Non-small cell Lung Cancer (NSCLC) and Hematological malignancies are leading indications in terms of maximum data readouts during the conference, followed by Pancreatic, Prostate and Gastric cancers. Summit’s Ivonescimab emerged as a strong competitor against NSCLC, challenging Keytruda's efficacy in lung cancer treatment. Acasunlimab showcased promising impact on overall survival in advanced cancer cases. IBI389 garnered significant attention for its potential to revolutionize pancreatic cancer treatment, supported by compelling efficacy data. Cadonilimab's success as a PD-1/CTLA-4 bispecific antibody in clinical trials earned recognition. These advancements signify a pivotal moment in oncology, offering hope for improved patient outcomes and transformative treatments.

Delveinsight has compiled a list of the most notable Bi-specific antibodies while detailing the most impactful investigational one’s.

Summit peaks on ivonescimab surprise

Ivonescimab, known as SMT112 in Summit’s license territories and as AK112 in China and Australia, is an investigational bispecific antibody. It recently gained marketing authorization in China. Summit Therapeutics made waves at ASCO with ivonescimab's victory over KEYTRUDA in Harmoni-2, a landmark for NSCLC Phase III trials. HARMONi-A also revealed promising results for EGFR-mutated NSCLC patients, boasting a superior ORR and improved PFS compared to chemotherapy alone. Akeso's Tetrabody bispecific platform shines again with ivonescimab's success, though it faces competition from treatments like TAGRISSO and RYBREVANT. Summit's deal with Akeso expands ivonescimab's reach to Latin America, the Middle East, and Africa for USD500 million upfront. Additionally, a trial conducted in China may not accurately represent the ethnic diversity of the US population. Despite challenges in the US market, FDA approval would mark a significant milestone for Akeso and the Chinese biopharmaceutical industry.

Genmab and BioNTech’s Acasunlimab makes a strong impression with its impact on overall survival

The ASCO meeting initially painted a challenging picture for Genmab and BioNTech's acasunlimab, but Phase II data from a post-checkpoint inhibitor NSCLC trial provided a glimmer of hope, with a median overall survival of 17.5 months in one arm. However, concerns remain regarding liver events and high dropout rates, with any Grade 3 adverse event leading to discontinuation. Despite these hurdles, plans for a Phase III trial by year-end are underway. However, Nanjing Leads Biolabs' pivotal Chinese study adds competition. Despite historical challenges with 4-1BB activation, Genmab and BioNTech are also evaluating GEN1042, an anti-CD40 x 4-1BB bispecific, with a decision on pivotal development expected this year.

IBI389 as a potential game-changer in pancreatic cancer treatment

CLDN18.2 has gained significant attention in gastrointestinal tumors, with expression rates in gastric cancer patients ranging from 40% to 87%. Similarly, pancreatic cancer patients show CLDN18.2 expression up to 50%-70%, highlighting its potential as a therapy target. Innovent presented groundbreaking clinical data on IBI389, an anti-CLDN18.2/CD3 bispecific antibody, demonstrating its efficacy in advanced G/GEJ tumors and PDAC. Unlike monoclonal antibodies, IBI389 redirects T cells to tumor cells by binding CLDN18.2 and CD3, inducing T cell-mediated killing. Both preclinical and clinical findings underscored significant anti-tumor effects, regardless of CLDN18.2 expression levels, marking a pioneering breakthrough in PDAC treatment. As of May 1, 2024, among 26 G/GEJC subjects receiving IBI389 monotherapy, 8 achieved partial response (PR), with an ORR of 30.8% and a DCR of 73.1%.