At Amgen, Dr. Jay Bradner, the Executive Vice President of Research and Development and Chief Scientific Officer, emphasized the strategic focus on advancing diverse modalities for challenging cancers. The results presented at ESMO highlight Amgen’s leadership in oncology through significant advancements in investigational and established therapies. These advancements are driven by a profound understanding of cancer biology and the use of precise therapeutics to target disease drivers with unprecedented accuracy.
Key presentations at ESMO include the initial findings from a Phase 1b study of LUMAKRAS plus Vectibix in combination with FOLFIRI for first-line patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). Additionally, data from a Phase 1 dose escalation and initial dose expansion study of AMG 193 selected for a symposium session, as well as the first-in-human study of xaluritamig in men with metastatic castration-resistant prostate cancer (mCRPC) were highlighted.
For further information on the abstracts presented by Amgen, please refer to the details provided below:
Abstracts and Presentation Times:
Amgen Sponsored Abstracts
- LUMAKRAS (sotorasib) plus Vectibix (panitumumab)
- Phase 1b study of Sotorasib (soto) + panitumumab (pani) and FOLFIRI in the first-line setting for KRAS-G12C mutated metastatic colorectal cancer (mCRC): Safety and efficacy from the phase 1b CodeBreaK 101 study
- AMG 193
- Phase 1 dose escalation and initial dose expansion results of AMG 193, an MTA-cooperative PRMT5 inhibitor, in patients with MTAP-deleted solid tumors
- Xaluritamig
- Circulating tumor cell (CTC) enumeration and overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC) treated with xaluritamig
- Xaluritamig, a STEAP1 x CD3 XmAb 2+1 immune therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC): Initial results from dose expansion cohorts in a Phase 1 study
LUMAKRAS (sotorasib) for NSCLC
- Sotorasib long-term clinical outcomes in pre-treated KRAS G12C-mutated advanced NSCLC: Pooled analysis from the CodeBreaK clinical trials
- Clinical characteristics and therapeutic sequences of KRAS G12C advanced Non-Small Cell Lung Cancer (aNSCLC) patients (pts) treated by sotorasib in the French post-marketing authorization early access (post-MA EA)
Bemarituzumab
- Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) protein overexpression and biomarker overlap in patients with advanced gastric or gastroesophageal junction cancer (GC/GEJC)
Investigator Sponsored Studies
- Vectibix (panitumumab)
- mRNA profiling as a biomarker of prognosis and response to first-line treatment in metastatic colorectal cancer: Discovery and validation of a gene expression signature in three randomized trials
- Circulating tumor DNA driving anti-EGFR rechallenge therapy in metastatic colorectal cancer: the RASINTRO prospective multicenter study
- Prospective validation of the metastatic colon cancer score (mCCS) in patients with RAS wild-type metastatic colorectal cancer treated with first-line panitumumab plus FOLFIRI/FOLFOX: Final results of the non-interventional study VALIDATE
About LUMAKRAS (sotorasib) / LUMYKRAS
LUMAKRAS, approved by the U.S. FDA in May 2021, received accelerated approval for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. The U.S. FDA completed the review of Amgen’s supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023, resulting in a complete response letter. The recommended dose for patients with KRAS G12C-mutated NSCLC is 960 mg once daily.
About Metastatic Colorectal Cancer and the KRAS G12C Mutation
Colorectal cancer (CRC) is the second leading cause of cancer deaths globally, representing 10% of all cancer diagnoses. It is also the third most commonly diagnosed cancer worldwide. KRAS mutations, particularly the KRAS G12C mutation, are prevalent in colorectal cancers, with the mutation present in approximately 3-5% of cases.
About Advanced Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is the leading cause of cancer-related deaths globally, surpassing colon, breast, and prostate cancers combined. The KRAS G12C mutation is the most common KRAS mutation in non-small cell lung cancer (NSCLC), present in about 13% of patients with non-squamous NSCLC.
The CodeBreaK clinical development program for sotorasib is focused on studying patients with advanced solid tumors bearing the KRAS G12C mutation to address the unmet medical needs in these cancers. Amgen is conducting several Phase 1b studies investigating sotorasib monotherapy and combination therapies across various advanced solid tumors, with enrollment open for CodeBreaK 101. Additionally, Phase 2 and Phase 3 studies are ongoing to evaluate sotorasib in NSCLC and CRC patients with KRAS G12C mutations.
For safety information on LUMAKRAS (sotorasib) and Vectibix (panitumumab), including hepatotoxicity, interstitial lung disease, and common adverse reactions, please refer to the prescribing information provided.
For more information about Amgen, their innovative medicines, and their commitment to fighting challenging diseases, visit Amgen.com and follow Amgen on social media platforms. Amgen has been recognized as one of the "World’s Most Innovative Companies" by Fast Company and as one of "America’s Best Large Employers" by Forbes in 2024. Amgen is listed on the Dow Jones Industrial Average and the Nasdaq-100 Index.
Contact:
Amgen, Thousand Oaks
- Elissa Snook, 609-251-1407 (media)
- Justin Claeys, 805-313-9775 (investors)
References:
- Rawla, P, et al. Gastroenterology Review. 2019;14(2):89-103.
- World Health Organization. 2022 Statistics. Available at: https://www.who.int/en/news-room/fact-sheets/detail/cancer. Accessed on May 17, 2024.
- Neumann J, et al. Frequency and type of KRAS mutations in routine diagnostic analysis of metastatic colorectal cancer. Pathol Res Pract. 2009;205(12):858-862.
- Jones RP, et al. Specific mutations in KRAS codon 12 are associated with worse overall survival in patients with advanced and recurrent colorectal cancer. Br J Cancer. 2017;116(7):923-929.
- Wiesweg M, et al. Impact of RAS mutation subtype on clinical outcome-a cross-entity comparison of patients with advanced non-small cell lung cancer and colorectal cancer. Oncogene. 2019;38(16):2953-2966.
- Sung H, et al. CA Cancer J Clin. 2021;71:209-249.
- Arbour KC, et al. Effects of Co-occurring Genomic Alterations on Outcomes in Patients with KRAS- Mutant Non-Small Cell Lung Cancer. Clin Cancer Res. 2018;24:334-340.
- Nassar AF, et al. Distribution of KRAS G12C Somatic Mutations across Race, Sex, and Cancer Type. N Engl J. Med. 2021;384:185-187.
- ClinicalTrials.gov. CodeBreaK 101. Available at: https://clinicaltrials.gov/ct2/show/NCT04185883. Accessed on May 7, 2024.
- ClinicalTrials.gov. CodeBreaK 201. Available at: https://clinicaltrials.gov/ct2/show/NCT04933695. Accessed on May 7, 2024.
- These data are a combined analysis of three studies, one of which was not Amgen supported.
(Source: Amgen)
