FDA Oks Phase 3 Trial of LAE201 for the Treatment of mCRPC


The protocol for a phase 3 clinical trial testing a new combination therapy targeting advanced prostate cancer has received approval from the FDA.

  • The FDA approved the phase 3 trial protocol to test a combination therapy (LAE201) for metastatic castration-resistant prostate cancer (mCRPC) that has progressed on standard treatments.

  • Phase 2 results showed promising efficacy and safety of LAE201, with a median radiographic progression-free survival (rPFS) of 8.1 months compared with the historical 2 to 4 months for patients with mCRPC on standard treatments.

  • LAE201 combines afuresertib (LAE002), a potentially more efficacious AKT inhibitor, and LAE001, a unique androgen synthesis inhibitor, targeting a critical pathway in mCRPC.

The FDA has approved the phase 3 trial protocol of afuresertib plus LAE001, a CYP17A1/CYP11B2 dual inhibitor (LAE201) for the treatment of patients with mCRPC who have received standard-of-care (SOC) treatment.1

"Since the phase 2 data of the combination therapy of [afuresertib] plus LAE001 demonstrated encouraging antitumor activity and safety profile in patients with mCRPC, a following phase 3 pivotal trial design has been discussed with the US FDA and the approval for the protocol has been received this month," said Yong Yue, MD, PhD, chief medical officer of Laekna, in a press release.

The phase 2, open-label, dose-escalation, and dose-expansion trial (NCT04060394) evaluated LAE201 in the US in June 2021, as well as in South Korea in September 2022. Investigators sought to assess the efficacy and safety of the combination for the treatment of patients with mCRPC.

As of November 21, 2023, 40 patients who progressed on 113 lines of standard treatments, including at least 1 line of abiraterone (Zytiga) or the second generation of androgen receptor antagonists, had been enrolled to the group receiving the recommended phase 2 dose of LAE201. Findings showed that the median rPFS was 8.1 months, which was a significant improvement compared with the median rPFS of 2 to 4 months historically seen for patients with mCRPC under standard treatments.

Prostate cancer, bladder cancer, men's health care: © Tom - stock.adobe.com

Prostate cancer, bladder cancer, men's health care: © Tom - stock.adobe.com

Of 12 patients who had measurable lesions at baseline based on RECIST 1.1, there were 2 confirmed partial responses (PRs) and 2 unconfirmed PRs seen.2 Looking at safety, the combination was generally well-tolerated, with manageable treatment-emergent adverse events.

"The approval marks a significant milestone for Laekna. The mCRPC post 1 to 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 [patients with] mCRPC who are in need of novel treatment options," added Yue in the press release.1

About the Combination

Afuresertib, a potent AKT inhibitor, has shown promise compared with other AKT inhibitors. The agent, which is 1 of the 2 AKT inhibitors that is in or has completed the pivotal-stage clinical development for anticancer treatment worldwide, inhibits AKT1, AKT2, and AKT3. Compared with other AKT inhibitors, afuresertib demonstrated higher efficacy, better potency, significant tumor inhibition exposure, and a better safety profile, according to public data.

LAE001 is an androgen synthesis inhibitor. The agent inhibits CYP17A1 and CYP11B2, and according to Laekna, it is the only dual CYP17A1/CYP11B2 inhibitor currently being studied in clinical trials for the treatment of prostate cancer globally.

LAE102 is Laekna’s first internally discovered antibody that has received an FDA investigational new drug application.

  1. Laekna announces FDA approval for the phase III clinical trial protocol of LAE002 (Afuresertib) plus LAE001 for the treatment of prostate cancer. News release. Laekna, Inc. May 23, 2024. Accessed May 23, 2024. https://tinyurl.com/3bhwtbum
  2. 2023 ESMO│Laekna (2105.HK) announces phase I/II data of LAE001 plus afuresertib in mCRPC. News release. Laekna. October 24, 2023. Accessed May 23, 2024. https://tinyurl.com/y35kwrdf
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