Iovance Biotherapeutics, Inc. IOVA
Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) is an oncology drug developer. Its lead program, Lifileucel (Amtagvi), is in Phase 3 for Previously treated advanced melanoma. Its next catalyst on record is lifileucel (Amtagvi): Iovance plans an additional supplemental BLA submission in 2027 for lifileucel in biomarker-enriched NSCLC. (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: lifileucel (Amtagvi) — Iovance plans an additional supplemental BLA submission in 2027 for lifileucel in biomarker-enriched NSCLC. (2027). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Lifileucel (Amtagvi) | Previously treated advanced melanoma | cell therapy | Approved |
| Proleukin (aldesleukin) | Metastatic renal cell carcinoma / metastatic melanoma | protein/peptide | Approved |
| Lifileucel combination with pembrolizumab (TILVANCE-301) | Frontline advanced melanoma | cell therapy | Phase 3 |
| Lifileucel (IOV-LUN-202) | Previously treated advanced non-small cell lung cancer (non-squamous mNSCLC) | cell therapy | Phase 2 |
| Lifileucel biomarker-enriched (POSITILITY) | Biomarker-enriched non-squamous mNSCLC | cell therapy | Phase 2 |
| Lifileucel | Previously treated advanced undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma | cell therapy | Phase 2 |
| Lifileucel frontline biomarker-enriched (OPTILISM) | Frontline biomarker-enriched non-squamous mNSCLC | cell therapy | Pre-clinical |
Recent results and decisions
- Nov 5, 2026positive 24.6% ORR in 69 patients with mNSCLC and 59.1% ORR in biomarker-selected mNSCLC subgroup in IOV-LUN-202 Cohorts 1 and 2.
We released our positive results for Cohorts 1 and 2 of our ongoing IOV-LUN-202 trial with a 24.6% ORR in 69 patients and excellent durability that is much greater than current standard of care.
Filing - Nov 5, 2026started POSITILITY trial for lifileucel in biomarker-selected mNSCLC is underway.
We are completing enrollment in Cohorts 1 and 2 and preparing for a supplemental Biologics License Application (sBLA) submission, while adding the new POSITILITY and OPTILISM trials supported by a remarkable 59.1% ORR in biomarker-selected patients.
Filing - Nov 5, 2026submitted Iovance plans a 2027 submission for lifileucel in advanced melanoma in additional markets.
Canada EU Australia Switzerland UK U.S. Potential Approval 1Q 2027 Planned 2027 Submission
Filing
9 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.