In a nutshell
This study aimed to investigate the long-term safety and effectiveness of inotuzumab ozogamicin (Besponsa) for patients with relapsed or unresponsive acute lymphoblastic leukemia.
This study concluded that this treatment was safe and effective for these patients.
Inotuzumab ozogamicin (InO) is a targeted therapy used to treat adults with relapsed/unresponsive B-cell acute lymphoblastic leukemia (ALL). A previous trial (INO-VATE) reported short-term outcomes with InO compared to standard of care (SoC) therapy. SoC is the standard treatment that is used to treat patients with a specific illness.
The final long-term results of the INO-VATE study were unknown.
Methods & findings
This study involved 326 adult patients with relapsed or unresponsive ALL. 164 patients were treated with InO and 162 patients were treated with SoC. 307 patients received one or more doses of the drug. They were followed up for an average of 29.6 months.
The complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) rate was 73.8% for the InO group compared to 30.9% for the SoC group. The CR rate is when all signs of cancer are gone. CRi is when all signs of cancer are gone but the blood cells have not fully recovered from the treatment.
The average overall survival (OS) was 7.7 months for the InO group compared to 6.2 months for the SoC group. The 2-year OS rate was 22.28% for the InO group compared to 10% for the SoC group. 39.6% of the InO group proceeded directly to stem cell transplantation after achieving CR/CRi compared to 10.5% of the SoC group.
More patients in the InO group needed to lowed the dose of treatment or to stop treatment due to side effects. The most common side effects in both groups of patients were hematologic (blood cells-related). Serious side effects such as low white cell count, low platelet (blood cells involved in clotting) were slightly more common in the InO group (51.8%) compared to the SoC group (50.3%).
The bottom line
This study concluded that patients with relapsed or unresponsive ALL who received InO in the INO-VATE trial had a greater likelihood of CR/CRi and that InO served as a bridge to stem cell transplantation. Side effects should be considered before InO treatment.
The fine print
Published By :
Mar 28, 2019