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Medscape
a day ago
- Health
- Medscape
Add-On Niraparib May Slow mHSPC
Adding the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib to abiraterone acetate plus prednisone delayed disease progression and postponed the onset of symptoms in patients with metastatic castration-sensitive prostate cancer with homologous recombination repair (HRR) genetic alterations, according to findings from the AMPLITUDE trial. An interim analysis also demonstrated an early trend toward improved overall survival in patients who received niraparib. These findings support adding niraparib to abiraterone acetate plus prednisone 'as a new treatment option' in patients with HRR alterations, said Study Chief Gerhardt Attard, MD, PhD, chair of medical oncology, University College London Cancer Institute, London, England, speaking at the American Society of Clinical Oncology (ASCO) 2025 annual meeting. The findings also highlight that 'it's going to be incredibly important that patients who get diagnosed with hormone-sensitive prostate cancer are tested to see if they have these mutations, so they can be offered the right therapy at the right time,' Outside Expert Bradley McGregor, MD, with Dana-Farber Cancer Institute in Boston, said during a press briefing. Ultimately, 'you don't know if you don't test,' McGregor added. About one quarter of patients with metastatic castration-sensitive prostate cancer have alterations in HRR genes, about half of which are BRCA mutations. These patients typically experience faster disease progression and worse outcomes. An androgen receptor pathway inhibitor, such as abiraterone, alongside androgen deprivation therapy with or without docetaxel, is standard therapy for these patients, but 'there is still a need for treatments that are tailored to patients whose tumors harbor HRR alterations,' Attard said in a press release. Adding niraparib to this standard regimen could help improve survival in these patients. In 2023, the FDA approved niraparib and abiraterone acetate to treat BRCA -mutated metastatic castration-resistant prostate cancer, after findings from the MAGNITUDE study demonstrated improved progression-free survival (PFS). The phase 3 AMPLITUDE trial set out to evaluate whether this combination would yield similar survival benefits in metastatic castration-sensitive prostate cancer with HRR mutations. In the study, 696 patients (median age, 68 years) with metastatic castration-sensitive prostate cancer and one or more HRR gene alterations were randomly allocated (1:1) to niraparib with abiraterone acetate plus prednisone or placebo with abiraterone acetate plus prednisone. Exclusion criteria included any prior PARP inhibitor therapy or androgen receptor pathway inhibitor other than abiraterone. Eligible patients could have received at most 6 months of androgen deprivation therapy, ≤ 6 cycles of docetaxel, ≤ 45 days of abiraterone acetate plus prednisone and palliative radiation. Baseline characteristics were well balanced between the groups. Just over half the patients in each group had BRCA1 or BRCA2 alterations. The majority had an electrocorticogram performance status of 0, but high-risk features with a predominance for synchronous metastatic disease and metastatic high volume. About 16% had received prior docetaxel, in keeping with real world data, Attard noted. At a median follow-up of 30.8 months, niraparib plus standard therapy led to a significant 37% reduction in the risk for radiographic progression or death. The median radiographic PFS (rPFS) was not reached in the niraparib group vs 29.5 months in the placebo group (hazard ratio [HR], 0.63; P = .0001). Patients with BRCA alterations, in particular, showed the greatest benefit, with niraparib reducing the risk for radiographic progression or death by 48% compared to placebo (median rPFS not reached vs 26 months; HR, 0.52; P < .0001). On the key secondary endpoint of time to symptomatic progression, adding niraparib led to a 'statistically and clinically' significant benefit — a 50% lower in the risk for symptomatic progression in the full population (HR, 0.50), and a 56% lower risk in BRCA -mutant group (HR, 0.44). The first interim analysis also showed an early trend toward improved overall survival favoring the niraparib combination, with a reduction in the risk for death of 21% in the HRR-mutant population (HR, 0.79; P = .10) and 25% (HR, 0.75; P = .15) in the BRCA -mutant population. Grade 3/4 adverse events were more common with the niraparib combination group compared to the placebo group (75% vs 59%), with anemia and hypertension being the most common. However, treatment discontinuations due to adverse remained low (15% with niraparib vs 10% with placebo). Attard noted, however, that half the target number of patients required for the final analysis died. Still, 'in my view, there's a clear trend for favoring survival in the patients randomized to niraparib,' he told attendees. 'Exciting News' for Patients The AMPLITUDE results are 'really exciting news for our patients,' McGregor said. Considering the poor prognosis of patients with metastatic castration-sensitive prostate cancer, 'it is reasonable to prioritize early access to PARP inhibitors for these men, at least for the ones with BRCA mutations,' added ASCO discussant Joaquin Mateo, MD, PhD, with Vall d'Hebron Institute of Oncology, Barcelona, Spain. However, Mateo explained, 'I think that for patients with mutations in the other genes, I will be more prudent, and I'll be on the lookout for the overall survival data to mature.' The other key conclusion, Mateo said, is that genomic profiling 'should be moved earlier into the patient course, and I am confident that embedding genomic profiling into the diagnostic evaluations of metastatic prostate cancer is also going to result in better quality of testing, more efficacious testing, and also a more equitable framework of access to testing for patients.'
Yahoo
7 days ago
- Business
- Yahoo
J&J data support earlier use of combo pill in prostate cancer
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial. Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncology's meeting in Chicago. They could potentially expand the number of people able to receive J&J's Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga. Akeega, along with hormone therapy, kept men with so-called BRCA mutations from getting sicker for longer than Zytiga and hormone therapy, reducing the relative risk of disease progression by nearly half. The combination also reduced by 56% the risk that BRCA-positive participants in the study experienced symptoms of disease progression. Akeega is already approved for men whose disease stops responding to hormone therapy if they have BRCA mutations, which often signal a more aggressive cancer. This stage of disease, classified as 'castration resistant,' is considered to be advanced. Akeega's constituent drug components target the proteins PARP and CYP17, respectively. Drugs aimed at CYP17 have been used in prostate cancer for more than a decade, while PARP inhibitors are more recent arrivals. However, in prostate cancer, PARP blockers are largely used in the castration-resistant setting, where testosterone suppression no longer keeps the disease in check. Some physicians and drugmakers have explored moving treatment to early-stage disease as a way of helping patients live longer. Amplitude was set up to test that hypothesis. 'The challenge is that when we use PARP inhibitors as monotherapy at the end of the treatment sequence, resistance rapidly develops, and the median time to radiographic progression-free survival is shorter than 12 months,' said Gerhardt Attard, a professor of medical oncology at University College London and lead author of the study, in a press conference presenting the data. 'This group of patients have poor outcomes, significantly worse outcomes than other patients.' Bradley McGregor, a genitourinary specialist with Dana-Farber Cancer Institute, said the study results will help clear up debate over where PARP inhibitors fit into treatment of people with hormone-sensitive disease. 'This data is quite compelling for the BRCA 1/2 patients where that magnitude of benefit is higher,' he said. Amplitude enrolled men with a broader set of mutations to homologous recombination repair, or HRR, genes, of which BRCA is one. The benefit in the overall population was smaller, with Akeega reducing the risk of radiographic progression by 37% and symptomatic progression by half. Akeega is currently approved only for the narrow BRCA-mutated population. Of the PARP inhibitors on the market, only AstraZeneca's Lynparza has won clearance for the broader HRR population, but its use is reserved for castration-resistant disease. Mark Wildgust, J&J's global medical affairs vice president for oncology, said the HRR results from Amplitude should stimulate some discussion with the Food and Drug Administration. The company must keep working with regulators 'to see if there is room or comfort to expand to that broader population,' he said. Trial investigators also analyzed results by specific HRR mutations beyond BRCA. With some, like one called PALB2, patients didn't see any benefit, Wildgust said. 'I think with smaller patient groups, it's a bit more difficult,' he added. Physicians will need to be able to identify the patients most likely to benefit, should Akeega gain an expanded approval in earlier-stage prostate cancer. 'You don't know if you don't test,' McGregor said. Akeega first won approval in 2023. Johson & Johnson didn't report annual sales for the drug in 2024. GSK has some rights to Zejula, Akeega's PARP-inhibiting ingredient, by way of its 2019 acquisition of the drug's developer, Tesaro Bio. J&J had previously licensed rights to niraparib in prostate cancer specifically, allowing it to market Akeega.
Yahoo
17-02-2025
- Health
- Yahoo
AVEO Oncology, an LG Chem company, Announces Tivozanib Presentations at ASCO GU 2025
BOSTON, Feb. 12, 2025 /PRNewswire/ -- AVEO Oncology, an LG Chem company ("AVEO"), is a biopharmaceutical company that is trying to provide differentiated solutions to improve cancer patients lives, announced today two poster presentations at the upcoming American Society of Clinical Oncology (ASCO) Genitourinary (GU) 2025 meeting this February 13-15, 2025, in San Francisco, CA. "We are excited to be presenting the latest tivozanib data at ASCO GU," said Edgar Braendle, AVEO's Chief Medical Officer, "and we look forward to sharing this important data with the genitourinary community and continue to build on the extensive tivozanib clinical story." Presentation Details Title: Integrated efficacy and safety exposure response (ER) analysis of tivozanib (TIVO) for the treatment of renal cell cancer (RCC)First Author: Bradley McGregor, MD, Dana-Farber Cancer InstituteAbstract Number: 461Poster Session: Poster Session C: Renal Cell Cancer; Penile, Testicular and Urethral CancersPoster Board: D29Date and Time: Saturday, February 15, 2025, 7:10-8:10 AM PT and 11:30 AM-12:45 PM PTLocation: Level 1, West Hall Title: Patient-reported outcomes (PROs) for tivozanib (TIVO) + nivolumab (NIVO) vs TIVO monotherapy in patients with renal cell carcinoma (RCC) following an immune checkpoint inhibitor (ICI): results of the phase 3 TiNivo-2 studyFirst Author: Katy Beckermann, MD, PhD, Vanderbilt UniversityAbstract Number: 459Poster Session: Poster Session C: Renal Cell Cancer; Penile, Testicular and Urethral CancersPoster Board: D27Date and Time: Saturday, February 15, 2025, 7:10-8:10 AM PT and 11:30 AM-12:45 PM PTLocation: Level 1, West Hall About FOTIVDA® (tivozanib)FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONSHypertension was reported in 45% of patients (22% ≥ Grade 3). Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis. Cardiac failures were reported in 1.6% of patients (1% ≥ Grade 3); 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure during treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation. Cardiac ischemia were reported in 3.2% of patients; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of patients, including death due to ischemic stroke (0.1%). Closely monitor patients at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke. Venous Thrombotic Events (VTE) were reported in 2.4% of patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue in patients who develop serious VTEs. Hemorrhagic Events were reported in 11% of patients; 0.2% of events were fatal. Use FOTIVDA with caution in patients who are at risk for or who have a history of bleeding. Proteinuria was reported in 8% of patients (2% = Grade 3). Monitor during treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment. Discontinue in patients who develop nephrotic syndrome. Gastrointestinal (GI) Perforation including fatal cases, has been reported in patients receiving FOTIVDA. Monitor for symptoms of GI perforation or fistula formation periodically throughout treatment with FOTIVDA. Permanently discontinue FOTIVDA in patients who develop severe or life-threatening GI perforation. Thyroid Dysfunction events were reported in 11% of patients (0.3% ≥ Grade 3). Monitor thyroid function before and during treatment with FOTIVDA. Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery and do not administer for at least 2 weeks after major surgery and until adequate wound healing is observed. Reversible Posterior Leukoencephalopathy Syndrome (RPLS) can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue if signs or symptoms of RPLS occur. Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA. Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. ADVERSE REACTIONSCommon adverse reactions include fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. Serious adverse reactions include bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%). DRUG INTERACTIONSAvoid coadministration with strong CYP3A4 inducers. USE IN SPECIFIC POPULATIONSAdvise women not to breastfeed during treatment and for at least 1 month after the last dose. The recommended dosage for patients with end-stage renal disease has not been established. Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established. To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or Please see full Prescribing Information for FOTIVDA® (tivozanib). About AVEO Pharmaceuticals, is an oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA® (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology and other novel targeted combinations in RCC and other indications, and has other investigational programs in clinical development. AVEO became a wholly owned subsidiary of LG Chem Life Sciences USA, Inc. on January 19, 2023. AVEO continues to operate under the AVEO Oncology, an LG Chem company, name. About LG Chem, Ltd. and LG Chem Life SciencesLG Chem, Ltd. (LG Chem) is a leading global chemical company with a diversi½ed business portfolio in the key areas of petrochemicals, advanced materials, and life sciences. The company manufactures a wide range of products from high-value added petrochemicals to renewable plastics, specializing in cutting- edge electronic and battery materials, as well as drugs and vaccines to deliver differentiated solutions for its customers. LG Chem Life Sciences develops, manufactures, and globally commercializes pharmaceutical products, with a focus on Oncology, Immunology, and Metabolic diseases. Our mission is to transform people's lives through inspiring science and leading innovation. For more information, please visit Contacts Media:John F. KoutenJFK Communications, (908) 227-4714 View original content to download multimedia: SOURCE AVEO Oncology Sign in to access your portfolio
