I-Mab has reported encouraging data from the Phase Ib/II study evaluating uliledlimab combined with toripalimab (TUOYI) in patients with treatment-naïve advanced non-small cell lung cancer (NSCLC).

Uliledlimab is the company’s highly differentiated CD73 antibody while toripalimab is a PD-1 antibody.

The dose expansion portion study is designed to explore the potential value of CD73 expression as a predictive biomarker.

It has also been designed to investigate the potential correlation between tumour CD73 expression and clinical response for treatment-naïve advanced NSCLC patients.

The study enrolled a total of 70 patients to assess the safety and efficacy of the combination therapy.

A favourable safety profile was observed at uliledlimab 30mg/kg Q3W in combination with toripalimab with treatment-related adverse events mostly of Grade 1 or Grade 2 in severity.

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The objective response rate (ORR) of 31.3% regardless of PD-L1 and CD73 expression was demonstrated in the efficacy evaluable population of 67 participants.

As identified by immunohistochemistry, CD73High was determined as >40% of tumour or immune cells with ≥1+ staining intensity.

Patients with CD73High demonstrated a higher ORR compared with those with CD73Low (53% vs. 18%).

Further, the ORR increased to 63% in patients with both PD-L1 tumour proportion score (TPS)≥1% and CD73High, whereas CD73Low patients had an ORR of 20%.

I-Mab intends to analyse progression-free survival and overall survival data when the data are completely mature.

I-Mab president and acting CEO Dr Andrew Zhu said: “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.”