Press release
LUMAKRAS® (SOTORASIB) COMBINED WITH VECTIBIX® (PANITUMUMAB) SHOWS CONFIRMED 30% OBJECTIVE RESPONSE RATE IN PATIENTS WITH KRAS G12C-MUTATED METASTATIC COLORECTAL CANCER
Phase 1b Results Demonstrate Encouraging Median Progression-Free Survival of 5.7 Months in Difficult-to-Treat Patient Population THOUSAND OAKS, Calif., Sept.
About this update from Amgen Inc.
[{"type":"text","content":"Phase 1b Results Demonstrate Encouraging Median Progression-Free Survival of 5.7 Months in Difficult-to-Treat Patient Population \nTHOUSAND OAKS, Calif., Sept. 12, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced updated data from its Phase 1b CodeBreaK 101 study, one of the most comprehensive global clinical development programs in patients with KRAS G12C-mutated colorectal cancer (CRC). These data show that combining LUMAKRAS®/LUMYKRAS® (sotorasib) with Vectibix® (panitumumab), Amgen's monoclonal anti-epidermal growth factor receptor (anti-EGFR) antibody, demonstrated encouraging efficacy and safety. Overall, the confirmed objective response rate (ORR) was 30% in patients with chemo-refractory metastatic colorectal cancer (mCRC). These data were presented today during an oral session at the European Society for Medical Oncology (ESMO) Annual Meeting in Paris, France.\n\"We are thrilled to see these CodeBreaK 101 results, which show that LUMAKRAS plus Vectibix achieved a 30% confirmed objective response rate in patients with KRAS G12C-mutated metastatic colorectal cancer. Treatment response rates can be as low as 2% in this patient population, and the current standard of care offers a median progression-free survival benefit of two months, so developing new treatment options is critically important for patients,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"These data are encouraging as we continue to focus on combination approaches in colorectal cancer, including advancing CodeBreaK 300, the Phase 3 LUMAKRAS plus Vectibix trial in the chemotherapy-refractory patient population.\"\nIn total, 40 patients with heavily pre-treated (median of two prior lines of therapy; range 1-7) KRAS G12C-mutated chemo-refractory mCRC were enrolled in the dose expansion cohort for the combination of LUMAKRAS and Vectibix. Disease control was seen in 37 patients for a total of 92.5% with a median progression free survival (PFS) of 5.7 months. There were no apparent differences found in the efficacy between left-sided and right-sided tumors. Tumor shrinkage of any magnitude was observed in 88% of patients, based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and the median Duration of Treatment (DoT) was 5.9 months with 25% of patients remaining on treatment at the time...