Developers Terminate Clinical Program for Ociperlimab in Lung Cancer

Investigators will share detailed results from AdvanTIG-302 (NCT04746924) in the future.

Developers BeiGene discontinued a clinical program assessing the investigational anti-TIGIT antibody ociperlimab (BGB-A1217) as a potential therapy for patients with lung cancer, according to a press release from the developers.¹

The decision to terminate the clinical program for ociperlimab followed a recommendation from an independent data monitoring committee to discontinue the phase 3 AdvanTIG-302 trial (NCT04746924) based on findings from a pre-planned futility analysis. Data showed that treatment with ociperlimab was unlikely to meet the trial’s primary end point of overall survival (OS). Additionally, there were no new safety signals.

Investigators will share detailed results from AdvanTIG-302 in the future.

“We evaluate our clinical programs to focus our resources on the most promising clinically differentiated candidates while thoughtfully de-prioritizing others. Our commitment remains steadfast: to discover and develop innovative treatments that are more affordable and accessible to [patients with] cancer worldwide,” Mark Lanasa, MD, PhD, chief medical officer for Solid Tumors at BeiGene, stated in the press release.¹ “We thank the investigators, their patients, and support staff whose participation and dedication made this research possible.”

Developers designed ociperlimab as a humanized IgG1 antibody that targeted TIGIT with potential checkpoint inhibitory activity.² The agent was intended to bind to TIGIT expressed on various immune cells such as tumor-infiltrating T lymphocytes to prevent TIGIT from interacting with the ligands CD112 and CD155. Investigators hypothesized that this mechanism could have enhanced the way CD112 and CD155 interacted with CD226, thereby leading to CD226 dimerization while activating the immune system to produce a T-cell–mediated immune response against cancer cells.

Investigators of the double-blind phase 3 AdvanTIG-302 study assessed the safety and efficacy of ociperlimab plus tislelizumab (Tevimbra) vs pembrolizumab (Keytruda) among adult patients with PD-L1–high, locally advanced, recurrent, or untreated metastatic non–small cell lung cancer (NSCLC).³ Patients were assigned to receive treatment with tislelizumab plus ociperlimab, pembrolizumab plus placebo, or tislelizumab plus placebo.

Treatment in the experimental arm consisted of tislelizumab at 200 mg intravenously plus ociperlimab at 900 mg intravenously once every 3 weeks. In the active comparator arm, patients received pembrolizumab at 200 mg intravenously followed by placebo once every 3 weeks. Additionally, investigators administered tislelizumab at 200 mg intravenously plus placebo once every 3 weeks to patients in the placebo comparator arm.

The trial’s primary end point was OS for up to approximately 58 months. Secondary end points included progression-free survival, overall response rate, and duration of response based on investigator assessment; health-related quality of life; time to deterioration; and adverse effects.

Patients 18 years and older with histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiation with or without chemoradiation or metastatic nonsquamous or squamous NSCLC were able to enroll on the trial. Other requirements for study entry included having no prior systemic therapy for metastatic NSCLC, PD-L1 expression in at least 50% of tumor cells, at least 1 measurable lesion per RECIST v1.1 guidelines, and an ECOG performance status of 0 or 1.

Those with known EGFR, ALK, BRAF V600E, or ROS1 mutations were ineligible for enrollment on the trial. Patients were also unable to enroll if they had prior treatment with anti–PD-1, anti–PD-L1, anti–PD-L2, or anti-TIGIT agents; active leptomeningeal disease or uncontrolled brain metastases; or active autoimmune diseases or history of autoimmune diseases with a chance of relapse.

References

1. BeiGene provides update on the ociperlimab (BGB-A1217) clinical development program. News release. BeiGene, Ltd. April 3, 2025. Accessed April 3, 2025. https://tinyurl.com/ycy4bzac
2. Ociperlimab. National Cancer Institute. Accessed April 3, 2025. https://tinyurl.com/3wzd93jk
3. A study of ociperlimab with tislelizumab compared to pembrolizumab in participants with untreated lung cancer. ClinicalTrials.gov. Updated March 25, 2025. Accessed April 3, 2025. https://tinyurl.com/mrunnecb