Leukemia

Asciminib, an investigational first-in-class STAMP (specifically targeting the ABL myristoyl pocket) inhibitor, was superior to standard treatment with bosutinib (Bosulif) in patients with chronic-phase chronic myeloid leukemia (CML) who previously received 2 or more tyrosine kinase inhibitors (TKIs) in the phase 3 ASCEMBL clinical trial. The results were presented at a late-breaker session at ASH 2020 by lead investigator Andreas Hochhaus, MD, Director, Department of Hematology and Oncology, Klinik für Innere Medizin II, Jena, Germany.

Maintenance therapy with azacitidine (Onureg) tablets improved overall survival (OS) in patients with acute myeloid leukemia (AML) who were in remission after intensive chemotherapy in the phase 3 QUAZAR AML-001 study. Survival was extended regardless of the patients’ measurable residual disease (MRD) status at study entry, reported Gail J. Roboz, MD, Director, Clinical and Translational Leukemia Program, Weill Medical College of Cornell University, New York, NY, at ASH 2020.

The randomized phase 2 CAPTIVATE clinical trial showed that first-line therapy with ibrutinib (Imbruvica) and venetoclax (Venclexta) for a fixed duration (ie, 12 cycles) led to a 30-month progression-free survival (PFS) in more than 95% of patients with chronic lymphocytic leukemia (CLL) and undetectable minimal residual disease (MRD). The results of the MRD cohort of the study were presented at ASH 2020.

The combination of 2 novel agents—umbralisib and ublituximab (U2)—represents a promising new treatment option for patients with chronic lymphocytic leukemia (CLL). In the phase 3 multicenter clinical trial UNITY-CLL, the median progression-free survival (PFS) was significantly longer with U2 than with standard-of-care chemoimmunotherapy, reported John G. Gribben, MD, DSc, FRCP, Centre Lead, Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, England, at ASH 2020.

On September 1, 2020, the FDA approved azacitidine (Onureg; Celgene), an oral nucleoside metabolic inhibitor, for maintenance treatment of adults with acute myeloid leukemia (AML) who had first complete remission (CR) or CR with incomplete blood count recovery after intensive induction chemotherapy and who are not candidates for intensive curative therapy. The FDA granted azacitidine an orphan drug designation and used its priority review for this indication.

A total of 80% of patients with relapsed or refractory indolent non-Hodgkin lymphoma (NHL) achieved a complete response (CR) to axicabtagene ciloleucel (Yescarta), and those responses have proved durable, according to the interim results of the phase 2 ZUMA-5 study, said Caron A. Jacobson, MD, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute, Boston, MA, at the ASCO 2020 virtual annual meeting.

Targeted therapy with the Bruton tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence), which is currently approved for the treatment of patients with non-Hodgkin lymphoma, has demonstrated durable remissions in treatment-naïve patients with chronic lymphocytic leukemia (CLL), according to the long-term data from the phase 2 CLL-001 study, which were presented at the ASCO 2020 virtual annual meeting.

According to long-term follow-up data presented at the ASCO 2020 annual meeting, anti-CD19 chimeric antigen receptor (CAR) T-cell therapy has demonstrated ongoing durable remissions lasting up to 113 months for follicular lymphoma, 99 months for chronic lymphocytic leukemia (CLL), and 97 months for diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL).

Orlando, FL—An investigational oral form of azacitidine (CC-486) as maintenance therapy induced a statistically significant improvement in overall survival (OS) compared with placebo in patients with newly diagnosed acute myeloid leukemia (AML) who achieved a complete response or complete response with incomplete hematologic recovery after treatment with induction chemotherapy.

Orlando, FL—Almost 50% of patients with chronic lymphocytic leukemia (CLL) who received treatment with the triplet of acalabrutinib (Calquence), venetoclax (Venclexta), and obinu­tuzumab (Gazyva) as first-line therapy achieved undetectable minimal residual disease (MRD) in the bone marrow after only 8 monthly cycles of therapy, according to data presented at ASH 2019.