APL-1706 with blue light cystoscopy shows superiority in bladder cancer detection

APL-1706 (Hexvix) in combination with blue light cystoscopy (BLC) demonstrated superiority over white light cystoscopy (WLC) alone in the detection of bladder cancer in Chinese participants, according to phase 3 trial findings¹ announced by Asieris, the developer of the technology, and Photocure, their partner, in joint news releases.^2,3

"This randomized-controlled trial reinforces the benefits of BLC with Hexvix in tumor detection over WLC alone with clinically convincing and statistically significant results," says Anders Neijber.

The findings were recently presented at the 43rd Congress of the Société Internationale d'Urologie (SIU) in Istanbul, Turkey.¹

Overall, 42 of 97 (43.3%) patients in the study who had received a diagnosis of non–muscle-invasive bladder cancer (Ta, T1, and carcinoma in situ [CIS]) had 1 or more additional lesions detected with APL-1706 plus BLC compared with WLC alone (P < .0001). Further, among the 114 patients included in the full analysis set, 13 patients had CIS, of whom 11 had additional CIS lesions detected with BLC that were not detected under WLC.

"APL-1706 is currently the only approved optical imaging for assisting in the diagnosis and surgery of bladder cancer worldwide. The data presented at the SIU conference further validates the tremendous clinical value of APL-1706. We believe that this innovative drug will bring significant benefits to bladder cancer patients in the local market. We will actively advance the related regulatory submissions in China, expediting its market entry to benefit more patients as soon as possible,” said Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, in a news release on the findings.²

In total, the study included 158 patients, of whom 37 were included in the training cases group, 6 were included in the standard WLC control group, 114 underwent BLC, and 1 patient dropped out of the study.

The detection rates for CIS, Ta, T1, and T2-4 tumor lesions with BLC were 94.7%, 100%, 98.2%, and 100%, respectively, compared with the detection rates seen with WLC of 42.1%, 76.1%, 91.2%, and 100%, respectively. The false positive rate of APL-1706 with BLC was 23.2%, compared with 16.0% with WLC alone.

Regarding safety, 200 mild to moderate adverse events were reported across 95 patients included in the study. Of those, 95.5% were unrelated to APL-1706. No serious adverse events were reported.

"This randomized-controlled trial reinforces the benefits of BLC with Hexvix in tumor detection over WLC alone with clinically convincing and statistically significant results. This is on the backdrop of this Chinese trial being the first [randomized controlled trial] RCT conducted with 4K high definition (HD) blue light equipment, making it a valuable addition to the body of evidence already available on BLC with Hexvix,” Photocure's Chief Medical Officer Anders Neijber stated in a news release.³ “It confirms that BLC with Hexvix is additive to WL also with high quality HD imaging technology. We are pleased to see and acknowledge that our partners at Asieris are driving innovation to support unmet needs in bladder cancer.”

References

1. A prospective, comparative, within-patient controlled multicenter phase III study comparing Blue Light Cystoscopy versus White Light Cystoscopy for the detection of bladder cancer in China. Presented at the 43rd Congress of the Société Internationale d'Urologie (SIU). October 11-14, 2023. Istanbul, Turkey. Abstract LBA-MP.02

2. Asieris unveiled results of its phase III clinical study for APL-1706, an imaging drug for diagnosis or surgery of bladder cancer, at the SIU 2023 Congress. News release. Asieris. October 12, 2023. Accessed October 16, 2023. https://www.prnewswire.com/news-releases/asieris-unveiled-results-of-its-phase-iii-clinical-study-for-apl-1706-an-imaging-drug-for-diagnosis-or-surgery-of-bladder-cancer-at-the-siu-2023-congress-301954806.html

3. Positive results for Hexvix phase III clinical trial in China presented at the SIU 2023 Congress. News release. Photocure. October 12, 2023. Accessed October 16, 2023. https://www.prnewswire.com/news-releases/positive-results-for-hexvix-phase-iii-clinical-trial-in-china-presented-at-the-siu-2023-congress-301954681.html