American Society of Hematology, Dec. 6 to 9

The annual meeting of the American Society of Hematology was held from Dec. 6 to 9 in Orlando, Florida, and attracted participants from around the world, including hematology specialists as well as clinical practitioners and other health care professionals. The conference featured presentations focusing on the diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems.

In the phase 3 GIMEMA ALL2820 trial, Sabina Chiaretti, M.D., Ph.D., of Sapienza University in Rome, and colleagues found a chemo-free targeted/immunotherapy-based approach to be significantly beneficial for patients with newly diagnosed Ph+ acute lymphoblastic leukemia (ALL) and found that it outperformed a tyrosine kinase inhibitor/chemotherapy-based backbone.

The authors conducted a randomized trial (2:1 ratio in favor of the chemo-free arm) designed for newly diagnosed Ph+ ALL patients (older than 18 years; no upper age limit), in which the chemo-free arm was based on induction with ponatinib (45 or 30 mg daily, depending on age) followed by at least two cycles of intravenous blinatumomab (maximum, five cycles). The control arm was based on the administration of imatinib and chemotherapy (again, dose adjusted according to age). A crossover was allowed from the control to the experimental arm in the case of molecular residual disease persistence or development of ABL1 mutations.

The researchers observed a significant advantage of the experimental arm over the control arm, with hematologic responses at the end of induction being 94.3 and 79.4 percent, respectively, while death was 2.5 and 10.2 percent, respectively, and off-treatment was 2.8 and 8.9 percent, respectively. In line with the findings, molecular responses after consolidation (two cycles of blinatumomab/four to six cycles of chemotherapy) were significantly better in the experimental arm (70.9 versus 48.7 percent); relapses occurred slightly less frequently in the experimental arm (6 versus 8 percent). Treatment was well tolerated overall. Event-free survival was 90 and 74 percent and overall survival was 94 and 77 percent in the experimental and control arms, respectively. Notably, patients undergoing crossover had an overall survival of 97 percent.

“These findings should be regarded as clinical practice-changing. Nonetheless, most countries do not have access to blinatumomab in the first-line setting,” Chiaretti said. “Thus, there is a strong wish that these results will lead to blinatumomab approval, not only for patients enrolled in the clinical trials, but for all patients.”

Several authors disclosed ties to pharmaceutical and biotechnology companies, including Amgen (blinatumomab) and Takeda (ponatinib).

Abstract No. 439