Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Inclusion Criteria:

• Male or female subjects ≥18 years of age, ≥19 years in Korea, or ≥20 years forsubjects in Japan and Taiwan

• Histologically confirmed diagnosis of CD20 positive iNHL with histological subtypelimited to:

1. FL Gr 1, Gr 2, or Gr 3a

2. MZL (splenic, nodal, or extra-nodal)

• Subjects with relapsed or refractory disease who received ≥1 prior lines of therapy

• Subjects must have at least one bi-dimensionally measurable lesion >1.5 cm

• Adequate hematologic parameters at screening unless abnormal values are due todisease

• Adequate renal and hepatic function

• Adequate cardiac function based on ECG and LVEF assessments

Exclusion Criteria:

• Histologically confirmed diagnosis of FL Gr 3b or transformed disease

• Prior therapy with PI3K inhibitors

• Ongoing or history of drug-induced pneumonitis

• Known lymphomatous involvement of the central nervous system

• Tested positive for or active viral infection with hepatitis B or C virus

• Tested positive or active infection with human immunodeficiency virus

• Tested positive, or active infection with human T-cell leukemia virus type 1

• Any uncontrolled clinically significant illness

• History of clinically significant cardiovascular abnormalities such as congestiveheart failure

• History of clinically significant gastrointestinal (GI) conditions

• Females who are pregnant