I-Mab has announced positive results from its Phase Ib/II study evaluating uliledlimab in combination with toripalimab for patients with treatment-naïve advanced non-small cell lung cancer (NSCLC). The study, involving 70 patients, assessed the safety and efficacy of the combination, revealing a favorable safety profile and promising clinical activity. These findings suggest a potential new treatment option for NSCLC, particularly for patients with specific biomarker profiles.
Uliledlimab and Toripalimab Combination Efficacy
The trial data demonstrated an objective response rate (ORR) of 31.3% in the efficacy evaluable population of 67 participants, irrespective of PD-L1 and CD73 expression. Notably, the study explored CD73 expression as a predictive biomarker, identifying CD73High as >40% of tumor or immune cells with ≥1+ staining intensity via immunohistochemistry.
CD73 as a Predictive Biomarker
Patients with CD73High expression exhibited a significantly higher ORR of 53% compared to those with CD73Low expression, who had an ORR of 18%. Furthermore, the ORR increased to 63% in patients with both PD-L1 tumor proportion score (TPS) ≥1% and CD73High expression, while CD73Low patients had an ORR of 20%. These results highlight the potential of CD73 as a predictive biomarker for uliledlimab and toripalimab combination therapy.
Future Directions
I-Mab intends to further analyze progression-free survival and overall survival data as it matures. Dr. Andrew Zhu, I-Mab president and acting CEO, stated, "The new results are compelling for uliledlimab as a new treatment for NSCLC and its potential to make a meaningful impact on patients’ lives. With this finding, we are in a unique position to apply CD73 as a predictive biomarker to raise the probability of treatment success for NSCLC. Building on encouraging results from this study, we intend to commence a biomarker-guided pivotal trial with the aim of providing these promising new treatment options to patients as quickly as we can."
