Inhibrx Reports INBRX-106 Combination Outperforms Keytruda
Inhibrx Reports INBRX-106 Combination Outperforms Keytruda
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Key Points
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The Phase 2 portion randomized 68 patients, with 63 evaluable for the primary endpoint: 29 in the INBRX-106 combination arm and 34 in the pembrolizumab control arm. The study enrolled treatment-naive patients with PD-L1 expression defined as a combined positive score (CPS) of 20 or higher.
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The HexAgon study is being conducted at more than 80 sites across the United States, Europe and Asia, and baseline prognostic factors were largely balanced between the two treatment groups.
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INBRX-106 is described as a hexavalent OX40 agonist, designed to target an immune pathway and being evaluated in combination with pembrolizumab for solid tumors.
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Among HPV-positive patients, 30% of those receiving the combination achieved a complete response, compared with no complete responses in the pembrolizumab-only group.
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Chief Executive Mark Lappe said the findings provide a rationale to expand development beyond HPV-positive disease and to investigate INBRX-106 in other highly immunogenic tumors and in combination with cancer vaccines.
Inhibrx Biosciences reported strong Phase 2 data for INBRX-106, an experimental cancer drug that nearly doubled response rates when combined with Merck's Keytruda. In 63 previously untreated patients with head and neck cancer, the combination achieved a 48.3% response rate compared with 26.5% for Keytruda alone, according to Inhibrx.
The results mark a major milestone for OX40, a long-sought immune checkpoint target in cancer therapy. CEO Mark Lappe said the findings validate expanding the drug beyond head and neck cancer to other highly immunogenic tumors and cancer vaccine combinations.
Combination Nearly Doubles Patient Response Rates
Among 63 evaluable patients in the Phase 2 HexAgon trial, those receiving INBRX-106 plus Keytruda showed dramatic improvements across all key measures. Complete responses—where tumors disappear entirely—occurred in 13.8% of combination patients versus none in the Keytruda-only group, according to Inhibrx.
Median progression-free survival, the time before cancer returns, reached 9.6 months with the combination versus 4.9 months with Keytruda alone. At six months, 72.4% of combination-treated patients remained progression-free compared with 42.8% in the control arm, according to trial data.
HPV-Positive Patients Show Exceptional Results
The strongest outcomes emerged in patients with HPV-positive head and neck cancer. Those receiving the combination achieved an 80% response rate and 90% six-month progression-free survival, Inhibrx reported. Among these patients, 30% achieved complete responses compared with none receiving Keytruda monotherapy.
These results convinced Inhibrx to expand enrollment by about 50 HPV-positive patients in the ongoing trial. The company also plans to explore an accelerated-approval pathway with regulators, potentially enabling faster market access.
OX40 Emerges as Breakthrough Immunotherapy Target
INBRX-106 is a hexavalent OX40 agonist, meaning it activates an immune system pathway long pursued by cancer researchers. Archynetys called it the first documented success for this checkpoint in oncology, breaking years of development efforts across the industry.
Inhibrx enrolled 68 patients across more than 80 sites in the United States, Europe, and Asia. The trial included only treatment-naive patients with high PD-L1 expression, focusing on populations most likely to benefit from immunotherapy combinations.
Broader Expansion Planned Across Solid Tumors
CEO Mark Lappe signaled plans to investigate INBRX-106 in other immunogenic cancers beyond head and neck disease. The company will also test the drug combined with cancer vaccines, representing a novel therapeutic strategy.
These Phase 2 findings provide the rationale for expanding into new cancer types and treatment combinations. TipRanks and Seeking Alpha highlighted the data as a major competitive win against established therapies like Keytruda monotherapy.
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