Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1)

This was a randomized, double-blinded, placebo-controlled, Phase 3 study, in which
approximately 310 participants with advanced or metastatic adenocarcinoma of the pancreas who
have failed, or were intolerant to first-line chemotherapy, were to be randomized (1:1) to
one of the following treatment groups:

- Treatment A (N = 155): Capecitabine + ruxolitinib

- Treatment B (N = 155): Capecitabine + placebo

Treatment consisted of repeating 21-day cycles. Capecitabine was self-administered for the
first 14 days of each cycle, and ruxolitinib/placebo was self-administered daily for each
cycle. Treatment for all participants continued as long as the regimen was tolerated, and the
participant did not meet discontinuation criteria. Participants who discontinued study
treatment before study termination were monitored for safety up to 30-35 days from the end of
treatment. All participants were followed for survival until study termination or the safety
follow-up visit.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas.

- Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2

- Received 1 prior chemotherapy regimen for advanced or metastatic disease (not
including neoadjuvant and/or adjuvant therapy).

- ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants
must have recovered or be at a new stable baseline from any related toxicities.

- Radiographically measurable or evaluable disease

- Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:

1. mGPS of 1: C-reactive protein >10 mg/L and albumin ≥35 g/L

2. mGPS of 2: C-reactive protein >10 mg/L and albumin <35 g/L

Exclusion Criteria:

- Received more than 1 prior regimen for advanced or metastatic disease.

- Ongoing radiation therapy, radiation therapy administered within 30 days of
enrollment.

- Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery,
immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor
embolization).

- Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase
deficiency (DPD), or other known hypersensitivity to active substances, including
fluorouracil (5-FU), or ruxolitinib, or any of their excipients.

- Prior treatment with a JAK inhibitor for any indication.