A "Blue Sky" Oppy In Localized Prostate Cancer: AUA Data & Mgmt/KOL Dinner

Research evidence excerpt

A "Blue Sky" Oppy In Localized Prostate Cancer: AUA Data & Mgmt/KOL Dinner

May 18, 2026

Before we get into the data, a quick refresher for those less familiar with

CADL

●Aglatimagene has an elegant MOA: this is a replication-defective

adenovirus that delivers a herpes virus thymidine kinase transgene

to cancer cells. Patients take oral valacyclovir, which is converted into

a toxic nucleoside analogue in cancer cells expressing the transgene,

causing immunogenic cell death.

●In prostate Ph3, aglatimagene was combined with radiotherapy:

patients with intermediate-to-high risk localized prostate cancer (N

= 745) were randomized 2:1 to aglatimagene + radiotherapy (RT) +

valacyclovir or placebo + RT + valacyclovir. Patients had the option to

take up to 6 mos of androgen deprivation therapy (ADT).

●Aglatimagene's MOA is synergistic with radiotherapy (RT): tumor

killing effects are amplified in cells with DNA damage, and

radiation causes a lot of that.

●Aglatimagene/PBO was locally administered as an intraprostatic

injection (4 injections across the prostate, 2ml total volume, in

a series of 3 injections over ~2 months).

●Primary endpoint in Ph3 was DFS, agreed in a Special Protocol

Assessment with the FDA (SPA), which is a big deal (<1% have been

rescinded).

●DFS = local failure (including positive 2-yr biopsy), regional

failure, distant metastases or death from any cause.

●Prostate cancer-specific DFS (key secondary endpoint, which

was updated at AUA) = same as DFS, but excludes deaths

unrelated to prostate cancer.

You can also check out our initiation HERE and 1-hr webinar walkthrough

HERE.

So what was new at AUA, and what matters?

●Prostate cancer-specific DFS (which excludes unrelated deaths)

deepened slightly from HR of 0.62 (p = 0.0046) to 0.61 (p = 0.0031).