Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with atebimetinib plus a modified schedule of gemcitabine and nab-paclitaxel will improve overall survival compared with standard gemcitabine and nab-paclitaxel when given as first-line treatment in patients with metastatic pancreatic adenocarcinoma.

Patients will be randomized to one of two arms: Arm A with atebimetinib + gemcitabine and nab-paclitaxel (modified dosing schedule) or Arm B with gemcitabine and nab-paclitaxel.

Inclusion criteria

• Must be ≥18 years of age
• Must have confirmed diagnosis according to AJCC staging as follows:

• Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Participants must be treatment naive as follows:

• First-line PDAC participants will have received no previous systemic anti-cancer therapy
• Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria
• Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values

Exclusion criteria

• Inability to swallow oral medications
• Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
• Participants with only locally advanced disease
• Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases