 expression, 13 patients had TPS 1-49%, of which 5 had partial responses (ORR of 38.5%; including one unconfirmed response), and 19 patients had TPS <1%, of which 3 had partial responses (ORR of 15.8%).
Preliminary safety findings indicate TSR-042 was generally well-tolerated, with a safety profile characteristic of approved anti-PD-1 inhibitors for NSCLC.
The GARNET study is intended to support a Biologics License Application (BLA) submission to the
A Phase 1 dose escalation study of TSR-033, an anti-LAG-3 monoclonal antibody, in patients with advanced solid tumors (CITRINO) [Poster Number: P325; Abstract: 10332]
Data from the monotherapy dose-escalation portion of the CITRINO study were presented and included 30 patients treated with different doses of TSR-033. There were no Grade ≥3 treatment-related treatment emergent adverse events reported. Exposure and peripheral receptor occupancy increased in a dose proportional manner from 20 milligrams to 720 milligrams.These preliminary findings indicate that TSR-033 was generally well tolerated across multiple dose levels, with a safety profile consistent to those of other immune checkpoint inhibitors.
Enrollment is ongoing for patients treated with TSR-033 in combination with 500 milligrams of TSR-042.
Investor Briefing and Webcast
About the AMBER Study
AMBER is an ongoing Phase 1 study of TSR-022, an anti-TIM-3 antibody, alone and in combination with TSR-042, an anti-PD-1 antibody. The study consists of two parts: dose escalation and cohort expansion. The monotherapy and combination dose-escalation parts of the study are complete. In the combination dose-escalation, patients were treated with 100 milligrams, 300 milligrams, or 900 milligrams of TSR-022 in combination with a fixed dose of TSR-042 (500 milligrams) every 3 weeks. The three expansion cohorts include NSCLC patients with progression following anti-PD-1 treatment, melanoma patients with progression following anti-PD-1 treatment, and colorectal cancer patients.
About the GARNET Study
GARNET is an ongoing multicenter, open-label, Phase 1 study of TSR-042 as a monotherapy in patients with advanced solid tumors. GARNET included a weight-based dose escalation study (Part 1) and a fixed-dose safety study (Part 2A), both of which have been completed. Results of these studies were used to determine the recommended Phase 2 dose (RP2D; 500 mg Q3W for the first 4 cycles then 1000 mg Q6W). The ongoing cohort expansion portion of GARNET is evaluating TSR-042 in four cohorts: MSI (microsatellite instability)-high endometrial cancer, MSI-high non-endometrial cancer, MSS (microsatellite-stable) endometrial cancer and previously treated recurrent / advanced anti-PD-1 naïve NSCLC.
About the CITRINO Study
CITRINO is an ongoing multicenter, open-label Phase 1 study evaluating TSR-033, an anti-LAG-3 antibody, alone or in combination with an TSR-042 in patients with advanced solid tumors in a broad range of solid tumors.
About TSR-042, TSR-022, and TSR-033
TSR-042 is an investigational humanized anti-programmed death (PD)-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2. TSR-042 is the only anti-PD-1 therapy being studied as monotherapy every 3 weeks for 4 doses then every 6 weeks thereafter. TSR-042 was developed as part of the collaboration between
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