Photocure Partner Asieris presented clinical trial and real-world data on Hexvix in China at ASCO GU 2024
Oslo, Norway, January 29, 2024: Photocure ASA (OSE: PHO), The Bladder Cancer Company, announces that its partner Asieris presented Phase III Clinical Study and Real-World Research Data for Hexvix® (APL-1706) at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU), on Friday, January 26, 2024 in San Francisco.
The poster presentation (Abstract No. 593) “Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer in China: An Analysis of Unpublished Clinical Trial and Real-World Data.” included data from a recent randomized controlled trial (RCT) as well as heretofore unpublished data from the Hexvix real-world evidence study (RWS) in China.
The study included 158 patients enrolled in an RCT, of which 114 underwent Blue Light Cystoscopy (BLC®) with Hexvix. 19 patients were included in the real-world study (RWS). Among patients diagnosed with Ta, T1, or CIS, 42 out of 97 patients (43.3%) in the RCT and 4 out of 12 patients (33.3%) in the RWS had at least one lesion detected with BLC but not with white light cystoscopy (WLC) (p<0.0001).
Both the RCT and RWS confirmed that Blue Light Cystoscopy with Hexvix demonstrated superior detection of bladder cancer in the Chinese population compared to WLC, especially in the CIS population, with good tolerability.
Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases. In January 2021, Asieris entered into a license agreement with Photocure ASA to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan. The new drug application (NDA) was accepted by the National Medical Products Administration (NMPA) in November 2023.
See Asieris’ full release here: https://asieris.com/asieris-releases-phase-iii-clinical-study-and-real-world-research-data-for-apl-1706-a-bladder-cancer-diagnosis-and-management-drug-at-the-2024-asco-gu/
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About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths in 2020.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
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 wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC 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 treat.4
1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [January 2022].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to https://photocure.com/partners/our-partners for further information on our commercial partners.
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com
