Inhibrx's INBRX-106 Nearly Doubles Response Rate in Phase 2 HNSCC — HPV+ cORR Hits 80% vs 33%
INBX has more than doubled off its 52-week low of $26.19 on elevated volume (5.1× avg).
Summary
Inhibrx's INBRX-106 plus pembrolizumab nearly doubled response rates versus pembrolizumab alone in Phase 2 HNSCC, with particularly strong results in HPV+ patients (80% vs 33% cORR). The company will expand the trial to pursue accelerated approval.
Key Events · Product Development and Regulatory · INBX
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Phase 2 Primary Endpoint Met
INBRX-106 plus pembrolizumab achieved 48.3% cORR vs 26.5% for pembrolizumab alone (Δ +21.8 points), with median PFS of 9.6 vs 4.9 months and 6-month PFS of 72.4% vs 42.8% in first-line HNSCC.
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HPV+ Subgroup Shows Striking Efficacy
In HPV+ patients, the combination achieved 80.0% cORR vs 33.3%, 30.0% complete responses vs 0%, and 90.0% six-month PFS vs 33.0%, with median PFS not yet reached vs 4.6 months.
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Accelerated Approval Pathway Planned
Inhibrx will expand the Phase 2 HexAgon trial by ~50 additional HPV+ OPSCC patients (CPS ≥1) to support a potential accelerated approval, targeting end of 2028/early 2029.
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First Randomized OX40 Agonist Benefit
INBRX-106 is the first OX40 agonist to demonstrate clinical benefit in a randomized study, validating the hexavalent format's high-order receptor clustering approach.
Analysis · INBX · Life Sciences
Inhibrx reported Phase 2 data showing INBRX-106 plus pembrolizumab nearly doubled the confirmed objective response rate versus pembrolizumab alone in first-line HNSCC (48.3% vs 26.5%), with median PFS of 9.6 vs 4.9 months. The HPV+ subgroup was even more striking: 80% cORR, 30% complete responses, and 90% six-month PFS versus 33% for pembrolizumab alone. The company plans to expand the Phase 2 trial by ~50 HPV+ patients to pursue an accelerated approval pathway, targeting end of 2028/early 2029. This is the first randomized evidence of clinical benefit for an OX40 agonist, validating a mechanism that has eluded bivalent approaches for years. The data positions INBRX-106 as potentially practice-changing in HPV+ HNSCC, a $4B+ market, and supports expansion into NSCLC, other immunogenic tumors, and cancer vaccine combinations. Against a backdrop of a $36.7M quarterly loss and $219.5M cash, this readout materially de-risks the pipeline and could attract partnership or financing interest.
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At the time of this filing, INBX was trading at $114.34 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.7B. The 52-week trading range was $26.19 to $155.29. This filing was assessed with positive market sentiment and an importance score of 9 out of 10.