Report scope. This 2026 Drug Asset Due Diligence Report evaluates Lirilumab as a potential licensing, partnership, acquisition, or option asset. The review separates verified evidence from open diligence questions across clinical development, intellectual property, market positioning, and transaction precedent.
Executive recommendation: CONDITIONAL GO
Lirilumab is a Monoclonal antibody associated with KIR2DL1 x KIR2DL2 x KIR2DL3 x KIR2DS1 x KIR2DS2 and a global highest development stage of Phase 2. The lead disclosed indication is Recurrent Squamous Cell Carcinoma of the Head and Neck. The current evidence supports a CONDITIONAL GO posture, subject to confirmation of study-level data, ownership, patent coverage, manufacturing readiness, and regional rights.
Decision memo
- Asset: Lirilumab
- Target: KIR2DL1 x KIR2DL2 x KIR2DL3 x KIR2DS1 x KIR2DS2
- Lead indication: Recurrent Squamous Cell Carcinoma of the Head and Neck
- Highest phase: Phase 2
- Matched trials: 8
- Matched result records: 17
- Matched asset deals: 2
Use PatSnap Life Sciences MCP servers to validate the Lirilumab diligence evidence.
1. Asset identity and development status
The first diligence task is entity resolution. Teams should reconcile development codes, nonproprietary names, salts, formulations, combinations, sponsors, and predecessor owners before relying on portfolio counts. For Lirilumab, the MCP profile identifies KIR2DL1 x KIR2DL2 x KIR2DL3 x KIR2DS1 x KIR2DS2 as the primary target context and Recurrent Squamous Cell Carcinoma of the Head and Neck as the lead indication. Global phase labels are useful orientation points, but investment decisions require country- and indication-level status verification.
Confirm the exact molecule, formulation, route, dose, biomarker definition, and current sponsor. Review discontinuations separately from active development so that an historical high phase is not mistaken for a live program.
Use PatSnap Life Sciences MCP servers to validate the Lirilumab diligence evidence.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT03532451 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT03347123 | Phase 1/2 | Terminated | Not disclosed | Not disclosed |
| NCT03341936 | Phase 2 | Active, not recruiting | Not disclosed | Not disclosed |
| NCT03203876 | Phase 1 | Completed | Not disclosed | Not disclosed |
| NCT02599649 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT02481297 | Phase 2 | Completed | Not disclosed | Not disclosed |
| NCT02399917 | Phase 2 | Terminated | Not disclosed | Not disclosed |
| NCT02252263 | Phase 1 | Completed | Not disclosed | Not disclosed |
The clinical program should be audited for randomization, comparator relevance, dose selection, endpoint hierarchy, multiplicity, analysis population, geographic mix, and readout timing. Early-stage programs require attention to pharmacokinetics, pharmacodynamics, adverse events, dose-limiting toxicities, and the rationale for the expansion dose.
Use PatSnap Life Sciences MCP servers to validate the Lirilumab diligence evidence.
3. Clinical readouts: what is known
PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy
Study: NCT03661320 | NCT03532451 (PrECOG PrE0807, Pubmed | Eur Urol Oncol). Phase: Phase 1. Enrollment: 43. Published: 2024-08-01.
2-yr OS rates = 82 % | 2-yr OS rates = 89 %
A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors
Study: NCT01714739 (CTgov). Phase: Phase 1/2. Enrollment: 337. Published: 2023-02-02.
Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5 = 4 Pts | Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5 = 16 Pts
Neodjuvant Nivolumab and Lirilumab, Followed by Surgery, Followed by Adjuvant Nivolumab and Lirilumab, in Patients With Relapsed, Resectable Squamous Cell Carcinoma of the Head and Neck
Study: NCT03341936 (CTgov). Phase: Phase 2. Enrollment: 29. Published: 2022-06-16.
1-Year Disease-Free Survival Percentage = 55.2 % (95%CI, 34.8 - 71.7)
Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
Study: NCT03532451 (PrE0807 | PrECOG PrE0807, CTgov). Phase: Phase 1. Enrollment: 43. Published: 2021-09-01.
Grade 3 or Higher Treatment Related Adverse Events as Assessed by CTCAE V5.0 = 0 % (90%CI, 0 - 0.21) | Grade 3 or Higher Treatment Related Adverse Events as Assessed by CTCAE V5.0 = 0.07 % (90%CI, 0.01 - 0.20)
Neoadjuvant and adjuvant nivolumab and lirilumab in patients with recurrent, resectable squamous cell carcinoma of the head and neck.
Study: NCT03341936 (ASCO 12021 | ASCO 22021). Phase: Phase 2. Enrollment: 29. Published: 2021-05-28.
DFS(1-year) = 70 % (95%CI, 48 - 84)
PrE0807: A phase Ib feasibility trial of neoadjuvant nivolumab (N) without or with lirilumab (L) in cisplatin-ineligible patients (pts) with muscle-invasive bladder cancer (MIBC).
Study: NCT03532451 (PrE0807, ASCO 12021 | ASCO 22021). Phase: Phase 1. Enrollment: 43. Published: 2021-05-20.
TRAE(grade 3) = 0 % (90%CI ) | TRAE(grade 3) = 6.7 % (90%CI, 1.2 - 19.5)
Lirilumab (Anti-KIR mAb) Combined With Rituximab for Relapsed, Refractory or High-risk Untreated Patients With Chronic Lymphocytic Leukemia (CLL)
Study: NCT02481297 (CTgov). Phase: Phase 2. Enrollment: 7. Published: 2020-05-26.
Participants With a Response = 0 Pts | Participants With a Response = 3 Pts
Phase II Combination of Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
Study: NCT02599649 (CTgov). Phase: Phase 2. Enrollment: 10. Published: 2020-01-06.
ORR = 1 Pts | Other (Not Including Serious) Adverse Events = 0 Pts
An Open-Label Phase II Study of Lirilumab (BMS-986015) in Combination With 5-Azacytidine (Vidaza) for the Treatment of Patients With Refractory/Relapsed Acute Myeloid Leukemia
Study: NCT02399917 (CTgov). Phase: Phase 2. Enrollment: 36. Published: 2019-09-24.
Participants With an Objective Response = 2 Pts | Participants With an Objective Response = 1 Pts
Double-Blind Placebo-Controlled Randomized Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission
Study: NCT01687387 (EFFIKIR, CTgov). Phase: Phase 2. Enrollment: 152. Published: 2019-02-08.
LFS(Median) = 6.7 Month (95%CI, 2.9 - 14.8) | LFS(Median) = 17.6 Month (95%CI, 11.2 - 25)
A Pilot Trial of Lirilumab With or Without Azacitidine for Patients With Myelodysplastic Syndrome.
Study: NCT02599649 (Pubmed | Clin Lymphoma Myeloma Leuk). Phase: Phase 2. Enrollment: 10. Published: 2018-10-01.
Adverse Event: Grade ≥3 adverse events attributable to study drug = Five patients experienced 8 episodes of Grade ≥3 adverse events attributable to study drug, with the most frequent being infection or neutropenic fever (75%)
A pilot trial of anti-KIR antibody with or without 5-azacitidine for myelodysplastic syndrome.
Study: NCT02599649 (ASCO2018). Phase: Phase 2. Enrollment: 10. Published: 2018-06-01.
Adverse Event: elevated bilirubin = 1 elevated bilirubin
A phase 1 study of lirilumab (antibody against killer immunoglobulin-like receptor antibody KIR2D; IPH2102) in patients with solid tumors and hematologic malignancies
Study: NCT01714739 (Pubmed). Phase: Phase 1. Enrollment: 37. Published: 2018-04-03.
TRAE = pruritus (19%), asthenia (16%), fatigue (14%), infusion-related reaction (14%), and headache (11%), mostly mild or moderate
Phase IB/II study of lirilumab with azacytidine (AZA) in relapsed AML.
Study: NCT02399917 (ASCO2017). Phase: Phase 2. Enrollment: 25. Published: 2017-05-30.
mDoR = 2.0 Month
Randomised Phase II Study Evaluating the Anti-tumour Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Human Monoclonal Anti-KIR Antibody, in Patients With Multiple Myeloma in Stable Partial Response After a First Line Therapy
Study: NCT00999830 (REMYKIR, CTgov). Phase: Phase 2. Enrollment: 27. Published: 2016-03-24.
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains = 0 Pts | Rate of Patients Achieving a Response Based on M-protein or Free Light Chains = 1 Pts
A Phase II Trial of IPH2101 (Anti-KIR) in Smoldering Multiple Myeloma (SMM)
Study: NCT01248455 (CTgov). Phase: Phase 2. Enrollment: 9. Published: 2015-05-15.
MR = 11 %
Multicenter Phase II Study on the Anti-tumor Activity, Safety and Pharmacology of Two Dose Regimens of IPH2101, a Fully Human Monoclonal Anti KIR Antibody, in Patients With Smoldering Multiple Myeloma (KIRMONO)
Study: NCT01222286 (KIRMONO, CTgov). Phase: Phase 2. Enrollment: 30. Published: 2014-05-09.
Rate of Patients Achieving an Objective Response = 0 Pts | Rate of Patients Achieving an Objective Response = 0 Pts
For every reported endpoint, obtain the protocol, statistical analysis plan, patient disposition, baseline characteristics, subgroup definitions, exposure duration, and full safety tables. Conference abstracts and registry summaries can support screening, but they should not replace source data review in a binding transaction.
Use PatSnap Life Sciences MCP servers to validate the Lirilumab diligence evidence.
4. Market and competitive position
The commercial case depends on differentiated efficacy, tolerability, convenience, biomarker reach, treatment setting, and access. A target-level market may be attractive while an individual asset remains undifferentiated. Benchmark Lirilumab against approved therapies and clinical competitors in Recurrent Squamous Cell Carcinoma of the Head and Neck, including likely standards of care at the expected launch date.
Build a scenario model around addressable patients, diagnosis and biomarker rates, line of therapy, duration, net price, uptake, displacement, combination costs, and probability-adjusted timelines. Test slower enrollment, delayed readout, narrower labels, safety restrictions, and competitor launches.
Use PatSnap Life Sciences MCP servers to validate the Lirilumab diligence evidence.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| 2011-07-06 | Bristol-Myers Squibb and Innate Pharma Announce Breakthrough Global License Agreement for an Investigational Immuno-Oncology Biologic | Active | License | Disclosed |
| 2006-04-05 | Innate Pharma and Novo Nordisk announce strategic partnership to research and develop drugs targeting natural killer cells | Active | Collaboration, License, Investment | Not disclosed |
Transaction records should be normalized for territory, asset scope, phase at signing, option mechanics, development obligations, cost sharing, royalties, milestones, and change-of-control terms. Undisclosed economics must not be converted into invented benchmarks.
6. IP and freedom-to-operate screen
Complete a family-level patent review covering composition of matter, sequence or construct claims, polymorph and salt claims, formulation, dosing, combinations, biomarkers, manufacturing, and method of use. Verify priority, ownership, assignments, prosecution status, term adjustments, extensions, oppositions, and regional coverage. Freedom to operate is a separate legal analysis and should include competitor claims and platform dependencies.
The diligence room should reconcile inventorship, employee and contractor assignments, university or platform licenses, sublicensing restrictions, government rights, and obligations triggered by development milestones or commercialization.
Use PatSnap Life Sciences MCP servers to validate the Lirilumab diligence evidence.
7. Principal risks and diligence gates
- Identity risk: resolve all aliases, formulations, combinations, and owners.
- Clinical risk: confirm source data, protocol deviations, endpoint definitions, and safety follow-up.
- Regulatory risk: review agency correspondence, meeting minutes, holds, commitments, and indication-specific pathways.
- IP risk: validate enforceable coverage, remaining life, ownership, and freedom to operate.
- CMC risk: assess process control, analytical methods, comparability, scale-up, supply, and cost of goods.
- Commercial risk: pressure-test differentiation, market access, competitive timing, and realistic adoption.
- Transaction risk: map rights, encumbrances, royalties, options, consent requirements, and change-of-control provisions.
8. Final go/no-go memorandum
CONDITIONAL GO
Proceed only through staged diligence. Before exclusivity or a binding offer, require a verified asset identity package, complete clinical data room, regulatory correspondence, patent-family schedule, freedom-to-operate opinion, CMC package, ownership chain, regional rights map, and risk-adjusted valuation. Any material mismatch between public records and source documents should pause the process until reconciled.
Method note: This report uses PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP data retrieved on 2026-10-14. It is a screening and diligence framework, not medical, legal, regulatory, or investment advice.
