Qilu Pharma's Three Cancer Immunotherapy Studies at ASCO 2024

The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting took place from May 31 to June 4, 2024, in Chicago, utilizing a hybrid format. Among the numerous clinical studies presented, three from Qilu Pharmaceutical were featured in poster sessions, focusing on innovative immunotherapeutic agents. These agents included QLF31907, a bispecific antibody targeting both PD-L1 and 4-1BB; iparomlimab and tuvonralimab, a combination product targeting PD-1 and CTLA-4; and iparomlimab, a monoclonal antibody targeting PD-1. The research encompassed treatments for advanced solid tumors, lymphoma, nasopharyngeal carcinoma, and solid tumors with DNA mismatch repair (dMMR) deficiency or high microsatellite instability (MSI-H).

One key study, led by Professor Tongyu Lin from Sichuan Cancer Hospital, explored QLF31907. This bispecific antibody blocks PD-L1 to reinstate T-cell receptor (TCR) signaling while engaging 4-1BB to deliver critical costimulatory signals for T-cell activation. This dual action encourages T-cell proliferation and activation, heightening the anti-tumor immune response. The phase I dose-escalation/expansion trial (Abstract No. 2534) focused on patients with advanced solid tumors and lymphoma, showcasing promising results.

Another notable study involved iparomlimab and tuvonralimab, which represent a distinctive immunotherapeutic strategy. This combination includes a PD-1 antibody IgG4 and a CTLA-4 antibody IgG1, administered in a set ratio. The CTLA-4 antibody is engineered for a shortened half-life to maintain PD-1 antibody levels while reducing CTLA-4 exposure. This approach aims to lower toxicity and enhance tolerability. Led by Professor Yan Huang from Sun Yat-sen University Cancer Center, the ongoing phase II trial (DUBHE-N-302, Abstract No. 6026) investigates this combination with gemcitabine and cisplatin for treating recurrent or metastatic nasopharyngeal carcinoma.

In this phase II trial, 29 patients were enrolled, with 24% having a baseline ECOG PS score of 1. After a median follow-up of 15.5 months, 62% of patients reported grade 3-4 treatment-related adverse events (TRAEs), with the most common being a reduction in neutrophil count (41%). Among the 28 patients who had at least one post-baseline tumor assessment, the objective response rate (ORR) was 82.1%. Median progression-free survival (mPFS) was 12.5 months, and for patients with high PD-L1 expression (CPS≥50), mPFS extended to 16.2 months. These findings highlight the combination's potential as a first-line treatment for recurrent/metastatic nasopharyngeal carcinoma.

Lastly, the updated results from a pivotal single-arm phase II study (Abstract No. 3578) on iparomlimab monotherapy were presented by Professors Weijian Guo and Feng Bi. This study focused on patients with advanced solid tumors who had exhausted standard treatment options. The data revealed a promising overall response rate (ORR) of 50.0%, with colorectal cancer patients showing an even higher ORR of 57.9%. At the time of data cutoff, the median duration of response (DOR), median progression-free survival (mPFS), and median overall survival had not yet been reached, emphasizing iparomlimab's robust and lasting efficacy. Additionally, prolonged treatment with iparomlimab proved to be safe and well-tolerated, with no new safety issues identified.

These studies underscore the potential of Qilu Pharmaceutical's novel immunotherapeutic agents in treating various advanced cancers, offering new hope for patients who have limited options.