Of 36 evaluable patients, a complete response was achieved in one patient with metastatic cutaneous melanoma and a durable partial response in one patient with metastatic uveal melanoma. Eleven patients had stable disease, including one with metastatic melanoma who remained stable in his disease throughout the two-year study period. The combination therapy was well tolerated, allowing higher dose levels to be explored.
The results support plans to initiate a phase IIa study aimed at treatment-naïve patients – who have not yet received any treatment for their disease. BioInvent expects that the study can begin in the second half of 2025.
Targets NSCLC and uveal melanoma
The upcoming phase IIa study will focus on treatment-naïve patients with advanced or metastatic NSCLC and uveal melanoma. NSCLC accounts for approximately 85 percent of all lung cancer cases. Response rates to anti-PD1 agents are determined by the level of PD-L1 expression, and patients with levels ≥50% show the best treatment responses. BI-1206 targets FcγRIIB, a receptor implicated in resistance to anti-PD-1 therapies, which has the potential to enhance the efficacy of pembrolizumab and improve the quality of responses. The study will include two phases; a signal-finding phase with up to 30 patients with NSCLC and 12 patients with uveal melanoma, followed by a dose-optimization phase.
The collaboration with MSD
In light of the promising Phase I results, BioInvent and MSD, a subsidiary of Merck & Co., Inc., which supplies pembrolizumab to the study, have agreed to continue studying the combination of BI-1206 and pembrolizumab – this time in earlier lines of treatment. The decision is motivated by the preclinical evidence showing that BI-1206 enhances the anti-PD-1 effects. The planned Phase IIa study, which is intended to start in H2 2025, will evaluate the potential of the combination therapy to address unmet medical needs in NSCLC and uveal melanoma – diseases that are currently burdened by limited effective treatment options.
Transition to subcutaneous administration
BioInvent has transitioned from intravenous (IV) to subcutaneous (SC) administration of BI-1206 to enhance its therapeutic efficacy. The SC formulation allows for slower systemic entry and prolonged target exposure, potentially improving both efficacy and safety. This transition is in line with BioInvent's strategy to optimize the drug's performance in combination with pembrolizumab, particularly in patients who have not previously received anti-PD-1 therapies.
Comments from CMO
We contacted Andres McAllister, CMO at BioInvent, to discuss the significance of these results and the company's next steps.
How significant is the complete response observed?
- The complete response observed during the study represents a significant milestone in evaluating the efficacy and potential of BI-1206. Achieving such a response is critical as it provides compelling evidence of the therapy's ability to effectively target the intended mechanism and deliver meaningful outcomes for patients. This outcome also serves as a strong foundation for advancing BI-1206 into further phases of clinical development with enhanced confidence.
What factors contributed to the decision to focus on NSCLC and uveal melanoma in the Phase IIa study?
- The decision to focus on non-small cell lung cancer (NSCLC) and uveal melanoma in the Phase IIa study was guided by several key factors. Firstly, these indications are characterized by substantial unmet medical needs, with limited treatment options available for patients. Secondly, the biological pathways targeted by BI-1206 align closely with the mechanisms involved in these cancers, making them ideal candidates for evaluation. Furthermore, the prevalence and clinical relevance of NSCLC and uveal melanoma ensure the study's outcomes will have a broad impact, enhancing the therapeutic potential of BI-1206.
How has the collaboration with MSD influenced the development of BI-1206?
- The partnership with MSD has been instrumental in advancing the development of BI-1206. MSD's expertise in oncology and immunotherapy has provided invaluable insights and resources, including access to cutting-edge research tools and collaborative networks. This collaboration has enabled a more robust design of clinical trials and facilitated the identification of optimal strategies for testing BI-1206. Moreover, MSD's involvement has helped accelerate the development timeline, ensuring the therapy reaches the patient population faster.
Finally, what are the primary objectives for the phase IIa study, and how will you measure success by the end of the signal-seeking phase?
- The primary objectives of the Phase IIa study are to evaluate the safety, tolerability, and preliminary efficacy of BI-1206 in the selected indications. Success will be measured by several criteria, including the achievement of meaningful clinical responses, the identification of biomarkers correlating with treatment outcomes, and the generation of data supporting progression to further development phases. By the conclusion of the signal-seeking phase, success will also be defined by the ability to demonstrate the therapeutic potential of BI-1206 in improving patient outcomes while maintaining favorable safety profiles.
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