Latest news with #PSMAfore
Yahoo
5 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
5 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Upturn
6 days ago
- Business
- Business Upturn
Novartis Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer
By GlobeNewswire Published on June 2, 2025, 10:15 IST Ad hoc announcement pursuant to Art. 53 LR At interim analysis, PSMAddition trial met its primary endpoint showing statistically significant and clinically meaningful benefit for Pluvicto™ plus hormone therapy versus hormone therapy alone, with positive trend in overall survival (OS) 1 Pluvicto is already approved for metastatic castration-resistant prostate cancer (mCRPC) and now shows potential in patients in an earlier disease setting 1,2 Novartis to present results at an upcoming medical meeting and, based on FDA feedback, will submit for regulatory review in the second half of the year Novartis is investigating a broad portfolio of RLTs in advanced cancers, including breast, colon, lung and pancreatic and is investing in multiple manufacturing facilities, with industry-leading infrastructure to accelerate delivery of RLTs to patients Basel, June 2, 2025 – Novartis today announced topline results from a pre-specified interim analysis of the Phase III PSMAddition trial. The trial met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) with a positive trend in overall survival (OS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC) treated with radioligand therapy (RLT), Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan), in combination with standard of care (SoC) versus SoC alone1. In PSMAddition, the SoC is a combination of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT)3. Almost all mHSPC patients ultimately progress to metastatic castration-resistant prostate cancer (mCRPC)4. There is a need for additional treatment options with novel mechanisms of action that further delay progression, prolong OS and improve disease control compared to the current SoC, while showing a favorable safety and tolerability profile. 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients,' said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer at Novartis. 'These results further strengthen our confidence in Pluvicto as a PSMA-targeted radioligand therapy. Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients.' This is the third positive read-out for Pluvicto in a Phase III trial, following the VISION and PSMAfore studies5,6. Results from PSMAddition in mHSPC show potential for treatment in an earlier setting with Pluvicto, which was recently granted US Food and Drug Administration (FDA) approval for earlier use in mCRPC, based on results from PSMAfore1,2. Novartis is harnessing the innovation of world-class scientists, strategic partnerships and one of the industry's most competitive pipelines to explore the potential of new, targeted therapies and precision medicine platforms to address the greatest unmet needs in prostate cancer. Data will be presented at an upcoming medical meeting and, based on FDA feedback, will be submitted for regulatory review in the second half of the year. About PSMAddition study PSMAddition (NCT04720157) is a Phase III, open-label, prospective, 1:1 randomized study comparing the efficacy and safety of Pluvicto in combination with SoC (ARPI + ADT) vs. SoC alone in adult patients with PSMA-positive mHSPC3. Patients randomized to the SoC alone arm are allowed to crossover to receive Pluvicto, upon confirmation of radiographic progression by blinded independent review committee (BIRC) and per the discretion of the treating physician3. The primary endpoint is rPFS, defined as the time to radiographic progression by PCWG3-modified RECIST V1.1 (as assessed by BIRC) or death3. The key secondary endpoint of OS is defined as time to death due to any cause3. About Pluvicto™ (INN: lutetium (177Lu) vipivotide tetraxetan) Pluvicto is an intravenous RLT that combines a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177)5,7. After administration into the bloodstream, Pluvicto binds to PSMA-expressing target cells, including prostate cancer cells that express PSMA, a transmembrane protein5,7. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death7. Pluvicto is the only PSMA-targeted agent approved for PSMA-positive mCRPC and is the first targeted RLT to demonstrate a clinical benefit for patients with PSMA-positive mHSPC1. Novartis is investigating Pluvicto in earlier stages of disease, including oligometastatic prostate cancer (PSMA-DC, NCT05939414). Novartis and radioligand therapy (RLT) Novartis is reimagining cancer care with RLT for patients with advanced cancers. By harnessing the power of targeted radiation and applying it to advanced cancers, RLT is designed to deliver treatment directly to target cells, anywhere in the body8,9. Novartis is investigating a broad portfolio of RLTs, exploring new isotopes, ligands and combination therapies to look beyond gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and prostate cancer and into breast, colon, lung and pancreatic cancer. Novartis has established global expertise, with specialized supply chain and manufacturing capabilities across its network of RLT production sites. To support growing demand for RLTs, we have expanded production capabilities in Millburn (NJ), Zaragoza (Spain), Ivrea (Italy) and a state-of-the-art facility in Indianapolis (IN). In Carlsbad (CA), Novartis is establishing its third US-based RLT manufacturing site to support expanded use of RLTs, create resiliency in its manufacturing network and optimize the delivery of medicines to patients on the West Coast. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'may,' 'could,' 'trend,' 'potentially,' 'upcoming,' 'progression,' 'progress,' 'investigating,' 'investing,' 'look beyond,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Pluvicto, or regarding potential future revenues from Pluvicto. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Pluvicto will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Pluvicto will be commercially successful in the future. In particular, our expectations regarding Pluvicto could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Data on file. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2025. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). identifier: NCT04720157. Updated March 5, 2025. Accessed June 2, 2025. Oing C, Bristow RG. Systemic treatment of metastatic hormone-sensitive prostate cancer—upfront triplet versus doublet combination therapy. ESMO Open 2023l doi: 10.1016/ Sartor O, J. de Bono KN, Chi K, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. NEJM 2021; doi: 10.1056/NEJMoa2107322. Morris M, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. The Lancet 2024; doi: 10.1016/S0140-6736(24)01653-2. University of Chicago Medicine. Lutetium-177 PSMA Therapy for Prostate Cancer (Pluvicto). Accessed June 18, 2024. Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision Cancer Treatment [published correction appears in AJR Am J Roentgenol. 2017 Oct;209(4):949. doi: 10.2214/AJR.17.18875]. AJR Am J Roentgenol. 2017;209(2):277-288. doi:10.2214/AJR.17.18264 Jurcic JG, Wong JYC, Knoc SJ, et al. Targeted radionuclide therapy. In: Tepper JE, Foote RE, Michalski JM, eds. Gunderson & Tepper's Clinical Radiation Oncology. 5th ed. Elsevier, Inc. 2021;71(3):209-249 # # # Novartis Media Relations E-mail: [email protected] Novartis Investor RelationsCentral investor relations line: +41 61 324 7944 E-mail: [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Medscape
19-05-2025
- Health
- Medscape
Prostate Cancer Highlights From AUA 2025
Prostate cancer highlights from the American Urological Association 2025 meeting include quality-of-life results from the phase 3 PSMAfore study, findings on androgen deprivation therapy (ADT) with or without darolutamide, and data on the prostate-specific membrane antigen (PSMA)–targeted radionuclide J591, as reported by Dr Brian Rini of Vanderbilt University in Nashville, Tennessee. Dr Rini begins with health-related quality-of-life results reported in the PSMAfore study examining 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer. Patients in the lutetium arm showed a delay to first symptomatic skeletal event with or without concomitant bisphenol A. There was also a shorter median time to improvement in pain and a favorable safety profile vs changes seen in patients receiving androgen receptor pathway inhibition. Next, Dr Rini reviews an analysis of the ARANOTE study, which looked at ultra-low prostate-specific antigen (PSA) response to ADT with or without darolutamide. Five times more ultra-low PSA responses were seen with darolutamide plus ADT vs ADT alone, and rates of PSA < 0.02 ng/mL were higher with darolutamide vs placebo regardless of baseline PSA. Finally, Dr Rini reviews data on the radionuclide J591, which is a PSMA-targeted actinium-225 therapy. He reports that when J591 is used in combination with other agents, there appears to be greater progression-free and overall survival vs single-agent therapy.
Yahoo
30-04-2025
- Business
- Yahoo
Novartis AG (NVS) Q1 2025 Earnings Call Highlights: Impressive Growth and Strategic Advancements
Sales Growth: Up 15% in Q1 2025. Core Operating Income: Increased by 27%. Core Margin: Reached 42.1%, up 400 basis points. Core Earnings Per Share: $2.28, up 31%. Free Cash Flow: $3.4 billion, up 66% in US dollars. Kisqali Growth: 56% in constant currency. Kesimpta Growth: 43% in constant currency. Pluvicto Growth: 21% in Q1. Leqvio Growth: 72% in the quarter. Cosentyx Growth: 18% in the quarter. Entresto Growth: 22%, reaching over $2.2 billion in global sales. Full-Year Guidance: Sales expected to grow high single digits; core operating income to grow low double digits. Warning! GuruFocus has detected 3 Warning Signs with FNNNF. Release Date: April 29, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Novartis AG (NYSE:NVS) reported double-digit sales growth of 15% and core operating income growth of 27% for Q1 2025. The company achieved a core margin of 42.1%, reflecting a 400 basis points improvement. Key products such as Kisqali, Kesimpta, and Pluvicto showed strong growth, with Kisqali growing 56% and Kesimpta 43% in constant currency. Novartis AG (NYSE:NVS) upgraded its full-year 2025 guidance, expecting high single-digit sales growth and low double-digit core operating income growth. The company made significant pipeline progress with three new approvals in the quarter, including Pluvicto, Vanrafia, and Fabhalta. The company faces potential challenges from tariffs and geopolitical uncertainties, which could impact its financial outlook. There is ongoing litigation concerning generic entries for key products like Entresto, which could affect future revenue. Novartis AG (NYSE:NVS) is dealing with pricing pressures in Europe, which may impact the launch and profitability of new medicines. The company needs to expand the number of sites capable of administering Pluvicto to fully realize its market potential. There are concerns about the impact of potential US policy changes, such as the most favored nation pricing, on the company's financial performance. Q: Can you provide insights on Novartis' exposure to tariffs and the impact on your financial outlook? A: Vasant Narasimhan, CEO, explained that Novartis has accounted for potential tariffs in its guidance and has taken actions to manage inventory and supply chain effectively. The company is investing $23 billion to ensure key US products are produced end-to-end in the US, aiming for a manageable impact on financials. Q: Could you elaborate on the gross to net positive impact and its distribution across the portfolio? A: Harry Kirsch, CFO, noted that the 2 percentage points impact was due to lower Medicaid utilization and favorable channel mix. This was broad-based across many brands, without distorting growth rates significantly. Q: What is the outlook for Pluvicto, especially regarding the PSMAfore launch in the US? A: Vasant Narasimhan, CEO, confirmed the $5 billion peak sales ambition for Pluvicto. The company expects rapid uptake in established accounts and is working to expand community capacity and referral networks to support broader adoption. Q: How does Novartis view the competitiveness of pelacarsen given emerging data from competitors? A: Vasant Narasimhan, CEO, stated that Novartis is focused on delivering Phase III trial results and establishing pelacarsen as a first-in-class therapy. The company is also developing less frequently dosed formulations to maintain competitiveness. Q: Can you discuss the potential impact of the Inflation Reduction Act (IRA) on Novartis, particularly regarding exclusivity differences between small and large molecules? A: Vasant Narasimhan, CEO, expressed optimism about legislative support for extending small molecule exclusivity from 9 to 13 years, which is a top priority for the industry. He also highlighted ongoing advocacy for PBM reform and fixing the 340B system. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
