BioInvent International AB has announced the initiation of a Phase 2a clinical trial evaluating its lead drug candidate BI-1206 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for patients with advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma.
The Phase 2a study follows encouraging results from BioInvent’s Phase 1 trial, where BI-1206 was found to be safe, well-tolerated, and showed promising clinical activity in heavily pre-treated patients.
Out of 36 evaluable patients, one achieved a complete response, one had a long-lasting partial response, and 11 maintained stable disease, despite having progressed on prior anti-PD1/L1 therapies.
The subcutaneous formulation of BI-1206 was noted for slower systemic entry, prolonged time on target, and improved safety.
“We are very pleased to initiate Phase 2a studies, which marks a significant milestone in our mission to bring BI-1206 to patients,” said Martin Welschof, CEO of BioInvent.
“The early clinical signs of efficacy observed in Phase 1 provide a strong rationale for moving forward in the first-line setting for NSCLC and uveal melanoma. Since BI-1206 addresses a mechanism of resistance to anti-PD1, its potential extends to all indications where pembrolizumab is approved,” he added.
The trial, registered as NCT04219254, will enroll patients at sites across Georgia, Germany, Poland, Romania, Spain, Sweden, and the US, with initial data expected in the second half of 2026.
The study will be conducted in two parts: a signal-seeking phase including up to 30 NSCLC and 12 uveal melanoma patients receiving BI-1206 plus pembrolizumab every 21 days for up to two years, followed by a dose optimization phase. In this phase, patients will be randomized to higher or lower doses of BI-1206, with a third cohort receiving pembrolizumab alone.
NSCLC, the most common type of lung cancer, accounts for roughly 85 percent of all cases, but response rates to checkpoint inhibitors remain low, rarely exceeding 25 percent. Uveal melanoma, though rare, is the most frequent non-cutaneous melanoma in adults, with about 7,000 new cases globally each year.
BI-1206 is designed to counter resistance caused by FcγRIIB-mediated degradation of PD-1 antibodies, potentially enhancing responses to therapies like pembrolizumab.
BioInvent, a clinical-stage biotech company, focuses on discovering and developing first-in-class immune-modulatory antibodies for cancer immunotherapy.
Its proprietary F.I.R.S.T™ technology platform identifies new targets and antibodies, supporting both in-house development and licensing opportunities.
The Phase 2a trial represents a key step in assessing BI-1206’s potential to improve outcomes for patients with NSCLC and uveal melanoma while advancing BioInvent’s broader immuno-oncology pipeline.