AbbVie Launches Pivotal Phase 2/3 Revival Trial of Pivekimab Sunirine in First-Line AML, Expands into Pediatric Setting
核心洞察
AbbVie (搜索) is initiating the pivotal phase 2/3 Revival trial testing pivekimab sunirine plus Venclexta and azacitidine in first-line AML patients unfit for intensive chemotherapy, with enrollment starting in July.
The CD123 (搜索)-targeting ADC previously demonstrated a 63% complete response rate in a phase 1/2 study of 49 first-line unfit patients, though two treatment-related deaths were observed.
AbbVie (搜索) has also launched a phase 1b pediatric trial evaluating pivekimab sunirine in children aged 6 months to 17 years with relapsed or refractory AML across approximately 30 global sites.
AbbVie (搜索) is advancing its CD123 (搜索)-targeting antibody-drug conjugate (ADC) pivekimab sunirine into a pivotal phase 2/3 trial in newly diagnosed acute myeloid leukemia (搜索) (AML), while simultaneously launching an early-stage pediatric study, signaling an aggressive expansion of the asset's clinical development program.
The phase 2/3 Revival trial, listed on clinicaltrials.gov and set to begin in July, will evaluate pivekimab sunirine in combination with Venclexta (venetoclax) and azacitidine versus venetoclax/azacitidine alone in first-line AML patients unfit for intensive chemotherapy. The study specifically targets CD123 (搜索)-positive disease, which accounts for approximately 50-75% of the AML population depending on the cutoffs used.
Revival Trial Design
The Revival study employs a two-phase structure. The open-label phase 2 portion will primarily assess complete response rate, while the subsequent double-blind phase 3 segment will evaluate both complete response rate and overall survival. This adaptive design presumably allows AbbVie (搜索) to ascertain early whether there is a meaningful benefit with the addition of pivekimab sunirine before committing to the larger confirmatory phase.
The trial enters a competitive landscape where menin inhibitors from Syndax, Kura, and Johnson & Johnson are also pursuing the first-line AML indication. AbbVie (搜索)'s strategy differs by targeting CD123 (搜索)-positive disease specifically, a biomarker present in the majority of AML cases.
Phase 1/2 Data and Safety Considerations
At the American Society of Hematology (ASH) annual meeting last year, investigators presented results from a phase 1/2 study of pivekimab sunirine plus venetoclax/azacitidine in 49 first-line unfit AML patients. The combination yielded a 63% complete response rate, with a median overall survival of 12.4 months. Patients with TP53 wild-type status demonstrated better outcomes on the survival metric.
However, safety signals warrant attention. Three patients discontinued treatment due to adverse events including myocardial infarction, soft tissue infection, and thrombocytopenia. Two deaths occurred, attributed to respiratory failure and pancytopenia. These findings underscore the toxicity challenges historically associated with CD123 (搜索) targeting.
The CD123 (搜索) target has proven difficult across the industry. Discontinued programs include AstraZeneca's ADC lixarkitug samrotecan (AZD9829), Xencor's monoclonal antibody vibecotamab, and CAR-T projects from Novartis (JEZ567) and Cellectis (UCART123). Pivekimab sunirine currently stands as the most advanced industry asset targeting CD123 and the only ADC in development for this target, according to OncologyPipeline.
Pediatric AML Expansion
In parallel, AbbVie (搜索) has launched a phase 1b study of pivekimab sunirine in pediatric patients with relapsed or refractory AML. The trial, first submitted on December 15, 2025, with a recent update on June 10, 2026, employs a single-arm, non-randomized, open-label design.
Children are stratified into three age-based cohorts running concurrently, spanning from six months to 17 years of age. Approximately 18 participants will be enrolled across roughly 30 global sites over a total study window of approximately 28 months. The primary objectives focus on safety and pharmacokinetics, with the primary completion date serving as a key milestone for data collection on these endpoints.
Pediatric AML remains an underserved indication despite intense competition in the broader AML space from companies including Novartis and Jazz Pharmaceuticals. A clean safety profile and early signals of activity could position AbbVie (搜索) to gain a strategic foothold in this niche.
Regulatory Status and Corporate Context
AbbVie (搜索) filed pivekimab sunirine with the FDA in September 2025 for blastic plasmacytoid dendritic cell neoplasm (搜索) (BPDCN), a very rare blood cancer, based on the phase 1/2 Cadenza trial. The company has not disclosed whether the submission has been accepted but has indicated a regulatory decision is expected sometime in 2026.
The asset was acquired through AbbVie (搜索)'s $10 billion acquisition of ImmunoGen in 2023, a deal primarily driven by the folate receptor alpha (FRα) ADC Elahere. The expanding clinical program for pivekimab sunirine reflects AbbVie's deepening commitment to hematology and oncology as it seeks to diversify beyond its immunology portfolio.