Tempus AI and Stemline Therapeutics partner to advance AI-driven ESR1 mutation testing in metastatic breast cancer

Tempus AI, Inc. (NASDAQ: TEM) and Stemline Therapeutics, Inc., a wholly owned subsidiary of the Menarini Group, have announced a collaboration to integrate Tempus Next, an AI-enabled care pathway intelligence platform, into the treatment workflow for ER+/HER2- metastatic breast cancer patients. The partnership is designed to improve ESR1 mutation testing, a critical step in personalizing treatment plans and optimizing precision oncology treatments for individuals with metastatic breast cancer.

With up to 50% of patients diagnosed with ER+/HER2- metastatic breast cancer developing ESR1 mutations due to prior endocrine therapy, timely detection is essential. These mutations can drive resistance to standard hormonal treatments, making it crucial for oncologists to identify them early. The Tempus Next platform will analyze clinical data from mBC patients receiving care in designated treatment centers and will notify clinicians when ESR1 testing has not been conducted at disease progression. By automating this process, Tempus aims to enhance adherence to oncology care guidelines, ensuring that physicians are equipped with real-time information to support breast cancer treatment strategies.

Why Is ESR1 Mutation Testing Critical in Breast Cancer Treatment?

ESR1 mutation testing has become a vital component of breast cancer treatment strategies as scientific advancements continue to shape the landscape of precision oncology treatments. The American Society of Clinical Oncology (ASCO) has updated its recommendations to include ESR1 mutation testing at every stage of metastatic breast cancer disease progression. These guidelines highlight the importance of identifying mutations that may render endocrine therapy ineffective, leading to disease advancement and limiting treatment options.

ESR1 mutations are often subclonal and heterogeneous, meaning they are not uniformly distributed within a tumor. This variation makes traditional tissue biopsy testing less reliable in detecting them. Instead, liquid biopsy has emerged as the preferred method due to its greater sensitivity in identifying genomic alterations within circulating tumor DNA. Unlike traditional biopsy methods, which rely on archived tissue samples collected before the cancer’s progression, liquid biopsy testing provides a more accurate and real-time picture of a patient’s evolving disease state.

Despite these established guidelines, ESR1 mutation testing is not consistently performed across all oncology centers. Many clinicians face workflow challenges, leading to gaps in oncology care pathways. The collaboration between Tempus and Stemline Therapeutics seeks to bridge this gap by embedding AI-driven decision support directly into clinical workflows, ensuring that testing is conducted in a timely and efficient manner.

How Does AI Integration Improve Breast Cancer Treatment Decisions?

The integration of AI-powered clinical decision support systems is transforming how oncologists navigate complex treatment pathways. The Tempus Next platform leverages machine learning and real-world clinical data to provide actionable insights, allowing physicians to make more informed decisions regarding metastatic breast cancer treatment.

By analyzing patient records in real-time, the platform identifies cases where ESR1 mutation testing is missing and sends notifications to clinicians, ensuring that testing aligns with up-to-date clinical oncology guidelines. These notifications are seamlessly incorporated into physicians’ existing workflows, reducing administrative burdens and enabling quicker, more precise decision-making.

Chris Scotto DiVetta, Senior Vice President of AI Applications at Tempus, emphasized the impact of this innovation, stating that the application of Tempus Next in breast cancer treatment strategies represents a major step forward in AI-assisted oncology. He noted that the platform is designed to help physicians implement the latest ASCO guidelines while ensuring that patients receive the most appropriate, guideline-recommended care.

What Are the Implications of This Collaboration for Breast Cancer Patients?

For patients with ER+/HER2- metastatic breast cancer, early and accurate detection of ESR1 mutations can significantly influence treatment outcomes. Identifying these mutations allows oncologists to tailor therapy by shifting to targeted treatments that address endocrine resistance. Stemline Therapeutics, which specializes in oncology drug development, recognizes the importance of incorporating AI into breast cancer treatment pathways.

Yasir Nagarwala, Senior Vice President of Medical Affairs at Stemline Therapeutics, underscored the importance of this collaboration, stating that ESR1 mutations play a critical role in driving metastatic breast cancer progression. He highlighted that therapies targeting these mutations already exist, making accurate ESR1 testing an essential step in precision oncology treatments. By working with Tempus, Stemline aims to improve how oncologists identify ESR1-positive patients, ultimately guiding more effective and personalized treatment plans.

What Role Will AI Play in the Future of Precision Oncology?

As machine learning and AI-powered platforms continue to reshape the healthcare industry, the role of AI in oncology care pathways is becoming increasingly significant. The ability to analyze vast amounts of clinical data in real time enables more precise breast cancer treatment strategies, improving patient outcomes and reducing gaps in oncology care guidelines adherence.

The collaboration between Tempus and Stemline Therapeutics represents a shift toward data-driven, AI-enhanced oncology decision-making, demonstrating the potential for technology to transform breast cancer treatment approaches. As AI-powered platforms become more widely adopted, they are expected to play a crucial role in the continued advancement of precision oncology treatments, ensuring that patients receive the most effective therapies tailored to their individual disease profiles.