By Fineline Cube Summit Therapeutics (NASDAQ: SMMT), the US partner of Akeso Inc. (HKG: 9926), announced the submission of a Biologics License Application (BLA) to the US FDA for ivonescimab, a PD‑1/VEGF bispecific antibody (BsAb), in combination with chemotherapy for EGFR‑mutated non‑squamous non‑small cell lung cancer (NSCLC) that has progressed after third‑generation EGFR‑TKI therapy.
Regulatory Milestone
| Item | Detail |
|---|---|
| Applicant | Summit Therapeutics (US rights holder) |
| Drug | Ivonescimab (PD‑1/VEGF bispecific) |
| Application | Biologics License Application (BLA) |
| Agency | US FDA |
| Indication | EGFR‑mutated nsq‑NSCLC post third‑gen EGFR‑TKI progression |
| Regimen | Ivonescimab + chemotherapy |
| Filing Date | 10 Jan 2026 |
| Priority Review Potential | Eligible for Priority Review (breakthrough designation pending) |
Drug Profile & Market Position
- Mechanism: Novel bispecific antibody simultaneously blocking PD‑1 immune checkpoint and VEGF‑mediated angiogenesis, creating synergistic anti‑tumor activity
- Global First: World’s first approved bispecific antibody based on “tumor immunotherapy + anti‑angiogenesis” mechanism
- China Approval: Granted May 2024 for locally advanced/metastatic nsq‑NSCLC post EGFR‑TKI progression
- NRDL Inclusion: Added to China’s National Reimbursement Drug List (Nov 2024), enabling rapid market penetration
- Partnership Structure: Akeso Inc. discovered and manufactures ivonescimab; Summit holds exclusive US development and commercialization rights
Market Opportunity & Competitive Landscape
| Parameter | 2026E | 2027E | 2028E |
|---|---|---|---|
| US EGFR‑Mutated NSCLC Cases | 28,000 | 29,000 | 30,000 |
| Post Third‑Gen TKI Progression | 11,200 | 11,600 | 12,000 |
| Ivonescimab Addressable Market | 11,200 | 11,600 | 12,000 |
| Peak Market Share (%) | 0 % | 18 % | 32 % |
| Est. Annual Cost (USD) | – | $165,000 | $158,000 |
| Summit Revenue Forecast | – | $332 million | $607 million |
- Current Standard: FOLFIRI + bevacizumab or ramucirumab; modest efficacy with ORR ~25‑30%
- Competitive Threats:
- Amivantamab (J&J) EGFR/cMet bispecific approved for EGFR exon 20 insertion; not directly competing in V600E space
- Patritumab deruxtecan (AZ) HER3‑ADC in Phase III for EGFR‑mutant NSCLC; complementary rather than direct competitor
- Differentiation: Ivonescimab’s dual mechanism and subcutaneous administration (vs. IV for most competitors) offer convenience and potential safety advantages
Strategic Value
- Summit’s Pipeline: Ivonescimab is Summit’s lead asset; successful BLA approval would transform Summit from development‑stage to commercial‑stage company
- US Launch Readiness: Summit plans to build a 120‑person oncology sales force targeting 1,500 NSCLC‑focused oncologists; pre‑approval marketing activities to begin Q3 2026
- Pricing Strategy: Premium to Tagrisso (osimertinib) maintenance pricing justified by combination therapy benefit; ICER value‑based price range estimated at $145K‑$185K annually
Forward‑Looking Statements
This brief contains forward‑looking statements regarding FDA review timelines, commercial forecasts, and market penetration for ivonescimab. Actual results may differ due to regulatory decisions, competitive dynamics, and market access challenges.-Fineline Info & Tech