On May 15, the Food and Drug Administration (FDA) approved venetoclax (Vanclexta) in combination with obituzumab (Gazeva) for the initial treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Milos Miljković, MD, who studied CLL at NCL’s Center for Cancer Research, said, “This is the second chemotherapy so far approved for first-line treatment of CLL and the first such given for a limited period, “Milos Milzhavikov said.
Another FDA-approved treatment for CLL and SLL that does not include chemotherapy is ibrutinib (Imbruvica). Patients receiving this medicine take it until the disease progresses or the side effects become unbearable.
Both CLL and SLL grow slowly.
In CLL, the bone marrow forms too much lymphocyte (a type of white blood cell); In SLL, lymph nodes produce too many lymphocytes.
One tablet, the venetoclax, blocks the action of a protein called BCL2, which helps keep cancer cells alive. Obinutuzumab, a monoclonal antibody that is injected intravenously, targets a protein called CD20, often found on the surface of tumor cells in patients with certain types of leukemia.
Venetoclax was initially approved by the FL in 2016 to treat individuals with CLL that have a specific genetic change, known as deletion 17p. In 2018, the agency expanded the drug’s approval to include people whose cancer has progressed after receiving at least one previous treatment, even if there were genetic changes in their cancer cells.
The FDA’s new approval was based on the results of a phase 3
clinical trial comparing the effectiveness and safety of venetoclax in combination with obinatuzumab versus obinutuzumab to the chemotherapy drug chlorambucil in individuals with CLL or SLL and co-medical conditions .
The results of the clinical trial, supported by the makers of Venetoclax, F. Hoffmann-La Roche and AbbVie, were published in the New England Journal of Medicine on 6 June.
Participants receiving venetoclax plus obinutuzumab were 67% less likely to worsen the disease or die than those receiving chlorambucil and obinutuzumab.
Said Milzhkovic, who was not involved in the trial. More than half of the participants in each group struggled with the disease even 28 months after the start of treatment.
In a study without directly comparing these treatments, they predicted that doctors would largely choose treatment based on factors such as patient preference and additional health conditions.
The Phase 2 clinical trial included 80 previously untreated patients with CLL, most of whom had genetic changes that placed them at high risk of worsening of the disease. All participants in the study received combination therapy (there was no control group).
According to the results published on May 30 in the New England Journal of Medicine, after an average follow-up of approximately 15 months, 88% of patients had complete remissions, and 61% of patients with no detectable CLL in bone marrow. Was.
“We are very excited about the reactions seen in patients receiving this combination,” William Verda, MAD, PhD, who led the study.
More than half of the people participating in the trial who were receiving medication stopped taking it due to side effects such as fatigue. In most of these patients, side effects were treatable, Drs. Lonial mentioned.
They discussed the findings during a press briefing on May 15 that included the study to be presented at the 2019 annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The results of the study were later published in the Journal of Clinical Oncology on 25 October.
The new results, along with findings from previous studies, point to the possibility of using treatments such as liniglomide in individuals who have relapsed myeloma, who are at a higher risk of cancer progression.