Study finds that ibrutinib and venetoclax are effective in first-line treatment in some patients with chronic lymphocytic leukemia

According to a study conducted at the University of Texas, MD-Cancer, Ibrutinib and Venetoclax, two FDA-approved drugs for the treatment of chronic lymphocytic leukemia (CLL), have been shown to be effective when 39 they are given in combination with high-risk patients and older patients, Center.

The results of the study were published in the May 29 issue New England Journal of Medicine. The principal investigators were Nitin Jain, M.D., badociate professor of leukemia, William Wierda, M.D., Ph.D., professor of leukemia; and Varsha Gandhi, Ph.D., Acting Head of Department of Experimental Therapeutics.

The researchers followed 80 previously untreated patients in a phase II study. The median age was 65 years old and 30% of them were over 70 years old. Ninety-two percent had high-risk genetic abnormalities. Eighty-eight percent of patients had complete remission with recovery of normal or incomplete blood counts after 12 cycles of treatment. Sixty-one percent of patients had complete remission with minimal undetectable residual disease.

"These results of efficacy are significantly better than those reported with ibrutinib or venetoclax monotherapy for CLL patients," Jain said. "In monotherapy, the majority of responses were partial and remissions with minimal residual disease undetectable in the bone marrow were rare."

Jain added that more robust treatments are needed for CLL patients, as the majority of patients are over 65 years old and existing treatments are not always effective.

"This group of patients often has unacceptable side effects, a complete remission rate, and a minimal undetectable residual disease," Jain said. "Our data showed that the combination of ibrutinib and venetoclax without chemotherapy showed no new toxic effect compared to what had previously been reported for different agents."

The study found that 60% of patients had developed a low white blood cell count, which was similar to what had been reported in other trials involving the combination of venetoclax. No new safety issues have been observed with combination therapy.

While the current median follow-up of the trial is 14.8 months, Mr. Jain said that "a longer follow-up is necessary to adequately badess the long-term safety of this badociation".

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The members of the study team included: Michael Keating, M.D .; Philip Thompson, M.D .; Alessandra Ferrajoli, M.D .; Jan Burger, M.D., Ph.D .; Gautam Borthakur, M.D .; Koichi Takahashi, M.D .; Zeev Estrov, M.D .; Tapan Kadia, M.D .; Marina Konopleva, M.D., Ph.D .; Yesid Alvarado, M.D .; Musa Yilmaz, M.D .; Courtney DiNardo, M.D .; Prithviraj Bose, M.D .; Maro Ohanian, D.O .; Naveen Pemmaraju, M.D .; Elias Jabbour, M.D .; Koji Sasaki, M.D .; Katrina Sondermann; Nichole Cruz; Chongjuan Wei, Ph.D .; Ana Ayala; and Hagop Kantarjian, M.D .; all of the leukemia department; Nathan Flower, MD, Department of Lymphoma and Myeloma; Rashmi Kanagal-Shamanna, M.D .; Keyur Patel, M.D., Ph.D .; and Jeffrey Jorgensen, M.D., Ph.D .; the department of hematopathology; Xuemei Wang, from the Department of Biostatistics; Naveen Garg, M.D., Department of Diagnostic Radiology; and William Plunkett, Ph.D., Department of Experimental Therapeutics.

The study was funded by AbbVie Inc.; the Andrew Sabin Family Foundation; the CLL Global Research Foundation; and the National Institutes of Health (P30 CA016672). The study was also funded by Moon Shot ™ Chronic Lymphocytic Leukemia, part of MD Anderson's Moon Shots ™ program, a collaborative effort to accelerate the development of scientific breakthroughs that can lead to clinical breakthroughs. save the lives of patients. Jain, Wierda and Gandhi have received a grant from AbbVie, and Jain has received honoraria from and has served on the AbbVie Advisory Board.