P1, N=12, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027

P2/3, N=306, Not yet recruiting, Actinium Pharmaceuticals

P1, N=24, Recruiting, Columbia University

P1/2, N=30, Recruiting, University of Texas Southwestern Medical Center | Not yet recruiting --> Recruiting | Trial completion date: May 2029 --> May 2030 | Trial primary completion date: May 2028 --> May 2029

P1/2, N=30, Not yet recruiting, University of Texas Southwestern Medical Center | Initiation date: Apr 2025 --> Jul 2025

P1/2, N=30, Not yet recruiting, University of Texas Southwestern Medical Center

Pts were randomized (1:1, N=153) to CC or Iomab-B with fludarabine and total body irradiation (2 Gy) followed by HCT (CC, n=77; Iomab-B, n=76). 131I-apamistamab led HCT significantly improves outcomes in pts with TP53 mutations, commensurate with rates observed in pts with wildtype TP53 in terms of CR, dCR and OS , overcoming the negative impact of this mutation. These data support the use of 131I-apamistamab led induction/conditioning and HCT in R/R AML, especially in patients with a TP53 mutation.

Pts were randomized (1:1) to CC or 131I-apamistamab with fludarabine and total body irradiation (2 Gy) followed by alloHCT. Pts with TP53 mutated R/R AML have a dismal prognosis and are seldom offered alloHCT due to high post-transplant relapse rates. 131I-apamistamab led alloHCT significantly improves survival outcomes in pts with TP53 mutations, commensurate with rates observed in pts with wildtype TP53, thereby overcoming the negative impact of this mutation. These data clearly support the use of 131I-apamistamab led induction and conditioning and alloHCT in R/R AML, including in patients with a TP53 mutation.

Patients >55 years of age with R/R AML were randomized (1:1) to receive Iomab-B followed by fludarabine, total body irradiation (2 Gy), and alloHSCT or CC (physician's choice of therapy, including targeted agents and alloHSCT if leukemia-free). Patients with failure of targeted therapies, including venetoclax, were able to undergo alloHSCT with the Iomab-B–led regimen. Of those who achieved dCR with Iomab-B, >70% had previous targeted-therapy failure, including >50% with previous venetoclax failure. The majority of dCR patients were long-term survivors.

Recent prospective data from the phase III ASAP Trial also suggest that in patients with poor response after initial first induction therapy or relapsed AML watchful waiting and sequential conditioning prior to allogeneic HCT result in comparable CR rates as could be observed with salvage chemotherapy with high-dose cytarabine plus anthracycline...Early HLA-typing of AML patients and their family members (possibly at the time of diagnosis), conditioning regimens incorporating novel agents, such as briquilimab or 131I-apamistamab, engineered donor grafts and maintenance therapy with novel agents or cell therapeutics have the potential to improve disease-free and overall survival in this patient population through improved disease control...Allogeneic HCT should be considered in this patient population, preferably in the context of a clinical trial testing novel treatment modalities. Updated prognostic score systems have the potential to identify subgroups of patients deriving the most benefit from these approaches.

Mycophenolate mofetil was switched to everolimus, and he was referred to dermatology...Before he could pursue recommended treatments, he was admitted in November 2021 for fever, worsening back pain, leukocytosis (WBC 131.6 thousand/µL; increased from 7.3 thousand/µL in October 2021), anemia (6 gm/dL), and thrombocytopenia (17 thousand/µL)... Chronic immunosuppression impairs anti-tumor immune surveillance and has a central role in oncogenesis after solid organ transplant. LT recipients receive even more immunosuppression. Immunosuppression modification with mammalian target of rapamycin inhibitors (everolimus) may interfere with cancer cell proliferation and angiogenesis.