Results from the PHASE3 study NCT05198934 investigating Sotorasib (Lumakras) and Panitumumab in participants with Kirsten Rat Sarcoma (KRAS) p.G12C mutated Colorectal Cancer (CRC) were posted on 2026-07-22. The trial showed that Sotorasib 960 mg plus Panitumumab achieved a median progression-free survival (PFS) of 5.62 months, compared to 2.04 months for investigator's choice.
Background
This study investigated Sotorasib in combination with Panitumumab for the treatment of previously treated participants with Kirsten Rat Sarcoma (KRAS) p.G12C mutated Colorectal Cancer (CRC).
Trial design
The PHASE3 study, identified as NCT05198934, enrolled 160 participants with Colorectal Cancer (CRC). The study aimed to compare progression-free survival (PFS) in previously treated participants with Kirsten Rat Sarcoma (KRAS) p.G12C mutated Colorectal Cancer (CRC). Participants were randomized to receive either Sotorasib 240 mg once daily (QD) and Panitumumab, Sotorasib 960 mg QD and Panitumumab, or investigator's choice (Trifluridine and Tipiracil, or Regorafenib).
Key results
Key efficacy outcomes included:
- For Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by BICR, the median PFS for the Trifluridine and Tipiracil or Regorafenib arm was 2.04 months.
- The Sotorasib 240 mg + Panitumumab arm showed a median PFS of 3.91 months.
- The Sotorasib 960 mg + Panitumumab arm demonstrated a median PFS of 5.62 months.
What this means
The results from the PHASE3 study NCT05198934 indicate that the combination of Sotorasib and Panitumumab improved progression-free survival (PFS) in previously treated participants with Kirsten Rat Sarcoma (KRAS) p.G12C mutated Colorectal Cancer (CRC) compared to investigator's choice. Specifically, the higher dose of Sotorasib 960 mg with Panitumumab showed a more pronounced improvement in median PFS, suggesting a potential benefit for this combination therapy in this patient population.
Source
This information was sourced from ClinicalTrials.gov, documenting the results of trial NCT05198934, which were posted on 2026-07-22. The study details are available on clinicaltrials.gov.
