Leronlimab Combo Shows Promise for Metastatic TNBC in Early Phase 1b/2 Trial Data

Leronlimab Combo Shows Promise for Metastatic TNBC in Early Phase 1b/2 Trial Data
Investigational therapy leronlimab is showing promise as a potential therapy for people with CCR5-positive metastatic triple-negative breast cancer (mTNBC), early data from a Phase 1b/2 clinical trial suggest. The open-label trial (NCT03838367) is testing a combination of leronlimab, also known as PRO 140 and developed by CytoDyn, plus chemotherapy agent carboplatin, in triple-negative breast cancer patients whose cancer is positive for the CCR5 protein and has spread to distant regions. After eight weeks of treatment, the first patient in the trial showed no signs of circulating tumor cells or cells more prone to forming metastasis in the blood. The patient also had lower levels of CCR5, which has a tumor-promoting function, in cancer-associated cells. This patient received eight weekly subcutaneous (under-the-skin) injections of leronlimab, at a dose of 700 milligrams, plus carboplatin. This is the highest leronlimab dose being tested in the trial. “The fourth blood sample from the mTNBC patient, drawn following eight weeks of treatment, demonstrates a notably sustained response to leronlimab,” Bruce Patterson, MD, CEO of diagnostic company IncellDx, said in a press release. “Other cancer-associated macrophage-like (CAML) cells in the blood sample were found at the lower limits of detection and were also decreased in size. Most importantly, the CAML cells had reduced CCR5 staining compared to samples taken from the patient three weeks earlier, reflecting an ongoing blockade of the CCR5 receptor by leronlimab,” Patterson added. The trial is being conducted in two parts: Phase 1b to determine the optimal dose of leronlimab, and Phase 2 to measure how long patients live without the disease worsening after receiving the established dose. Phase 2
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