-=Galectin Therapeutics (GALT) : positive melanoma treatment data

 

Galectin Therapeutics announces positive top-line results for Belapectin trial in combination with KEYTRUDA in patients with metastatic melanoma and head and neck cancer

• Galectin announced top-line clinical data from the extension cohort of an investigator-initiated Phase 1b clinical trial of Belapectin, a galectin-3 inhibitor, in combination with KEYTRUDA (pembrolizumab) in patients with metastatic melanoma and head and neck cancer.
• The treatment consisted of Belapectin 4 mg/Kg of lean body mass administered every three weeks by infusion, after the infusion of pembrolizumab. Pembrolizumab was administered according to its label. Patients' response was evaluated at day 85, according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The median number of treatment cycles was four (range 3-15) for melanoma patients and five (range 4-8) for head and neck cancer patients.
• The combination of Belapectin and pembrolizumab was well tolerated and appeared safe. The most frequent adverse event related to pembrolizumab, in six patients, was grade 1 (mild) pruritus (itching), a known and labeled side-effect of pembrolizumab. The second most frequent adverse event related to pembrolizumab was grade 2 fatigue in three patients. All other adverse events were mild (grade 1). There were no grade 3 or above adverse events. Similar to the initial phase 1 study results, the frequency and severity of toxicities related to pembrolizumab, notably immune-mediated adverse events, was less than anticipated. No adverse event was deemed related to belapectin.