11 slides from Actinium Pharmaceuticals, Inc. (delaware)'s conference presentation, 2023
Slide 1: 131I-apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML
131I-apamistamab-Led Allogeneic Hematopoietic Cell Transplant Significantly Improves Overall Survival in Patients with TP53 Mutated R/R AML Hannah Choe, MD, Ben K. Tomlinson, MD, Boglarka Gyurkocza, MD, Rajneesh Nath, MD, Stuart Seropian, MD, Mark R. Litzow, MD, Camille N. Abboud, MD, Patrick J. Sti
Slide 2: Background
Background • Patients with TP53 mutated R/R AML have a dismal prognosis with limited treatment options and are seldom offered alloHCT due to high post-transplant relapse rates. • 131I-apamistamab (Iomab-B) is an anti-CD45 radioimmunoconjugate designed to deliver high dose targeted radiation to hemat
Slide 3: SIERRA – A Phase 3 Randomized Trial in R/R AML
SIERRA – A Phase 3 Randomized Trial in R/R AML Total Accrual: N=153 Iomab-B No CR HCT Endpoints: Pre-Specified Primary: Crossover* CR dCR dCR = CR/CRp lasting Active, Relapsed ≥180 days post-CR *Control arm subjects or Refractory RANDOMIZED 1:1 with no CR offered AML crossover Secondary: OS and EFS
Slide 4: Personalized Single Dose Combined Induction/Conditioning
Personalized Single Dose Combined Induction/Conditioning RIC Dosimetric Dose Therapeutic Dose FLU TBI ≤20 mCi • Upper limit of 24 Gy to liver 30 mg/m2/d 200 cGy • Median 16 Gy to marrow HCT -19 -18 -15 -12 -4 -3 -2 -1 0 Imaging Tac/CSA + MMF RIC: reduced intensity conditioning; FLU: fludarabine; TBI
Slide 5: SIERRA Patient Distribution
SIERRA Patient Distribution 153 Pts Randomized Iomab-B Conventional Care N=76 N=77 1 pt did not • 4 pts did not receive receive treatment dosimetric dose (TP53+) • 6 pts did not proceed to therapeutic dose with HCT Achieved • TP53+: 33.3% (2 / 6) No CR/CRp/MLFS CR/CRp/MLFS 66 patients received Cross
Slide 6: Baseline Characteristics in Patients with TP53 Mutations (N = 37)
Baseline Characteristics in Patients with TP53 Mutations (N = 37) Iomab-B (N=17) Conventional (N=10) Crossover (N=10) Age, years 63 (56-74) 66 (61-71) 64 (55-74) Median (Range) N (%) Pts >65 yrs: 6 (35.3) Pts >65 yrs: 7 (70.0) Pts >65 yrs: 4 (40.0) Primary Induction Failure: 12 (70.6) Primary Induct
Slide 7: CR and dCR by TP53 Mutation Status and Treatment Received
CR and dCR by TP53 Mutation Status and Treatment Received • Overall dCR Rates at 6 months were 22% in the Iomab-B group vs. 0% in the CC group (95% CI;12.29, 34.73; p<0.0001), irrespective of TP53 mutational status. • Median OS of TP53 positive patients on CC arm was 1.66 mos versus 5.49 mos in TP53
Slide 8: Improved Survival with 131I-apamistamab in TP53 Mutation
Improved Survival with 131I-apamistamab in Patients with TP53 Mutation Iomab-B + Conventional Crossover Care N = 27 N = 10 Survival Probability (%) Median OS (mos) 5.49 1.66 Iomab-B + (95% CI) (3.94, 8.25) (0.99, 2.96) Crossover CC Hazard Ratio 0.23 (95% CI) (0.10, 0.52) p value (log-rank) 0.0002 Ov
Slide 9: SIERRA Trial Patients with TP53 Mutation
SIERRA Trial Patients with TP53 Mutation
Slide 10: Treatment-Emergent Adverse Events (Grade ≥3)
Treatment-Emergent Adverse Events (Grade ≥3) TP53 Positive Patients TP53 Negative Patients Receiving Iomab-B + Standard HCT Receiving Iomab-B + HCT1 HCT1 N = 14 N = 83 N = 23 Febrile Neutropenia 11 (47.8) 35 (42.2) 7 (50.0) N (%) Mucositis2 4 ( 17.4) 13 (15.7) 3 (21.4) N (%) Sepsis 4 (17.4) 8 (9.6)
Slide 11: Conclusions
Conclusions • Patients with TP53-mutated relapsed or refractory AML have a dismal prognosis and are generally unable to access potentially curative alloHCT due to resistant disease. • 131I-apamistamab led alloHCT significantly improves survival outcomes in this very high-risk patient population with