This study will enroll adults with confirmed metastatic pancreatic ductal adenocarcinoma (PDAC, systemic PDAC treatment naïve), Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1, and adequate organ function. Participants will receive pumitamig (also known as BNT327, BMS-986545, or PM8002) in combination with chemotherapy.
Have a histologically or cytologically confirmed metastatic PDAC. A tissue sample, archival or fresh, must be provided during the screening period, unless biopsy is not feasible due to safety concerns.
Have not received prior systemic therapy for unresectable metastatic PDAC. For participants who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative-intent, the interval should be at least 6 months from the end of the last treatment to relapse.
Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures) are not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system [CNS] metastasis should not be considered as a measurable lesion).
Agree to discontinue strong inhibitors or inducers of cytochrome P450 enzyme (CYP3A), CYP2C8, glucuronosyltransferase 1 family, polypeptide A cluster 1A (UGT1A1) at least 2 weeks prior to starting study treatment, and change to other treatment regimens at screening if such drugs are used.
Have received prior systemic anticancer therapy for unresectable metastasis disease. Prior adjuvant, neo-adjuvant, and peri-operative therapy is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment
Any immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting study treatment.
PD(L)-1/VEGF bispecific antibody, including monotherapy with either category or combinations thereof.
Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 14 days before starting study treatment. Exception: Excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergies) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).
Parallel
Pumitamig
DrugIntravenous (IV) infusion
Nab-paclitaxel
DrugIV infusion
Gemcitabine
DrugIV infusion
mFOLFIRINOX
DrugIV infusion
Confirmed overall response rate
For each treatment arm. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) is observed as best overall response.
Occurrence of treatment emergent adverse events (TEAEs) by severity
According to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v5.0\]). By relationship and for each treatment arm.
Occurrence of dose interruptions, reductions, and discontinuations due to TEAEs
For each treatment arm.
Disease control rate
Defined as the percentage of study participants in whom a confirmed CR or confirmed PR or stable disease (SD), (per RECIST v1.1, SD assessed at least 6 weeks after randomization/assignment to treatment) is observed as best overall response.
Duration of response
Defined as the time from first objective response (CR or PR per RECIST v1.1) to first occurrence of objective tumor progression (disease progression as assessed by the investigator per RECIST v1.1), or death from any cause, whichever occurs first.
Progression free survival
Defined as the time from first dose of study treatment to first documented tumor progression (disease progression assessed by investigator per RECIST v1.1), or death from any cause, whichever occurs first.
Overall survival
Defined as the time from first dose of study treatment to death from any cause.
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BioNTech SE
Lead sponsor
Bristol-Myers Squibb
Collaborator
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborator
