Oncorix
oncorizumab
Phase IIIStatus: Under Review
Therapeutic Area: Oncology•Manufacturer: PharmaCorp Inc
Overview
Description
A novel monoclonal antibody targeting PD-L1 for the treatment of advanced non-small cell lung cancer.
Mechanism of Action
PD-L1 inhibitor that blocks the interaction between PD-1 and PD-L1, restoring T-cell mediated anti-tumor immunity.
Indication
Advanced non-small cell lung cancer (NSCLC) in patients who have progressed on prior therapy.
Market Projections
Financial outlook and market data
$2500M
Estimated Revenue
$15.0B
Market Size
8.5%
Growth Rate
2028
Peak Sales Year
Projected Revenue Growth
20242030
Clinical Development Timeline
Progress through clinical trial phases
✓
Preclinical
Completed
✓
Phase I
Completed
✓
Phase II
Completed
4
Phase III
In Progress
5
Approved
Not Started
| Phase | Status | Timeline | Participants | Primary Endpoint | Results |
|---|---|---|---|---|---|
| Preclinical | Completed | 2018-01 - 2019-06 | - | - | Demonstrated efficacy in xenograft models |
| Phase I | Completed | 2019-09 - 2020-12 | 45 | Safety and tolerability | Well tolerated, MTD established |
| Phase II | Completed | 2021-03 - 2022-09 | 180 | Objective response rate | ORR of 42%, median PFS 8.2 months |
| Phase III | In Progress | 2023-01 | 650 | Overall survival | - |
| Approved | Not Started | - | - | - | - |
Regulatory Approval Status
Approval status across different regions
U
United States
Under ReviewAgency: FDA
Date: 2024-06
Priority review granted
E
European Union
SubmittedAgency: EMA
Date: 2024-08
J
Japan
PlannedAgency: PMDA
Submission expected Q1 2025