FDA Approves LUMAKRAS + Vectibix for KRAS G12C-Mutated mCRC

The AMG 510 Study Team would like to thank you for your ongoing commitment to the 20190172 study for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutation. We are thrilled to announce that the FDA approved LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) as a targeted, biomarker-driven combination therapy for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDAapproved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This approval is based on the pivotal Phase 3 CodeBreaK 300 study, which demonstrated that LUMAKRAS plus Vectibix is the first and only targeted treatment combination for chemorefractory KRAS G12C-mutated mCRC to show superior progression-free survival (PFS) compared to the investigated standard-of-care (SOC). You can read our press release here.

In addition, we would like to take this opportunity to inform you that per our study timelines, all subjects on Long Term Follow-Up (LTFU) will be completing the study on 14 March 2025. At that time, all sites with only subjects on LTFU can consider the study completed and can begin to reconcile data and start site closure activities. A final survival sweep will be conducted leading up to the end of LTFU to confirm subject status.

For those sites with subjects still receiving IP, subjects are permitted to continue receiving treatment until disease progression, unacceptable toxicity, start of another anticancer therapy, withdrawal of consent, loss to follow-up, or death, whichever occurs earliest. Sites with subjects still on treatment may not close until all subjects have ended the study. Subjects still on IP after 14 March 2025 will not enter LTFU after end of IP. Only Safety Follow-Up (SFU) visits will still be required. Once SFU visits have been conducted for these subjects, data will need to be reviewed and reconciled before the site closure activities can begin.

Should you have any other issues or concerns, please reach out to your CRA as soon as possible.

Thank you for your continued dedication and contribution to this study. Please file a copy of this letter in your Investigator Site File

 

Sincerely,
The 20190172 Global Study Team