Joy Emeh
Updated on: October 11, 2024 7:43 pm GMT
Amgen has announced the presentation of significant data from its oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2024, emphasizing its commitment to developing targeted therapies for various challenging cancers. Held from September 13 to 17 in Barcelona, this year’s conference showcases breakthroughs from both Amgen-sponsored and investigator-sponsored studies focusing on colorectal, lung, prostate, and gastric cancers, leveraging molecularly targeted modalities.
Amgen’s Strategy in Oncology
Dr. Jay Bradner, Amgen’s executive vice president and chief scientific officer, remarked on the data shared during the congress, stating, “The breadth of these data reflects our strategy to advance diverse modalities for difficult-to-treat cancers.” He further emphasized that the results underscore Amgen’s commitment to leadership in oncology, aiming to significantly enhance patient outcomes through both investigational and established therapies.
Highlights of Key Presentations
Amgen’s presentations during ESMO 2024 feature critical information regarding its leading drug candidates including LUMAKRAS® (sotorasib) and Vectibix® (panitumumab). Below are the details of the focused studies:
Amgen-Sponsored Abstracts
- LUMAKRAS® (sotorasib) plus Vectibix® (panitumumab)
- AMG 193 Xaluritamig
- LUMAKRAS® (sotorasib) for NSCLC
- Bemarituzumab
Investigator-Sponsored Studies
- Vectibix® (panitumumab)
LUMAKRAS®: Approval and Studies
LUMAKRAS, a treatment targeting KRAS G12C mutations, received accelerated approval from the U.S. Food and Drug Administration (FDA) on May 28, 2021. Subsequent reviews resulted in a complete response letter regarding Amgen’s supplemental New Drug Application seeking full approval in December 2023. The FDA acknowledged that a postmarketing requirement to assess the safety and efficacy of LUMAKRAS at different doses has been met, referring to the 960 mg daily dose indicated for patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC).
Understanding KRAS Mutations
Colorectal cancer remains a major health challenge, ranking as the second leading cause of cancer-related deaths globally. Approximately 10% of all cancer diagnoses are attributed to this disease, with the KRAS mutation present in about 3-5% of colorectal cancer cases. Similarly, lung cancer represents the leading cause of cancer deaths, with KRAS G12C being the most prevalent mutation found in roughly 13% of patients with non-squamous NSCLC.
Amgen is actively engaged in clinical trials, including:
- CodeBreaK 101: This program studies patients with advanced solid tumors harboring the KRAS G12C mutation, addressing unmet medical needs.
- CodeBreaK 201: A Phase 2 randomized study evaluating LUMAKRAS in patients with stage IV KRAS G12C-mutated NSCLC in need of first-line treatment.
- CodeBreaK 202: A Phase 3 study assessing the efficacy of LUMAKRAS alongside carboplatin and pemetrexed as initial treatment for advanced NSCLC.
- CodeBreak-301: A Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI as first-line therapy for KRAS G12C-mutated colorectal cancer.
Vectibix®: A Focus on RAS Mutations
Vectibix, the first fully human monoclonal antibody approved by the FDA for the treatment of metastatic colorectal cancer (mCRC), has demonstrated significant efficacy, particularly in combination therapies. Approved for use alongside FOLFOX in patients with wild-type KRAS mCRC, Vectibix remains a vital part of treatment options for patients experiencing disease progression after traditional chemotherapy regimens.
Safety Information for Vectibix®
Importantly, Vectibix carries a boxed warning for dermatologic toxicity, which affects a significant portion of patients, with severe reactions occurring in 15% during treatment. Patients are monitored closely for these adverse effects throughout the treatment process.
Amgen’s Broader Efforts
Amgen continues to innovate in biopharmaceuticals, driven by a desire to deliver groundbreaking treatments to patients battling severe health issues. The company has been recognized for its contributions to oncology and other medical fields, receiving accolades for being one of the “World’s Most Innovative Companies” and “America’s Best Large Employers.”
Furthermore, Amgen remains committed to transparency, providing ongoing updates on clinical trials and patient outcomes concerning their therapies. As part of its pipeline, Amgen is exploring solutions for heart disease, osteoporosis, inflammatory diseases, and rare disorders.
Amgen is working hard to fight cancer by focusing on new treatments that are designed to target the specific genes involved in different types of cancer. With strong information from ESMO 2024, Amgen is strengthening its role in this important battle.
