Advancement in Combination Biomarker-Driven Therapy for Adult Patients with Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer (mCRC)

Colorectal cancer (CRC) is the third leading cause of cancer-related deaths in the United States.¹

There is a critical need for more effective treatment options for patients with CRC, particularly for those with previously treated metastatic CRC (mCRC).²

In fact, the survival rate for mCRC remains distressingly low, with fewer than 20% of people diagnosed surviving beyond five years.¹ For patients in the third-line setting, the situation is even more dire: standard therapies yield median overall survival of less than one year, and patients' response rates are less than 10%.³

Furthermore, KRAS mutations are among the most common genetic alterations in colorectal cancers. The KRAS G12C mutation is present in approximately 3-5% of colorectal cancers as determined by an FDA-approved biomarker test and is historically associated with worse mortality rates and inferior outcomes compared to non-mutated tumors, resulting in a challenging prognosis.^2,4-6

Now, there is a new targeted treatment combination option available for adult patients with chemorefractory KRAS G12C-mutated mCRC, hopefully offering a beacon of hope where previously there were few alternatives.⁷

Exploring the mCRC Patient Experience

Patients living with mCRC face many emotional and physical challenges, but patients like Gina remain optimistic about the future.

“Being diagnosed with mCRC helped me become more connected to the people I love,” Gina reflects. “It showed me the power of vulnerability, and revealed the purpose of what I could do moving forward.” Gina’s experience underscores the personal impact of cancer – the need for innovative treatments to improve outcomes for patients.

New therapies are essential to offer patients with these challenging diseases more effective and personalized treatment options.

An Innovative, Targeted Combination Approach to mCRC

Amgen has been dedicated to advancing innovative biomarker-driven therapies for decades, and this new approval marks KRAS expansion into a new tumor type using a unique combination to address a significant unmet need for patients with mCRC. This approach, which combines a KRAS^G12C inhibitor and an anti-EGFR inhibitor, may enhance the inhibition of KRAS G12C signaling in patients with mCRC KRAS G12C mutations, a population in which EGFR inhibitors do not elicit a response.⁷

Together, the combination approach offers a new option for KRAS G12C-mutated mCRC, which has historically been linked to worse mortality rates and outcomes compared to non-mutated tumors.^2,5,6

“Our focus continues to be on developing innovative therapies that help improve long-term outcomes for patients with devastating and difficult-to-treat diseases like metastatic colorectal cancer,” said Jean-Charles Soria, MD, PhD, senior vice president of Global Oncology Development at Amgen. “This new targeted combination therapy is a much-needed advancement in the metastatic colorectal cancer treatment paradigm and demonstrates our unrelenting commitment to delivering hope for these patients.”

To dive deeper into Amgen's latest milestone in mCRC, click here.

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References:

1. Biller L, et al. JAMA. 2021;325(7):669-685.
2. Fakih M, et al. The Oncologist. 2022;27(8):663–674.
3. Prager GW, et al. N Engl J Med. 2023;388(18):1657-1667.
4. Neumann J, et al. Pathol Res Pract. 2009;205(12):858-862.
5. Jones RP, et al. Br J Cancer. 2017;116(7):923-929.
6. Wiesweg M, et al. Oncogene. 2019;38(16):2953-2966.
7. Fakih M, et al. N Engl J Med. 2023;389(23): 2125-2139.