Efficacy

Besponsa (Inotuzumab Ozogamicin) for Leukemia

Besponsa, known generically as inotuzumab ozogamicin, is an antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The efficacy of Besponsa was primarily demonstrated in a key phase 3 clinical trial known as INO-VATE ALL. In this study, patients treated with Besponsa showed a higher complete remission rate compared to those who received standard therapy. The complete remission rate was approximately 81% for patients receiving Besponsa compared to 29% in the standard therapy group. Moreover, Besponsa demonstrated a significant improvement in progression-free survival, which is a measure of the time patients lived without worsening of their disease.

Additionally, Besponsa has shown potential in providing a bridge to stem cell transplantation for patients with relapsed or refractory ALL. A higher percentage of patients treated with Besponsa were able to undergo subsequent stem cell transplantation, which is considered a potentially curative approach, compared to those treated with standard chemotherapy regimens. This is an important consideration given the poor prognosis associated with relapsed or refractory ALL.

Tibsovo (Ivosidenib) for Leukemia

Tibsovo, or ivosidenib, is an oral medication approved for the treatment of acute myeloid leukemia (AML) with a specific genetic mutation known as isocitrate dehydrogenase-1 (IDH1). The efficacy of Tibsovo was evaluated in a multicenter, single-arm, open-label clinical trial involving patients with relapsed or refractory AML with an IDH1 mutation. The trial demonstrated a 41.6% overall response rate, with 21.6% of patients achieving complete remission. Additionally, for those who achieved a response, the median duration of response was 8.2 months, indicating a significant period of disease control.

Moreover, Tibsovo has shown efficacy in patients with newly diagnosed AML who are aged 75 years or older or who have comorbidities that preclude the use of intensive induction chemotherapy. In a separate clinical trial, patients treated with Tibsovo had a complete remission rate of 42.4%, with a median duration of response of 10.1 months. These results suggest that Tibsovo offers a valuable treatment option for a subset of AML patients who have historically had limited therapeutic options due to their age or health status.