Phase II Trial Evaluating the Efficacy of 177Lutetium-PSMA-617 Treatment in Patients With Metastatic Clear Cell Renal Carcinoma Cell With Progressive Disease on First-line or Second-line Systemic Treatment

Background This study is for adults with advanced kidney cancer that has spread to other parts of the body and has continued to progress despite treatment with immunotherapy and targeted therapy. Unfortunately, treatment options at this stage of the disease are limited. The existing treatments' ability to work against cancer has not been fully looked into.
Rationale The goal of this study is to examine if a new drug treatment called 177Lutetium-PSMA-617, hereafter referred as 177Lu-PSMA-617, which holds the active ingredient 177Lutetium-PSMA and has been used as a standard treatment for advanced prostate cancer since December 2022, can also help treat advanced kidney cancer.
The drug 177Lu-PSMA-617 is being tested as an experimental treatment that targets a specific protein on cancer cells. This protein, known as prostate-specific membrane antigen (PSMA), is present on the surface of kidney cancer cells. Therefore, before the treatment begins, participants will undergo a PET (positron-emission tomography) scan to check if their kidney cancer cells express high levels of PSMA. This scan uses a small amount of radioactive material (in the form of 177Lutetium) to visualize the presence of PSMA on the cancer cells. Only participants who test positive for PSMA can take part in the study. In this approach, PSMA serves two purposes. First, it helps assess whether the cancer expresses this protein and allows 177Lu-PSMA-617 to specifically target and attach to the cancer cells. Second, 177Lu-PSMA-617 delivers a small amount of radiation directly to the tumour, which helps kill cancer cells while minimizing damage to normal cells. This type of treatment is known as a radiopharmaceutical.
Objective The primary aims are to find out if 177Lu-PSMA-617 is useful against kidney cancer and to assess its safety. Throughout the study, participants will undergo several imaging assessments to check their disease and response to treatment.
The study also includes the collection of tissue samples. Together with the information collected from the imaging assessments, this will allow further research into markers that may lead to earlier detection of tumour spread or help identify individuals who may benefit more from treatment with 177Lu-PSMA-617.
Treatment All participants will receive 177Lu-PSMA-617 through an intravenous injection at a standard dose of 7,400 MBq (megabecquerel: a measure of radioactivity). Treatments will be administered approximately every six weeks, for a maximum of six times.
Blood tests are done before and during treatment to check the participant's health and to detect any early side effects from the treatment. Different types of scans are performed before, during, and after 177Lu-PSMA-617 administration to check how well the treatment is working. After treatment ends, follow-up visits will be scheduled every six weeks during the first year. In the second year, your doctor will decide how often you need to come in for visits. These appointments are important for monitoring how the body continues to respond to the treatment. The entire study period will last approximately two years from the time of study entry.
Participants
The study will include approximately 56 participants who will be tested for PSMA expression, to obtain a minimum of 48 participants expressing PSMA entering the study. To qualify, participants must:
* Be diagnosed with advanced kidney cancer previously treated with immunotherapy and targeted therapy.
* Test positive for PSMA on a PET scan.
* Be generally healthy and able to perform daily activities.
* Be at least 18 years of age.
Benefit-risk analysis The drug 177Lu-PSMA-617 has proven to work well in treating advanced prostate cancer and could be a promising new treatment possibility for kidney cancer, although this has not yet been shown. By joining this study, participants will contribute to valuable research to better understand kidney cancer and improve treatment options for future patients. Participating in this study offers a chance to try a new treatment, which might help people with advanced kidney cancer live longer and prevent the disease from getting worse, especially for those who have limited treatment options left after immunotherapy and targeted therapy.
With all new treatments, there are possible risks and side effects associated with them. Side effects of the drug 177Lu-PSMA-617 may include feeling tired, nausea, dry mouth, loss of appetite, and changes in blood cells. While not all side effects are known yet, the study team will carefully follow participants for any side effects during and after treatment. It is important to understand that while the study is being done to provide new information, there are still some questions on the treatment's safety and how well it will work.

Start Date30 Oct 2025

Sponsor / Collaborator-

NCT06894511

/ Not yet recruitingPhase 2

A Phase II, Open-label, Multi-Center, Randomized Study Comparing the Combination of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) and Androgen Receptor Pathway Inhibitor (ARPI) vs. Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in First-line Treatment of Patients With Prostate-Specific Membrane Antigen (PSMA)-Positive Progressive Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to assess whether the combination of AAA617 (administered for 6 cycles at a dose of 7.4 GBq (200 mCi) +/- 10%) and ARPI improves radiographic progression-free survival (rPFS) or time to death compared to AAA617 alone in PSMA-positive mCRPC patients who were previously treated and progressed on ARPI in the biochemical recurrence (BCR)-non metastatic hormone sensitive prostate cancer (mHSPC), mHSPC, or non-metastatic Castration Resistant Prostate Cancer (nmCRPC) setting and have not previously received a taxane-containing regimen in the castrate resistant prostate cancer (CRPC) setting.

Start Date22 Aug 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT06514521

/ Not yet recruitingNot Applicable

A Post Marketing Surveillance on PluvictoTM (Lutetium(177Lu) Vipivotide Tetraxetan) in South Korea; An Open-label, Non-interventional, Primary Data Collection, Multi-center, Non-comparative, Non-randomized Observational Study to Assess Safety and Effectiveness of Pluvicto in Real World Setting

Post marketing study on Pluvicto in Korea

Start Date29 May 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Lutetium (177 Lu) Vipivotide Tetraxetan

100 Translational Medicine associated with Lutetium (177 Lu) Vipivotide Tetraxetan

100 Patents (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

548

Literatures (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

01 Apr 2025·Clinical Genitourinary Cancer

Activity of 177Lu-PSMA-617 in Patients With Advanced Prostate Cancer and Brain Metastases

Article

Author: Rami, Avina ; Jacene, Heather ; Stoltenberg, Hailey ; Lang, Min ; Ravi, Praful ; Wolanski, Andrew ; Rashid, Narmeen S ; Ritzer, Jolivette

01 Apr 2025·CLINICAL NUCLEAR MEDICINE

225Ac-PSMA-617 Augmentation After Insufficient Response Under 177Lu-PSMA-617 Radioligand Therapy in mCRPC: Evaluation of Outcome and Safety From a Prospective Registry (REALITY Study)

Article

Author: Nagel, Lea Sophie ; Schaefer-Schuler, Andrea ; Speicher, Tilman ; Khreish, Fadi ; Bartholomä, Mark ; Ezziddin, Samer ; Rosar, Florian ; Blickle, Arne ; Maus, Stephan ; Burgard, Caroline ; Bastian, Moritz B. ; Petto, Sven

Background:

Even though the introduction of 177Lu-PSMA-617 RLT represents a major milestone in the treatment of mCRPC, there are still patients who do not respond adequately to this therapy and for whom there are only limited options left. Augmenting 177Lu-PSMA-617 RLT with the alpha-emitter 225Ac-PSMA-617 may present an escalating treatment option to increase efficacy. In this study, we aim to evaluate outcome and safety of 225Ac-PSMA-617 augmentation to 177Lu-PSMA-617 RLT in patients who present insufficient response to monotherapy with 177Lu-PSMA-617 RLT.

Patients and Methods:

The study included n = 51 mCRPC patients enrolled in a prospective registry receiving 177Lu-PSMA-617 monotherapy and showing insufficient response, followed by initiation of 225Ac-PSMA-617 augmentation, with adjusted activities depending on individual patient characteristics. Biochemical response, progression-free survival, and overall survival were assessed. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0).

Results:

After initiation of 225Ac-PSMA-617 augmentation to 177Lu-PSMA-617 RLT, 24/51 patients (47.1%) exhibited partial remission, 16/51 (31.4%) stable disease, and 11/51 (21.6%) progressive disease. The median progression-free survival and overall survival rates were 6.3 months and 9.1 months, respectively. The majority of CTCAE gradings remained stable after initiating augmentation. Severe adverse events were rare, and no treatment termination due to side effects was recorded.

Conclusions:

225Ac-PSMA-617 augmented 177Lu-PSMA-617 radioligand therapy seems to be an effective escalating treatment option in patients after failure of conventional 177Lu-PSMA-617 RLT and represents a promising approach balancing antitumor effect and tolerable side effects.

01 Apr 2025·JOURNAL OF NUCLEAR MEDICINE

Therapy-Related Myeloid Neoplasms After [¹⁷⁷Lu]Lu-PSMA Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer: A Case Series

Article

Author: Hofman, Michael S ; Tran, Ben ; Buteau, James P ; Sutherland, Duncan E K ; Ravi Kumar, Aravind S ; Au, Lewis ; Kostos, Louise ; Kong, Grace ; Sandhu, Shahneen ; Emmett, Louise ; Wyatt, Alexander W ; Azad, Arun A ; Eifer, Michal ; Goncalves, Isaac ; Kwan, Edmond M ; Medhurst, Elizabeth

[¹⁷⁷Lu]Lu-prostate-specific membrane antigen (PSMA) therapy has a favorable toxicity profile in patients with metastatic castration-resistant prostate cancer (mCRPC). Therapy-related myeloid neoplasm (t-MN) has been described after [¹⁷⁷Lu]Lu-DOTATATE but has not, to our knowledge, yet been reported after [¹⁷⁷Lu]Lu-PSMA. This case series describes 5 patients with mCRPC who developed t-MN after [¹⁷⁷Lu]Lu-PSMA at our institution. Methods: In this single-center retrospective analysis, we reviewed all patients with mCRPC treated with [¹⁷⁷Lu]Lu-PSMA. Patients who developed biopsy-proven t-MN during or after [¹⁷⁷Lu]Lu-PSMA treatments are summarized with descriptive statistics. Results: From August 26, 2015, to December 31, 2022, 5 of 381 (1.3%) patients treated with [¹⁷⁷Lu]Lu-PSMA were subsequently diagnosed with t-MN. Their median age at cycle 1 (C1) was 78 y (range, 65-80 y). The median time from C1 to t-MN diagnosis was 33.6 mo (range, 6.0-58.8 mo). Previous treatments included docetaxel (n = 5), external-beam radiotherapy to metastases (n = 5), abiraterone (n = 4), enzalutamide (n = 3), and cabazitaxel (n = 3). On PSMA PET/CT, 4 (80%) patients had predominantly bone metastases and 1 (20%) had predominantly nodal metastases. They were treated with [¹⁷⁷Lu]Lu-PSMA-617 (n = 3) or [¹⁷⁷Lu]Lu-PSMA-I&T (n = 2). A median of 7 cycles (range, 4-12 cycles) of [¹⁷⁷Lu]Lu-PSMA was administered, with a median total cumulative activity of 49.2 GBq (range, 31.3-79.0 GBq). Prostate-specific antigen reduction of at least 50% or at least 80% from baseline was seen in 5 (100%) and 4 (80%), respectively. All had prostate-specific antigen progression preceding t-MN diagnosis. t-MN diagnosis included myelodysplastic syndrome with single-lineage dysplasia (n = 2), myelodysplastic syndrome with excess blasts 1 (n = 1), acute promyelocytic leukemia (n = 1), and acute myeloid leukemia (n = 1). At t-MN diagnosis, all patients presented with at least grade 2 cytopenia, involving one or more blood cell lines. Marrow genetic analysis revealed unfavorable karyotypes or mutations in all patients. Most patients received supportive care after t-MN diagnosis. Survival was 8.1, 31.3, 43.0, 56.0, and 60.4 mo from C1 and 1.8, 2.1, 6.8, 10.3, and 12.4 mo from t-MN diagnosis. Conclusion: In the mCRPC population after chemotherapy, we describe a low incidence of t-MN after [¹⁷⁷Lu]Lu-PSMA therapy. Ongoing follow-up is necessary to further define the true incidence of t-MN or other unexpected delayed toxicities, particularly with earlier use of [¹⁷⁷Lu]Lu-PSMA in the disease course.

352

News (Medical) associated with Lutetium (177 Lu) Vipivotide Tetraxetan

14 Apr 2025

·www.prnewswire.com

With Young Adult Cancer on the Rise, New Therapies Spark Investor Buzz

Equity Insider News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, April 14, 2025 /PRNewswire/ -- Equity Insider News Commentary – Routine medical appointments or cancer screenings—critical for catching the disease in earlier, more treatable stages—has dropped to just over 50% of the population. At the same time, doctors are raising alarm bells over a noticeable increase in cancer diagnoses among younger adults, especially women. With proposed funding cuts to the NIH now on the table and new estimates suggesting that drug tariffs could add $10,000 or more to treatment costs, the path forward may rely less on government programs and more on private-sector breakthroughs. So far in 2025, several oncology innovators have stepped forward with meaningful updates, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), CEL-SCI Corporation (NYSE-American: CVM), OS Therapies Incorporated (NYSE-American: OSTX), BeiGene, Ltd. (NASDAQ: ONC), and Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM). Continue Reading Pelareorep Facts Forecasts show cancer's global footprint expanding sharply, with annual case counts expected to rise 20% by 2030 and swell by 75% by mid-century, according to Statista. Meanwhile, Precedence Research projects the global immunotherapy drugs market will reach nearly US$1.2 trillion by 2033, driven by an 18% compound annual growth rate. Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) recently turned heads after securing a new share purchase agreement with Alumni Capital that could provide up to US$20 million in flexible financing, and potentially increase available capital by nearly 45% of the company's valuation at the time of the announcement. The deal gives Oncolytics the right—but not the obligation—to raise capital over a 15-month period through equity sales under its own control. For a clinical-stage company heading toward multiple inflection points, the agreement offers an important advantage: access to cash if and when it's strategically needed. The announcement was met with heightened market interest, driving a notable spike in share price and trading volume on Friday, as investors reacted to the added financial runway and the timing of upcoming trial updates. The capital agreement reinforces a broader narrative taking shape in 2025. Oncolytics continues to advance pelareorep, its intravenously delivered immunotherapy, which triggers a systemic immune response against tumors. Pelareorep is being tested across multiple solid tumor types where outcomes remain poor, including HR-positive HER2-negative metastatic breast cancer, pancreatic ductal adenocarcinoma (PDAC), and advanced anal cancer. All three indications are now being studied in multi-drug combination trials that reflect real-world treatment settings and physician preferences. "With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO in a recent update. "Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission." In breast cancer, the company recently completed a randomized Phase 2 trial called BRACELET-1. In this study, patients treated with pelareorep and paclitaxel outperformed those receiving paclitaxel alone, showing a near doubling in progression-free survival. The company has stated that the data support moving ahead with a larger registrational study, expected to begin later this year. If new results mirror those seen in BRACELET-1, Oncolytics may have the foundation to submit for accelerated approval in this indication. Meanwhile, the company continues to expand its gastrointestinal cancer program. A pancreatic cancer cohort within the GOBLET study is moving toward full enrollment, after clearing safety hurdles with regulators in Germany. Patients will receive pelareorep alongside a modified FOLFIRINOX chemotherapy regimen—with or without the checkpoint inhibitor atezolizumab. Interim efficacy results from this arm are expected later in 2025 and may inform the structure of a future registration-enabling trial. Notably, Oncolytics is working with the Pancreatic Cancer Action Network (PanCAN) on this cohort, as they provided a US$5 million grant to fund it. In advanced anal cancer, pelareorep is being tested with atezolizumab in another GOBLET cohort. Among the first 12 patients, four showed partial responses and one had a complete response lasting over 15 months. Based on these early outcomes—stronger than what's typically seen from checkpoint inhibitors alone—the company has expanded the cohort to include an additional 18 patients. Pelareorep's unique mechanism of action has garnered attention from key opinion leaders in immunotherapy. During a recent event hosted by H.C. Wainwright, Profs. Martine Piccart and Alexander Eggermont emphasized pelareorep's ability to turn so-called "cold" tumors "hot," potentially enhancing the effectiveness of checkpoint inhibitors and other cancer therapies in difficult-to-treat cancers like PDAC and HR+/HER2- metastatic breast cancer. As of the end of Q4 2024, Oncolytics reported $15.9 million in cash on hand, with operations funded into the third quarter of 2025. With late-stage trials being planned, multiple data readouts on the horizon, and a flexible US$20 million equity facility now in place, the company enters Q2 not just with momentum—but with the financial agility to match it. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: CEL-SCI Corporation (NYSE-American: CVM) is gaining traction after a study published in Cancer Cell validated its approach to seeking early approval for Multikine, its lead immunotherapy candidate for head and neck cancer. "The data from both our completed Multikine neoadjuvant Phase 3 study and the study published in Cancer Cell show that newly diagnosed locally advanced head and neck cancer patients who were treated with immune therapies before surgery and had tumor responses, were also likely to have better overall survival," said Geert Kersten, CEO of CEL-SCI. "This is quite logical—when a person's tumor shrinks in response to immunotherapy treatment before the tumor is removed by surgery—their survival outcome is expected to be better." Patients who responded to Multikine before surgery had significantly higher survival rates than those who didn't respond. The FDA has approved a 212-patient confirmatory trial to support the company's regulatory path forward. "We believe that the recent greater availability of peer-reviewed published data specific to neoadjuvant therapy and early tumor response in head and neck cancer supports our development and regulatory efforts," added Kersten. OS Therapies Incorporated (NYSE-American: OSTX), has completed its acquisition of Advaxis Immunotherapies' listeria-based cancer programs, securing full IP ownership and strengthening its leadership in this emerging therapeutic category. "We are thrilled to have now consolidated all of the intellectual property for the listeria cancer immunotherapy platform into OS Therapies, positioning us to fully expand it in the years ahead and improve the standard of care across cancer treatment in the years ahead," said Paul Romness, CEO of OS Therapies. "We now have late-stage, mid-stage and early-stage cancer immunotherapy candidates, a rich pipeline of preclinical cancer immunotherapy candidates and a long IP runway to in order to fully leverage this powerful cancer immunotherapy platform." The company's pipeline now includes three clinical-stage immunotherapies and eight additional preclinical assets aimed at more than 30 cancer types. Its lead candidate, OST-HER2, is expected to be submitted for FDA accelerated approval by year-end for recurrent, lung-metastatic osteosarcoma. If approved, the company would become eligible for a Priority Review Voucher, currently valued at $150 million. BeiGene, Ltd. (NASDAQ: ONC) recently received a positive opinion from the European Medicines Agency's CHMP for TEVIMBRA (tislelizumab) in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer, based on a Phase 3 study showing a significant overall survival benefit. Weeks earlier, the FDA approved TEVIMBRA with chemo for first-line treatment of PD-L1-positive esophageal squamous cell carcinoma after another Phase 3 trial showed a 34% reduction in the risk of death. "Today's positive CHMP opinion marks another important step for TEVIMBRA to potentially expand its indications in a fourth disease area in Europe to reach more patients affected by cancer," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "TEVIMBRA is the cornerstone of our solid tumor portfolio with 58 regulatory approvals in 18 months and is being studied in combination with multiple novel molecules with the potential to herald the next wave of cancer therapeutics." TEVIMBRA is now approved in over 45 countries and remains the backbone of BeiGene's expanding solid tumor portfolio. Actinium Pharmaceuticals, Inc. (NYSE-American: ATNM) recently unveiled ATNM-400, a first-in-class, non-PSMA targeting prostate cancer radiotherapy powered by the potent alpha-emitter Actinium-225, showing 99.8% tumor inhibition in preclinical models. The company plans to present these data at AACR 2025, targeting a major unmet need in patients who progress after Pluvicto. "The current era of radiotherapy is built on the clinical and commercial success of Pluvicto in prostate cancer," said Sandesh Seth, Chairman and CEO of Actinium. "The field is now looking to address patients that do not respond or progress after Pluvicto therapy. We believe ATNM-400 can address this high unmet need and we are incredibly excited by our data to date." Alongside ATNM-400, Actinium is advancing clinical programs across AML, solid tumors, and cell therapy conditioning—backed by a robust patent portfolio and expanding in-house manufacturing infrastructure. Source: CONTACT: Equity Insider [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Photo: Logo: SOURCE Equity Insider WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultImmunotherapyPhase 3Phase 2

13 Apr 2025

·medcitynews.com

BMS Immunotherapy Combo Gets Two FDA Nods for GI Cancers in Span of a Week - MedCity News

The pairing of two Bristol Myers Squibb immunotherapies is now permitted for the first-line treatment of two types of gastrointestinal cancers, after regulatory decisions handed out this past week that convert the accelerated approval status of the drug combination to full FDA approval in both indications. The drugs, Opdivo and Yervoy, belong to the class of medicines called checkpoint inhibitors. On April 8, the FDA approved use of this drug combination for adults and children age 12 and older whose colorectal cancer has metastasized or cannot be removed by surgery. The cancer must also be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), references to biomarkers that indicate the stability of DNA in a tumor. The regulatory submission was based on the results of an open-label Phase 3 test that compared the Opdivo/Yervoy combination to either Opdivo alone or chemotherapy. Results showed the immunotherapy combination led to a 38% reduction in the risk of disease progression or death compared to Opdivo monotherapy, and by 79% compared to chemo, both in the first-line setting. The study is ongoing to assess secondary measures, including overall survival. BMS said it will continue working with study investigators to present these data and longer-term follow-up results in the future. Sponsored Post Changes in Nurse Staffing Answer Clinician Demands The ongoing nursing shortage facilitates high turnover rates since nurses know they won’t have difficulties finding new jobs. In order to retain and attract staff, it’s in a facility’s best interest to understand what nurses want. By Tomasz Rezik On April 11, the FDA approved the combination of Opdivo and Yervoy for treating advanced cases of hepatocellular carcinoma. In the pivotal test in this indication, the drug combination led to median overall survival of 23.7 months. The comparator arm, in which patients received standard of care drugs sorafenib or levantinib, median overall survival was 20.6 months. At three years, the drug combination showed an overall survival rate of 38% versus 24% in the comparator arm. FDA approval of Opdivo plus Yervoy in hepatocellular carcinoma follows the European Commission’s early March approval of the drug combination in this indication. There’s plenty of news on the regulatory front. Here’s a recap of other recent highlights: New and Expanded Regulatory Approvals —Argenx drug Vyvgart Hytrulo received an additional approval for dosing of the product via a prefilled syringe. The drug, supplied in vials, previously received FDA approvals for the autoimmune conditions chronic inflammatory demyelinating polyneuropathy and generalized myasthenia gravis. Analysts say prefilled syringes bring patients a more convenient dosing option while giving Argenx the opportunity to get more market share by penetrating into earlier lines of therapy. Sponsored Post Understanding EGPA: The Role of Eosinophils and Advancements in Treatment Options FASENRA® (benralizumab) injection, for subcutaneous use, 30 mg is indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). FASENRA provides a treatment option for HCPs to consider when managing this challenging disease. By FASENRA, Sponsored Content —Amgen’s Uplizna expanded its label to include the treatment of immunoglobulin G4-related disease (IgG4-RD), an immune-mediated inflammatory disorder that can affect multiple organs. The regulatory decision makes the intravenously infused antibody the first FDA-approved treatment for this rare and chronic disease. Uplizna was first approved in 2020 as a treatment for neuromyelitis optica spectrum disorder. —Bayer’s Viktrakvi now has full FDA approval for the treatment of NTRK gene fusion-positive solid tumors in adults and children without a known acquired resistance mutation. The drug received accelerated approval in this indication in 2018. —AstraZeneca and Daiichi Sankyo welcomed European Union approval of Datroway as a treatment for metastatic breast cancer that is HR positive and HER2 negative. Datroway received FDA approval in the same indication in January. The drug is an antibody drug conjugate designed to target the cancer protein TROP2. —Novartis drug atrasentan, brand name Vanrafia, was awarded accelerated approval as a new treatment for the kidney disorder immunoglobulin A nephropathy (IgAN). The drug is an oral small molecule designed to block the endothelin A receptor. It’s one of two IgAN nephropathy drugs that came via the $3.2 billion acquisition of Chinook Therapeutics in 2023. Novartis’s internal IgAN research yielded the complement inhibitor Fabhalta, which received accelerated approval in this indication last summer. —Speaking of Fabhalta, that Novartis drug expanded its label to include C3 glomerulopathy, making the twice-daily pill the first approved treatment for this rare kidney disorder. Fabhalta is a small molecule designed to block the complement protein C3. It was first approved in 2023 as a treatment for the rare blood disorder paroxysmal nocturnal hemoglobinuria. —Sanofi received FDA approval for fitusiran, brand name Qfitlia, as a treatment for both hemophilia A and B. The drug leverages RNA interference to lower levels of AT, a protein that inhibits blood clotting. The approval covers the treatment of adults and children age 12 and older with or without inhibitors, which are antibodies that can develop in hemophilia patients, making it more difficult to control bleeding. By contrast, new Pfizer drug Hympavzi is approved only for hemophilia A and B patients without inhibitors while Sanofi’s Alhemo is approved only for hemophilia A and B patients with inhibitors. —Blockbuster AstraZeneca cancer immunotherapy Imfinzi landed European Union approval for the treatment of limited-stage small cell lung cancer. This new approval is based on Phase 3 results showing a 27% reduction in the risk of death compared to a placebo. The FDA approved Imfinzi for this indication last December. —Imfinzi also added perioperative treatment of muscle invasive bladder cancer to its list of FDA-approved indications. The newest FDA nod covers use of the drug in combination with chemotherapy before surgery to remove the bladder, followed by Imfinzi as an adjuvant monotherapy. In the pivotal study supporting this new indication, results showed a 32% reduction in the risk of cancer recurrence and a 25% reduction in the risk of death compared to neoadjuvant chemotherapy alone. —The European Commission approved Pfizer vaccine Abrysvo for protection against respiratory syncytial virus (RSV). The regulatory decision expands the vaccine’s approval to adults ages 18 to 59. European regulators initially approved the vaccine in 2023 for preventing lower respiratory tract disease in adults age 60 and older. Abrysvo won FDA approval the same year. —The FDA expanded approval of Novartis’s Pluvicto to include use as an earlier line of treatment — after anti-androgen drugs and before chemotherapy — for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Pluvicto was initially approved in 2022 for PSMA-positive mCRPC that has already been treated with an anti-androgen drug and chemotherapy. Novartis said this expansion is important because about half of patients do not live long enough to receive a second-line treatment. —Exelixis cancer drug Cabometyx expanded its FDA-approved uses to advanced cases of pancreatic neuroendocrine tumors (pNET) and extra-pancreatic neuroendocrine tumors (epNET). The approval covers adults and children age 12 and older. Cabometyx is a small molecule designed to block enzymes that support cancer growth. The drug was first approved in 2016 for advanced renal cell carcinoma. —GSK landed FDA approval for Blujepa, an oral antibiotic developed to treat uncomplicated urinary tract infections. While drugs are already available for these infections, they can become resistant to treatment. Blujepa is designed to block two enzyme targets key to bacterial DNA replication, an approach intended to lower the potential for drug resistance. —The European Commission approved Capvaxive, a pneumococcal vaccine developed by Merck to protect against the 21 Streptococcus pneumoniae serotypes that lead to the majority of cases of invasive pneumococcal disease including eight that are not covered by any other available pneumococcal vaccine. The European regulatory decision covers adults age 18 and older. Capvaxive received FDA approval last July. —Alynlam Pharmaceuticals drug Amvuttra received FDA approval for treating cardiomyopathy caused by transthyretin amyloidosis (ATTR). The RNA interference drug was first approved in 2022 for the treatment of polyneuropathy caused by ATTR. In the cardiomyopathy indication, it will compete with Pfizer’s Vyndaqel and Vyndamax, which are established as the standard of care, as well as Attruby, a BridgeBio Pharma drug that received FDA approval last fall. —Bristol Myers Squibb’s Breyanzi received European Commission approval for relapsed or refractory follicular lymphoma. The CAR T-therapy received accelerated FDA approval in this indication last May. —Geron Corporation’s Rytelo received European Commission approval for the treatment of transfusion-dependent anemia caused by lower-risk myelodysplastic syndrome, a progressive type of blood cancer. The intravenously infused drug is the first telomerase inhibitor to reach the market. Rytelo landed FDA approval last June. —Neffy, an epinephrine nasal spray that ARS Pharmaceuticals developed to treat allergic reactions to insect bites, medications, and food, expanded its FDA approval to include patients weighing 15 to 30 kilograms (about 33 to 60 pounds). The product’s initial approval last year covered its use in patients weighing 30 kg or more. —Roche subsidiary Genentech received FDA approval for tenecteplase, brand name TNKase, as a treatment for acute ischemic stroke in adults. Genentech said TNKase is the first stroke medicine approved by the FDA in nearly 30 years. It’s the second approved indication for the clot-busting drug. The FDA approved it in 2000 for treating acute myocardial infarction. —A Neurotech Pharmaceuticals cell and gene therapy administered via a surgical implant received FDA approval for the treatment of macular telangectasia type 2. The therapy, brand name Encelto, is the first approved treatment for this rare vision-loss disorder. Regulatory Setbacks —The FDA missed the April 1 regulatory decision target date for Novavax’s Covid-19 vaccine. Politico reported the holdup was due to the intervention of Sara Brenner, the FDA’s principal deputy commissioner, who asked for more data. Novavax said it has responded to all of the FDA’s information requests and believes the application is ready for approval based on the submitted Phase 3 data. Novavax’s protein-based vaccine initially received FDA emergency use authorization in 2022, a status that it retained under amended authorizations in 2023 and last year, both times for new formulas that covered the prevalent variants at the time. Full FDA approval would put the vaccine on par with the approved messenger RNA vaccines marketed by Pfizer and Moderna. Novavax’s Covid-19 vaccine will be co-commercialized with Sanofi under a partnership announced last year. —Roche paused European clinical tests of the Duchenne muscular dystrophy gene therapy Elevidys, the pharmaceutical giant said in a letter to the World Duchenne Organization. The move follows Sarepta Therapeutics’ recent report of a liver failure-associated patient death. Roche said the European Medicines Agency asked for a clinical hold on four studies until the inquiry into the cause of death is complete. Under a 2019 deal with Sarepta, Roche holds rights to Elevidys outside of the U.S. —For the second time, the FDA has rejected Aldeyra Therapeutics drug reproxalap as a treatment for dry eye disease. The agency turned down an application for the drug in 2023. According to Aldeyra, the FDA’s latest complete response letter said the new drug application failed to demonstrate efficacy. The regulator asked the company to run at least one more clinical trial. Among the concerns raised by the FDA is differences in baseline scores, which may have affected interpretation of trial results. Aldeyra said results from two ongoing studies are expected later in the current quarter, potentially paving the way for a mid-year resubmission of the application. —The European Medicines Agency refused marketing authorization for Eli Lilly Alzheimer’s disease drug Kisunla. Safety was the main reason cited, particularly the brain inflammation and bleeding that is a known complication risk associated with all drugs in the same class of Alzheimer’s medicines. The agency said the drug’s benefits were not enough to outweigh the potentially fatal safety risks. The FDA approved Kisunla last July. —In other Alzheimer’s drug news, Eisai again failed to persuade Australia’s drugs regulator to register Leqembi. The pharma company had asked the Therapeutics Goods Administration (TGA) to reconsider its October 2024 decision to not register the drug in Australia. Eisai’s request for reconsideration covered a narrower indication, but Eisai said the TGA did not agree that safety has been established for these patients.

Drug ApprovalClinical ResultPhase 3ImmunotherapyVaccine

10 Apr 2025

·www.biopharmadive.com

Amid tariff turmoil, Novartis commits to spending $23B on U.S. manufacturing

Dive Brief:Novartis will substantially expand its U.S. footprint, announcing Thursday plans to spend $23 billion over five years to build six new factories, expand three existing ones and add a new research and development hub.The Swiss drugmaker said its expansion will allow it to manufacture all of the medicine intended for U.S. patients in the country, at a time when President Donald Trumps tariff policies have thrown global trading plans into turmoil. Novartis follows Eli Lilly, Merck & Co. and Johnson & Johnson in rolling out new capital expenditure initiatives as Trump pressures major corporations to bring manufacturing to the U.S.Novartis plan appears to reverse some of the companys recent pullback in the U.S., including closure of an R&D hub in San Diego the announced site of the new U.S. R&D site and shutdown of sites in North Carolina, Colorado, and Illinois. The company has disclosed closure of seven manufacturing sites between 2021 and 2024.Dive Insight:Novartis expansion will substantially boost its capital spending, which has run around $1 billion the past several years. It will also broaden Novartis commercial footprint, adding six new facilities to the 12 it already has. In the U.S., it currently lists its subsidiary headquarters in New Jersey, an R&D hub in Cambridge, Massachusetts, and plants in Indianapolis and New Jersey.Novartis said it will build two new plants to manufacture radiopharmaceuticals like its cancer drugs Pluvicto and Lutathera in Florida and in Texas, as well as expand existing plants in Indianapolis, Millburn, New Jersey, and Carlsbad, California.The sites for four facilities havent been determined yet. Three will make biologic drug substances, products, devices and packages, while the fourth will make chemical drug substances, pills and packaging.Already, Novartis relies on U.S. sites to make some of its most complex medicines, such as cell and gene therapies. With the new investment, it will locate some of its antisense oligonucleotide drug manufacturing in the U.S. for the first time.Novartis will also establish a $1.1 billion biomedical research innovation hub in San Diego. That site is due to open between 2028 and 2029.These investments will enable us to fully bring our supply chain and key technology platforms into the U.S. to support our strong U.S. growth outlook, said CEO Vas Narasimhan, in a statement.He also said the company is well-positioned to adjust to trade disruptions, stating that executives are fully confident in our 2025 guidance, mid- to long-term sales growth outlook and 2027 core margin guidance of 40%+.“Novartis is scheduled to release first quarter 2025 results on April 29. '

Oligonucleotide

100 Deals associated with Lutetium (177 Lu) Vipivotide Tetraxetan

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Approved

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Indication	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Canada	Advanced Accelerator Applications USA, Inc.	25 Aug 2022
PSMA-Positive Castration-Resistant Prostatic Cancer	United States	Novartis Pharmaceuticals Corp.	23 Mar 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Phase 3	France	Novartis AG	12 Sep 2024
Oligometastatic Prostate Carcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Japan	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Austria	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	12 Mar 2024
Oligometastatic Prostate Carcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	12 Mar 2024

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2025	Not Applicable	Prostatic Cancer	117	177Lutetium-PSMA-617 (Luminal A-like (LumA))	bjnefzeehr(knbtytgrlj) = cknwmyhkrz ummixtoanx (irlcppnknl )	Positive	28 Apr 2025
				177Lutetium-PSMA-617 (Luminal B-like (LumB))	bjnefzeehr(knbtytgrlj) = jrfrssztnh ummixtoanx (irlcppnknl )
ASCO_GU2025 Manual	Not Applicable	Metastatic Prostate Carcinoma EPCAM \| DLL3 \| CHGA ... View more	24	177Lu-PSMA-617	rqndhtjzbf(dmwgsflkcn) = hzlxrlbnuz pexcgutysu (upayxeuarj )	Positive	13 Feb 2025
				177Lu-PSMA-617 (AR-V7-positive)	cllfijrtvk(izjmkdjizn) = srlossoudt vttktjhuht (cpaipfrhaq )
ASCO_GU2025 Manual	Not Applicable	Metastatic castration-resistant prostate cancer	643	177Lu-PSMA-617	rzphtjgzbl(rpfkccyseb) = rsivmmwafz aggbmwuebr (fnicymefap, 14.6 - 16.3) View more	Negative	13 Feb 2025
NCT03511664 (VISION, ASCO_GU2025) Manual	Phase 3	Metastatic castration-resistant prostate cancer	551	177Lu-PSMA-617 + ARPIs	qwrosbohxl(rafojyrjtd) = trpswdkocu flnspuxknh (pqqgzshduh )	Positive	13 Feb 2025
				177Lu-PSMA-617	qwrosbohxl(rafojyrjtd) = anvciujgdr flnspuxknh (pqqgzshduh )
ASCO_GU2025	Not Applicable	Metastatic castration-resistant prostate cancer	100	lutetium-177-PSMA-vipivotide tetraxetan (Lu177-PVT) (Bone only)	hlijbpbptd(slplsleiux) = roqwjttmly pamazrqspw (kajilaabwk, 43 - 70) View more	Positive	13 Feb 2025
				lutetium-177-PSMA-vipivotide tetraxetan (Lu177-PVT) (Lung-involved)	hlijbpbptd(slplsleiux) = tpjxoktvnc pamazrqspw (kajilaabwk, 27 - 79) View more
PRECISION (ASCO_GU2025)	Not Applicable	Metastatic castration-resistant prostate cancer prostate-specific antigen	152	Abiraterone	wssvslvcyf(dnrzsngjsz) = ttlbjmepnh bnsqfhgyqv (mzfttwutxt ) View more	Positive	13 Feb 2025
				Enzalutamide	wssvslvcyf(dnrzsngjsz) = ahldttxlmf bnsqfhgyqv (mzfttwutxt ) View more
ASCO_GU2025	Not Applicable	Metastatic castration-resistant prostate cancer prostate-specific membrane antigen (PSMA)	72	lutetium-177-PSMA-617 (In-field progression (IFP))	gzrjlmcsry(akwpfxwplt) = noylcioufr wzlrourwsl (jainoieahl, 6.2 - 12.8) View more	Positive	13 Feb 2025
VISION trial (ASCO_GU2025)	Not Applicable	Metastatic castration-resistant prostate cancer PSMA PET+	84	177Lu-PSMA-617 (Caucasian patients)	jubgfhzifn(gkmgchugqm) = oekebtsjzo hlvhvzsiru (ffppspqegc ) View more	Positive	13 Feb 2025
				177Lu-PSMA-617 (Black patients)	jubgfhzifn(gkmgchugqm) = ssufhvhvsf hlvhvzsiru (ffppspqegc ) View more
ASCO_GU2025	Not Applicable	Metastatic castration-resistant prostate cancer	256	177Lu-PSMA-617 with ARPI	wtlspgizws(hvofzhhrab) = hcyrsuwzrv ilnzfaruzf (blbsnlpjcq, NE - NE)	-	13 Feb 2025
				177Lu-PSMA-617 alone	wtlspgizws(hvofzhhrab) = fdgmsrotdr ilnzfaruzf (blbsnlpjcq, 11.6 - 19.1)
PRECISION (ASCO_GU2025)	Not Applicable	Metastatic castration-resistant prostate cancer prostate-specific antigen	431	177Lu-PSMA-617taxane (Prompt cohort (1 ARPI and 1 taxane))	hvhqtjystn(tthdgalktu) = xvqmndrvcv nsmbwugcde (mdvgpvodck ) View more	Positive	13 Feb 2025
				177Lu-PSMA-617 (Deferred cohort (>1 ARPI and/or >1 taxane))	hvhqtjystn(tthdgalktu) = qjpwscmxpy nsmbwugcde (mdvgpvodck ) View more

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