INBX News & Events

Inhibrx Biosciences announced an update on the INBRX-106 Phase 2/3 clinical trial in combination with Keytruda, or pembrolizumab, as a first-line treatment for patients with locally advanced unresectable or metastatic head and neck squamous cell carcinoma, or HNSCC, and the Phase 1/2 trial evaluating patients with checkpoint inhibitor refractory or relapsed non-small cell lung cancer, or NSCLC, in combination with Keytruda. The Company also provided a brief progress update on the expansion cohorts investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma. Inhibrx has recruited 46 of the 60 patients in the randomized Phase 2 portion of the Phase 2/3 clinical trial evaluating INBRX-106 in combination with Keytruda versus Keytruda as a first-line treatment for patients with unresectable or metastatic HNSCC. Inhibrx expects to complete enrollment in the Phase 2 portion of the trial during the first quarter of 2026. This trial is recruiting patients who have not received prior systemic therapy for unresectable or metastatic HNSCC and have tumor PD-L1 CPS expression equal to or greater than 20. In November 2025, Inhibrx completed enrollment of the Phase 1/2 trial evaluating 34 patients in checkpoint inhibitor refractory or relapsed NSCLC in combination with Keytruda. Primary endpoints for this cohort are objective response rate, disease control rate, duration of response and safety. The current datasets for both HNSCC and NSCLC lack sufficient maturity to support an interpretation and conclusion on the viability of this program. Inhibrx expects that in the second half of 2026, the data should be mature enough to inform whether INBRX-106, in combination with Keytruda, demonstrates superior efficacy and sustained clinical benefit relative to the current standard of care. In late October 2025, Inhibrx completed enrollment of 44 patients in the expansion cohort of the Phase 1/2 trial evaluating ozekibart in combination with FOLFIRI in heavily pretreated advanced or metastatic, unresectable colorectal cancer. As previously reported, ozekibart in combination with FOLFIRI was well tolerated, with durable responses and a high rate of disease control. The progression free survival data should be mature in the Q2 of 2026, and we plan to provide an update at that time. Inhibrx expects to complete enrollment in the Phase 1/2 trial of ozekibart in combination with irinotecan and temozolomide for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma in the second quarter of 2026. If the current response and duration trends observed continue,

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Inhibrx Biosciences announced positive topline results from the registrational ChonDRAgon study investigating ozekibart as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma. The company also provided updates on the ongoing expansion cohorts investigating ozekibart in combination with FOLFIRI in late-line colorectal cancer and in combination with irinotecan and temozolomide in refractory Ewing sarcoma. The ChonDRAgon study met its primary endpoint of a statistically significant and clinically meaningful median progression-free survival for patients with advanced or metastatic chondrosarcoma treated with ozekibart vs. placebo. Ozekibart achieved a 52% reduction in the risk of disease progression or death compared to placebo, more than doubling median PFS to 5.52 months versus 2.66 months for placebo. Ozekibart is the first investigational therapy to demonstrate a significant PFS benefit in a randomized trial for chondrosarcoma, a disease with no approved systemic options. Other key secondary endpoints, including disease control rate, and delay to deterioration in pain and physical function, further supported the clinical benefit observed with ozekibart. Ozekibart was generally well tolerated, with a manageable safety profile. One hepatotoxicity-related fatal event occurred early in the study, prior to the implementation of mitigation measures. Results from the Phase 1 trial of ozekibart in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal cancer show a 23% overall response rate and an overall disease control rate of 92%. The Phase 1 trial of ozekibart in combination with irinotecan and temozolomide (IRI/TMZ) for advanced or metastatic, unresectable, relapsed, or refractory Ewing sarcoma showed a 64% overall response rate, and a disease control rate of 92%, with the majority of patients experiencing measurable tumor reduction.