On May 15, 2024, the internationally renowned medical journal Nature Medicine (Latest impact factors: 82.9) published an article titled "Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial." This article presents comprehensive data from a multi-center Phase 3 FLAMES clinical study with co-leading PI Professor Wu Xiaohua from the Fudan University Shanghai Cancer Center, Shanghai, China and Professor Liu Jihong from the Sun Yat-sen University Cancer Center, Guangzhou, China.
The FLAMES trial enrolled newly diagnosed patients with high-grade serous or endometrial ovarian cancer in FIGO stages III-IV, who had completed first-line chemotherapy and achieved either a complete response (CR) or partial response (PR). These patients were randomly assigned to receive either 100 mg of Senaparib or placebo orally at a ratio of 2:1. The primary endpoint of the study was progression-free survival (PFS), which was assessed by blind Independent Center Review (BICR). The top-line results of the study were initially presented as a late breaking oral presentation at ESMO in 2023. According to the study findings published in Nature Medicine, Senaparib demonstrated significant improvement in PFS compared to placebo (median PFS not reached vs 13.6 months, HR 0.43, 95%CI 0.32-0.58, P < 0.0001), irrespective of BRCA status. Additionally, this publication also included detailed data on homologous recombination repair defect (HRD) in Chinese ovarian cancer patients using Myriad Genetics - an internationally accepted method for such analysis. The results indicated that both HRD positive and HRD negative populations derived benefit from Senaparib maintenance therapy, providing valuable insights for precision treatment approaches among ovarian cancer patients in China.
Professor Wu Xiaohua of the Fudan University Shanghai Cancer Center, the principal investigator of FLAMES commented, “I am delighted that the findings of FLAMES have been published by Nature Medicine, representing a significant milestone in the field of gynecological oncology in China. This publication attests to the exceptional quality of Senaparib's clinical data and FLAMES study, as recognized by esteemed international institutions. The presented efficacy and safety data suggest that Senaparib may have advantages over other PARP inhibitors, offering a promising new option for first-line maintenance therapy in advanced ovarian cancer for all patients.”
Dr. Chih-Yi Hsieh, Chief Medical Officer of IMPACT Therapeutics, commented, “This study presents the first HRD data in a Chinese population utilizing a validated HRD assay for newly diagnosed advanced ovarian cancer patients treated with a PARP inhibitor. Encouragingly, regardless of HRD status, patients in the Senaparib treatment arm exhibited prolonged progression-free survival compared to control arm. These findings further validate the potential of Senaparib as an effective therapy for advanced ovarian cancer and enhance our confidence in its clinical efficacy, providing a robust foundation for future research and application.”
Dr. CAI Sui Xiong, Chief Executive Officer of IMPACT Therapeutics, commented, “We are pleased that Senaparib's findings is published in the prestigious international journal Nature Medicine. As a highly potent PARP inhibitor, Senaparib has consistently demonstrated significant benefits in terms of progression-free survival in FLAMES study. We eagerly anticipate the approval of Senaparib as it offers patients a more effective and reliable treatment option. Our commitment remains steadfast in advancing the research and development of Senaparib, expanding its clinical applications, and contributing to the treatment of cancers associated with the DNA Damage Repair pathway (DDR).”
About Senaparib
Senaparib, discovered and 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. Senaparib has demonstrated its promising anti-tumor effect, including significant efficacy in ovarian cancer in early-phase trials, 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, 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 completed FPI.
Source: IMPACT Therapeutics
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