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Tamibarotene + Ven + Aza combination in patients with AML: Interim results from the SELECT-AML-1 phase II trial
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During the SOHO 2024 Annual Meeting, Borate presented interim efficacy and safety results from the phase II SELECT-AML-1 trial (NCT04905407) of tamibarotene in combination with Ven and Aza in patients with newly diagnosed AML with RARA overexpression.1 A total of 51 patients were randomized to receive either tamibarotene + Ven + Aza (n = 25) or Ven + Aza (n = 26).1 |
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The primary endpoint of CR/CRi was achieved in 60% in the tamibarotene + Ven + Aza group vs 69% in the Ven + Aza group, with a median duration of response of 293 months vs 253 months, respectively. ORR was 80% and 73%, respectively. |
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In the prespecified efficacy futility analysis, CR/CRi was achieved in 65% of patients receiving tamibarotene + Ven + Aza (n = 20) vs 70% of patients receiving Ven + Aza (n = 20). ORR was 85% and 75%, respectively. |
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The incidence of any grade TEAE was 100% in the tamibarotene + Ven + Aza group (n = 24) vs 89% in Ven + Aza group (n = 27). The most common non-hematologic TEAEs occurring in ≥25% of patients were constipation (42% vs 19%), diarrhea (38% vs 22%), nausea (33% vs 33%), peripheral edema (29% vs 11%), pruritus (29% vs 0%), weight loss (25% vs 11%), reduced appetite (21% vs 26%), and dyspnea (21% vs 26%). The addition of tamibarotene to Ven and Aza did not cause any additive myelosuppression. |
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The findings suggest that the tamibarotene + Ven + Aza combination was well tolerated; however, it did not show any improvements in CR/CRi and ORR compared with Ven + Aza. The prespecified efficacy analysis showed similar response rates between the two groups. However, there remains an opportunity to evaluate the longer-term impact on the duration of response, survival, and salvage therapy. |
Abbreviations: AML, acute myeloid leukemia; Aza, azacitidine; CR, complete remission; CRi, complete remission with incomplete hematologic recovery; ORR, overall response rate; SOHO, Society of Hematologic Oncology; TEAE, treatment-emergent adverse event; Ven, venetoclax.
- Borate U. SELECT-AML-1: Phase 2 randomized trial of tamibarotene in combination with venetoclax and azacitidine in adult patients with previously untreated AML with RARA overexpression, who are ineligible for standard induction therapy. Poster# AML-347. Presented at: Society of Hematologic Oncology 2024 Annual Meeting; Sep 4–7, 2024; Houston, US.
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