Inhibrx Biosciences Presents INBRX-109 Data Update at ESMO Sarcoma and Rare Cancers Congress 2026

Phase 1 Study of Ozekibart (INBRX-109) Combined With Irinotecan and Temozolomide Shows Robust Antitumor Activity in Relapsed/Refractory Ewing Sarcoma

Mar. 12, 2026 at 10:50am

Inhibrx Biosciences presented updated findings from a phase 1 study evaluating the tetravalent death receptor 5 (DR5) agonist ozekibart (INBRX-109) in combination with irinotecan and temozolomide (IRI/TMZ) in patients with relapsed/refractory Ewing sarcoma. The combination demonstrated robust antitumor activity, with an objective response rate of 64.5% and a disease control rate of 87.1%. The safety profile was consistent with IRI/TMZ, with no new safety signals observed.

Why it matters

Ewing sarcoma is a rare, aggressive tumor with poor outcomes, especially in the relapsed/refractory setting. The combination of ozekibart and IRI/TMZ represents a potential new treatment option that could significantly improve outcomes for these patients, including those who have progressed on prior IRI/TMZ regimens.

The details

In the ongoing phase 1 study, 39 patients with advanced or metastatic Ewing sarcoma received ozekibart at the recommended phase 2 dose of 3 mg/kg every 3 weeks in combination with IRI (50 mg/m2/day on days 1-5) and TMZ (100 mg/m2/day on days 1-5). The most common treatment-emergent adverse events were diarrhea, nausea, anemia, and vomiting, which were consistent with the known safety profile of IRI/TMZ. Four patients (10.3%) discontinued treatment due to adverse events.

  • The data cutoff for this analysis was January 15, 2026.
  • Median follow-up at the time of data cutoff was 6.01 months (range, 0-27.2 months).

The players

Inhibrx Biosciences, Inc.

An American biopharmaceutical company focused on developing novel biologics, including the tetravalent DR5 agonist ozekibart (INBRX-109).

Ana Sebio

The presenter of the data at the ESMO Sarcoma and Rare Cancers Congress 2026.

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What they’re saying

“These findings support further evaluation of ozekibart + IRI/TMZ in relapsed/refractory Ewing sarcoma.”

— Ana Sebio

What’s next

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The takeaway

The combination of ozekibart and IRI/TMZ demonstrated robust antitumor activity and a manageable safety profile in patients with relapsed/refractory Ewing sarcoma, including those who had progressed on prior IRI/TMZ regimens. These results support further development of this combination as a potential new treatment option for this patient population with high unmet medical need.