Novartis Announces Significant rPFS Benefit with Lutetium [177Lu] Vipivotide Tetraxetan in PSMA-Positive mHSPC Patients in Phase III PSMAddition Trial

• In the interim analysis, PSMAddition reached its primary endpoint, showing that lutetium [177Lu] texiveptide injection combined with standard treatment had a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared to standard treatment alone.（rPFS）Benefit, and overall survival（OS）Showing a positive trend 

• [177Lu] Lutetium Lu 177 dotatate Injection has been approved for metastatic castration-resistant prostate cancer.（mCRPC）Patients, now showing application potential in the early-stage prostate cancer patient population 
  

• Novartis Plans to Announce the Results of This Study at the Upcoming Medical Conference and According to the U.S. Food and Drug Administration（FDA）The feedback is expected to submit the regulatory review application in the second half of this year.

• Novartis is in the field of advanced tumors(Including breast cancer, colon cancer, lung cancer, and pancreatic cancer)Development of a Wide Range of Radioligand Therapies（RLT）Product portfolio, while building multiple production bases, fully accelerate the supply of RLT with industry-leading infrastructure.

Novartis recently announced the top-line results of the pre-specified interim analysis from its Phase III PSMAddition trial. The trial met its primary endpoint, demonstrating activity in prostate-specific membrane antigen（PSMA）Positive Metastatic Hormone-Sensitive Prostate Cancer（mHSPC）In patients, radioligand therapy（RLT）Lutetium [177Lu] Texiveptide Injection (lutetium(¹⁷⁷Lu)vipivotide tetraxetan)Combined Standard Treatment（SoC）Compared with SoC alone, radiological progression-free survival（rPFS）Benefits with statistical significance and clinical meaning, along with overall survival（OS）Showing a positive trendIn the trial, SoC specifically refers to androgen receptor pathway inhibitors.（ARPI）Combined Androgen Deprivation Therapy（ADT）Solution.

Almost all patients with mHSPC will eventually progress to metastatic castration-resistant prostate cancer.（mCRPC）. Therefore, compared with the existing SoC,There is an urgent need for a treatment regimen based on a novel mechanism of action, with the aim of further delaying disease progression, extending OS, improving disease control effectiveness, and ensuring good safety and tolerability.

Progression of metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a challenging issue, significantly impacting patient survival. These results further reinforce our confidence in lutetium [177Lu] vipivotide tetraxetan injection as a PSMA-targeted radioligand therapy. Following the recent FDA approval based on the PSMAfore trial for mCRPC, these data suggest its potential to improve treatment outcomes when used at an earlier disease stage and address unmet clinical needs in patients with mHSPC.

This is following the VISION and PSMAfore studies, Lutetium [177Lu] Texiveptide Injection Achieves Third Positive Outcome in Phase III Clinical Trial; Previously, Based on the PSMAfore Trial Results, Lutetium [177Lu] Texiveptide Injection Received FDA Approval for Frontline mCRPC TreatmentThe data from mHSPC patients in the PSMAddition trial further confirms the potential of Lutetium [177Lu] Texiveptide Injection for treating earlier stages of the disease. With the innovative capabilities of top global scientists, strategic collaborations, and a highly competitive R&D pipeline, Novartis continues to explore the potential of novel targeted therapies and precision medicine platforms, committed to addressing significant unmet needs in the field of prostate cancer treatment.

The relevant data will be announced at the upcoming medical conference, and based on feedback from the FDA, Novartis plans to submit a regulatory review application in the second half of 2025.

PSMAddition（NCT04720157）It is a Phase III, open-label, prospective, 1:1 randomized study comparing Lutetium [177Lu] Texiveptide Injection in combination with SoC in patients with PSMA-positive mHSPC.（ARPI+ADT）Compared with the efficacy and safety of SoC alone 3. Patients randomized to the SoC alone group may be subject to an independent blinded review committee.（BIRC）After confirming radiological progression and based on the judgment of the attending physician, choose to cross-administer Lutetium [177Lu] Texiveptide Injection.. The primary endpoint of the study is rPFS, defined as PCWG3-modified RECIST V1.1(Evaluated by BIRC)Time to radiologic progression or death . The key secondary endpoint was OS, defined as the time to death from any cause.。

[177Lu] Lutetium Lu 177 dotatate injection is a radioligand therapy administered via intravenous injection.（RLT）, composed of targeting ligands and therapeutic radionuclides(Lutetium-177)Combined to formAfter entering the bloodstream, Lutetium [177Lu] Texiveptide Injection can specifically bind to prostate cancer cells expressing PSMA. Following binding, the energy released by the radioisotope can destroy the target cells and adjacent cells, inhibiting their replication ability and/or inducing tumor cell death.Lutetium [177Lu] Texiveptide Injection is currently the only PSMA-targeted drug approved outside of China for the treatment of PSMA-positive mCRPC, and it is also the first targeted RLT to demonstrate clinical benefit in patients with PSMA-positive mHSPC.Novartis is exploring the use of Lutetium [177Lu] Texiveptide Injection in earlier stages of disease, including oligometastatic prostate cancer.（PSMA-DC，NCT05939414）

Novartis is advancing radioligand therapy（RLT）Reshaping the Treatment Landscape for Advanced Cancer. By directly and precisely delivering therapeutic radiation to target tumor cells in any part of the body for the treatment of advanced cancer.Novartis is developing a broad portfolio of RLT, exploring new isotopes, ligands, and combination therapies, expanding the application scope from gastrointestinal pancreatic neuroendocrine tumors.（GEP-NETs）And prostate cancer, extending to the fields of breast cancer, colon cancer, lung cancer, and pancreatic cancer. Novartis has established a specialized supply chain and production network globally, including advanced production bases in Millburn, New Jersey, Zaragoza, Spain, Ivrea, Italy, and Indianapolis, Indiana, USA. The new production base in Carlsbad, California, will serve as the third RLT production base in the United States, supporting the widespread application of RLT, strengthening the production network, and optimizing drug supply for patients on the West Coast.

Editorial Responsibility | Yong

Proofreading │ Jiebolian

Reference Source:

1.https://mp.weixin.qq.com/s/ZMlNvFOwcf0PhO98URgcFA

Exciting Live Broadcast Preview

Press and hold to scan the QR code and participate immediately ↓

Recommendation 1

June 19, 15:00-16:00

In vivoLatest Research Progress in CAR-T

Dian Dian "Share”、“Like" and "In view", charge me up a bit~"