New York, N.Y., April 18, 2024 – PRISM MarketView – More than 83,000 new cases of bladder cancer are diagnosed in the US each year, and the illness is responsible for around 17,000 deaths annually. Urothelial carcinoma accounts for 90% of bladder cancers in the US and western Europe, and surgery, followed by chemotherapy or radiation is the current standard of care.

There are 24 drugs approved by the FDA for bladder cancer, but due to invasive and life-changing surgical procedures, researchers continue to pursue safer and more effective bladder-sparing treatments to improve the experience, quality of life and survival rate of patients.

Significant progress has been made in the last 12 months. In December 2023, the FDA approved Astellas Pharma’s ($ALPMF) Padcev (enfortumab vedotin-ejfv) in combination with Merck’s ($MRK) Keytruda (pembrolizumab), which represented the first advance in extending patient survival in advanced bladder cancer in almost 40 years. 

In January 2024, Australian biotechnology company, Immutep Limited ($IMMP) enrolled and safely dosed the first patient it its Phase 1 trial which will evaluate eftilagimod alpha (efti) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma. Efti plus BAVENCIO® is a chemotherapy-free immuno-oncology (IO) that has shown promising signals of efficacy and a favorable safety profile in advanced solid tumors.

In March 2024, Bristol Myers Squibb ($BMY) won FDA approval for Opdivo in combination with the chemotherapy drugs cisplatin and gemcitabine as a treatment for unresectable or metastatic urothelial carcinoma.

Notable performers on Friday were Q32 Bio ($QTTB) soared +21.3%, and +43.0% overall for the week, Adaptive Biotechnologies ($ADPT) finished the day up +14.9%, and PMV Pharmaceuticals ($PMVP) gained +13.3% after Jefferies Financial Group initiated coverage of the company with a buy rating and a $5.00 price target on the stock.

PRISM Headlines in Bladder Cancer 

FDA Accepts UroGen’s Investigational New Drug Application for Bladder Cancer Treatment

The FDA has accepted UroGen Pharma’s (Nasdaq: URGN) Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-103 uses UroGen’s RTGel® platform technology, a proprietary sustained-release, reverse-thermal hydrogel that can improve the therapeutic profiles of existing drugs. The company’s share price was up 0.13% to reach $15.12 in intraday trading on Monday following the news.
Ferring Pharmaceuticals Initiates Three New Clinical Trials in Bladder Cancer

 Privately-held specialty pharmaceutical group, Ferring Pharmaceuticals, has initiated three new US-based clinical trials evaluating ADSTILADRIN in patients with non-muscle invasive bladder cancer (NMIBC), and plans to expand select clinical trials outside of the US later in 2024.
Positive Data for Protara Therapeutics in Bladder Cancer Trial
Protara Therapeutics (Nasdaq: TARA) has released positive data from its ongoing clinical program of TARA-002, the company’s investigational cell-based therapy, being evaluated in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC). TARA-002 is targeting NMIBC including Bacillus Calmette-Guérin (BCG)-Unresponsive, BCG-Experienced and BCG-Naïve patient populations.
Natera Advances Signatera™ for Bladder Cancer
 Natera, Inc. (Nasdaq: NTRA) has reported positive data from its global, double-blind, randomized, Phase 3 IMvigor011 study which is evaluating outcomes in muscle-invasive bladder cancer (MIBC) patients who tested serially negative with Signatera™, Natera’s personalized and tumor-informed molecular residual disease (MRD) test.

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