Inhibrx Biosciences, a clinical-stage biopharmaceutical company focused on developing novel biologic therapeutic candidates, has released updated interim data from its phase 1/2 study evaluating ozekibart (INBRX-109) in combination with Folfiri in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC).
The CRC cohort continued to demonstrate a compelling signal of activity in a heavily pretreated patient population.
Of the 45 evaluable patients, approximately 70% received ozekibart as a fourth-line therapy, and 80% had previously progressed on irinotecan-based regimens. The following data were observed as of the cutoff date:
- Objective response rate (ORR): efficacy was assessed in 45 evaluable patients, resulting in an ORR of 20% per recist v1.1 criteria. Historically, the current standard of care has yielded limited response rates (ORR of 1-6% per recist v1.1 criteria). Nearly half of responses were durable with a duration of response exceeding 6 months. Responses were observed irrespective of RAS/RAF mutation status.
- Progression-free survival (PFS): the median PFS for the evaluable population was 5.5 months. Notably, 42% of patients remained progression-free at the six-month landmark, with nine patients remaining on therapy, suggesting that a significant portion of patients achieve durable disease control that extends well beyond the median PFS.
- Disease control rate (DCR): the overall disease control rate (partial responses and stable disease as best response) remained robust at 87%, further supporting the potential of ozekibart to control tumour growth in a heavily pre-treated population.
- Safety and tolerability: Ozekibart in combination with Folfiri continues to maintain a manageable safety profile. The most common treatment-related adverse events (TEAEs) were diarrhoea, fatigue, and nausea, which were largely grade one or two and consistent with the known side effects of Folfiri. Despite the majority of the patients (68%) presenting with liver metastases at baseline, no significant liver toxicity was observed.
Inhibrx plans to meet with the US Food and Drug Administration (FDA) in the second half of 2026 to discuss plans to initiate a first-line registrational trial in CRC.
The company also plans to discuss with the FDA the potential for accelerated regulatory pathways for ozekibart in fourth-line colorectal cancer and in refractory Ewing sarcoma. Additionally, the company submitted a biologics license application (BLA) to the FDA for ozekibart in conventional chondrosarcoma in April 2026.
