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The median overall survival (mOS) for patients that received higher doses (≥ 525 mg) of leronlimab plus chemotherapy was 12+ months (95% CI, 5.5 – 12+ months), which is superior to SOC chemotherapy (6.6 months) or Sacituzumab Govitecan (SG) (11.8 months), an antibody drug conjugate that received accelerated approval by the FDA in 2020 and regular approval in 2021 for the treatment of patients with unresectable locally advanced or mTNBC who have received ≥ 2 prior systemic therapies. Previously SG received fast track and breakthrough therapy designations. 12% patients in the SG Phase III trial had brain metastasis.

The mOS for patients that received leronlimab plus carboplatin was 12+ months (95% CI, 5.4 – 12+ months). There were 13 mTNBC patients in that group.

The median progression-free survival (mPFS) for patients that received higher doses (≥ 525 mg) of leronlimab plus chemotherapy was 6.2 months (95% CI, 2.6 – 7.5 months), which is significantly longer compared to SOC chemotherapy (2.3 months) or SG (4.8 months).

Available data from 12 subjects who had measurable lesions by PET/CT scans at baseline and after start of leronlimab induction, showed that 11 (92%) patients exhibited stable or partial response to leronlimab, with 3 (25%) PRs, 8 (66.7%) SDs and 1 (8%) having progressive disease after the first follow up scan.

The LifeTracDx™ liquid biopsy algorithm clearly distinguishes responders to leronlimab. 75% of the patients who exhibited lower level of circulating cells after leronlimab or at baseline exhibited statistically significant improvement in mOS (Hazard Ratio (HR): 36.0 (95% CI, 6.2 – 207.6, p=0.0004)) and in mPFS (HR: 5.8 (95% CI, 1.4 – 23.6, p=0.0354)), respectively.

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