Entrectinib Drug Asset Due Diligence Report 2026

This Entrectinib Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Approved

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Entrectinib can convert its Small molecule drug profile and ALK x ROS1 x TrkA x TrkB x TrkC biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Entrectinib (query alias: entrectinib)
Modality / target	Small molecule drug; ALK x ROS1 x TrkA x TrkB x TrkC; ALK inhibitors, ROS1 inhibitors, TrkA antagonists
Highest global status	Approved
Originator	Nerviano Medical Sciences S.r.l
Active developers	F. Hoffmann-La Roche Ltd., Hoffmann-La Roche, Inc., Roche China Holding Ltd.

The MCP disease footprint includes Non-Small Cell Lung Cancer, Reactive oxygen species 1 positive non-small cell lung cancer, NTRK fusion-positive solid tumors. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT06694129	Not Applicable	Not yet recruiting	40	Progression free survival
NCT07199959	Not Applicable	Recruiting	38	biomarker profile
CTR20253434	Not Applicable	已完成	32	Not disclosed

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

188eP - Skeletal muscle, subcutaneous and intramuscular fat as prognostic biomarkers in TKI-treated fusion-positive NSCLC

Not Applicable; n=17; evaluation: Positive. Reported fields: PFS(T1): HR = 1.11, P-Value = 0.03; HR = 1.02, P-Value = 0.04; PFS(T1): HR = 1.11, P-Value = 0.03; HR = 1.02, P-Value = 0.04; PFS(T1): HR = 1.11, P-Value = 0.03; HR = 1.02, P-Value = 0.04

Clinical and molecular characteristics of NTRK fusion–positive solid tumors treated with entrectinib: An international multicenter retrospective real-world cohort study

Not Applicable; n=461; evaluation: Positive. Reported fields: Adverse Event: edema = 23%

687P - Targeted therapy in adult BRAF-mutant and NTRK-fusion glioblastomas and comparison with NTRK-fusion pediatric high-grade gliomas

Not Applicable; n=25; evaluation: Positive. Reported fields: DCR = 75.0 % ; DCR = 66.0 % ; DCR = 50.0 %

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Entrectinib addresses Non-Small Cell Lung Cancer, Reactive oxygen species 1 positive non-small cell lung cancer, NTRK fusion-positive solid tumors. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 1 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2013-10-31	Ignyta Inc, an oncology precision medicine biotechnology company, announced today its successful completion of a reverse merger with Infinity Oil & Gas Company.	Not disclosed	US$3.5M upfront

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “ALK mutations and uses thereof”. The milestone feed surfaced a patent-application signal described as “Combined RTK and ALK inhibition in RTK driven cancers”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO