Phase 3 trial of blue light cystoscopy with Hexvix in NMIBC meets primary end point

The phase 3 bridging trial (NCT05600322) exploring the detection rate and safety of Hexvix (Hexaminolevulinate Hydrochloride) blue light cystoscopy (BLC) compared with white light cystoscopy (WLC) in patients with non–muscle-invasive bladder cancer (NMIBC) in mainland China has met its primary end point.¹

Results of the phase 3 study will be submitted to the Chinese National Medical Products Administration for a new drug application in the coming months.

Linda Wu, PhD, the Chief Development Officer of Asieris, the distributer of the diagnostic, said in a news release,¹ "The clinical data of Hexvix further confirms its outstanding clinical performance. We sincerely thank all the researchers and participants for their dedication and efforts in advancing this clinical study. This marks a significant milestone in our company's comprehensive efforts to create an integrated diagnostic and therapeutic solution in the field of bladder cancer. We will continue to vigorously advance the follow-up work, aiming to achieve commercialization and benefit more bladder cancer patients as soon as possible."

A total of 158 adult patients with NMIBC including tumors with stage carcinoma in situ (CIS), Ta, and T1 were enrolled in the prospective, self-controlled, multicenter trial. Participants in the study were instilled with 50 mL Hexvix intravesical solution before undergoing both BLC and WLC. The primary end point of the study was the proportion of patients with at least 1 histology-confirmed lesion detected with Hexvix BLC that was missed by WLC.

According to the news release,¹ “In January 2021, Asieris entered into a license agreement with Photocure ASA (Photocure, OSE:PHO), a bladder cancer specialty company based in Oslo, Norway, to obtain the exclusive registration and commercialization rights of Hexvix in mainland China and Taiwan.”

Asieris also indicated that results of the phase 3 study will be submitted to the Chinese National Medical Products Administration for a new drug application in the coming months and will be presented during upcoming academic conferences.

Previous data on Hexvix

A phase 3 trial of Hexvix (previously Cysview) BLC (NCT02560584) was conducted in the US to compare BLC and WLC with Hexvix in patients with high risk of recurrence.² Patients included in the study received 100 mg Hexvix intravesical solution before cystoscopy.

Findings showed that 9 of 26 patients who were confirmed to have carcinoma in situ upon operating room examination had disease detected only with BLC (95% CI, 17.2-55.7; P < .0001). Further, BLC identified additional malignant lesions in 29 of the 63 patients with confirmed malignancy. Specificity for BLC and WLC was found to be 9.1%.

In total, 12 adverse events were reported during surveillance, though none were found to be serious.

The authors concluded, “Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.”

References

1. Asieris announces positive phase III bridging trial of Hexvix, a diagnostic drug for bladder cancer. News release. Asieris Pharmaceuticals. August 11, 2023. Accessed August 11, 2023. https://www.prnewswire.com/news-releases/asieris-announces-positive-phase-iii-bridging-trial-of-hexvix-a-diagnostic-drug-for-bladder-cancer-301898631.html

2. Daneshmand S, Patel S, Lotan Y, et al. Efficacy and safety of blue light flexible cystoscopy with hexaminolevulinate in the surveillance of bladder cancer: A phase III, comparative, multicenter study. J Urol. 2018;199(5):1158-1165. doi:10.1016/j.juro.2017.11.096