N-803 (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)

QUILT-2.005: Comparing BCG + IL-15 Superagonist N-803 vs BCG Alone in BCG-Naïve NMIBC - Bobby Reddy

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Sam Chang speaks with Sandeep (Bobby) Reddy about the FDA-approved agent Anktiva combined with BCG for BCG-unresponsive non-muscle invasive bladder cancer. Dr. Reddy discusses the results from the QUILT 2.005 trial, showing high durability and response rates in patients. He explains the mechanism of Anktiva, which enhances immune response without increasing regulatory T cells, leading to significa...

Addressing BCG Supply Shortages, Workflow, and Enhancing Bladder Cancer Treatment through Strategic Partnerships - Patrick Soon-Shiong

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Ashish Kamat and Patrick Soon-Shiong delve into the current status and future prospects of Anktiva for bladder cancer. Dr. Soon-Shiong addresses concerns about the BCG shortage and the steps taken to ensure its availability through a partnership with the Serum Institute of India, which will provide both traditional and next-generation recombinant BCG. He explains that Anktiva is designed to be use...

Novel Bladder Cancer Treatment: Mechanisms, Clinical Findings, and Implications - Patrick Soon-Shiong

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Ashish Kamat and Patrick Soon-Shiong explore the clinical development and FDA approval of Anktiva for bladder cancer. Dr. Soon-Shiong outlines the journey from initial studies in BCG-naive and BCG-unresponsive patients to approval. Anktiva, combined with BCG, shows high complete remission rates and prolonged duration of response, providing a significant advancement in bladder preservation. Dr. Soo...

The Triangle Offense: Harnessing NK Cells, T-Cells, and Memory Cells in Bladder Cancer - Patrick Soon-Shiong

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Ashish Kamat interviews Patrick Soon-Shiong about the approval of Anktiva for bladder cancer treatment. Dr. Soon-Shiong shares his journey from pancreatic surgery at UCLA to developing this innovative therapy. He emphasizes the need to activate the immune system, particularly natural killer (NK) cells, which play a crucial role in targeting cancer cells. Anktiva, an IL-15 based therapy, works syne...

Assessing the Effectiveness of N-803 for BCG Unresponsive Bladder Cancer: Promising Complete Remission Rates and Improved Long-Term Response - Patrick Soon-Shiong

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Sam Chang is joined by Patrick Soon-Shiong for a discussion on the effectiveness of N-803 for BCG unresponsive bladder cancer. They discussed the importance of an ideal profile for such an agent, which includes complete remission rate, durability of the response, and high cystectomy avoidance rate. They also highlighted the importance of the agent's safety and tolerability for urologists. The N-80...

QUILT Trial: A Comprehensive Look at BCG Unresponsive Bladder Cancer and the Role of N-803 - Karim Chamie

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Petros Grivas welcomes Karim Chamie to discuss the exciting developments in urothelial cancer, focusing on the QUILT trial involving BCG unresponsive, high-risk non-muscle invasive bladder cancer patients. Dr. Chamie shares insights into historical treatments, the limitations of current approaches, and the breakthroughs achieved by combining intravesical BCG with the Interleukin-15 super agonist,...

Underlying Mechanism of Action of N-803 + BCG Inducing Durable Complete Response in BCG Unresponsive NMIBC -Patrick Soon-Shiong

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Patrick Soon-Shiong joins Ashish Kamat in a discussion on the mechanism of action of N-803 (Anktiva TM ) + BCG Inducing Durable Complete Response in BCG Unresponsive NMIBC. N-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Dr. Soon-Shiong summarizes the May 2021 phase 1 publication Safety, Tolerability, and Lo...

Advances in Treatment Options for BCG Unresponsive CIS and Papillary Non-Muscle Invasive Bladder Cancer - QUILT 3.032 - Sam Chang

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Sam Chang joins Ashish Kamat to discuss the results of the QUILT study, which he presented at the GU ASCO 2022 annual meeting. QUILT 3.032 is an open-label, multicenter phase 3 study of intravesical bacillus calmette-guerin (BCG) plus N-803 in patients with BCG-unresponsive high-grade non-muscle-invasive bladder cancer (NMIBC) (NCT03022825) with CIS and papillary disease. Given the observed strong...