ordastobart (INBRX-106) / Elpiscience, Inhibrx Biosci - LARVOL DELTA

The Company is currently conducting a Phase 1/2 study of INBRX-106 in the perioperative setting of non-small cell lung cancer (NSCLC), with initial results targeted by mid-2027 (PRNewswire) - "This readout is expected to provide important clinical insights to inform future development, demonstrating the potential for INBRX-106 to extend well beyond head and neck cancer into not only perioperative lung cancer, but broader solid tumor indications."

P1/2 data • Non Small Cell Lung Cancer

Inhibrx Biosciences…announced the primary endpoint results from the randomized and controlled Phase 2 portion of the HexAgon study, which is evaluating the safety and efficacy of INBRX-106…in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) (PRNewswire) - "The primary endpoint analysis, which had a data cutoff of August 19, 2026, demonstrated a confirmed objective response rate (cORR) of 48.3% for INBRX-106 plus pembrolizumab compared with 26.5% for pembrolizumab alone. Four patients (13.8%) in the combination arm achieved a complete response compared with no complete responses in the control arm. Median progression-free survival (PFS) continues to mature. As of the data cutoff, median PFS was 9.6 months for INBRX-106 plus pembrolizumab compared with 4.9 months for pembrolizumab alone, with six-month PFS rates of 72.4% and 42.8%, respectively.....Based on these results, Inhibrx plans to expand the randomized Phase 2 portion of the HexAgon trial by approximately 50 additional HPV+...OPSCC patients (CPS ≥ 1), to support a potential accelerated regulatory pathway. Following the Phase 2 expansion, the Company plans to align with the FDA on this framework and initiate the Phase 3 portion of the HexAgon trial..."

FDA event • P2 data • Trial status • Oropharyngeal Cancer • Squamous Cell Carcinoma of Head and Neck

Upcoming Milestones:…INBRX-106 (PRNewswire) - "The Company plans to announce progression-free survival (PFS) data from the randomized Phase 2 trial in head and neck squamous cell carcinoma (HNSCC) in combination with pembrolizumab in the third quarter of 2026."

P2 data • Squamous Cell Carcinoma of Head and Neck

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1/2 | N=340 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | Active, not recruiting ➔ Recruiting | Trial completion date: May 2027 ➔ Jul 2033 | Trial primary completion date: Oct 2026 ➔ Jul 2033

Enrollment open • First-in-human • Trial completion date • Trial primary completion date • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-1 • PD-L1 • TMB

Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Providence Health & Services | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jun 2026 ➔ Jun 2027

Combination therapy • Enrollment open • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: Inhibrx, Inc. | Trial completion date: Mar 2024 ➔ Mar 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1/2 | N=333 | Recruiting | Sponsor: Inhibrx, Inc. | Phase classification: P1 ➔ P1/2 | N=200 ➔ 333

Combination therapy • Enrollment change • Metastases • Phase classification • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1 | N=333 | Recruiting | Sponsor: Inhibrx, Inc. | Phase classification: P1/2 ➔ P1

Combination therapy • Metastases • Phase classification • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1/2 | N=333 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | Phase classification: P1 ➔ P1/2

Combination therapy • Metastases • Phase classification • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

Neoadjuvant INBRX-106 (Hexavalent OX40 Agonist) in Combination With Pembrolizumab as a Chemotherapy-sparing Regimen for Stage II TNBC (Triple Negative Breast Cancer) Patients (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: Providence Health & Services

Combination therapy • New P2 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Next Steps (PRNewswire) - "The progression-free survival data from the Phase 2 portion of the HexAgon study are expected to become available in the fourth quarter of 2026. The Company plans to begin the Phase 3 portion of the HexAgon study during the third quarter of 2026...Based on these promising early results, the Company also aims to evaluate INBRX-106 across broader indications to potentially improve the efficacy of checkpoint inhibitors. This strategy includes initiating a study in the perioperative setting in non-small cell lung cancer (NSCLC) later this quarter....In addition, the Company is beginning to plan for expansion into the front-line metastatic NSCLC setting, with studies expected to begin in 2027."

New trial • P2 data • Trial status • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

Inhibrx Reports Interim Phase 2 Data for INBRX-106 in First-Line HNSCC; Initial Results Demonstrate Potential Costimulatory Benefit Over PD-1 Monotherapy (PRNewswire) - "In the evaluable population, 11 out of 25 patients (44.0%) in the INBRX-106 combination arm achieved a confirmed objective response, compared with 6 out of 28 patients (21.4%) in the control arm. This represents a 22.6% absolute increase in confirmed responses. Three complete responses were observed in the INBRX-106 combination arm, reflecting tumor clearance, while no complete responses were observed with pembrolizumab alone....These clinical findings were supported by pharmacodynamic data, which showed up to a 15-fold increase in peripheral CD8+ and CD4+ T-cell proliferation and up to a four-fold increase in activation in INBRX-106 combination-treated patients compared with up to 2.5-fold and 1.5-fold increases, respectively, in those receiving pembrolizumab alone."

P2 data • Squamous Cell Carcinoma of Head and Neck

Recent Corporate Highlights and Upcoming Milestones: INBRX-106 (Financial Times) - "We plan to announce progression-free survival (PFS) data from the randomized Phase 2 trial in HNSCC in combination with pembrolizumab in the fourth quarter of 2026."

P2 data • Squamous Cell Carcinoma of Head and Neck

Inhibrx To Host Webcast Presentation to Provide Clinical Update on INBRX-106 HexAgon Study in First Line HNSCC (PRNewswire) - "...Webcast presentation...to provide interim results from the randomized, first-line Phase 2 portion of the HexAgon study, which is evaluating the safety and efficacy of INBRX-106, a hexavalent OX40 agonist, in combination with pembrolizumab (the combination arm) versus pembrolizumab monotherapy (the control arm) in first-line patients with treatment-naïve, PD-L1 positive (CPS ≥ 20) metastatic or unresectable recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)."

P2 data • Squamous Cell Carcinoma of Head and Neck

Inhibrx’s cancer duo could be pharma’s next big takeout target: report (Firstwordpharma Press Release) - "Inhibrx Biosciences may be close to spinning off another portion of its pipeline. Its shares jumped about 37% on Wednesday after a report from Reuters detailed interest from several pharmas, including Merck & Co., in buying a pair of experimental cancer drugs from the biotech. According to people familiar with the matter, the deal could be worth $9 billion, including a $1-billion price tag for ozekibart (INBRX-109) and $8 billion for INBRX-106, a hexavalent OX40 agonist....In addition to Merck, the German drugmaker Merck KGaA and Japanese firm Ono Pharmaceuticals are also reportedly interested in Inhibrx's cancer assets."

Commercial • Oncology

HexAgon-HN: INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC (clinicaltrials.gov) - P2/3 | N=410 | Active, not recruiting | Sponsor: Inhibrx Biosciences, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Upcoming Milestones:…INBRX-106 (PRNewswire) - "(i) We plan to announce interim objective response rate ('ORR') data from the randomized Phase 2/3 trial in head and neck squamous cell carcinoma ('HNSCC') in combination with KEYTRUDA (pembrolizumab) in the second quarter of 2026; and (ii) We plan to announce PFS data from the randomized Phase 2/3 trial in HNSCC in combination with pembrolizumab in the fourth quarter of 2026 at the European Society for Medical Oncology ('ESMO') 2026 Congress."

P2/3 data • Squamous Cell Carcinoma of Head and Neck

INBRX106-01-201: Phase 2/3 Randomized Study of INBRX-106 Add-on to Pembrolizumab in First-Line PD-L1 CPS ?20 R/M HNSCC (HexAgon-HN) (clinicaltrialsregister.eu) - P2/3 | N=175 | Active, not recruiting | Sponsor: Inhibrx Biosciences Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1/2 | N=296 | Active, not recruiting | Sponsor: Inhibrx Biosciences, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

Inhibrx Biosciences Provides Progress Updates on the INBRX-106 Program... (PRNewswire) - "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....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....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..."

Clinical data • Enrollment status • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

KEYNOTE A99: Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) (clinicaltrials.gov) - P1/2 | N=333 | Recruiting | Sponsor: Inhibrx Biosciences, Inc | Trial completion date: May 2026 ➔ May 2027 | Trial primary completion date: Feb 2026 ➔ Oct 2026

First-in-human • Trial completion date • Trial primary completion date • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • ALK • EGFR • PD-L1 • TMB

Upcoming Milestones (PRNewswire) - "Initial Phase 2 data from the INBRX-106 randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA (pembrolizumab) are expected during the fourth quarter of 2025, as well as interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer trial."

P1/2 data • P2 data • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

A Study of ES102 (OX40 Agonist) in Combination With JS001 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Elpiscience Biopharma, Ltd. | Recruiting ➔ Completed | N=82 ➔ 30

Enrollment change • Trial completion • Oncology • Solid Tumor • PD-L1

HexAgon-HN: Phase 2/3, randomized study of the hexavalent OX40 agonist INBRX-106 in combination with pembrolizumab vs pembrolizumab alone as first-line treatment for recurrent/metastatic head and neck cancer with a PD-L1 combined positive score of ≥20. (ASCO 2025) - P1/2, P2/3 | "Lancet. 2019; 394:1915-1928."

Clinical • Combination therapy • Metastases • P2/3 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering. (PubMed, J Immunother Cancer) - P1/2 | "Our data establish hexavalent INBRX-106 as a differentiated and more potent OX40 agonist, showcasing its ability to overcome the limitations of conventional bivalent therapies by inducing superior receptor clustering and multimeric engagement. This unique clustering mechanism amplifies OX40 signaling, driving robust T-cell activation, proliferation, and effector function in preclinical and clinical settings. These findings highlight the therapeutic potential of INBRX-106 and its capacity to redefine OX40-targeted immunotherapy, providing a compelling rationale for its further clinical development in combination with checkpoint inhibitors."

Journal • Oncology • Solid Tumor • CD8 • TNFA