A recent press release by the global biopharmaceutical research company, AbbVie, reported a positive opinion by CHMP granted to VENCLYXTO® combined with obinutuzumab to treat chronic lymphocytic leukemia (CLL).
A positive opinion by CHMP, which is the Committee for Medicinal Products for Human Use, is a step towards receiving authorization from the European Commission to enter the market. The final decision by the CHMP is expected within the next six months.
According to AbbVie’s V.P. of Development, the combination would be the first and only chemotherapy-free treatment for previously untreated CLL patients. The treatment would be administered for twelve months.
The lead investigator of the trial agrees and points out that for the first time untreated CLL patients can rely on a treatment that is free from chemotherapy, offering improved results and longer overall survival.
The CLL14 trial was conducted in collaboration with a German Study Group and involved 216 patients.
About the Trial
The CLL14 multicenter trial was conducted in collaboration with German CLL researchers.
CHMP’s positive opinion was based on the results of the CLL14 Phase 3 clinical trial. VENCLYXTO (venetoclax) was administered in tablet form for twelve 28 day cycles and was combined with obinutuzumab (216 patients) that was administered for six cycles.
This combination was compared with chlorambucil combined with obinutuzumab (216 patients).
Progression-free survival (PFS), which is the length of time the disease does not progress during treatment, was the primary endpoint.
The secondary endpoint was negative minimal residual disease in peripheral blood and in the bone marrow. Also noted was the overall complete response.
The PFS was determined by the trial investigator. The investigator’s assessment was that the patients receiving the VENCLYXTO and obinutuzumab combination achieved longer PFS than patients receiving the combination of chlorambucil and obinutuzumab.
Three patients were reported to have experienced tumor lysis syndrome, which is a serious complication that can occur when a large number of tumor cells are destroyed by a drug. This is common in the treatment of leukemias and lymphomas when the residue from the damaged cells pours into the bloodstream.
In the CLL14 trial, the tumor lysis cases occurred after treatment with obinutuzumab and before venetoclax was administered.
Chronic Lymphocytic Leukemia (CLL) represents about one-third of new leukemia diagnoses in the western hemisphere.
CLL is a slow-growing blood cancer whereby immature lymphocytes (a form of white blood cells) accumulate in the bone marrow and in the blood.
VENCLYXTO® is developed by AbbVie and Roche. It is identified as a first-in-class medicine that uses a new and unique mechanism of action in the treatment of a medical condition.
The drug selectively inhibits the B-cell lymphoma-2 (BCL-2) protein. BCL-2 precludes cancer cells from self-destruction (apoptosis). VENCLYXTO targets the BCL-2 protein thus restoring apoptosis.
VENCLYXTO has been approved in fifty countries. This includes the United States. Roche and AbbVie are hoping to bring VENCLYXTO to other countries and are contacting worldwide regulatory agencies.
AbbVie, an R&D biopharmaceutical company, is involved in the development of some of the most complex conditions across the globe. The company is focused on four therapeutic areas in over 75 countries: oncology, immunology, neuroscience, and virology (the study of viruses).