Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma

Study IPI-145-08 is an international, multicenter, randomized, double-blind,
placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and
safety of IPI-145 in combination with rituximab vs placebo in combination with rituximab in
subjects with previously treated CD20-positive follicular lymphoma.

Approximately 400 subjects will receive 25 mg of IPI-145 or placebo, orally BID for 28 day
continuous cycles, in combination with 375 mg/m2 of Rituximab given once weekly for 4 weeks
during Cycle 1 and then once on Day 1 of Cycles 4, 6, 8, and 10. Patients will remain on
treatment for up to 27 cycles and may continue treatment if clinical benefit is observed.

Inclusion Criteria:

- Diagnosis of CD20-positive FL:

- Histology grades 1, 2 or 3a

- Biopsy-confirmed histopathological diagnosis of FL. Biopsy specimen should be
obtained ≤2 years prior to randomization, unless medically contraindicated

- CD20 immunophenotyping performed ≤2 years prior to randomization

- First or subsequent relapse following at least one induction therapy regimen
containing rituximab in combination with an anthracycline or rituximab in combination
with an alkylating agent

- Patients in first relapse must be chemoresistant or intolerant to chemotherapy

- No response or disease progression ≤ 24 months from start of last previous therapy

- At least 1 measurable disease lesion >1.5 cm in at least one diameter by CT/CT-PET or
magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an
area that was previously irradiated that has documented progression

Exclusion Criteria:

- Clinical evidence of other indolent forms of lymphoma (e.g., marginal zone lymphoma
[MZL], small lymphocytic lymphoma [SLL])

- Transformation to a more aggressive subtype of lymphoma or grade 3b FL

- Refractory to rituximab: defined as disease progression while receiving or within 6
months of completing either weekly rituximab induction therapy, or rituximab-based
chemoimmunotherapy induction

- Intolerance to rituximab or severe allergic or anaphylactic reaction to any humanized
or murine monoclonal antibodies

- Prior allogeneic hematopoietic stem cell transplant (HSCT)

- Known Central Nervous System (CNS) lymphoma; subjects with symptoms of CNS disease
must have a negative CT scan and negative diagnostic lumbar puncture

- Prior treatment with a PI3K inhibitor or BTK inhibitor

- History of tuberculosis within the preceding two years

- Ongoing systemic bacterial, fungal, or viral infections at randomization (defined as
requiring IV antimicrobial, antifungal or antiviral agents)

- Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically
excluded if all other I/E criteria are met

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

- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia
requiring medication or mechanical control within the last 6 months