IMM2510/AXN-2510 Combo Yields Preliminary Responses in Advanced NSCLC

The treatment combination elicited partial responses in 80% of patients with squamous NSCLC and 46% in nonsquamous NSCLC.

The PD-L1 and VEGF bispecific antibody IMM2510/AXN-2510 (‘2510) plus chemotherapy showed preliminary activity in the front-line treatment of patients with advanced non–small cell lung cancer (NSCLC), according to a press release on findings from a phase 2 trial (NCT06746870) from the developers, ImmuneOnco Biopharmaceuticals.¹

At the data cut-off of July 1, 2025, with 33 patients having been dosed with the therapy, partial responses (PRs) were observed in 62% of efficacy evaluable patients (n = 21), including 80% (n = 8/10) in those with squamous NSCLC and 46% (n = 5/11) in those with nonsquamous NSCLC. Most evaluable patients had 1 tumor assessment at data cut-off.

Results came from an open-label, phase 2 trial that evaluated the efficacy and safety of the treatment combination in patients with stage IV metastatic or recurrent NSCLC or unresectable locally advanced or metastatic triple-negative breast cancer.²

Previously, in May 2025, the developers announced that the trial would complete enrollment in the third quarter of 2025, with initial results shared in the second half of 2025.³ In the release, they noted the estimated enrollment was approximately 60 patients, with more than 30 patients having NSCLC.

The developers announced that additional data on patients with NSCLC will be shared at an upcoming medical conference.

“‘2510 has demonstrated early but compelling activity in [patients with] front-line NSCLC,” Professor Caicun Zhou, MD, PhD, director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator of the study, stated in the press release.¹ “The PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with ‘2510 in this setting.”

Eligible patients are 18 years or older with NSCLC that is EGFR wild-type and negative for ALK or ROS1 fusion genes; in cohort 1a, patients have nonsquamous NSCLC, and in cohort 1b, patients have squamous NSCLC.² Additional enrollment criteria include no prior receipt of systemic treatment for advanced NSCLC, and if neoadjuvant/adjuvant therapy had been previously received, it must have been 12 or more months from study initiation; measurable lesions per RECIST v1.1 guidelines; an ECOG performance status of 0 or 1; and an expected survival of at least 12 weeks. In cohort 2, patients have breast cancer.

Reasons for trial exclusion include receipt of approved or investigational anti-tumor treatments within 4 weeks of study treatment, receipt of nonspecific immunomodulatory treatments within 2 weeks of study treatment, receipt of any antibody or inhibitor targeting PD-(L)1 or VEGF, laboratory abnormalities, uncontrolled chronic disease, and uncontrolled brain metastases.

In cohort 1a, treatment consists of intravenous ‘2510 at 10 mg/kg or 20 mg/kg once every 3 weeks in phase 1, with chemotherapy given as pemetrexed plus cisplatin or carboplatin. In cohort 1b, treatment consists of intravenous ‘2510 at 10 mg/kg or 20 mg/kg once every 3 weeks, with chemotherapy given as paclitaxel plus cisplatin or carboplatin.

The trial’s primary end points are the objective response rates in all patient populations.

Regarding safety, no dose-limiting toxicities were observed in the 33 patients who were evaluable for safety analysis. No treatment-related adverse events (TRAEs) led to dose reduction or death, and 1 TRAE led to drug discontinuation. The most common grade 3 or higher TRAEs were hematologic, with uncommon clinical sequelae. The investigators noted that the safety profile of ‘2510 supports further clinical development.

“We are delighted to witness the progress of ‘2510 in front-line NSCLC. [These] data pave the way for its advancement into phase 3 clinical studies and provides valuable insights to support further research across multiple indications,” added Tian Wenzhi, MD, chief executive officer of ImmuneOnco.¹

References

1. ImmuneOnco announced preliminary safety & efficacy data from the clinical trial studying IMM2510/AXN-2510, a PD-L1xVEGF bispecific antibody, in combination with chemotherapy in front-line NSCLC in China. News release. Instil Bio and ImmuneOnco Biopharmaceuticals. July 31, 2025. Accessed July 31, 2025. https://tinyurl.com/mvkvp8cf
2. A phase II clinical study to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of IMM2510 in combination with chemotherapy as first-line treatment in subjects with non-small cell lung cancer or triple-negative breast cancer. ClinicalTrials.gov. Updated December 24, 2024. Accessed July 31, 2025. https://tinyurl.com/2uexmks4
3. Instil Bio and ImmuneOnco announced the phase 2 trial in first-line NSCLC of IMM2510/AXN-2510 (‘2510), a PD-L1xVEGF bispecific antibody, in combination with chemotherapy in China is on track to complete enrollment in Q3 2025; initial results anticipated in 2H 2025. News release. Instil Bio and ImmuneOnco Biopharmaceuticals. May 22, 2025. Accessed July 31, 2025. https://tinyurl.com/yxn8thsu