Turning Point Therapeutics Presents Initial Clinical Data From Phase 1 SHIELD-1 Study of Novel MET/SRC/CSF1R Inhibitor TPX-0022 at 2020 EORTC-NCI-AACR Symposium - Seite 2

Preliminary efficacy data was available for 15 evaluable patients with baseline measurable disease and at least one post-baseline scan.

As of the 15 October 2020 data cut-off date:

Preliminary Safety and Pharmacokinetic (PK) Results (n=22)

• A total of 22 patients with MET-dysregulated advanced solid tumors were treated with TPX-0022 at dose levels from 20 mg once daily (QD) to 120 mg QD.
• TPX-0022 was generally well tolerated, with the most frequent treatment emergent adverse event (TEAE) being Grade 1 or 2 dizziness.
• TEAEs reported in greater than 20 percent of patients were dizziness (55%); lipase increased (32%); fatigue (32%); amylase increased (27%); nausea (27%); vomiting (27%); constipation (23%); and anemia (23%).
• The majority of treatment related adverse events (TRAEs) were Grade 1 or 2 and there were no Grade 4 or 5 TRAEs
• The maximum tolerated dose had not been determined, with one dose-limiting toxicity of treatment-related Grade 2 dizziness at 120 mg QD. 
• PK data suggested sustained MET inhibition throughout the dosing interval across all doses.

Preliminary Efficacy Results (n=15)

• A total of 15 patients were evaluable for efficacy by investigator assessment, including 10 who were MET TKI-naïve: four with colorectal cancer (CRC), three with non-small cell lung cancer (NSCLC), and three with gastric or GE junction cancer (GC or GEJ). In addition, five patients were MET TKI-pretreated, all with NSCLC.
• Of 10 MET TKI-naïve patients, five achieved a partial response, including three with GC or GEJ cancer, one with CRC, and one with NSCLC. All three evaluable patients with gastric or GEJ tumors achieved a response.
• Of the five responses, three patients achieved a confirmed response, and two patients remained on treatment in a response awaiting confirmation at the time of the data cut-off.
• Of the five MET TKI-pretreated NSCLC patients, three patients treated with multiple rounds of prior therapy achieved a best response of stable disease with two patients showing tumor measurement improvements (-27%, and -75% accordingly).
• Nine of 15 patients (9/15) achieved clinical benefit (confirmed and unconfirmed partial response or stable disease).
• Six of 15 patients (6/15) remained on treatment with duration of treatment ranging from 7.6+ to 34+ weeks.

“We are encouraged by the emerging early safety and efficacy data across multiple tumor types, including the high unmet medical need area within MET-amplified gastric cancer where there are no approved targeted therapies,” said Mohammad Hirmand, M.D., chief medical officer. “MET driven cancers affect a large and growing population of patients who have limited therapeutic options. Based on these early study findings, we look forward to advancing the development of TPX-0022.”