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FDA Approves Phase III Trial Protocol for Laekna’s LAE002 Plus LAE001 Combination for the Treatment of Prostate Cancer


Approval for the Phase III protocol of LAE002 Plus LAE001 come as a result of posiive Phase II data, which showed promising benefits for metastatic castration-resistant prostate cancer (mCRPC) patients.

Human Body Organs Anatomy (Kidneys with Urinary Bladder). Image Credit: Adobe Stock Images/magicmine

Image Credit: Adobe Stock Images/magicmine

Laekna announced that the FDA approved the Phase III clinical trial protocol for LAE002 (afuresertib, an AKT inhibitor) combined with LAE001 (a CYP17A1/CYP11B2 dual inhibitor) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) after standard of care (SOC) treatments (LAE201). According to the company, the approval comes amid encouraging Phase II results, which led to talks with the FDA and eventual approval to proceed on Phase III.

Phase II results found that the median radiographic progression-free survival (rPFS) was 8.1 months, considerably higher than the typical 2-4 months under common treatments. The trial consisted of 40 individuals who had responded positively to 1-3 lines of SOC treatments. Adverse effects were reported to be manageable, with the therapy being considered tolerable for the most part.1

"Since the Phase II data of the combination therapy of LAE002 (afuresertib) plus LAE001 demonstrated encouraging anti-tumor activity and safety profile in patients with mCRPC, a following Phase III pivotal trial design has been discussed with the U.S. FDA and the approval for the protocol has been received this month," said Yong Yue, PhD, chief medical officer, Laekna, in a press release. "The approval marks a significant milestone for Laekna. The mCRPC post 1-3 lines of SOC are difficult-to-treat late-stage cancer with poor outcomes. It is an unmet medical need worldwide. We look forward to bringing this precision therapy to mCRPC patients who are in need of novel treatment options."

In 2021, Laekna reported its first findings from two studies of LAE001, one as a monotherapy for early stage of prostate cancer, and the second study with combination therapy of LAE001 + afuresertib in drug-resistant late-stage prostate cancer. The company reported that both studies yielded promising results. Overall, it was found that LAE001 monotherapy without a steroid was safe at the 50mg BID level, with the combination therapy supporting a potential clinical benefit for treating drug-resistant mCRPC.2

“The topline data reported by Laekna Therapeutics at the ESMO Congress, a top international academic conference marks significant progress for Laekna’s clinical programs,” said Young, in a press release. “With the continued advancement of the above two studies, we have seen more encouraging results in the enrolled patients in the past three months. We hope patients with both early- and late-stage prostate cancer can soon benefit from these two new innovative medicines.”

According to the American Cancer Society (ACA), prostate cancer is the second most common cancer in men in the United States. This year, ACA estimated that there are around 299,010 new cases of prostate cancer, with 35,250 deaths. 1 in 8 men are expected to be diagnosed with it during their lifetime, although most men are able to recover from it.3

“The prostate cancer death rate declined by about half from 1993 to 2013, most likely due to earlier detection and advances in treatment,” reports the ACA. “In recent years, the death rate has stabilized, likely reflecting the rise in cancers being found at an advanced stage.”


1. Laekna Announces FDA Approval for the Phase III Clinical Trial Protocol of LAE002 (Afuresertib) PLUS LAE001 for the Treatment of Prostate Cancer. PR Newswire. May 23, 2024. Accessed May 23, 2024. https://www.prnewswire.com/news-releases/laekna-announces-fda-approval-for-the-phase-iii-clinical-trial-protocol-of-lae002-afuresertib-plus-lae001-for-the-treatment-of-prostate-cancer-302154036.html

2. Laekna Therapeutics reported positive results in two clinical studies for the treatment of various stages of prostate cancer at the ESMO Congress. Laekna. September 16, 2021. Accessed May 23, 2024. https://en.laekna.com/new/171.html

3. Key Statistics for Prostate Cancer. American Cancer Society. Accessed May 23, 2024. https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html

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