### Amgen to Present Data from Multiple Early-Stage Clinical Trials at ESMO 2024
Amgen, a leading biotechnology company, is set to showcase groundbreaking data from various early-stage clinical trials at the European Society for Medical Oncology (ESMO) Congress in 2024. The data encompasses diverse modalities targeting challenging cancers and highlights significant advancements in both investigational and established therapies.
“We are thrilled to present these results at ESMO, highlighting our commitment to advancing innovative treatments for difficult-to-treat cancers,” commented Jay Bradner, M.D., Executive Vice President, Research and Development, and Chief Scientific Officer at Amgen. “Our leadership in oncology is evident through these ESMO results, showcasing our ability to target dominant drivers of disease with remarkable precision by leveraging incisive therapeutics.”
Key presentations at the ESMO Congress include:
– **First findings from the Phase 1b study of LUMAKRAS® plus Vectibix® in combination with FOLFIRI in first-line patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC).**
– **Phase 1 dose escalation and initial dose expansion data from AMG 193 selected for a presidential symposium session.**
– **First-in-human study of xaluritamig in men with metastatic castration-resistant prostate cancer (mCRPC).**
For more detailed information on the abstracts presented by Amgen at ESMO, please refer to the following:
#### Amgen Sponsored Abstracts
– **LUMAKRAS® (sotorasib) plus Vectibix® (panitumumab)**
– **Abstract presentation:** Sotorasib + panitumumab and FOLFIRI in the first line (1L) setting for KRAS-G12C mutated metastatic colorectal cancer (mCRC): Safety and efficacy from the phase 1b CodeBreaK 101 study. *(Abstract #505O)*
– **Presentation time:** Sunday, September 15, from 3:05 – 3:15 p.m. CEST
– **AMG 193**
– **Abstract presentation:** Phase 1 dose escalation and initial dose expansion results of AMG 193, an MTA-cooperative PRMT5 inhibitor, in patients with MTAP-deleted solid tumors. *(Abstract #3482)*
– **Presentation time:** Monday, September 16, from 16:30 – 18:15 p.m. CEST
– **Xaluritamig**
– **Abstract presentation:** Circulating tumor cell (CTC) enumeration and overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC) treated with xaluritamig. *(Abstract #1610P)*
– **Abstract presentation:** 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. *(Abstract #1598P)*
#### LUMAKRAS® (sotorasib) for NSCLC
– **Abstract presentation:** Sotorasib long-term clinical outcomes in pre-treated KRAS G12C-mutated advanced NSCLC: pooled analysis from the CodeBreaK clinical trials. *(Abstract #1305P)*
– **Abstract presentation:** Clinical characteristics and therapeutic sequences of KRAS G12C advanced Non-Small Cell Lung Cancer (aNSCLC) patients treated by sotorasib in the French post-marketing authorization early access (post-MA EA). *(Abstract #1307P)*
#### Bemarituzumab
– **Abstract presentation:** Fibroblast growth factor receptor 2 isoform IIIb (FGFR2b) protein overexpression and biomarker overlap in patients with advanced gastric or gastroesophageal junction cancer (GC/GEJC). *(Abstract #1420P)*
#### Investigator Sponsored Studies
– **Vectibix® (panitumumab)**
– **Abstract presentation:** 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. *(Abstract #581P)*
– **Abstract presentation:** Circulating tumor DNA driving anti-EGFR rechallenge therapy in metastatic colorectal cancer: the RASINTRO prospective multicenter study. *(Abstract #517P)*
– **Abstract presentation:** 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. *(Abstract #585P)*
#### About LUMAKRAS® / LUMYKRAS® (sotorasib)
LUMAKRAS received accelerated approval from the U.S. FDA on May 28, 2021. The U.S. FDA completed its review of Amgen’s supplemental New Drug Application (sNDA) seeking full approval of LUMAKRAS on December 26, 2023.
For full prescribing information on LUMAKRAS, visit [here](https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/lumakras/lumakras_pi_hcp_english.ashx).
#### About Metastatic Colorectal Cancer and the KRAS G12C Mutation
Colorectal cancer (CRC) is a leading cause of cancer deaths worldwide, constituting 10% of all cancer diagnoses. It is the third most common cancer globally.
About 3-5% of colorectal cancers carry the KRAS G12C mutation, one of the most prevalent genetic alterations in this cancer type.
#### About Advanced Non-Small Cell Lung Cancer and the KRAS G12C Mutation
Lung cancer is a major cause of cancer-related mortality worldwide, surpassing colon, breast, and prostate cancers combined.
The KRAS G12C mutation is the most frequent KRAS mutation in non-small cell lung cancer (NSCLC), with about 13% of non-squamous NSCLC patients harboring this mutation.
#### About CodeBreaK
The CodeBreaK clinical development program by Amgen aims to address an unmet medical need for patients with advanced solid tumors carrying the KRAS G12C mutation. Ongoing Phase 1b studies are investigating sotorasib monotherapy and combination therapy across various advanced solid tumors.
#### LUMAKRAS® (sotorasib) U.S. Indication
LUMAKRAS is indicated 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. This indication is approved under accelerated approval based on overall response rate and duration of response.
Kindly note that the safety and effectiveness of LUMAKRAS are subject to clinical confirmation in ongoing trials.
#### Important Safety Information
– **Hepatotoxicity:** LUMAKRAS can cause hepatotoxicity leading to liver injury and hepatitis.
– **Interstitial Lung Disease (ILD)/Pneumonitis:** LUMAKRAS can cause ILD/pneumonitis, which can be fatal.
– **Most Common Adverse Reactions:** Common adverse reactions include diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough.
For a comprehensive view of safety information, please refer to the prescribing information.
#### About Vectibix® (panitumumab)
Vectibix is the first fully human monoclonal anti-EGFR antibody approved by the FDA for metastatic colorectal cancer. It is used as a monotherapy or in combination therapy following disease progression.
For further information on the indication and limitation of use for Vectibix, please visit [here](http://www.vectibix.com/).
### About Amgen
Amgen is at the forefront of innovation in biotechnology, developing, manufacturing, and delivering innovative medicines to combat challenging diseases. With over 40 years of industry experience, Amgen continues to push the boundaries of science to improve patient outcomes.
In 2024, Amgen was recognized as one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes, among other accolades. Amgen’s commitment to excellence is reflected in its diverse portfolio of medicines addressing cancer, heart disease, osteoporosis, inflammatory diseases, and rare diseases.
For more updates, visit [Amgen’s website](https://www.amgen.com) and follow Amgen on social media platforms like [Twitter](https://twitter.com/amgen), [LinkedIn](https://www.linkedin.com/company/amgen/), [Instagram](https://www.instagram.com/amgenbiotech/), [TikTok](https://www.tiktok.com/@amgenbiotech), [YouTube](https://www.youtube.com/amgen), and [Threads](https://www.threads.net/@amgenbiotech).
#### Amgen Forward-Looking Statements
The information in this press release contains forward-looking statements based on Amgen’s current expectations and beliefs. These statements are subject to risks and uncertainties, as detailed in Amgen’s Securities and Exchange Commission reports.
For more information, visit the [original content article](https://www.prnewswire.com/news-releases/amgen-to-present-data-from-multiple-early-stage-clinical-trials-at-esmo-2024-302247205.html).
### Source
Amgen
**[Original Article Link](https://www.prnewswire.com/news-releases/amgen-to-present-data-from-multiple-early-stage-clinical-trials-at-esmo-2024-302247205.html)**