Sepalna (senaparib) / IMPACT Therap, Huadong Medicine, Pharmanovia - LARVOL DELTA

A PBPK-VBE approach for bioequivalence extrapolation of senaparib capsule strengths in the context of nonlinear pharmacokinetics: bridging from the clinical starting dose to the linear pharmacokinetic range. (PubMed, Front Pharmacol) - "Under all evaluated conditions including variations in sample size, intra-individual variability levels, and prandial states (fasted and fed), the geometric mean ratios (GMRs) of key pharmacokinetic (PK) parameters consistently approached 100%, thereby confirming bioequivalence across the specified dosing range. This PBPK-VBE framework provides supportive evidence for bioequivalence bridging of senaparib capsule strengths across the linear dose range, illustrating the potential utility of this approach for formulation bridging when direct clinical BE studies across all dose levels are impractical."

Journal • PK/PD data • Oncology • Ovarian Cancer • Solid Tumor

Updated Progression-Free Survival (PFS) Results from the FLAMES Study: First-Line Maintenance Senaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer (aOC) (ESMO 2026) - No abstract available

Clinical • Metastases • Oncology • Ovarian Cancer • Solid Tumor

IMPACT Therapeutics and Pharmanovia Announce Positive CHMP Opinion for Senaparib, as a Potential First-Line Maintenance Treatment of Advanced High-Grade Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (Businesswire) - "Following the CHMP’s recommendation for approval, senaparib will be submitted to the European Commission (EC) for final decision. Once approved by the EC, senaparib will be authorized for marketing in all EU Member States and European Economic Area (EEA) countries. The positive opinion from CHMP is primarily based on the results of the pivotal Phase III FLAMES study."

CHMP • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

Efficacy and safety of PARP inhibitors in older patients with advanced ovarian cancer: a systematic review and network meta-analysis. (PubMed, Front Oncol) - "Similar benefits were observed in older patients (≥65 years), with significant PFS improvements for olaparib (HR, 0.44; 95% CI, 0.25-0.77), rucaparib (HR, 0.43; 95% CI, 0.19-0.97), and niraparib (HR, 0.56; 95% CI, 0.38-0.83). In the overall adult population, senaparib, veliparib, and olaparib were associated with significant improvements in PFS...However, treatment was associated with increased hematologic and gastrointestinal toxicities. Further studies should assess geriatric outcomes, long-term safety, and patient-reported outcomes."

Clinical • Journal • Retrospective data • Review • Gynecologic Cancers • Hematological Disorders • Oncology • Ovarian Cancer • Solid Tumor

IMPACT Therapeutics Signs Exclusive License Agreement with Pharmanovia for Senaparib in Europe, Middle East and North Africa, Australia and New Zealand (PRNewswire) - "Marketing Authorisation Application (MAA) of senaparib for 1L maintenance therapy for adult patients with advanced ovarian cancer in Europe was formally accepted by the European Medicines Agency (the 'EMA') in August 2025, with approval expected in the second half of 2026. Under the licensing agreement in relation to the Exclusive Partnership, IMPACT has granted exclusive manufacturing, development and commercialisation rights of senaparib for maintenance monotherapy for advanced epithelial high-grade ovarian, fallopian tube and primary peritoneal cancer to Pharmanovia in 66 countries, including, among others, all 27 European Union member states, as well as the United Kingdom, Norway, Iceland, Switzerland, Liechtenstein, Australia, New Zealand and countries in the Middle East and North Africa."

EMA approval • Licensing / partnership • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

Safety and tolerability of PARP inhibitors in cancer patients: a network meta-analysis of randomized controlled trials. (PubMed, BMC Cancer) - "In our study, pamiparib demonstrates the most favorable safety profile among evaluated PARP inhibitors relatively, while senaparib might be associated with a higher incidence of AEs. PARPi plus anti-angiogenic drug or chemotherapy might cause the most occurrence of AEs relatively. Therefore, on the basis of balancing efficacy and safety, selecting optimal PARPi and formulating tailored combination therapy for individual patients is necessary."

Journal • Retrospective data • Review • Oncology

Comparative efficacy and safety of first-line maintenance therapies in advanced ovarian cancer: A biomarker-stratified Bayesian network meta-analysis of 16 phase III trials (ESMO-Gynae 2026) - "In the BRCAm network, PARPi monotherapies dominated efficacy (olaparib SUCRA 92%; senaparib 88%); adding immune checkpoint inhibitors ranked lowest (SUCRA 12%). For HRd patients, olaparib plus bevacizumab achieved the highest probability of maximizing progression-free survival (SUCRA 94%), outperforming triplet combinations (SUCRA 78%). In the HRp network, individualized-dose niraparib (SUCRA 85%) provided the greatest advantage over baseline bevacizumab...For HRd patients, combining a PARPi with an anti-angiogenic yields peak efficacy. Across all biomarker subgroups, individualized PARPi dosing is vital for optimizing the therapeutic index and mitigating severe hematological events."

Biomarker • IO biomarker • Metastases • P3 data • Retrospective data • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

Advancements in the manufacturing routes for the synthesis of marketed PARP inhibitors. (PubMed, RSC Adv) - "To date, seven PARP inhibitors have received marketing approval, namely, olaparib, rucaparib, niraparib, talazoparib, fuzuloparib, pamiparib and senaparib, in various countries. These modern approaches integrate key transformations, such as amide bond formation, C-H activation, carbopalladation, heterocycle construction, and stereocontrolled cyclisation, enabling improved efficiency and scalability. In parallel, the incorporation of green chemistry principles, particularly in one of the manufacturing routes of olaparib, has led to more sustainable process development."

Journal • Review • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

FLAMES shows activity of maintenance senaparib in ovarian cancer patients. (PubMed, Gynecol Pelvic Med) - No abstract available

Journal • Oncology • Ovarian Cancer • Solid Tumor

Senaparib Potentiates ¹⁷⁷Lu-LNC1011 Radioligand Therapy by Amplifying Irreparable DNA Damage in PSMA-Positive Prostate Cancer (SNMMI 2026) - "Senaparib potentiates ¹⁷⁷Lu-LNC1011 radioligand therapy in PSMA-expressing prostate tumor models by aggravating DNA damage and disrupting DNA repair–associated pathways. These findings support Senaparib as a clinically relevant radiosensitizing partner for PSMA-directed RLT and warrant further translational development of this combination strategy."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

RESO: A Prospective Observational Study of Senaparib in the Treatment of Epithelial Ovarian Cancer (clinicaltrials.gov) - P=N/A | N=500 | Not yet recruiting | Sponsor: Zhejiang Cancer Hospital

New trial • Real-world evidence • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A Non-Interventional Study of Senaparib as First-Line Maintenance Therapy in Newly Diagnosed Advanced Ovarian Cancer (ChiCTR) - P=N/A | N=50 | Sponsor: West China Second University Hospital of Sichuan University; West China Second University Hospital of Sichuan University

New trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Real-World Study of Senaparib for First-Line Maintenance Therapy in Patients with Newly Diagnosed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (ChiCTR) - P4 | N=50 | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P4 trial • Real-world evidence • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Discovery and development of a potent and highly selective ATR inhibitor IMP9064 (AACR 2025) - P1/2 | "IMP9064 has entered a phase 1/2 study to evaluate the safety and efficacy either as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT05269316). The recommended phase 2 dose (RP2D) has been determined and IMP9064 is currently in expansion studies for selected tumors."

Colorectal Cancer • Oncology • Solid Tumor • PKMYT1

Efficacy and safety of PARP inhibitors monotherapy or combination therapy with anti-angiogenics in ovarian cancer: a network meta-analysis. (PubMed, Front Oncol) - "Besides, niraparib+bevacizumab ranked first in improving PFS, followed by olaparib+ cediranib...In monotherapy, senaparib has shown good efficacy...A reasonable treatment plan should be selected based on the individual conditions of patients. https://www.crd.york.ac.uk/prospero/, identifier CRD 420251003413."

Journal • Monotherapy • Retrospective data • Review • Cervical Cancer • Oncology • Ovarian Cancer • Solid Tumor • Uterine Cancer

Efficacy and Safety of Senaparib Maintenance Therapy in Patients with p53-Abnormal Endometrial Carcinoma After Adjuvant Chemotherapy (ChiCTR) - P=N/A | N=42 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New trial • P53mut • Endometrial Cancer • Oncology • Solid Tumor • TP53

Real-world study of senaparib capsule as first-line maintenance treatment in patients with newly diagnosed advanced ovarian cancer, primary peritoneal cancer，or fallopian tube cancer (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Henan Provincial People's Hospita,medical; Henan Provincial People's Hospita,medical

New P4 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Multicenter, Single-Arm, Prospective Clinical Study on Senaparib Combined with Bevacizumab for First-Line Maintenance Therapy in Newly Diagnosed BRCA Wild-Type Advanced Ovarian Cancer (ChiCTR) - P4 | N=62 | Recruiting | Sponsor: Women’s Hospital, Zhejiang University School of Medicine; Women’s Hospital, Zhejiang University School of Medicine

New P4 trial • Oncology • Ovarian Cancer • Solid Tumor • MUC16

A Single-Center, Prospective Clinical Study of Senaparib Alone or in Combination with Bevacizumab as First-Line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination-Proficient (HRP) Ovarian Cancer (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

New P4 trial • Oncology • Ovarian Cancer • Solid Tumor • MUC16

A Single-Arm Prospective Clinical Study of Senaparib as First-Line Maintenance Treatment in HRD-Negative Advanced Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (ChiCTR) - P=N/A | N=60 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital, Sun Yat-sen University Cancer Research Institute); Sun Yat-sen Universit

New trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • HRD • MUC16

Study on the efficacy and safety of QL1706 combined with Senaparib in neoadjuvant therapy for ovarian Cancer: A prospective, single-arm clinical study (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: The Fourth Hospital of Hebei Medical University; Fourth Hospital of Hebei Medical University

New trial • Oncology • Ovarian Cancer • Solid Tumor

A real-world study on the use of Senaparib for first-line maintenance treatment of newly diagnosed BRCAwt advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine

New P4 trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Poly (ADP-ribose) polymerase (PARP) inhibitors approved for the treatment of cancer. (PubMed, Pharmacol Res) - "The FDA has approved four PARP inhibitors (olaparib, rucaparib, niraparib, and talazoparib) for the treatment of ovarian, breast, prostate, and pancreatic cancer...The Chinese NMPA has approved three PARP antagonists (fuzuloparib, pamiparib, senaparib) for the treatment of ovarian cancer. All seven of these drugs are orally bioavailable and fall within the criteria of Lipinski's rule of five. Drug resistance develops in most PARP-inhibitor-treated cancer patients within one or two years."

Journal • Review • Breast Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

Unveiling the power of PARP inhibitors: a meta-analysis on newly diagnosed advanced ovarian cancer maintenance therapy. (PubMed, Expert Rev Anticancer Ther) - "Notably, senaparib showed superior PFS efficacy compared to veliparib and niraparib. PARPi showed efficacy in improving PFS as maintenance therapy for newly diagnosed advanced OC, although no OS advantage was observed. PROSPERO (CRD420251020275)."

Journal • Retrospective data • Review • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

PARP Inhibitor Maintenance After First-Line Chemotherapy in Advanced-Stage Epithelial Ovarian Cancer: A Systematic Review and Meta-Analysis. (PubMed, JAMA Netw Open) - "Observed treatment efficacy and toxic effects varied across PARP inhibitor regimens; for example, the risk ratio for any recurrence or death in the overall study group ranged from 0.53 (95% CI, 0.40-0.70) for senaparib to 0.83 (95% CI, 0.68-1.00) for olaparib, while the risk ratio for high-grade adverse events ranged from 1.15 (95% CI, 0.64-2.06) for veliparib to 4.73 (95% CI, 2.77-8.07) for niraparib. In this study, no subgroup showed an association between first-line PARP inhibitor maintenance therapy in advanced-stage EOC and improved OS, and findings suggest that the consistency of associated PFS benefits may vary, particularly in homologous recombination proficient and BRCA wild type tumors. Variability in efficacy and toxic effects across subgroups and PARP inhibitor regimens underscores the importance of individualized treatment decisions."

Clinical • Journal • Retrospective data • Review • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD