Recent Updates
Recently added Catalysts

Treatment with blinatumomab given subcutaneously.

Phase 2

Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) | Unknown | Oncology |Amgen Inc.|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07301424Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALLPHASE2 NOT YET_RECRUITING 80 — — Jul 1, 2026Dec 1, 2031May 6, 20261 Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
• MR4 rate for BCR-ABL1 by PCR after 2 cycles of blinatumomab
At end of cycle 2 of blinatumomab (each cycle is 28 days).

After 2 cycles of blinatumomab, the bone marrow will be tested for MRD by PCR for BCR-ABL. The rate of MRD4 (MRD\<10\[-4\]) at this timepoint will constitute a primary outcome.

Complete molecular response (CMR) by IgR (Clonoseq[R]) after 2 cycles of blinatumomab.
At end of cycle 2 of Blinatumomab (each cycle being 28 days).

After 2 cycles of Blinatumomab the marrow will be tested for MRD by Clonoseq. The rate of MRD negativity by IgR will constitute a primary outcome.

Secondary Endpoints
Complete response rate
Determined at the end of the 70 day induction phase
Patient and caregiver experience
At screening, end of induction (Day 70), end of cycles 2 and 5 of blinatumomab, and one year after start of maintenance therapy with ponatinib.
Molecular response duration
From the time of documented remission at Day 70 of induction, until the date of first documented molecular progression, assessed up to 5 years from the start of treatment.
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment with subcutaneous blinatumomab plus ponatinibEXPERIMENTAL -
Interventions
NameTypeDescription
Treatment with blinatumomab given subcutaneously.DRUGPrevious studies have used intravenous blinatumomab combined with a TKI (ponatinib or dasatinib) for patients with BCR-ABL positive B-ALL. This study is using subcutaneous blinatumomab combined with ponatinib for previously untreated patients with this disease.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Ph positive \[either t(9;22) and/or BCR-ABL1 positive\] ALL, CD19 positive 2. Age ≥18 years at time of informed consent 3. No prior induction treatment for ALL. A brief corticosteroid pre-phase (\< 1 week), or hydroxyurea for cytoreduction or symptom control is permitted. 3\...

Countries:Canada
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07301424studyFirstPostDate: changed