Inavolisib Drug Asset Due Diligence Report 2026

This Inavolisib 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 Inavolisib can convert its Small molecule drug profile and PI3Kα biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Inavolisib (query alias: inavolisib)
Modality / target	Small molecule drug; PI3Kα; PI3Kα inhibitors
Highest global status	Approved
Originator	Genentech, Inc.
Active developers	Genentech, Inc., F. Hoffmann-La Roche Ltd., Roche Holding AG

The MCP disease footprint includes Hormone receptor positive HER2 negative breast cancer, Breast Cancer, PIK3CA mutation/HR-positive/HER2-negative Breast Cancer. 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
NCT07618390	Phase 2	Not yet recruiting	160	Progression-free survival (PFS)
NCT07694973	Phase 2	Not yet recruiting	62	Objective response rate (ORR)
NCT07522697	Phase 2	Not yet recruiting	48	Objective response rate (ORR)

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.

Reproduce the asset-to-trial workflow with PatSnap MCP

3. Clinical readouts: what is known

Characterization of inavolisib-associated hyperglycemia in metastatic hormone receptor–positive (HR+) breast cancer.

Not Applicable; n=40; evaluation: Positive. Reported fields: HbA1c = 5.5 %

548P - Phase I/Ib trial of inavolisib (INAVO) + pertuzumab (P) + trastuzumab (H) for PIK3CA-mutated (mut), HER2-positive advanced breast cancer (HER2+ aBC)

Phase 1; n=9; evaluation: Positive. Reported fields: mPFS = 6.4 month ( 3.4 - 8.7)

Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer

Phase 3; n=not disclosed; evaluation: Positive. Reported fields: mOS = 27.0 month (95%CI, 22.8 - 38.7); mOS = 34.0 month (95%CI, 28.4 - 44.8)

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

Inavolisib addresses Hormone receptor positive HER2 negative breast cancer, Breast Cancer, PIK3CA mutation/HR-positive/HER2-negative Breast Cancer. 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
2024-07-31	Chugai In-Licenses PI3K Inhibitor Inavolisib for Breast Cancer with a PIK3CA Mutation	Phase 3	Financial terms not disclosed

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 “Use of ATR inhibitors in combination with PI3k alpha inhibitors”.

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