Sotorasib Drug Asset Due Diligence Report 2026

This Sotorasib 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 Sotorasib can convert its Small molecule drug profile and KRAS G12C biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Sotorasib (query alias: sotorasib)
Modality / target	Small molecule drug; KRAS G12C; KRAS G12C inhibitors
Highest global status	Approved
Originator	Amgen, Inc.
Active developers	Amgen, Inc., Amgen Europe BV, Verastem, Inc.

The MCP disease footprint includes KRAS G12C mutant Colorectal Cancer, KRAS G12C mutant Non-small Cell Lung Cancer, Non-Small Cell Lung 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
NCT07543172	Phase 2	Not yet recruiting	29	Progression free survival (PFS)
NCT07172919	Phase 2	Recruiting	14	Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
NCT07563738	Phase 1/2	Recruiting	229	Incidence of Dose Limiting Toxicities and Adverse Events

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

A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects With Stage IV NSCLC Whose Tumors Harbor a KRAS G12C Mutation in Need of First-line Treatment (CodeBreaK 201)

Phase 2; n=42; evaluation: not stated. Reported fields: -; -; -

Circulating tumor DNA dynamics following molecularly targeted therapy for non–small cell lung cancer.

Not Applicable; n=839; evaluation: Positive. Reported fields: CtDNA clearance = 2.0 Pts ; CtDNA clearance = 3.0 Pts ; CtDNA clearance = 26.0 Pts

Sotorasib vs adagrasib in the 2L+ setting: Outcomes in a large, multi-institutional, real-world database of KRAS-G12C mutated mNSCLC.

Not Applicable; n=1133; evaluation: Positive. Reported fields: mOS = 8.7 month ; mOS = 9.6 month

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

Sotorasib addresses KRAS G12C mutant Colorectal Cancer, KRAS G12C mutant Non-small Cell Lung Cancer, Non-Small Cell Lung 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: 6 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
2022-01-13	BridgeBio Announces Clinical Collaboration with Amgen to Study BBP-398, a Potentially Best-in-class SHP2 Inhibitor, in Combination with LUMAKRAS® (sotorasib) in Advanced Solid Tumors with the KRAS G12C Mutation	Phase 1	Financial terms not disclosed
2021-09-20	Verastem Oncology and Amgen Partner to Evaluate VS-6766 in Combination with LUMAKRAS™ (sotorasib) in Patients with KRAS G12C-Mutant Non-Small Cell Lung Cancer	Approved	Financial terms not disclosed
2021-09-16	Boehringer Ingelheim Enters Clinical Collaboration with Amgen to Study BI 1701963, a SOS1::pan-KRAS Inhibitor, in Combination with LUMAKRAS™ (sotorasib), a KRASG12C Inhibitor	Approved	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 “Combination therapies comprising a KRAS g12c inhibitor and pembrolizumab”. The milestone feed surfaced a patent-application signal described as “Pharmaceutical composition of KRAS G12C inhibitor and Ly2090314 and application thereof”. The milestone feed surfaced a patent-application signal described as “Pharmaceutical composition of KRAS G12C inhibitor and camptothecin and application thereof”.

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