The combination of obinutuzumab (Gazyva), acalabrutinib (Calquence), and venetoclax (Venclexta) failed to meet the pre-specified rate of undetectable measurable or minimal residual disease (uMRD) following optimal debulking with bendamustine in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).
nubrutinib) and the only approved BCL2 blocker (venetoclax) are referred to as being double refractory. Double refractory disease is one of the greatest unmet needs in CLL / SLL.
Since the introduction of Novel agents (NA) in 2013, the treatment paradigm for CLL has changed significantly with the increased use of novel agents for both first-line (1L) and refractory chronic lymphocytic leukemia (CLL).
TG Therapeutics, after a decade of development, is withdrawing its application for the combination of ublituximab and UKONIQ (umbralisib) (combination referred to as U2) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
At the American Society of Hematology (ASH) 2021, Dr. Alan Skarbnick, Director of the CLL program at Novant Health Cancer Institute in Charlotte, NC, interviewed Dr. Constantine Tam, a hematologist at the Peter McCallum Cancer Center in Melbourne, Australia. They discussed the results of a phase 1 clinical trial testing the combination of three different drugs:
Clinical Trial Results Clinical Trial Results No drugs receive FDA approval for use in CLL / SLL or come to market without being first evaluated for safety, efficacy, dosage, and many other factors
The combination of umbralisib plus ublituximab, often abbreviated to U2, has promising activity in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL / SLL) as shown in this ASH 2021 abstract:
Ask the Doctor Question: First diagnosed with CLL in 2007 on Watch and Wait for 6-months, then had FCR light for two rounds. Lymphocytes dropped so significantly that I stopped the
Welcome back to day two of ASH 2021, the 63rd American Society of Hematology Annual Conference and Exhibition, this year a hybrid meeting held in Atlanta, Georgia and virtually around the world.
