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Promising Results for IMP9064 Monotherapy in Advanced Solid Tumors Presented at ESMO 2024 [Barcelona, Spain] – At the European Society for Medical Oncology (ESMO) 2024 Congress, encouraging findings from the first-in-human Phase 1/2 study of IMP9064, an ATR inhibitor, demonstrating its potential as a treatment for patients with advanced solid tumors (AST) with favorable safety profile was presented as a poster.

Highlights of the poster (refer to ESMO2024 for more details):

Poster Board：632P

Title:Results from the first-in-human study of ATR inhibitor, IMP9064 monotherapy dose escalation in patients with advanced solid tumors

Session：Developmental therapeutics

Session Date: 14 September 2024

Study Overview

The study involved a dose-escalation and dose-expansion design to evalsuate IMP9064 both as a monotherapy and in combination with senaparib, a PARP inhibitor. IMP9064 was administered orally once daily in a 3 days on/4 days off regimen, with doses ranging from 7.5 mg to 320 mg.

Key Findings

★ Patient Enrollment: As of Jun 19th, 2024, 34 patients enrolled, with various tumor types, including colorectal, endometrial cancer and lung cancers.

★ Safety and Tolerability: 76.5% of patients experienced treatment-related adverse events (TRAEs). Grade 3 TRAEs reported in ≥ 2 patients included anemia (14.7%) and diarrhea (5.9%), with no TRAEs with grade 4 or grade 5, or  leading to drug discontinuation occurred.

★ Efficacy: Among efficacy evalsuable patients, one endometrial cancer patient showed a partial response (PR) with a notable tumor reduction of 31.8% at the 6-week scan, and by 45.5% at the 12th week scan, which is ongoing. The disease control rate (DCR) was 64.5%. The median progression-free survival (PFS) was 4.0 months.

★ Pharmacokinetics: IMP9064 was quickly absorbed, with peak concentration reached in about 4.5 hours, and  plasma exposure increased with higher doses.

Additional Research

The study also explored the relationship between IMP9064 plasma concentration and its pharmacodynamic effects, including phospho-Chk1 expression. Molecular response assessments indicated that 6 out of 14 patients showed favorable ctDNA changes, suggesting potential efficacy in specific genetic contexts.

Conclusion

The study suggests that IMP9064 has a good safety profile and shows promising early efficacy in advanced solid tumors. The recommended phase 2 dose (RP2D) was declared and it’s moving to phase 2 with monotherapy expansion in selected tumors.

"These results highlight the potential of IMP9064 as a promising therapeutic option for patients facing advanced solid tumors," said Chih-Yi Hsieh, chief medical officer and executive vice president of IMPACT Therapeutics, "We are eager to advance this research."