A PD-L1xVEGF bispecific antibody from China’s ImmuneOnco Biopharmaceuticals has shown early promise in shrinking lung tumors, instilling hope that the asset can succeed in a newly approved U.S. trial.
In a phase 2 trial conducted in China, tumors diminished in 62% of patients with advanced non-small cell lung cancer (NSCLC) given IMM2510 in combination with chemotherapy, including eight of 10 with squamous NSCLC and five of 11 with non-squamous NSCLC, ImmuneOnco announced in a July 31 release.
One patient discontinued IMM2510 due to a treatment-related adverse event, the biotech said, but otherwise there were no dose reductions or deaths. Most of the grade 3 or higher adverse events were blood-related, with immune events and typical VEGF side effects like hypertension, proteinuria and hemoptysis uncommon and mostly low in severity.
“We are delighted to witness the progress of IMM2510 in front-line NSCLC,” ImmuneOnco CEO Wenzhi Tian, M.D., said in the release. “This data paves the way for its advancement into phase 3 clinical studies and provides valuable insights to support further research across multiple indications.”
The top-line data follow the FDA’s approval of ImmuneOnco partner Instil Bio’s phase 1b/2 trial of IMM2510 in the U.S. Instil licensed ex-China rights to the bispecific in August 2024.
Studying the cancer candidate in a global population “will be a critical milestone in the clinical development of IMM2510,” Instil Chief Medical Officer Jamie Freedman, M.D., Ph.D., said in a July 2 release announcing the FDA’s go-ahead.
The lack of data from outside of China was an albatross around the neck of ivonescimab, Akeso and Summit Therapeutics’ Keytruda-defeating PD-1xVEGF bispecific, until recently. Ivonescimab impressed analysts in May in its first global trial, reducing the risk of progression or death by 48% in patients with previously treated EGFR-mutated non-squamous NSCLC.
Ivonescimab, which is approved in China, first beat Merck’s Keytruda at improving progression-free survival in NSCLC in September 2024 in a phase 3 trial in China.
Since Akeso and Summit’s success, the PD-1xVEGF arena has rapidly filled with competitors. BioNTech went out and secured the full rights to its own bispecific just months after ivonescimab’s victory over Keytruda, with the asset later scoring a win in a phase 2 trial in China.
Merck itself has bought into the bispecific hype, licensing an asset from LaNova Medicines for $588 million upfront last November, while Bristol Myers Squibb decided to just go halfsies on BioNTech’s bispecific for a whopping $1.5 billion upfront.
Pfizer then joined in on the fun in May of this year, paying 3SBio $1.25 billion upfront for ex-China rights to a clinical PD-1xVEGF candidate. And fellow pharma giants Eli Lilly and Novartis are keeping a close eye on the field, too.