A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO)

This is an open-label, single arm safety and efficacy study of duvelisib administered orally
to subjects who have been diagnosed with iNHL (Follicular Lymphoma, Marginal Zone Lymphoma,
or Small Lymphocytic Lymphoma) whose disease is refractory to rituximab and to either
chemotherapy or RIT.

Approximately 120 subjects will receive 25 mg duvelisib BID over the course of 28-day
treatment cycles for up to 13 cycles.

After completing 13 treatment cycles of duvelisib, subjects may continue to receive
additional cycles of duvelisib until disease progression or unacceptable toxicity. However,
to receive additional cycles of duvelisib beyond 13 cycles, subjects must have evidence of
response (CR or PR) according to the IWG criteria1 by the end of Cycle 13.

Inclusion Criteria:

- Subjects who have been diagnosed with indolent NHL that has progressed.

- Subjects must have exhibited lack of CR or PR or progression within 6 months after the
last dose of a chemotherapy induction regimen or RIT.

- Subjects must have rituximab-refractory disease, defined as lack of CR or PR or PD
within 6 months of last dose.

- Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension
by CT, PET/CT or MRI.

- Adequate renal and hepatic function.

Exclusion Criteria:

- Candidate for potentially curative therapies in the opinion of the investigator.

- Previous treatment with a PI3K inhibitor or BTK inhibitor.

- Prior history of allogeneic hematopoietic stem cell transplant (HSCT).

- Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents
within 4 weeks before first dose of study drug.

- Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of
lymphoma.

- Symptomatic central nervous system (CNS) NHL.

- Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of
study treatment.

- Prior, current, or chronic hepatitis B or hepatitis C infection, positive result for
hepatitis C virus antibodies (HCV Ab) or hepatitis B surface antigen (HBsAg) or
hepatitis B core antibodies (HBcAb)

- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
requiring medication or mechanical control within the last 6 months prior to first
dose of study drug