k8凯发(中国)天生赢家·一触即发

On November 7, 2023, IMPACT Therapeutics presented, in the form of plenary oral presentation, the clinical data for senaparib, a PARP inhibitor, as first-line maintenance therapy in advanced ovarian cancer patient at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting，including the first time  disclosure of the subgroup efficacy data by the investigators.  The New Drug Application of Senaparib in this indication has been accepted for review by the China National Drug Administration (NMPA).

Highlighted Oral Presentation (For more details, refer to the IGCS Congress 2023):

Abstract ID: PO012LBA / #1511

Title: FLAMES: Randomized Phase 3 Trial of Maintenance Senaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

Session：Plenary 03: Oral Abstract Presentations – Ovarian Cancer

* The interim analysis reveals that maintenance senaparib confers a significant extension of progression-free survival in newly diagnosed advanced ovarian cancer patients compared with placebo, as assessed by blinded independent central review (BICR assessed median PFS not reached vs. 13.6 months, HR 0.43, 95% CI 0.32-0.58, P < 0.0001), irrespective of BRCA status.

* Furthermore, efficacy measures evalsuated by the investigators align closely with BICR assessments, demonstrating a significant improvement in PFS with senaparib versus placebo (median PFS not reached vs. 11.1 months, HR 0.43, 95% CI 0.32-0.57, P < 0.0001). This improvement remains consistent regardless of factors like BRCA mutation status, FIGO stage, and residual disease status after debulking surgery.

" We are delighted to announce the inaugural presentation of superior efficacy results by investigator from FLAMES studies at this year's IGCS Annual Global Meeting, which further validate the consistency between investigator and BICR evalsuated efficacy data, reaffirming the exceptional quality and reliability of FLAMES studies. Previously, an NDA for Senaparib has been successfully submitted and accepted for review by NMPA. We eagerly anticipate the approval of Senaparib, a highly potent PARP inhibitor independently discovered and developed in China, with hopes of realizing our commitment to advanced ovarian cancer patients in the future.“，said Dr. Chih-Yi Hsieh, Chief medical Officer of IMPACT Therapeutics.

“After the primary endpoint of the FLAMES study was published at ESMO for the first time, we are delighted for the presentation of FLAMES research data once again at IGCS international conference. Innovation is at the core of medicine, the innovative drug design of Senaparib with its demonstrated efficacy and safety in treating advanced ovarian cancer have enabled its inclusion in both ESMO and IGCS. We are confident that Senaprib will obtain NMPA approval for marketing, providing new treatment options for patients with advanced ovarian cancer. Our ultimate goal is to benefit advanced ovarian cancer patients in China as well as worldwide.” said Dr. Sui Xiong Cai, Chief Executive 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).

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.