On March 10, 2024, IMPACT Therapeutics announced the presentation of the data on its PARP inhibitor Senaparib (IMP4297) for first-line maintenance therapy in newly diagnosed advanced ovarian cancer patients during the BEST ORAL SESSION at the European Society of Gynecological Oncology Congress. The data was presented as an oral report by Professor Xiaohua Wu, Director of the Gynecological Oncology Department at Fudan University Cancer Hospital. The New Drug Application of Senaparib is currently undergoing evaluation by the China National Drug Administration (NMPA).

Highlighted Oral Presentation (For more details, refer to the ESGO Congress 2024):

Title: Senaparib Maintenance in Newly Diagnosed Advanced Ovarian Cancer: FLAMES Study

BEST ORAL SESSION  Presenter: Professor Xiaohua Wu

• The FLAMES study enrolled newly diagnosed, FIGO stage III-IV, high-grade serous or endometrioid ovarian cancer patients who have completed 1L platinum-based chemotherapy with complete response (CR) or partial response (PR). They were randomized (2:1) to receive Senaparib or placebo 100 mg/day orally. The primary endpoint was progression-free survival (PFS) evaluated by blinded independent central review (BICR) according to RECIST v1.1.

• In addition to the PFS data assessed by BICR and its corresponding subgroup results, the PFS data assessed by investigator and its respective subgroup outcomes were also published. These findings strongly support that Senaparib demonstrates significantly superior efficacy compared to the control group, with a high level of consistency between both BICR and investigator assessed PFS, including its corresponding subgroup results .

“The data presented in this study include BICR and investigator assessed PFS data, along with corresponding subgroup results. Encouragingly, both the BICR and investigator assessed data and corresponding subgroups data consistently demonstrate that patients treated with Senaparib exhibit significantly prolonged observed PFS compared to the control group. Moreover, analysis confirms this advantage across various subgroups such as BRCA status, best response to platinum chemotherapy (CR/PR), age, and disease stages. These findings further validate the potential of Senaparib as a therapeutic option for advanced ovarian cancer patients, establishing a solid foundation for future research and clinical application.”, said Dr. Chih-Yi Hsieh, Chief Medical Officer of IMPACT Therapeutics.

About Senaparib

• Senaparib, developed by IMPACT Therapeutics, is a potent and novel PARP (1/2) inhibitor. Its distinctive molecular structure ensures exceptional target selectivity and wide safety window. The early-phase trials demonstrated the promising anti-tumor effect of Senaparib, including significant efficacy in ovarian cancer, and has met its primary endpoint for advanced ovarian cancer maintenance treatment following first-line therapy in the pivotal FLAMES phase 3 study. In September 2023, Impact Therapeutics announced that the National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Senaparib in China, as a first-line maintenance treatment of adult patients with ovarian epithelial carcinoma, fallopian tube cancer or primary peritoneal cancer following a response to platinum-based chemotherapy. In addition, in August 2022, the fixed dose combination capsules of Senaparib and temozolomide for the treatment of adult patients with small cell lung cancer was granted orphan-drug designation by the U.S. Food and Drug Administration (FDA). In December 2023, IMPACT and Huadong Medicine entered into an agreement for promotion of Senaparib. Under the collaboration agreement, Huadong Medicine receives exclusive commercial promotion rights of Senaparib in mainland China.

About IMPACT Therapeutics

IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage responses (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT pipeline products include PARP inhibitor (Senaparib/IMP4297), Wee1 inhibitor (IMP7068), ATR inhibitor (IMP9064)，and PARP1 selective inhibitor (IMP1734, in collaboration with Eikon Therapeutics), as well as other novel DDR pathway inhibitors. The lead clinical program, PARP inhibitor (Senaparib/IMP4297), has successfully completed Phase III pivotal trial in ovarian cancer first-line maintenance (FLAMES study) setting with best-in-class efficacy and safety profile. Based on the results of the FLAMES study, The Senaparib New Drug Application (NDA)  has been accepted for review by the National Medical Products Administration (NMPA) of China. Wee1 inhibitor IMP7068 and ATR inhibitor IMP9064 is undergoing global Phase I clinical study. PARP1 selective inhibitor IMP1734 has obtained IND clearance from FDA and NMPA, as well as FPI.