BioInvent Announces Initiation of BI-1206 Phase 2a Trial in Advanced or Metastatic NSCLC and Uveal Melanoma

LUND, SE / ACCESS Newswire / October 8, 2025 / BioInvent International AB ("BioInvent") (Nasdaq Stockholm:BINV) (STO:BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced the initiation of a Phase 2a clinical trial evaluating BI-1206 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) and uveal melanoma in the first-line setting.

As presented at ASCO 2024, in Phase 1, BI-1206 was deemed to be safe and well-tolerated and demonstrated promising clinical activity in heavily pre-treated patients, with one complete response (CR), one long-lasting partial response (PR), and 11 patients with stable disease (SD) out of 36 evaluable patients. All patients had progressed after previous treatments with anti-PD1/L1 agents. The subcutaneous formulation provided slower systemic entry and prolonged time on target while improving safety and tolerability.

"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, Chief Executive Officer of BioInvent. "The early clinical signs of efficacy observed in the Phase 1 trial provide a strong rationale for moving forward in the first line setting in NSCLC and uveal melanoma, two areas of important medical need. Since BI-1206 addresses a mechanism of resistance to anti-PD1, the potential of BI-1206 extends to all indications where pembrolizumab is approved."

The Phase 2a trial (NCT04219254) will evaluate the safety and efficacy of BI-1206 in combination with pembrolizumab in patients with advanced or metastatic NSCLC and uveal melanoma. Patients will be enrolled at sites in Georgia, Germany, Poland, Rumania, Spain, Sweden and the US, with first data expected in H2 2026.

The trial will be conducted in two parts. In the first part, or signal-seeking phase, up to 30 NSCLC and 12 uveal melanoma patients will receive BI-1206 and pembrolizumab every 21 days for up to 2 years. Following the signal-seeking phase, the study will proceed to a dose optimization phase, designed to refine the dosing strategy to maximize both efficacy and tolerability of the combination. During dose optimization, patients will be randomized to receive a higher or a lower dose of BI-1206. A third cohort will receive pembrolizumab alone.