ORLANDO – In young patients who experience relapse after chemotherapy for B-cell acute lymphoblastic leukemia (B-ALL), the novel agent blinatumomab (Blincyto, Amgen) can be used instead of intensive chemotherapy to try to achieve a second remission, experts say.
In fact, blinatumomab should be the new standard of care in these patients because it yielded better overall survival, was less toxic, and allowed more patients to proceed to transplant, said Robert A. Brodsky, MD, professor of medicine and director of the division of hematology at Johns Hopkins University, Baltimore.
Dr. Brodsky was commenting on new data presented in a late-breaking abstract (LBA1) at the annual meeting of the American Society of Hematology, for which he holds the role of secretary.
These results are “truly practice changing,” he told journalists at a press briefing.
Cure rates for B-ALL in children and adolescents and young adults (AYAs) are high, but for the small group of patients who experience relapse (about 15%), the prognosis is poor.
When relapse occurs in these patients, “it’s a real problem,” Dr. Brodsky explained. “At that point, the major emphasis is trying to get them back into full remission and get them to a transplant,” he continued, “but it’s very hard to get these patients back into remission.”
The standard treatment approach for these patients includes intensive chemotherapy. In the new study, this was compared to monotherapy with blinatumomab, which is described as a bispecific T-cell engager antibody.
The results were presented by Patrick A. Brown, MD, from the division of pediatric oncology at the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University.
The Children’s Oncology Group Study AALL1331 trial was conducted in 208 children and AYA patients with B-ALL after a first relapse. Median follow-up was 1.4 years.
Blinatumomab was superior in achieving both disease-free survival (59.3 plus or minus 5.4% at 2 years vs. 41% plus or minus 6.2% at 2 years with chemo; P = .05) and overall survival (79.4 plus or minus 4.5% at 2 years vs. 59.2 plus or minus 6% at 2 years with chemo; P = .05).
In addition, more patients who received blinatumomab subsequently underwent transplant (79% vs. 45% with chemo; P less than .0001).
The drug was also better tolerated than chemotherapy, causing fewer and less severe toxicities, including fewer cases of grade 3+ infection, sepsis, and mucositis.
Dr. Brown concluded that, for children and AYA patients with high- or intermediate-risk first relapse of B-ALL, blinatumomab is superior to standard chemotherapy as postreinduction consolidation prior to transplant, resulting in fewer and less severe toxicities, higher rates of minimum residual disease response, greater likelihood of proceeding to hematopoietic stem cell transplant, and improved disease-free and overall survival.
Dr. Brown noted that blinatumomab already has conditional approval from the Food and Drug Administration for use in relapsed ALL in both adults and children, but that approval was based on clinical trial data in adults. This is now the definitive trial in children and AYAs, and it should support full approval for this indication, he said.
Dr. Brown has relationships with Novartis, Servier, and Jazz. Many coauthors also have relationships with pharmaceutical companies. Dr. Brodsky has relationships with Achillion, Alexion, and UpToDate.
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