A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs

Timeframe: Up to 10 years

Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.

SRI Primary: Determination of the recommended Phase III dose (RP3D)

Timeframe: Up to 1 year

The RP3D will be the dose of Surovatamig selected for the Phase 3 part based on safety data compiled during the safety run-in part

Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy

Timeframe: Up to 10 years

PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.

Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy

Timeframe: Up to 10 years

ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.

Safety Run in and Phase 3: ORR at EoI (Investigator assessed)

Timeframe: Up to 10 years

ORR defined as the proportion of participants achieving either a PR or CR at End of Induction based on Lugano 2014 Response Criteria

Safety Run In and Phase 3: CR Rate

Timeframe: Up to 10 years

CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria

Safety Run In and Phase 3: CR at EoI

Timeframe: Up to 10 years

Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria

Safety Run In and Phase 3: DoR

Timeframe: up to 10 years

DoR will be defined from the time of first response until progression based on Lugano 2014 criteria, or death due to any cause

Safety Run In and Phase 3: PFS (Investigator assessed)

Timeframe: Up to 10 years

PFS (Investigator assessed) is defined as time from randomization until disease progression based on Lugano 2014 Response Criteria or death due to any cause

Safety Run In and Phase 3: OS

Timeframe: Up to 10 years

OS is defined as time until the date of death

Phase 3: CR rate at 30 months (CR30)

Timeframe: Up to 30 months

Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria

Phase 3: Time to First Subsequent Therapy or Death (TFST)

Timeframe: Up to 10 Years

TFST will be defined as the time from randomization until the start date of first subsequent anti-lymphoma therapy or death due to any cause

Phase 3: Time from randomisation to second progression or death (PFS2)

Timeframe: Up to 10 Years

PFS2 will be defined as the time from randomization until the earliest of the progression event, after first subsequent therapy, or death due to any cause