PD-L1 inhibition

The key inclusion criteria^1-4 are –

• Age ≥18 years
• Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or HR-low/HER2- BC per AJCC 8th edition
  a) TNBC defined as: ER and PR <1% on IHC; negative for HER2 with 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on ISH.
  b) HR-low/HER2- BC defined as: ER 1% to <10% and/or PR 1% to <10% (neither hormone receptor may be ≥10%); negative for HER2 with 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on ISH
• ECOG PS 0 or 1
• Provision of acceptable tumor sample prior to randomization
• Adequate bone marrow reserve and organ function within 7 days before randomization

References:

1. Study NCT06112379. ClinicalTrials.gov website. 

2. McArthur H, et al. Poster presented at: SABCS; December 5-9, 2023; San Antonio, TX. Poster O1-20-13.

3. Loibl S, et al. Poster presented at: ESMO BC; May 15-17, 2024; Berlin, Germany. Poster 159TiP.

4. Amin MB, et al. AJCC Cancer Staging Manual. 8th ed. New York: Springer; 2017.

The key exclusion criteria^1-4 are –

• Evidence of severe/uncontrolled systemic diseases including active infection requiring IV treatment, serious chronic gastrointestinal conditions associated with diarrhea, active bleeding diseases, significant cardiac or psychological illness, chronic or previously complicated diverticulitis, or history of allogeneic organ transplant
• History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.
• Active or prior documented autoimmune or inflammatory disease with certain exceptions
• Evidence of distant disease
• Clinically significant corneal disease
• Active or uncontrolled hepatitis B or C infection, uncontrolled HIV infection, or active tuberculosis
• Suspected, current, or previous non-infectious ILD/pneumonitis that require(d) steroids
• Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or HR-low/HER2- BC including chemotherapy, radiation therapy, endocrine therapy, immune-mediated therapy (eg, anti-CTLA-4 and anti-PD-(L)1 antibodies, excluding therapeutic anticancer vaccines), retinoid therapy, or targeted therapy
• Prior exposure to the following treatment:
  a) Chloroquine/hydroxychloroquine with ≤14 days washout before randomization
  b) Immunosuppressive medication <14 days before first dose of study intervention
  c) Live, attenuated vaccine <30 days before first dose of study intervention