-     A multi-center phase Ib/III study in China and the United States led by Professor Binghe Xu, MD, PhD, Academician of the Chinese Academy of Engineering

-     70% of the patients enrolled in phase Ib study were previously treated with CDK4/6 inhibitors 

-     Demonstrated a confirmed objective response rate (ORR) of 30% and a median progression-free survival (PFS) of 7.3 months

SHANGHAI and WARREN, N.J., Dec. 11, 2023 /PRNewswire/ -- Laekna (2105.HK), a clinical-stage biotechnology company, announced reporting the results of a phase Ib study to evaluate the efficacy and safety of afuresertib plus fulvestrant in patients with locally advanced or metastatic HR+/HER2- breast cancer who failed standard of care therapies at the 2023 San Antonio Breast Cancer Symposium (SABCS) on December 8.

From May 2022 to April 2023, 20 patients (19 female and 1 male) with locally advanced or metastatic HR+/HER2- breast cancer who had failed 1-2 lines of endocrine therapy were enrolled in the Phase Ib study. The median duration of follow-up was 11 months.

As of October 16, 2023, the main study results are as follows:

-        70% of the patients were previously treated with CDK4/6 inhibitors.

-        Among the total patient population, the confirmed ORR was 30% (95% CI, 11.9, 54.3),  the median PFS was 7.3 months (95% CI, 3.7, NE). The disease control rate (DCR) was 80%.

-        Among the 11 patients with specific biomarker alterations (PIK3CA/AKT1/PTEN), the confirmed objective response rate was 45.4% (95% CI, 16.7, 76.6), the disease control rate was 82%, and the median PFS was 7.3 months (95% CI, 3.6, 8.2).

-        Among the 17 Chinese patients, the confirmed ORR was 29.4% (95% CI, 10.3, 60.0), the disease control rate was 82.4%,  and the median PFS was 7.3 months (95% CI, 3.6, 8.2).

-        The results demonstrated a well-tolerated safety profile of afuresertib plus fulvestrant. No dose modification was required during the safety run-in period. No patient discontinued treatment due to TEAE. No serious adverse event (SAE) was reported. 

Investigators concluded that the combination therapy of afuresertib and fulvestrant has shown promising efficacy with a well-tolerated safety profile, supporting further evaluation in the upcoming Phase III part of the study.

Academician Binghe Xu, the lead investigator of the study, said: "While therapies for breast cancer are increasing, the treatment of drug resistance remains one of the clinical challenges. With the approval of the world's first AKT inhibitor last month, patients with locally advanced or metastatic HR+/HER2- breast cancer now have new hope. The Phase Ib data of the combination therapy of afuresertib and fulvestrant are promising. I look forward to the next Phase III study of afuresertib in breast cancer."

"Biomarkers of response and/or resistance to endocrine-based therapies has become a prominent topic in the field of breast cancer treatment. It is also the central theme of the 'Poster Spotlight Session' in which our study was presented," said Dr. Yong Yue, Chief Medical Officer of Laekna. "Compared with the PFS data of 3-4 months for fulvestrant monotherapy^[1], the median PFS of afuresertib plus fulvestrant is significantly increased to 7.3 months, with a favorable safety profile."

Lakena has initiated the Phase III pivotal trial of afuresertib plus fulvestrant in the treatment of HR+/HER2- breast cancer. The company strives to bring new hope to patients.

Notes

Breast cancer

The latest data released by the International Agency for Research on Cancer (IARC) of the World Health Organization show that the number of new cases of breast cancer in 2020 reached 2.26 million worldwide, surpassing lung cancer for the first time and becoming the world's most prevalent cancer with 685,000 deaths. The latest epidemic data of malignant tumors in China also show that breast cancer has ranked first among women, with about 420,000 new cases each year^[2].

Approximately 69% of breast cancer patients in the United States are considered HR+/HER2^[3], and the proportion of this subtype among Chinese patients is 62%^[4]. Although most patients with this type of breast cancer initially benefit from first/second-line endocrine ± CDK4/6 inhibitors and/or chemotherapy, most may develop drug resistance after a period, leading to treatment failure.

With further research on AKT, it has been demonstrated that factors such as PTEN loss and AKT/PIK3CA mutation can lead to excessive activation of the AKT signaling pathway, resulting in the occurrence, development, and drug resistance of tumors, especially prevalent in HR+ breast cancer. AKT has consequently emerged as a popular target for treating tumors.

Afuresertib

Afuresertib (LAE002) is an AKT inhibitor developed by Laekna. Laekna has initiated multiple clinical studies of combination therapies with Afuresertib in patients with PROC, HR+/HER2− breast cancer, mCRPC, TNBC, PD-1-resistant cervical cancer, and endometrial cancer.

—End—

About Laekna

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapies to cancer and liver fibrosis patients worldwide.

As of June 30, 2023, Laekna has initiated six clinical trials for afuresertib (LAE002), LAE001 and LAE005 to address unmet medical needs in cancers, such as ovarian cancer, breast cancer and prostate cancer. Among the six clinical trials, three are multi-regional clinical trials (MRCTs), including one pivotal trial.

Laekna's internal drug discovery platform has discovered 12 drug candidates. LAE102 is our first internally discovered antibody that has obtained an IND approval from the FDA. Its potential indications include muscle regeneration, obesity, and cancer.

Laekna, Inc. was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange") on June 29, 2023. The stock code is 2105.HK.

For more information, please visit: https://www.laekna.com/

or https://www.linkedin.com/company/74110713/

Forward Looking Statements

This press release may contain certain "forward-looking statements" which are not historical facts, but instead are predictions about future events based on Laekna's current beliefs, assumptions, and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.

[1] N Engl J Med 2023;388:2058-70.

[2] Global Cancer. IARC. http://gco.iaic.fr/

[3] Cancer Stat Facts: Female Breast Cancer Subtypes; SEER 22 2016–2020

[4] Breast cancer subtypes and survival in Chinese women with operable primary breast cancer. Chin J Cancer Res, 2011. 23(2): p. 134-9.

Source: Laekna Related Stocks: HongKong:2105