Thursday, November 9, 2023

IMFINZI (durvalumab) plus bevacizumab met primary endpoint for progression-free survival in liver cancer eligible for embolization in EMERALD-1 Phase III trial

Results from the EMERALD-1 Phase III trial have showcased positive high-level outcomes for AstraZeneca's IMFINZI (durvalumab) when combined with transarterial chemoembolization (TACE) and bevacizumab. 

This combination exhibited a statistically significant and clinically meaningful improvement in the progression-free survival (PFS) primary endpoint compared to TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolization.

The trial is ongoing, focusing on the secondary endpoint of overall survival (OS).

Hepatocellular carcinoma is the most prevalent form of liver cancer, ranking as the third-leading cause of cancer-related deaths, with approximately 900,000 new cases diagnosed annually worldwide. 

About 20-30% of patients are suitable for embolization, a procedure that restricts blood supply to the tumor while allowing the delivery of chemotherapy or radiation therapy directly to the liver. Despite being the standard of care, most patients undergoing embolization face rapid disease progression or recurrence.

Dr. Riccardo Lencioni, the principal investigator in the trial, emphasized that patients eligible for embolization often experience high rates of progression or recurrence without the opportunity for early intervention using effective systemic therapy.

The results for durvalumab plus bevacizumab suggest a potential shift in treating this challenging disease, demonstrating, for the first time, that adding an immunotherapy combination to TACE significantly enhances progression-free survival.

Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, expressed optimism about the potential of IMFINZI-based treatment in EMERALD-1, anticipating a groundbreaking application of immunotherapy in earlier stages of liver cancer. 

The company looks forward to discussing these findings with regulatory authorities and monitoring the maturation of survival data over time to bring this innovative treatment option to patients.

The safety profiles for IMFINZI and TACE plus bevacizumab were consistent with the known profiles of each medicine, and there were no new safety findings. The detailed data will be presented at an upcoming medical meeting and shared with regulatory authorities.

AstraZeneca is actively engaged in a comprehensive clinical development program to further evaluate IMFINZI across various gastrointestinal cancer settings. 

This includes combinations with bevacizumab in adjuvant HCC (EMERALD-2) and with IMJUDO (tremelimumab-actl), lenvatinib, and TACE in embolization-eligible HCC (EMERALD-3).

Bristol Myers Squibb and Tempus enter into collaboration for AI approaches

 

Tempus, a prominent player in the realm of artificial intelligence and precision medicine, has unveiled a strategic and multi-year research collaboration with Bristol Myers Squibb. 

Together, these two entities are set to embark on a journey aimed at identifying and validating new targets swiftly and with heightened confidence. This process will leverage multimodal datasets, computational methodologies, and patient-derived disease models, particularly in the realm of specific cancer disease areas.

The collaborative efforts of the Tempus and Bristol Myers Squibb teams will initially be concentrated on the crucial task of pinpointing fresh drug targets.

The primary objective is to broaden the spectrum of options for patients who lack effective therapies or have become refractory to existing treatments. This joint endeavor will unfold in a highly collaborative manner, with both teams delving into Tempus' expansive multimodal database to analyze disease cohorts. 

Employing systems biology approaches, they aim to unearth novel targets that can be rapidly and iteratively tested using Tempus' repository of patient-derived organoids.

Tempus, recognized as a technology powerhouse, is at the forefront of advancing precision medicine through the practical application of artificial intelligence in the healthcare domain. 

Boasting one of the world's largest libraries of multimodal data and an operating system that renders this data accessible and practical, Tempus delivers AI-enabled precision medicine solutions to physicians. This not only facilitates personalized patient care but also catalyzes the discovery, development, and delivery of optimal therapeutics.

The overarching goal is to ensure that each patient reaps the benefits of treatments informed by the experiences of those who came before them. 

Tempus achieves this by furnishing physicians with tools that evolve and learn as the company accumulates more data, thereby contributing to a continuous cycle of improvement and innovation in healthcare.