Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML.
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Gyurkocza Boglarka, Nath Rajneesh, Seropian Stuart, Choe Hannah, Litzow Mark R, Abboud Camille, Koshy Nebu, Stiff Patrick, Tomlinson Benjamin, Abhyankar Sunil, Foran James, Hari Parameswaran, Chen George, Al-Kadhimi Zaid, Kebriaei Partow, Sabloff Mitchell, Orozco Johnnie J, Jamieson Katarzyna, Silverman Margarida, Van Besien Koen, Schuster Michael, Law Arjun Datt, Larkin Karilyn, Pandit-Taskar Neeta, Rowley Scott D, Munshi Pashna, Cook Rachel, Levy Moshe Y, Lazarus Hillard M, Sandmaier Brenda M, Pagel John M, Reddy Vijay, MacDougall James, McNamara Kathleen, Spross Jennifer, Haeuber Elaina, Vusirikala Madhuri, Nahar Akash, Desai Avinash, Giralt Sergio
Аннотация
METHODS: SIERRA (ClinicalTrials.gov identifier: NCT02665065) was a phase III open-label trial. Patients age ≥55 years with active RR AML were randomly assigned 1:1 to either an 131I-apamistamab-led regimen before alloHCT or conventional care followed by alloHCT if initial complete remission (CR)/CR with incomplete platelet recovery (CRp) occurred. Initial response was assessed 28-56 days after alloHCT in the 131I-apamistamab group and 28-42 days after salvage chemotherapy initiation; patients without CR/CRp or with AML progression could cross over to receive 131I-apamistamab followed by alloHCT. The primary end point was durable complete remission (dCR) lasting 180 days after initial CR/CRp. Secondary end points were overall survival (OS) and event-free survival (EFS), assessed hierarchically in the intention-to-treat (ITT) population.
RESULTS: The ITT population included 153 patients (131I-apamistamab [n = 76]; conventional care [n = 77]). In total, 44/77 conventional care arm patients crossed over and 40/77 (52%) received 131I-apamistamab and alloHCT, with six patients (13.6%) experiencing a dCR. In the ITT population, the dCR rate was significantly higher with 131I-apamistamab (17.1% [95% CI, 9.4 to 27.5]) than conventional care (0% [95% CI, 0 to 4.7]; P < .0001). The OS hazard ratio (HR) was 0.99 (95% CI, 0.70 to 1.41; P = .96), and the EFS HR was 0.23 (95% CI, 0.15 to 0.34), with HR <1 favoring 131I-apamistamab. Grade ≥3 treatment-related adverse events occurred in 59.7% and 59.2% of the 131I-apamistamab and conventional care groups, respectively.
CONCLUSION: The 131I-apamistamab-led regimen was associated with a higher dCR rate than conventional care in older patients with RR AML. 131I-apamistamab was well tolerated and could address an unmet need in this population.