Report scope. This 2026 Drug Asset Due Diligence Report evaluates Volasertib 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
Volasertib is a Small molecule drug associated with PLK1 and a global highest development stage of Phase 2. The lead disclosed indication is Acute Myeloid Leukemia. 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: Volasertib
- Target: PLK1
- Lead indication: Acute Myeloid Leukemia
- Highest phase: Phase 2
- Matched trials: 11
- Matched result records: 28
- Matched asset deals: 3
Use PatSnap Life Sciences MCP servers to validate the Volasertib 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 Volasertib, the MCP profile identifies PLK1 as the primary target context and Acute Myeloid Leukemia 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 Volasertib diligence evidence.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT02905994 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| NCT02875002 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| NCT02861040 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| NCT02757248 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| JPRN-jRCT2080223164 | Phase 1 | Status not disclosed | Not disclosed | Not disclosed |
| NCT02722135 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| NCT02721875 | Phase 1 | Terminated | Not disclosed | Not disclosed |
| NCT02527174 | Phase 1 | Withdrawn | Not disclosed | Not disclosed |
| NCT02273388 | Phase 1 | Completed | Not disclosed | Not disclosed |
| JPRN-jRCT2080222574 | Phase 1 | Status not disclosed | Not disclosed | Not disclosed |
| NCT02201329 | 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 Volasertib diligence evidence.
3. Clinical readouts: what is known
An Open-label Fixed Sequence Trial to Investigate the Potential Drug-drug Interaction of Intravenous Volasertib Co-administered With a P-gp and CYP3A4 Inhibitor (Itraconazole p.o.) in Patients With Various Solid Tumours
Study: NCT01772563 (CTgov). Phase: Phase 1. Enrollment: 28. Published: 2023-09-01.
volasertib(Geometric Mean) = 6690 nanogram*hour/milliliter (ng*h/mL) | volasertib(Geometric Mean) = 7140 nanogram*hour/milliliter (ng*h/mL)
A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy
Study: NCT01721876 (CTgov). Phase: Phase 3. Enrollment: 666. Published: 2021-11-19.
ORR = 38 Pts | ORR = 123 Pts
Adjunctive Volasertib in Patients With Acute Myeloid Leukemia not Eligible for Standard Induction Therapy: A Randomized, Phase 3 Trial
Study: NCT01721876 (Pubmed). Phase: Phase 3. Enrollment: 666. Published: 2021-08-02.
ORR(N=371) = 25.2 % | ORR(N=371) = 16.8 %
An Open Label Phase I Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Intravenous Volasertib in Combination With Subcutaneous Azacitidine in Patients With Previously Untreated High-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Not Candidates for Haematopoetic Stem Cell Transplant
Study: NCT01957644 (CTgov). Phase: Phase 1. Enrollment: 16. Published: 2019-02-08.
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1 = NA Milligram (mg) | Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1 = NA Milligram (mg)
An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBW 2992 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Study: NCT01206816 (CTgov). Phase: Phase 1. Enrollment: 57. Published: 2019-02-01.
Number of Participants With Dose Limiting Toxicities (DLT) = 0 Pts | Number of Participants With Dose Limiting Toxicities (DLT) = 0 Pts
Investigation of the Metabolism, Excretion and Pharmacokinetics of an Openlabel Single Dose of 300 mg [14C]Volasertib Administered Intravenously in Patients With Various Solid Tumours With a Possible Extension Phase With Nonlabelled Drug
Study: NCT01145885 (CTgov). Phase: Phase 1. Enrollment: 7. Published: 2019-01-31.
Whole Blood(Geometric Mean) = 1746 nmol/L | Percentage of Participants With Drug Related Adverse Events = 100.0 %
An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients >= 65 Years With Acute Myeloid Leukemia
Study: NCT02003573 (CTgov). Phase: Phase 1. Enrollment: 13. Published: 2019-01-31.
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1 = 400 Milligram (mg)
An Open Label, Phase I Trial of Intravenous Administration of Volasertib as Monotherapy and in Combination With Azacitidine in Patients With Myelodysplastic Syndrome After Hypomethylating Agents Treatment Failure
Study: NCT02721875 (CTgov). Phase: Phase 1. Enrollment: 1. Published: 2018-08-09.
Number of Patients With Dose Limiting Toxicities (DLT) in the First Cycle = 0 Pts
An Open-label Phase I Study of Once Every Three Weeks Intravenous Treatment With BI 6727 in Japanese Patients With Advanced Solid Tumours
Study: NCT01348347 (CTgov). Phase: Phase 1. Enrollment: 15. Published: 2018-08-06.
Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD). = 0 Pts | Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD). = 0 Pts
Open, Non-controlled, Dose Escalating Phase I Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Tolerability and Toxicity of Volasertib in Paediatric Patients From 2 Years to Less Than 18 Years of Age With Acute Leukaemia or Advanced Solid Tumour, for Whom no Effective Treatment is Known
Study: NCT01971476 (CTgov). Phase: Phase 1. Enrollment: 22. Published: 2018-07-30.
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) = 0 Pts | Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) = 0 Pts
An Open Label Phase I Trial of Intravenous Volasertib in Combination With Subcutaneous Azacitidine in Japanese Patients With Higher-risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Study: NCT02201329 (CTgov). Phase: Phase 1. Enrollment: 5. Published: 2018-07-30.
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD) = 2 Pts
An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 in Combination With Oral BIBF 1120 in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Study: NCT01022853 (CTgov). Phase: Phase 1. Enrollment: 30. Published: 2018-07-30.
Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD). = 0 Pts | Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD). = 0 Pts
An Open Label, Phase I Trial of Intravenous Once Every 2 Weeks Administration of BI 6727 (Volasertib) in Japanese Patients With Acute Myeloid Leukemia
Study: NCT01662505 (CTgov). Phase: Phase 1. Enrollment: 19. Published: 2018-07-30.
MTD of Volasertib = 450 milligram (mg)
An Open-label, Single-arm, Phase II Trial of Intravenous BI 6727 in Patients With Locally Advanced, Metastatic or Recurrent Urothelial Cancer of the Bladder, Renal Pelvis, or Ureters After Failure of Prior Chemotherapy
Study: NCT01023958 (CTgov). Phase: Phase 2. Enrollment: 50. Published: 2017-11-22.
Objective Tumour Response According to RECIST Criteria = 14.0 % (95%CI, 5.8 - 26.7)
A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer
Study: NCT00824408 (CTgov). Phase: Phase 2. Enrollment: 143. Published: 2016-09-20.
Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.(Median) = 1.4 Month (95%CI, 1.2 - 1.9) | Progression Free Survival (PFS) Time From the Date of Randomization to Date of Disease Progression or Death, Whichever Occurred First.(Median) = 3.3 Month (95%CI, 1.9 - 5.7)
Volasertib Versus Chemotherapy in Platinum-Resistant or -Refractory Ovarian Cancer: A Randomized Phase II Groupe des Investigateurs Nationaux pour l'Etude des Cancers de l'Ovaire Study
Study: NCT01121406 (Pubmed | J Urol | J Clin Oncol). Phase: Phase 2. Enrollment: 109. Published: 2016-03-01.
DCR(24-week) = 30.6 % (95%CI, 18.0 - 43.2) | DCR(24-week) = 43.1 % (95%CI, 29.6 - 56.7)
Phase I trial of volasertib, a Polo-like kinase inhibitor, in Japanese patients with advanced solid tumors
Study: NCT01348347 (Pubmed | Invest New Drugs). Phase: Phase 1. Enrollment: 15. Published: 2016-02-01.
MTD(maximum tolerated dose) = 300 mg
A Randomized, Open-Label Phase II Trial of Volasertib as Monotherapy and in Combination With Standard-Dose Compared With Pemetrexed Monotherapy in Second-Line Treatment for Non-Small-Cell Lung Cancer
Study: NCT00824408 (Pubmed | Clin Lung Cancer). Phase: Phase 2. Enrollment: 143. Published: 2015-11-01.
Adverse Event: decreased appetite = 14 [31%]/13 [28%]/2 [6%] | Adverse Event: decreased appetite = 14 [31%]/13 [28%]/2 [6%]
A phase I, dose-escalation study of volasertib combined with nintedanib in advanced solid tumors
Study: NCT01022853 (Pubmed | Ann Oncol). Phase: Phase 1. Enrollment: 30. Published: 2015-11-01.
DLT = 2 pts treated with the MTD experienced grade 3 increased ALT (both) and AST
A phase I study of volasertib combined with afatinib, in advanced solid tumors
Study: NCT01206816 (Pubmed | Cancer Chemother Pharmacol). Phase: Phase 1. Enrollment: 57. Published: 2015-10-01.
MTD = The MTDs were volasertib 300 mg plus afatinib 30 mg days 2-21 and 70 mg days 2-6 of a 3-week cycle for Schedules A and B, respectively. | MTD = The MTDs were volasertib 300 mg plus afatinib 30 mg days 2-21 and 70 mg days 2-6 of a 3-week cycle for Schedules A and B, respectively.
Phase II Randomized Trial of the Polo-like Kinase 1 Inhibitor BI 6727 Monotherapy Versus Investigator´s Choice Chemotherapy in Ovarian Cancer Patients Resistant or Refractory to Platinum-based Cytotoxic Therapy
Study: NCT01121406 (CTgov). Phase: Phase 2. Enrollment: 110. Published: 2015-08-13.
Disease Control Rate (DCR) at Week 24 According to Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1 = 43.1 % (95%CI, 29.5 - 56.7)
Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy
Study: NCT00804856 (Pubmed | Blood). Phase: Phase 2. Enrollment: Not disclosed. Published: 2014-08-28.
Adverse Event: gastrointestinal events = LDAC + volasertib led to an increased frequency of adverse events that was most pronounced for neutropenic fever/infections and gastrointestinal events | Adverse Event: gastrointestinal events = LDAC + volasertib led to an increased frequency of adverse events that was most pronounced for neutropenic fever/infections and gastrointestinal events
An open-label, single-arm, phase 2 trial of the polo-like kinase inhibitor volasertib (BI 6727) in patients with locally advanced or metastatic urothelial cancer
Study: NCT01023958 (Pubmed | Cancer). Phase: Phase 2. Enrollment: 50. Published: 2014-04-01.
DoR = 41 Week
027 - A randomised, open-label phase II trial of volasertib as monotherapy and in combination with standard dose pemetrexed compared with pemetrexed monotherapy in second-line non-small cell lung cancer (NSCLC)
Study: NCT00824408 (WCLC2013). Phase: Phase 2. Enrollment: 131. Published: 2013-10-30.
mPFS = 1.4 Month | mPFS = 3.3 Month
Phase II trial of volasertib (BI 6727) versus chemotherapy (CT) in platinum-resistant/refractory ovarian cancer (OC).
Study: NCT01121406 (ASCO2013). Phase: Phase 2. Enrollment: 109. Published: 2013-05-20.
24-wk DCR = 31 % (95%CI, 18–43) | 24-wk DCR = 43 % (95%CI, 30–57)
A phase I dose-escalation study of volasertib (BI 6727) combined with nintedanib (BIBF 1120) in advanced solid tumors.
Study: NCT01022853 (ASCO2013). Phase: Phase 1. Enrollment: 30. Published: 2013-05-20.
All grade AEs = 69 % | SD = 6 Month
A phase I dose-escalation study of the polo-like kinase 1 inhibitor volasertib (BI 6727) with two different dosing schedules in patients with advanced solid malignancies.
Study: ASCO2011. Phase: Phase 1. Enrollment: 52. Published: 2011-05-20.
MTD(maximum tolerated dose) = 300 mg | MTD(maximum tolerated dose) = 150 mg
Final analysis of a phase I single dose-escalation study of the novel polo-like kinase 1 inhibitor BI 6727 in patients with advanced solid tumors.
Study: ASCO2010. Phase: Phase 1. Enrollment: 65. Published: 2010-05-20.
MTD = 400 mg
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 Volasertib 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 Volasertib against approved therapies and clinical competitors in Acute Myeloid Leukemia, 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 Volasertib diligence evidence.
5. Transaction precedent and economics
| Date | Transaction | Status | Type | Disclosed value |
|---|---|---|---|---|
| 2021-11-11 | Oncoheroes Biosciences Inc. Out-licences volasertib to Notable Labs for the Global Adult Development of Its Anticancer Therapy | Active | License | Not disclosed |
| 2021-02-15 | SHEPHERD Therapeutics and Oncoheroes Biosciences to Partner for the Discovery, Development, and Commercialization of Oncology Therapeutics For Rare Cancers | Active | License | Not disclosed |
| 2019-09-16 | Oncoheroes Biosciences Inc. and Boehringer Ingelheim International GmbH sign exclusive licensing agreement for volasertib | Active | License | 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 Volasertib 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.
