Latest news with #Rucaparib
Medscape
09-07-2025
- Health
- Medscape
Rucaparib Benefits HRD-Negative Ovarian Cancer Subgroups
Rucaparib maintenance therapy provided consistent benefits across all subgroups of patients grouped by prognostic factors of their homologous recombination deficiency-negative ovarian cancer tumors. Vanda Salutari, MD, of the Gynecology Oncology Unit at Policlinico Agostino Gemelli in Rome, Italy, presented this and other findings of a subgroup analysis of the ATHENA-MONO trial at ESMO Gynecological (ESMO Gyn) Cancers Congress 2025. Homologous recombination deficiency (HRD)-negative disease represents the largest subgroup in ovarian cancer, comprising approximately 44% of patients in the ATHENA-MONO study, Salutari noted in her presentation. These patients, characterized as BRCA wild-type with low loss of heterozygosity (< 16%), experience worse progression-free survival (PFS) and overall survival outcomes than those with BRCA mutations or HRD-positive disease. The trial revealed encouraging efficacy data for the treatment regimen in patients who are historically associated with poor prognosis, the investigator said. In the original ATHENA-MONO analysis, rucaparib imparted a 35% reduction in progression risk compared with placebo in this subgroup of HRD-negative patients, and this 'was also supported by an interim analysis of overall survival,' she explained. The ATHENA-MONO trial enrolled patients with newly diagnosed stage III-IV advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed frontline platinum-doublet chemotherapy and achieved complete or partial response. Patients were randomized 4:1 to receive oral rucaparib 600 mg twice daily or placebo for up to 24 months. In the HRD-negative population (189 patients receiving rucaparib, 49 receiving placebo), rucaparib demonstrated an improvement in investigator-assessed PFS. The median PFS was 12.1 months in the rucaparib group compared with 9.1 months in the placebo group (hazard ratio [HR], 0.65; 95% CI, 0.45-0.95). The subgroup analysis revealed strong benefits in specific patient populations. The most pronounced benefit was observed in patients with measurable disease (HR, 0.25; 95% CI, 0.08-0.80) and in those with elevated CA-125 levels (HR, 0.29; 95% CI, 0.10-0.84). Patients with residual disease after chemotherapy (HR, 0.38; 95% CI, 0.19-0.79) and those who underwent interval debulking surgery (HR, 0.53; 95% CI, 0.32-0.88) also derived strong benefits. Salutari concluded her presentation by describing what she saw as the clinical implications of her research. 'First-line rucaparib maintenance reduced the risk of progression in patients with advanced, HRD-negative high-grade ovarian cancer across all prognostic factors evaluated,' Salutari emphasized. 'These data suggest that rucaparib is a potential beneficial therapeutic option for all patients, including those with HRD-negative tumors.' Potential Mechanisms Driving Efficacy Jean-Emmanuel Kurtz, MD, PhD, of the University of Strasbourg, Strasbourg, France, serving as the external discussant, explained that the benefit of PARP inhibitor therapy in HRD-negative disease seen in this trial was somewhat unexpected. 'In HRD-negative cells, in theory, PARP inhibition would not drive any outcome benefit because of synthetic lethality,' Kurtz said. 'However, we know from the PRIMA study that [PARP inhibitors] provide PFS benefit in HRD-negative patients, and this was also found in ATHENA-MONO.' Kurtz explained that PARP inhibitors may work through alternative mechanisms in HRD-negative cells, including immune activation. 'PARP inhibitors do something in those cells. They induce a senescence-like phenotype and upregulate a series of cytokines and chemokines. This senescence-associated phenotype recruits immune cells to the tumor that potentially activate immune responses,' he said. Kurtz added that tumor burden appears to also be a driver of rucaparib efficacy in the HRD-negative population. 'What is interesting here is that the hazard ratio differences might be driven by patients with poor prognosis risk factors, such as FIGO, CR-125, and measurable disease,' he said. Manageable Safety Profile The safety analysis revealed no new safety signals in the HRD-negative population, with an adverse event profile consistent with that in previous rucaparib studies. The most common any-grade treatment-emergent adverse events in patients who received rucaparib were asthenia (63.5%), nausea (59.3%), and anemia (46.6%). Salutari said that grade 3 or higher treatment-emergent adverse events were manageable, with anemia (26.5%), neutropenia (14.8%), and elevated liver enzymes (13.2%) being the most common grade 3 or higher treatment-emergent adverse events in the rucaparib group. Implications and Future Directions According to Kurtz, the results of this analysis add to growing evidence that PARP inhibitors may have utility beyond their established role in HRD-positive disease. He noted the complexity of ovarian cancer biology, describing it as 'like a jigsaw puzzle with different shapes' that includes BRCA wild-type, HRD non- BRCA , genomic and somatic BRCA -mutated populations, and a 'grey zone' of testing failures and undetected mutations. He added that the ATHENA-MONO findings complement results from other maintenance trials, including PRIMA with niraparib, suggesting a potential class effect of PARP inhibitors in HRD-negative disease. 'Data from the ATHENA-MON demonstrated that rucaparib efficacy is associated with HRD, but in HRD-negative patients, tumor burden may drive the drug efficacy,' Kurtz concluded. Further research is needed to identify biomarkers that could better predict which HRD-negative patients are most likely to benefit from maintenance therapy with PARP inhibitors, he added. Salutari reported financial relationships with MSD, AbbVie, AstraZeneca, GSK, ImmunoGen, and Menarini. Kurtz reported financial relationships with AstraZeneca, Eisai, GSK, Chugai Pharma, PharmaMar, and MSD.
Web Release
10-04-2025
- Business
- Web Release
Hikma signs exclusive licensing agreement with pharma& to bring innovative oncology treatment to MENA
By Editor_wr On Apr 10, 2025 Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, has announced an exclusive licensing agreement with pharmaand GmbH (pharma&), a global pharmaceutical company based in Vienna, Austria. This agreement grants Hikma exclusive rights to commercialise rucaparib across the Middle East and North Africa (MENA) region. Rucaparib, marketed as Rubraca®, is an innovative small-molecule oral therapy designed to inhibit poly (ADP-ribose) polymerases (PARPs), a family of proteins critical to DNA repair in cancer cells. This mechanism makes rucaparib an important treatment option for patients battling ovarian cancer, the 8th most common cancer in women globally[1], and prostate cancer, the 4th most common cancer worldwide and the second most common cancer in men[2]. Rucaparib has received regulatory approval from both the European Medicines Agency (EMA) and the United States Food and Drug Administration (U.S. FDA). Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA, said: 'We are pleased to add rucaparib, an innovative oncology treatment, to our growing oncology portfolio in MENA. This agreement is a major step to further enhance patients' access to life-changing treatments and address critical medical needs across the region. By strengthening our oncology portfolio, we reaffirm our commitment to providing advanced cancer treatments and supporting our purpose of putting better health within reach, every day.' As the company's first innovative small-molecule oral therapy in oncology approved by both the U.S. FDA and EMA, this partnership strengthens Hikma's promise of providing better access to life saving treatment options and its commitment to improving patient outcomes. [1] Ovarian cancer statistics | World Cancer Research Fund [2] Prostate cancer statistics | World Cancer Research Fund Comments are closed.
Zawya
10-04-2025
- Business
- Zawya
Jordan: Hikma signs licensing agreement to bring innovative oncology treatment to MENA
AMMAN — Hikma Pharmaceuticals PLC (Hikma) on Wednesday announced an exclusive licensing agreement with pharmaand GmbH (pharma&), a global pharmaceutical company based in Vienna, Austria. The agreement grants Hikma exclusive rights to commercialise rucaparib across the Middle East and North Africa (MENA) region, the Jordan New Agency, Petra, reported. Rucaparib, marketed as Rubraca, is an innovative small-molecule oral therapy designed to inhibit poly (ADP-ribose) polymerases (PARPs), a family of proteins critical to DNA repair in cancer cells. This mechanism makes rucaparib an 'important' treatment option for patients battling ovarian cancer, the eighth most common cancer in women globally, and prostate cancer, the fourth most common cancer worldwide and the second most common cancer in men. Rucaparib has received regulatory approval from the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA). Hikma Executive Vice Chairperson and President of MENA Mazen Darwazah said: "We are pleased to add rucaparib, an innovative oncology treatment, to our growing oncology portfolio in MENA.' 'This agreement is a major step to further enhance patients' access to life-changing treatments and address critical medical needs across the region. By strengthening our oncology portfolio, we reaffirm our commitment to providing advanced cancer treatments and supporting our purpose of putting better health within reach, every day,' Darwazah added. As the company's first innovative small-molecule oral therapy in oncology approved by the USFDA and EMA, this partnership boosts Hikma's promise of providing better access to life saving treatment options and its commitment to improving patient outcomes, he noted. © Copyright The Jordan Times. All rights reserved. Provided by SyndiGate Media Inc. (
Jordan Times
09-04-2025
- Business
- Jordan Times
Hikma signs licensing agreement to bring innovative oncology treatment to MENA
Hikma Pharmaceuticals PLC announces an exclusive licensing agreement with pharmaand GmbH to commercialise rucaparib across the Middle East and North Africa (Petra photo) AMMAN — Hikma Pharmaceuticals PLC (Hikma) on Wednesday announced an exclusive licensing agreement with pharmaand GmbH (pharma&), a global pharmaceutical company based in Vienna, Austria. The agreement grants Hikma exclusive rights to commercialise rucaparib across the Middle East and North Africa (MENA) region, the Jordan New Agency, Petra, reported. Rucaparib, marketed as Rubraca, is an innovative small-molecule oral therapy designed to inhibit poly (ADP-ribose) polymerases (PARPs), a family of proteins critical to DNA repair in cancer cells. This mechanism makes rucaparib an 'important' treatment option for patients battling ovarian cancer, the eighth most common cancer in women globally, and prostate cancer, the fourth most common cancer worldwide and the second most common cancer in men. Rucaparib has received regulatory approval from the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA). Hikma Executive Vice Chairperson and President of MENA Mazen Darwazah said: "We are pleased to add rucaparib, an innovative oncology treatment, to our growing oncology portfolio in MENA.' 'This agreement is a major step to further enhance patients' access to life-changing treatments and address critical medical needs across the region. By strengthening our oncology portfolio, we reaffirm our commitment to providing advanced cancer treatments and supporting our purpose of putting better health within reach, every day,' Darwazah added. As the company's first innovative small-molecule oral therapy in oncology approved by the USFDA and EMA, this partnership boosts Hikma's promise of providing better access to life saving treatment options and its commitment to improving patient outcomes, he noted.
Zawya
09-04-2025
- Business
- Zawya
Hikma signs exclusive licensing agreement with pharma& to bring innovative oncology treatment to MENA
Amman – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, has announced an exclusive licensing agreement with pharmaand GmbH (pharma&), a global pharmaceutical company based in Vienna, Austria. This agreement grants Hikma exclusive rights to commercialise rucaparib across the Middle East and North Africa (MENA) region. Rucaparib, marketed as Rubraca®, is an innovative small-molecule oral therapy designed to inhibit poly (ADP-ribose) polymerases (PARPs), a family of proteins critical to DNA repair in cancer cells. This mechanism makes rucaparib an important treatment option for patients battling ovarian cancer, the 8th most common cancer in women globally [1], and prostate cancer, the 4th most common cancer worldwide and the second most common cancer in men [2]. Rucaparib has received regulatory approval from both the European Medicines Agency (EMA) and the United States Food and Drug Administration (U.S. FDA). Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA, said: 'We are pleased to add rucaparib, an innovative oncology treatment, to our growing oncology portfolio in MENA. This agreement is a major step to further enhance patients' access to life-changing treatments and address critical medical needs across the region. By strengthening our oncology portfolio, we reaffirm our commitment to providing advanced cancer treatments and supporting our purpose of putting better health within reach, every day.' As the company's first innovative small-molecule oral therapy in oncology approved by both the U.S. FDA and EMA, this partnership strengthens Hikma's promise of providing better access to life saving treatment options and its commitment to improving patient outcomes. For inquiries: Zaina AlAtiyat Manager, MENA Communications & Corporate Affairs ZAlAtiyat@ About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the MENA and Europe. For more information, please visit: [1] Ovarian cancer statistics | World Cancer Research Fund [2] Prostate cancer statistics | World Cancer Research Fund
