Saturday, June 15, 2024

Prostate Cancer Treatment: FDA Approves Phase III Trial Protocol for Laekna’s LAE002 and LAE001 Combination Therapy

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Prostate cancer treatment has advanced as Laekna Therapeutics announced that the Food and Drug Administration (FDA) has approved the Phase III clinical trial protocol for the combination of LAE002 (afuresertib, an AKT inhibitor) and LAE001 (a CYP17A1/CYP11B2 dual inhibitor) for treating metastatic castration-resistant prostate cancer (mCRPC) after standard of care (SOC) treatments (LAE201). This approval follows promising Phase II results, leading to discussions with the FDA and the subsequent go-ahead for the Phase III trial.

The Phase II trial results indicated that the median radiographic progression-free survival (rPFS) for patients treated with the combination therapy was 8.1 months, significantly higher than the typical 2-4 months achieved with common treatments. The trial involved 40 individuals who had previously responded positively to 1-3 lines of SOC treatments. Adverse effects were reported to be manageable, and the therapy was generally considered tolerable.

Dr. Yong Yue, chief medical officer at Laekna, expressed optimism about the approval: “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. 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 need novel treatment options.”

Laekna Reports Promising Results from LAE001 Studies in Early and Late-Stage Prostate Cancer

In 2021, Laekna reported its initial findings from two studies of LAE001. The first study investigated LAE001 as a monotherapy for early-stage prostate cancer, and the second study evaluated the combination therapy of LAE001 and afuresertib in drug-resistant late-stage prostate cancer. Both studies yielded promising results, demonstrating that LAE001 monotherapy without a steroid was safe at the 50mg BID level. Furthermore, the combination therapy showed potential clinical benefits for treating drug-resistant mCRPC.

Dr. Young, in a press release, highlighted the significance of these findings: “The topline data reported by Laekna Therapeutics at the ESMO Congress, a top international academic conference, marks significant progress for Laekna’s clinical programs. 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.”

Prostate cancer remains a major health concern, being the second most common cancer among men in the United States. According to the American Cancer Society (ACA), approximately 299,010 new cases of prostate cancer and 35,250 deaths are expected this year alone. The ACA reports that 1 in 8 men will be diagnosed with prostate cancer during their lifetime, though most men recover from it.

Prostate Cancer

FDA Approves Phase III Trial for Laekna’s LAE002 and LAE001 Combo, Marking Progress in Prostate Cancer Treatment

“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.”

The FDA’s approval of the Phase III trial protocol for the LAE002 and LAE001 combination therapy represents a significant step forward in the treatment of metastatic castration-resistant prostate cancer. Laekna’s innovative approach, leveraging its GlueXplorer platform, aims to address unmet medical needs and improve outcomes for patients with this challenging condition.

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As Laekna progresses to the next stage of clinical trials, the collaboration with the FDA and the promising results from earlier phases provide a strong foundation for potentially bringing a new, effective treatment option to patients battling mCRPC. The ongoing research and development efforts underscore the company’s commitment to pioneering precision therapies and advancing the field of oncology.

 

Resource: American Cancer Society, May 24, 2024

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