Russian patients with acute lymphoblastic leukemia (ALL) became available for therapy inotuzumab ozogamicin (conjugate monoclonal antibodies with the medicinal product). The drug is indicated for the treatment of adult patients with recurrent or refractory CD22–positive B-cell ALL from progenitor cells. In clinical studies inotuzumab demonstrated the superiority of efficiency compared to standard chemotherapy: a doubling of the number of patients who achieved complete remission and increased 2-year overall survival.
The incidence of ALL is about 1.6 cases per 100 thousand population. The probability of diagnosis of ALL in 50-year-old man is 1 in 125 000, and for 70 years- 1 to 60 000. Mostly this disease is common in Europe (where are diagnosed each year approximately 10,000 new cases of ALL in adults), the USA, China and Japan.
The main goal of induction treatment of patients with OLL is to achieve complete remission followed by consolidation and maintenance therapy, when the patient is standard risk ALL, and allogeneic transplantation of hematopoietic stem cells (HSCT), if the patient belongs to a high risk group. However, although 80-90% of adults achieve a complete response (AT), most of them have subsequently revealed a relapse, and the frequency of recovery does not exceed 40%. For adult patients with relapsed or refractory (resistant to treatment) form ALL the five-year overall survival is less than 10%.
Application inotuzumab ozogamicin for the treatment of R/R OLL of B-cells was assessed in the framework of the international, multicenter, randomized, open phase III study INO-VATE 1022. The drug demonstrated a statistically significant increase in the proportion of patients who achieved complete remission (CR) or complete remission with incomplete hematologic recovery (PRN) compared with standard chemotherapy. Under inotuzumab 80.7% of patients achieved remission compared to only 29.4 percent in the control group. Statistically significantly more patients treated with new drug (43,3%) compared to HT (11,1%) were able to continue to receive potentially curative procedure of hematopoietic stem cell transplantation (HSCT).