Dr Wang said she thought the study was important because “it draws attention to the unmet need for effective non-toxic treatments for older adults with AML. These patients represent the majority of individuals with this disease. As shown here, their expected outcomes with best supportive care only are dismal, with most surviving only a few months.”

Amadori and colleagues found that the overall survival benefit with gemtuzumab ozogamicin  was consistent across most subgroups. In addition, this treatment approach appeared to be highly beneficial in patients with high CD33 expression status as well as in patients with a favorable/intermediate cytogenetic risk profile.


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Women in the study also tended to fare better with gemtuzumab ozogamicin  than men. Complete remission plus complete remission with incomplete recovery of peripheral blood counts occurred in 27% of the patients receiving gemtuzumab ozogamicin.

The investigators noted that serious AEs were similar between the 2 treatment arms and there was no excess mortality from AEs in the patients receiving gemtuzumab ozogamicin.

Dr Wang said these findings do not represent a major treatment advance for AML per se. However, she said they are an important step in finding better treatment options for this patient population. While the study results were statistically significant, she would  argue that in real life the difference was not substantially different.

“Instead, this study offers us hope that newer ADCs, such as Seattle Genetics’ SGN33A currently in development for AML therapy, may someday prove even more effective in this difficult-to-treat patient population,” she said.

Jeffrey Lancet, MD, who is chair of the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, FL, agreed with Dr Wang. He acknowledged the study’s importance in that it indicated modest disease-modifying ability of gemtuzumab ozogamicin  in older patients with AML. However, he did not see the findings as a major advance, given the availability of other agents with similar if not better efficacy in the same setting.

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“The problem is that other agents such as azacitidine, decitabine, and low-dose cytarabine are also felt to be superior to best supportive care in older AML patients, so there is no way to know how gemtuzumab ozogamicin actually compares to other available agents in this setting because a randomized comparison between gemtuzumab ozogamicin  and cytarabine/azacitidine/decitabine has not been done. In the current study, the median overall survival of only 4.9 months in the gemtuzumab ozogamicin  treated patients does not suggest that gemtuzumab ozogamicin  is better than other available lower intensity frontline therapies such as azacitidine, decitabine, or low-dose cytarabine,” Dr Lancet told Cancer Therapy Advisor.

Reference

  1. Amadori S, Suciu S, Selleslag D, et al. Gemtuzumab ozogamicin versus best supportive care in older patients with newly diagnosed acute myeloid leukemia unsuitable for intensive chemotherapy: results of the randomized phase III EORTC-GIMEMA AML-19 trial [published online ahead of print January 25, 2016]. J Clin Oncol. doi: 10.1200/JCO.2015.64.0060.