The CHMP has granted a positive opinion for Venclyxto® (venetoclax) in combination with obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL).
The positive opinion is based on results from the Phase III CLL14 clinical trial, which evaluated the efficacy and safety of Venclyxto in combination with obinutuzumab compared with chlorambucil in combination with obinutuzumab.
“The positive CHMP opinion for this new indication in chronic lymphocytic leukaemia is an important step forward for patients and underscores the growing utility of Venclyxto in treating this common blood cancer,” said Neil Gallagher, MD, PhD, chief medical officer and vice president of development. “If approved by the EC, the venetoclax and obinutuzumab combination would be the first chemotherapy-free option for treatment-naïve patients with chronic lymphocytic leukaemia where dosing can be completed in one year.”
The primary endpoint was progression-free survival (PFS; the time on treatment without disease progression or death) as assessed by an investigator. At the time of analysis, investigator-assessed results demonstrated that patients treated with Venclyxto plus obinutuzumab achieved superior PFS compared to patients treated with obinutuzumab plus chlorambucil. Adverse events were consistent with the known safety profiles of venetoclax and obinutuzumab alone. At least one AE of any grade occurred in 94.3% of patients in the venetoclax combination arm, with the most common Grade 3/4 AEs in patients being febrile neutropenia and infections. Tumour lysis syndrome (TLS) was reported in three patients in the venetoclax plus obinutuzumab group (all during treatment with obinutuzumab and before venetoclax). Results from the CLL14 trial were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.
“Chemotherapy has historically been the first treatment for patients with chronic lymphocytic leukaemia. If the venetoclax plus obinutuzumab combination is approved in the EU, previously-untreated patients will, for the first time, have a chemotherapy-free, fixed-duration treatment option,” said Michael Hallek, MD, lead investigator of the CLL14 study, Director of the Department of Internal Medicine and Center of Integrated Oncology Cologne-Bonn at the University Hospital Cologne in Germany, and Head of the German CLL Study Group. “The early use of venetoclax plus obinutuzumab combination has the potential to change the treatment paradigm for chronic lymphocytic leukemia as it has been demonstrated to improve outcomes, allowing patients to live longer without disease progression.”