#United States #AbbVie #North Chicago #CLL #venetoclax

AbbVie Strengthens Treatment Landscape for CLL

AbbVie, a global biopharmaceutical company based in North Chicago, Illinois, has recently announced that it has received approval from the European Commission (EC) for expanding the indications of its drug, Venetoclax, for patients with untreated chronic lymphocytic leukemia (CLL). This approval allows the use of Venetoclax in combination with Acalabrutinib, regardless of whether Obinutuzumab is included, and with Ibrutinib, providing significant enhancements to the treatment landscape for patients newly diagnosed with CLL.

The expanded label comes on the back of data gleaned from the Phase 3 AMPLIFY trial, the Phase 3 GLOW trial, and the Phase 2 CAPTIVATE trial. These studies reveal the efficacy and safety of these combination therapies, which present new options for CLL patients. The fixed-duration combination therapies utilizing Venetoclax could potentially allow for treatment-free periods, a significant milestone in managing the treatment journey of those affected by CLL.

The EC's approval applies across all EU member states, along with Iceland, Norway, and Liechtenstein, signifying a broad impact on the treatment options available to CLL patients in these regions.

Svetlana Kobina, vice president of global medical affairs in AbbVie’s oncology division, articulated the significance of this approval. She stated, "The combination therapy involving Venetoclax demonstrates strong efficacy and a favorable safety profile for first-line CLL treatment. The inclusion of fixed-duration regimens without chemotherapy in the label meets the evolving needs of patients and healthcare providers, allowing them to consider treatment strategies that may enable treatment pauses. Our efforts at AbbVie are focused on revolutionizing standard care for patients living with cancer through innovative therapies."

The efficacy of combined therapies featuring Venetoclax and Acalabrutinib is supported by the results of the AMPLIFY trial, while combinations with Ibrutinib stem from findings in both the GLOW trial and the CAPTIVATE trial.

Professor Paolo Ghia, a notable figure in oncology from Università Vita-Salute San Raffaele in Milan and a member of the AMPLIFY and CAPTIVATE steering committees, shared insights regarding CLL. He remarked, "CLL remains a challenging cancer to cure, and many patients experience recurrences. However, the management of this condition can be effectively accomplished through combination therapies. The new combination options utilizing Venetoclax provide a means to relieve the treatment burden for patients living with CLL, allowing for sustained responses in treatment-naive patients without the need for lengthy infusion treatments or continuous therapy."

Chronic Lymphocytic Leukemia is one of the most prevalent forms of leukemia in adults, arising from aberrations in the blood cells that eventually develop into a specific kind of white blood cell known as lymphocytes. Recent years have seen improvements in treatment outcomes; however, patients still face difficult decisions when choosing treatments that cater to their unique needs.

Jan Rynne, interim development lead at the European CLL Association, commented on the implications of new combination therapy options. He noted, "Those living with CLL tackle numerous challenges in disease management, which can adversely affect their mental health and overall quality of life. The prospect of being able to pause treatment, afforded by the addition of these combination therapies, is critically important for the quality of life for patients living with CLL and their families."

Detailed information regarding adverse reactions, dosage, contraindications, and other considerations associated with the combination of Venetoclax with Acalabrutinib and Ibrutinib for treating treatment-naive adult CLL patients is available in the product summary.

Trials Supporting Approval

AMPLIFY Trial

The AMPLIFY trial (NCT03836261) focused on untreated patients without chromosomal 17p deletion or TP53 mutations. This phase 3, randomized, multi-center, non-blind trial evaluated the fixed-duration combination of Venetoclax with Acalabrutinib (with or without Obinutuzumab) against immuno-chemotherapy. Results indicated that the combination therapy notably reduced the risk of disease progression or death by 35% compared to immuno-chemotherapy. Notably, the median progression-free survival (PFS) for the combination therapy group had yet to be reached, while the chemotherapy-immunotherapy group's median PFS was 47.6 months, highlighting the significant potential of the combined regimens.

GLOW Trial

The GLOW trial (NCT03462719), which evaluated the fixed-duration combination of Venetoclax with Ibrutinib against Chlorambucil and Obinutuzumab, yielded clinical improvements in PFS and overall survival for older CLL patients and those with comorbidities, achieving a 73% lower risk of disease progression and a 54% decrease in mortality risk compared to traditional regimens. The median PFS was 65 months for the Venetoclax and Ibrutinib group versus just 23 months for the comparator group.

CAPTIVATE Trial

The CAPTIVATE trial (NCT02910583) investigated the use of fixed-duration combination therapy versus treatment interruption based on minimal residual disease (MRD) in untreated CLL/SLL adult patients. At the 5.5-year mark, PFS rates were recorded at 66%, while 97% of patients similarly maintained an untreated state after the combined regimen.

About Venetoclax

Venetoclax is a groundbreaking drug that selectively binds and inhibits the BCL-2 protein, crucial in preventing the self-destruction of cancer cells. Developed collaboratively by AbbVie and Roche, this drug has received approval in over 80 countries, including the United States, where it is marketed through a partnership involving Genentech.

AbbVie’s Commitment to Oncology

AbbVie strives to improve treatment standards for patients facing difficult cancers. The company continues to advance a diverse pipeline of innovative therapies for various blood and solid tumors, focusing on creating targeted treatments that suppress or eliminate cancer cell proliferation.

To learn more about AbbVie’s oncology portfolio, check their webpage here.