Divarasib Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Divarasib 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.
Phase 3
Highest phase
19
Registered trials
12
Result records
1
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 Divarasib 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 | Divarasib (query alias: divarasib) |
|---|---|
| Modality / target | Small molecule drug; KRAS G12C; KRAS G12C inhibitors |
| Highest global status | Phase 3 |
| Originator | Genentech, Inc. |
| Active developers | Roche Holding AG, Hoffmann-La Roche, Inc., Genentech, Inc. |
The MCP disease footprint includes KRAS G12C mutant non-squamous non-small cell lung cancer, Advanced Lung Non-Small Cell Carcinoma, KRAS G12C mutant 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 |
|---|---|---|---|---|
| NCT06793215 | Phase 3 | Recruiting | 600 | Progression-Free Survival (PFS) |
| NCT07541170 | Phase 3 | Not yet recruiting | 400 | Disease-free Survival (DFS), as Determined by the Investigator |
| NCT06734208 | Phase 1 | Completed | 31 | Plasma Concentration of Divarasib |
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
238P - Neoadjuvant divarasib shows manageable safety and promising activity in patients with resectable, early-stage, KRAS G12C+ NSCLC: First results from the NAUTIKA1 KRAS G12C+ cohort
Phase 2; n=15; evaluation: Positive. Reported fields: AE = The most common adverse events (AEs; ≥20% pts) during the neoadjuvant phase were nausea (80%), diarrhoea (73%), constipation (33%), vomiting (27%) and fatigue (20%); most were Gr 1-2. No AEs of aspartate aminotransferase or alanine aminotransferase increase occurred. No pts discontinued neoadjuvant treatment due to AEs.
927MO - Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors
Phase 1; n=32; evaluation: Positive. Reported fields: Adverse Event: aspartate aminotransferase increased = >10% ; Adverse Event: aspartate aminotransferase increased = >10% ; Adverse Event: aspartate aminotransferase increased = >10%
Single-Agent Divarasib in Patients With KRAS G12C-Positive Non-Small Cell Lung Cancer: Long-Term Follow-Up of a Phase I Study
Phase 1; n=65; evaluation: Positive. Reported fields: AE = Divarasib continued to be well tolerated, and the safety profile beyond 1 year was consistent with the overall safety profile.
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
Divarasib addresses KRAS G12C mutant non-squamous non-small cell lung cancer, Advanced Lung Non-Small Cell Carcinoma, KRAS G12C mutant 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: 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 |
|---|---|---|---|
| 2024-07-17 | Genentech sinks SHP2 pact, leaving Relay to race thinning field | Phase 2/3 | US$75.0M upfront; US$720.0M milestones; US$795.0M stated total |
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 “Joint use of FAK inhibitor and KRAS g12c inhibitor”.
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
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 15 July 2026. Counts and status fields may change as source records update.
