- Trial Phase
- Approved
- Time to Market
- Already approved and marketed since May 2021 (NSCLC) and January 2025 (colorectal cancer combination).
- Why 4/10
- LUMAKRAS is already approved and commercialized with no pending PDUFA or pivotal readout in the next ~12 months. The next hard catalyst would be a CodeBreaK 202 Phase 3 topline readout, but no specific date has been announced and estimated primary completion is around mid-2027. The drug is a modest contributor to Amgen's overall revenue, so even binary events would move the stock modestly.
Watch for the CodeBreaK 202 Phase 3 readout (sotorasib + chemo in first-line NSCLC), which could expand the addressable patient population significantly if positive. Also monitor how quickly Roche's divarasib, which beat LUMAKRAS head-to-head at ESMO 2026, gains regulatory approval and market share. Neither catalyst is imminent; LUMAKRAS is a slow-moving, modest contributor within Amgen's massive portfolio.
Price Chart
Executive Summary
LUMAKRAS (sotorasib) is Amgen's first-in-class KRAS G12C inhibitor, FDA-approved since May 2021 for second-line non-small cell lung cancer and expanded in January 2025 to colorectal cancer in combination with Vectibix. The drug remains under accelerated approval for NSCLC after the FDA denied full conversion in December 2023. Sales are growing modestly (Q3 2026: $102M, +6% YoY), but the drug faces serious competitive pressure from Roche's divarasib, which beat LUMAKRAS head-to-head at ESMO 2026, and from other next-generation RAS inhibitors. For Amgen, a mega-cap biotech with $40B+ annual revenue, LUMAKRAS is a small product and not a major stock-moving catalyst.
How It Works
LUMAKRAS is an oral pill that targets a specific mutated form of the KRAS protein called G12C. KRAS mutations were long considered "undruggable" because the protein's smooth surface made it hard to block. Sotorasib works by covalently binding to the mutated G12C version of KRAS, locking it in its inactive state and shutting down the cancer-driving signals that would otherwise tell cells to grow and divide uncontrollably.
Trial Status
LUMAKRAS received FDA accelerated approval in May 2021 for second-line KRAS G12C-mutated NSCLC based on the Phase 2 CodeBreaK 100 trial. A confirmatory Phase 3 trial (CodeBreaK 200) met its primary endpoint, but the FDA issued a Complete Response Letter in December 2023 denying full approval, citing concerns over the reliability of the PFS endpoint. The drug remains on the market under accelerated approval. In January 2025, the FDA approved sotorasib in combination with Amgen's Vectibix (panitumumab) for KRAS G12C-mutated metastatic colorectal cancer based on the Phase 3 CodeBreaK 300 trial. Amgen is running CodeBreaK 202, a Phase 3 trial testing sotorasib plus chemotherapy as a first-line treatment for PD-L1-negative KRAS G12C NSCLC.
The Two-Sided Case
Upcoming Catalysts
- CodeBreaK 202 Phase 3 readout: sotorasib plus chemotherapy versus pembrolizumab plus chemotherapy in first-line PD-L1-negative KRAS G12C NSCLC (no specific date announced; estimated primary completion around June 2027 per clinical trial databases)
- CodeBreaK 301 Phase 3 readout: sotorasib plus panitumumab and FOLFIRI in first-line KRAS G12C-mutated metastatic colorectal cancer
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report