HR-negative/HER2-low Breast Carcinoma

Oct. 03, 2024 -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces patient enrolment has been completed in the randomised Phase II portion of the AIPAC-003 (Active Immunotherapy and PAClitaxel) clinical trial. The Phase II enrolled 65 metastatic hormone receptor positive (HR+), HER2-negative/low or triple-negative breast cancer patients who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. Patients across 22 clinical sites in Europe and the United States have been randomised 1:1 to receive either 30mg or 90mg dosing of eftilagimod alpha (“efti”) in combination with paclitaxel to determine the optimal biological dose consistent with the FDA’s Project Optimus initiative. Further updates will be provided after data collection, data cleaning, and analysis. For more information on the trial, please visit clinicaltrials.gov (NCT05747794). Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com. The content above comes from the network. if any infringement, please contact us to modify.

FLEX data underscores MammaPrint® utility in accurately predicting 3-year outcome in patients with High Risk early-stage breast cancer when treated with neo/adjuvant chemotherapy IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)-- Agendia, Inc. today announced it will present new data on the 3-year outcome of patients with hormone receptor-positive (HR+), HER2-negative early-stage breast cancer when treated with two different chemotherapy regimens at the 2024 Annual American Society of Clinical Oncology (ASCO) Meeting, taking place in Chicago, IL. on May 31st, 2024. The data will be presented in an oral discussion by Joyce O’Shaughnessy MD, Director, Breast Cancer Research, Baylor University Medical Center, Texas Oncology and the Sarah Cannon Research Institute in Dallas, TX, Primary Investigator of the FLEX Study, titled [O'Shaughnessy, J., et al.]. The FLEX study investigates the 3-year outcome of patients with HR+HER2-, genomically High Risk Luminal B-Type early breast cancer, who have undergone treatment consisting of chemotherapy with taxane and cyclophosphamide (TC) or chemotherapy with anthracycline + TC (AC-T). All patients are enrolled in the prospective, non-randomized, observational FLEX Study (NCT03053193). This study utilized both MammaPrint and BluePrint® to determine tumor subtype. Results showed that patients with MammaPrint H1 Luminal B-Type tumors demonstrated similar 3-year outcomes when treated with either TC (97.1%) or AC-T (95.3%), suggesting that patients who are classified as H1 may be able to avoid the toxicity of an anthracycline. However, patients with MammaPrint H2 Luminal B-Type tumors demonstrated a significantly higher relapse-free survival when treated with AC-T (97.7%) than with TC alone (86.4%). These findings indicate that MammaPrint H2 tumors benefit from the addition of an anthracycline to their adjuvant chemotherapy regimen. "The ability to tailor treatment regimens to a patient’s tumor biology is crucial to optimize outcomes and quality of life. MammaPrint's utility in guiding treatment planning is highlighted by these new data evaluating chemotherapy selection," said Dr. O'Shaughnessy. "The FLEX Study and sub-studies, such as this one, enable increased precision in identifying patients that are more responsive to specific systemic therapy regimens, and continue to aid selection of treatments for patients with HR+/HER2-negative early-stage breast cancer." “These new findings demonstrate the strength of the FLEX research platform in evaluating the different aspects of breast cancer during its diagnosis and treatment stages, allowing for more precise and individualized treatment recommendations,” said William Audeh, MD, Chief Medical Officer at Agendia. “This study offers a preliminary signal towards groundbreaking insight into MammaPrint High Risk tumors and how they best respond to chemotherapy regimens, underscoring the clinical utility of MammaPrint in the selection of treatment. We remain committed to advancing breast cancer research to help deliver the best standard of practice to women undergoing breast cancer care.” Additional data supporting MammaPrint utility in treatment selection will be presented by investigators from the ISPY2 trial in a poster titled Hormone Receptor Positive HER2-negative/MammaPrint High-2 Breast Cancer Closely Resembles Triple Negative Breast Cancer: Results from Gene Expression Data from the ISPY2 Trial [Rios-Hoyo, A., et al.]. By using data from the ISPY-2 trial, this poster demonstrates that MammaPrint H2 tumors have molecular and clinical similarities to triple negative breast cancer tumors, underscoring critical insight into how treatment plans can be optimized to achieve the best result for the patient. Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages. About Agendia Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint® + BluePrint®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment. Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world's largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer. About MammaPrint MammaPrint® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman’s risk of distant metastasis, MammaPrint® provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint® listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories – ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life’s plans. About BluePrint BluePrint® is a gene expression profiling test that reveals the driving forces behind a tumor’s growth at the earliest stage possible in a woman’s breast cancer care journey to help optimize and personalize treatment planning. As the only molecular subtyping test available in the U.S., BluePrint® goes where pathology cannot, offers critical insights that providers may otherwise have not known to act on, and gives women the best chance to return to a life not defined by cancer. BluePrint® measures the activity of 80 key genes that are involved in a tumor's growth to classify a tumor as Luminal-type, HER2-type, or Basal-type, each of which warrant distinct treatment pathways. By revealing the distinct underlying biology of a woman's tumor, BluePrint® can catch often misclassified, yet highly aggressive, Basal tumors, so women can be prescribed the most appropriate treatment from the start.

- 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: or 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. [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