Nearly 40 years ago, KRAS was identified as a fundamental driver of many human cancers, but science could not yet determine how to target the protein.1 Its smooth surface didn't appear to have anything for a targeted therapy to latch on to, which led some scientists to declare KRAS "undruggable."1 At Amgen, our scientists always believed it was possible.
Fast forward to 2013 when scientists were able to use advanced techniques to get a clear image of the KRAS protein. That image was a revelation as it showed a small groove, a potential latching point for a molecule, and we theorized we could start to bring the pieces together.2
The dedicated scientists in Amgen Oncology's research and development group immediately began looking for a molecule that could use that groove to potentially block KRAS protein activity. Many potential candidates were synthesized and tested before sotorasib was identified.3
We focused our efforts on that one molecule – sotorasib – took a collective deep breath and went to work as quickly as possible for patients with the KRAS G12C mutation who had limited therapy options following first-line treatment.2
In less than three years from the first patient dosed to the FDA accelerated approval of LUMAKRAS® (sotorasib) for the treatment of non-small cell lung cancer (NSCLC), we had the world's first KRASG12C inhibitor available to patients from the fastest clinical development program in Amgen's history.4,5
What is LUMAKRAS® (sotorasib)?
LUMAKRAS® is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC): that has spread to other parts
of the body or cannot be removed by surgery, and whose tumor has an abnormal KRAS G12C gene, and who have received at least one prior treatment for their cancer.
Your healthcare provider will perform a test to make sure that LUMAKRAS® is right for you. It is not known if LUMAKRAS® is safe and effective in children.
Important Safety Information
What should I tell my healthcare provider before taking LUMAKRAS®?
Before taking LUMAKRAS®, tell your healthcare provider about all your medical conditions, including if you: have liver problems; have lung or breathing problems other than lung cancer; are pregnant or plan to become pregnant. It is not known if LUMAKRAS® will harm your unborn baby; are breastfeeding or plan to breastfeed. It is not known if LUMAKRAS® passes into your breast milk. Do not breastfeed during treatment with LUMAKRAS® and for 1 week after the final dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. LUMAKRAS® can affect the way some other medicines work, and some other medicines can affect the way LUMAKRAS® works. Especially tell your healthcare provider if you take antacid medicines, including Proton Pump Inhibitor (PPI) medicines or H2 blockers during treatment with LUMAKRAS®. Ask your healthcare provider if you are not sure.
Clinical Trial Results
In a clinical trial, 126 adults were given an oral treatment called LUMAKRAS®. The trial evaluated how many adults responded to LUMAKRAS®, meaning their tumors either shrank or disappeared from initial scan. The trial also measured how long the tumor responded to LUMAKRAS®.6
Important Considerations: The approval of LUMAKRAS® in these patients is based on a study that measured the size of tumor shrinkage. Talk to your doctor to see if LUMAKRAS® is right for you.
Bringing awareness to NSCLC
Our goal has been focused on providing targeted treatment options to KRAS G12C-mutated NSCLC patients by giving healthcare professionals the world's first targeted therapy for this type of cancer, which has a very poor prognosis for patients who have progressed beyond first-line treatment.12
Oncologists welcomed the approval of LUMAKRAS® as an option in their toolbox.
Laurie S. was one of those patiently waiting. She had been enjoying life, running her bookkeeping company and spoiling her dogs and her two cats. In late 2017, cancer was not yet on her mind.
It was around that time that Laurie started coughing and was eventually diagnosed with NSCLC. After pushing for a biomarker test, two years later, she found out her cancer carried the KRAS G12C mutation. Not long after, in 2021, she learned about LUMAKRAS® and realized that, although her mutation had been deemed undruggable, there was a targeted treatment.1,14 Watch the video below to learn more about Laurie's journey with NSCLC.
"If it was not for that test, I would not be on this drug," Laurie, a LUMAKRAS® patient, explained.
While not the norm a few years ago, comprehensive biomarker testing has become a component of the treatment journey for patients with NSCLC and their healthcare providers. Approximately 1 in 8 people living with NSCLC have the KRAS G12C biomarker and the only way to identify the KRAS G12C mutation is to test for it.15 KRAS G12C can be detected by various methods.16 KRAS testing is recommended by guidelines from professional societies as part of a broad comprehensive panel or targeted testing in NSCLC.17 Patients should talk to their doctor for more information on KRAS G12C and/or biomarker testing.
As of Q1 2022, more than 1,500 physicians in both academic and community settings across the U.S. have experience with LUMAKRAS®.18
Approximately 80% of patients with NSCLC are being tested by their oncologists at diagnosis for the KRAS G12C mutation as of early 2022.19 We will continue to advocate for biomarker testing and discussion of results so all people with cancer have the information they need to access the most appropriate treatment plan.
Patients around the world have received LUMAKRAS®/LUMYKRAS® through either the clinical development program or commercial use. Worldwide, it has been approved in 40 markets including United Arab Emirates, the European Union, Switzerland, Japan and South Korea, and in Canada and Great Britain.
Today, Laurie is enjoying Florida's sunshine and hopes to travel to South Africa, Israel, Australia and New Zealand. She's quick to express her appreciation for the scientific community that brought this first-of-its-kind treatment.
"I'm going to live my life, I'm going to try to pack in as much as I can," she said. "I plan on being here a long time. I'm not going anywhere*."
Amgen's mission is to serve patients, and this is at the forefront of everything we do every day.