Photocure ASA: Positive data from Phase 3 US Blue Light Cystoscopy with Cysview® study presented at AUA 2017 meeting in Boston
- 21.5% of patients with recurrence of bladder cancer would have been missed if BLFC with Cysview had not been used in the surveillance setting, which is highly significant (p<0.0001)
- Photocure plans to file a supplemental NDA with FDA later this year
Oslo, Norway, May 15th, 2017: Photocure ASA (Photocure, PHO:OSE), today announced that new Phase 3 study results with Blue Light Flexible Cystoscopy (BLFC(TM)) with Hexvix®/Cysview®* were presented during a late-breaking plenary session at the American Urological Association (AUA) Annual Meeting in Boston, Massachusetts on Sunday May 14th. The study showed that BLFC with Cysview detected bladder cancer recurrence in 21.5% of the patients undergoing surveillance cystoscopy that otherwise would have been missed with white light (WL) alone, which is highly significant (p<0.0001). Of note, the study showed that nine out of twenty-six patients (34.6%) with flat, more aggressive high grade lesions (carcinoma in situ; CIS) were diagnosed using confirmatory Blue Light Cystoscopy with Cysview alone and not WL (p<0.0001). The study also showed that there was no increase in the rate of related adverse events after repeated administration of Cysview in bladder cancer patients undergoing cystoscopy examination.
The study was a prospective, open, comparative, within-patient controlled study, included 304 patients with non-muscle invasive bladder cancer (NMIBC) enrolled at 17 academic institutions in the US. In the study BLFC with Cysview was used with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System.
"This study shows that BLFC can provide a significant advantage for patients in terms of early detection of tumor recurrence which may improve treatment and therefore lead to better outcomes," says one of the lead investigators J. Stephen Jones, MD, president of Cleveland Clinic Regional Hospitals and Family Health Centers. "92.7% of the patients said it was worthwhile to undergo BLFC and 93.8% said that they would do it again. The results of the study show that BLFC will play a significant role in outpatient management of bladder cancer."
White light cystoscopy is the current standard of care for bladder cancer surveillance. Multiple studies have demonstrated that Blue Light Cystoscopy (BLC) with Cysview using a rigid endoscope in the operating room improves detection of bladder cancer, with a reduction in recurrence rates observed when compared to procedures using white light. The objective of the Phase 3 study in the surveillance setting was to determine if BLFC using a flexible cystoscope in the office setting can improve detection of tumors when compared to WL cystoscopy alone.
"As a result of the extensive follow up that NMIBC patients require there are approximately 1.4 million surveillance cystoscopies with flexible cystoscopes performed in the US annually. This market represents a large potential opportunity for Photocure. We are very pleased with these significant results for the detection of recurrent bladder cancer. The patient related outcomes also indicate that BLFC with Cysview adds considerable value to the patient. With these positive efficacy and safety results we believe we have fulfilled our post marketing commitments for the current approved use and we are committed to working with the Food and Drug Administration (FDA) to bring BLFC with Cysview to the physicians and patients in the US." said Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA."
Click here for a link to the abstract: http://bit.ly/BLFCC-LateBreaking.
In addition, on May12th at the AUA annual meeting, data from the largest Bladder Cancer Registry Study in the US was presented at a Poster session "Blue Light Cystoscopy for the diagnosis of Urothelial Bladder Cancer: results from a prospective multicenter registry". The results from 9 centers included 1325 lesions, from 517 procedures in 426 patients. The conclusion of the study was that BLC significantly increased the detection of CIS and papillary lesions over WLC alone and can result in upstaging and upgrading in about 13% of patients, which can affect patient outcomes.
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US1, 2, 3. In 2016, it is estimated that 76,960 new cases of bladder cancer will occur along with 16,390 deaths due to bladder cancer. Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, chronic bladder irritation and infections, and prior diagnosis of bladder cancer. Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year4, 5.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall6. NMIBC is still in the inner layer of cells. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat7.
Hexvix® is a drug that is taken up selectively by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions (US)/ reduced risk of recurrence and progression (Nordic).
Hexvix® is the tradename in Europe, Cysview® in the US and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix® in Europe, excluding the Nordic region. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.
About KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ GmbH & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ GmbH & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. For more information, call (800) 421-0837 or visit the company's website at www.karlstorz.com.
About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO). Information about Photocure is available at www.photocure.com.
For more information, please contact:
President and CEO, Photocure ASA
Tel: +47 913 19 535
Chief Financial Officer
Tel: +47 450 55 000
MCS Healthcare public relations
Tel: +1 732 589-0757
1 SEER Cancer Statistics Factsheets: Bladder Cancer. National Cancer Institute. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed April 2016.
2 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf . Accessed April 2016.
3 Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178 (6):2314-2330.
4 Avritscher EB et al., Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology. 2006; 68:549-553.
5 Botteman et al. Clinical model of lifetime costs of treating bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003; 21:315-1330.
6 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.
7 Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.