Amgen’s Lumakras/Vectibix
Amgen’s combination therapy has been approved by the US Food and Drug Administration (FDA) to treat a subset of colorectal cancer patients. Lumakras (sotorasib) and Vectibix (panitumumab) have been authorised for use in adults with KRAS G12C-mutated metastatic colorectal cancer who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Colorectal cancer is the third most commonly diagnosed cancer globally, with approximately 1.8 million new cases of the disease diagnosed in 2022. The disease typically affects older adults, though it can develop at any age.
The FDA’s decision was supported by results from the open-label CodeBreaK 300 trial, which randomised 160 patients to receive either a 960mg or 240mg oral dose of Lumakras once daily, both taken in combination with a 6mg/kg intravenous dose of Vectibix every two weeks, or investigator’s choice of standard of care (SOC) trifluridine/tipiracil or regorafenib.
Progression-free survival (PFS), the study’s major efficacy outcome measure, was 5.6 months in the Lumakras 960mg/Vectibix arm and two months in the SOC cohort, while the final PFS analysis for patients receiving Lumakras 240mg/Vectibix compared to SOC was not statistically significant. Once-daily Lumakras 960mg plus 6mg/kg Vectibix every two weeks, which is the dosing regimen recommended by the FDA, also demonstrated an overall response rate of 26%, compared to 0% in the SOC group, as well as a median duration of response of 4.4 months.
Alongside its authorisation of Lumakras/Vectibix, the FDA has approved Qiagen’s companion diagnostic device, the therascreen KRAS RGQ PCR Kit, to help identify patients who may be eligible for Amgen’s combination.
The announcement comes just over a month after Amgen unveiled a $1bn investment to establish a second US drug substance manufacturing facility in North Carolina. The expansion builds on the company’s previously announced $550m commitment in Holly Springs, bringing its total planned investment in the area to more than $1.5bn.
Amgen said the expansion will enhance its global biomanufacturing network and leverage “decades of operational expertise and technological advancements” to ensure the reliable and efficient delivery of medicines to patients globally.
