Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer

BeiGene33 enrolled

Overview

The main purpose of this study was to help meet the medical needs of people in China with certain types of solid tumors that have specific genetic changes called microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR). The study looked at how well the drug tislelizumab works and how safe it is when given before surgery (neoadjuvant treatment) for these types of tumors.

This study enrolled participants with Stage II or III resectable colorectal cancer (CRC). Participants with unknown microsatellite instability (MSI) or mismatch repair (MMR) status provided blood and tumor tissue samples during a prescreening period (within 56 days before the first dose) for central laboratory confirmation of MSI status. Participants with known MSI-high (MSI-H) or deficient MMR (dMMR) status by local laboratory also underwent central confirmation when tumor samples were available. Eligible participants received tislelizumab 200 mg by intravenous infusion once every 3 weeks for 3 cycles as neoadjuvant therapy. After completion of neoadjuvant treatment, participants underwent complete surgical removal (R0 resection) of their tumor, and surgical specimens were assessed for pathological response, including major pathological response (MPR) and pathological complete response (pCR). Post-surgery, participants continued adjuvant therapy and follow-up as determined by their investigator.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

TislelizumabDRUG

200 milligrams (mg) administered through an intravenous (IV) infusion once every 3 weeks for 3 treatment cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants had an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. * Participants had a pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III colon or rectal cancer (CRC) with microsatellite instability-high (MSI-H) status confirmed by a sponsor-designated central laboratory, or known MSI-H status confirmed by a local laboratory. Participants were required to be eligible for complete surgical removal of the tumor (R0 resection) with curative intent. * Participants had evaluable or measurable disease as assessed by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. * Participants had adequate blood counts and organ function, as defined by protocol-specified laboratory test results obtained within 7 days before the first dose of study treatment. Exclusion Criteria: * Participants had received any prior treatment for their current colorectal cancer, including chemotherapy, radiotherapy, or immunotherapy. * Participants had any condition requiring systemic treatment with corticosteroids at doses greater than 10 milligrams (mg) of prednisone per day, or other immunosuppressive medications within 14 days before the first dose. * Participants had active autoimmune diseases or a history of autoimmune diseases that could potentially relapse. Note: Additional protocol-defined inclusion and exclusion criteria may have applied.

Locations (8)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Liaoning Cancer Hospital and Institute

Outcomes

Primary Outcomes

Major Pathological Response (MPR) Rate

MPR rate is defined as the percentage of participants whose resected primary tumor shows 10% or less remaining viable cancer cells after completing neoadjuvant therapy.

Time frame: Approximately 10 weeks after first dose of study treatment

Secondary Outcomes

Pathological Complete Response (pCR) Rate

Defined as the percentage of participants with a complete absence of residual tumor (no remaining cancer cells) in the surgically resected primary tumor and in all resected lymph nodes after completing neoadjuvant therapy.

Time frame: Approximately 10 weeks after first dose of study treatment

Event Free Survival (EFS)

Defined as the time from the first dose of study treatment until the first occurrence of any of the following events: * Disease progression that prevents complete surgical remover of the tumor * Local or distant recurrence after surgery * Death from any cause The median and other quartiles of EFS were estimated using the Kaplan-Meier Method.

Time frame: From first dose to final analysis data cutoff (03JAN2025), disease progression, initiation of a new anticancer therapy, or death; whichever came first. Median follow-up was 21.7 months.

2-Year and 3-Year Event Free Survival (EFS)

The 2-year and 3-year EFS rates are defined as the percentage of participants without any EFS events at 24 months and 36 months after the first dose. EFS rates were estimated by the Kaplan-Meier method with 95% CI estimated using Greenwood's formula.

Time frame: 24 months and 36 months after first dose

Number of Participants Experiencing Adverse Events

The incidence of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and immune-mediated adverse events (imAEs), was assessed for all participants who received at least one dose of study treatment. SAEs were defined as events that resulted in death, were life-threatening, required or prolonged hospitalization, caused significant disability, or were considered important medical events. imAEs were defined as adverse events consistent with immune-related mechanisms, such as autoimmune-like toxicities requiring clinical evaluation or immunosuppressive management.

Data from ClinicalTrials.gov

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