Amgen to Present Early-Stage Trial Data at ESMO 2024

Amgen has announced the release of new data from its extensive oncology pipeline and portfolio at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona. The presented abstracts include data from both Amgen-sponsored and investigator-sponsored studies targeting colorectal, lung, prostate, and gastric cancers using molecularly targeted treatments.

Jay Bradner, M.D., Executive Vice President of Research and Development and Chief Scientific Officer at Amgen, emphasized that the diverse data reflects the company's strategy to advance therapies for challenging cancer types. Bradner highlighted that the ESMO results demonstrate Amgen's leadership in oncology by contributing significant advancements in both investigational and established therapies. He noted that by leveraging a deep understanding of cancer biology and cutting-edge therapeutics, Amgen can target dominant disease drivers with unprecedented precision.

Key presentations at the ESMO Congress included several first findings, such as:

1. Phase 1b study of LUMAKRAS® plus Vectibix® in combination with FOLFIRI for first-line KRAS G12C-mutated metastatic colorectal cancer (mCRC).
2. Phase 1 dose escalation and initial dose expansion data from AMG 193, an MTA-cooperative PRMT5 inhibitor, selected for a presidential symposium.
3. First-in-human study of xaluritamig in men with metastatic castration-resistant prostate cancer (mCRPC).

These presentations underscore Amgen's ongoing commitment to developing targeted therapies for various tumor types.

The abstracts presented at the ESMO Congress include a range of studies:

- LUMAKRAS® (sotorasib) plus Vectibix® (panitumumab): A study on the safety and efficacy of combining sotorasib and panitumumab with FOLFIRI in first-line KRAS-G12C mutated mCRC.
- AMG 193: Results from a Phase 1 study on dose escalation and initial dose expansion of AMG 193 in patients with MTAP-deleted solid tumors.
- Xaluritamig: Initial results from a Phase 1 study on xaluritamig, a STEAP1 x CD3 XmAb 2+1 immune therapy for mCRPC.

Additionally, the following studies were highlighted:

- Sotorasib for NSCLC: Long-term clinical outcomes and therapeutic sequences for KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) patients treated with sotorasib.
- Bemarituzumab: Overexpression of FGFR2b protein and biomarker overlap in patients with advanced gastric or gastroesophageal junction cancer.

Investigator-sponsored studies also provided valuable insights:

- Vectibix® (panitumumab): Studies on mRNA profiling as a biomarker for prognosis and response to first-line treatment in metastatic colorectal cancer, and circulating tumor DNA driving anti-EGFR rechallenge therapy in metastatic colorectal cancer.

About LUMAKRAS® (sotorasib)

LUMAKRAS received accelerated approval from the U.S. FDA on May 28, 2021, for treating adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The FDA completed its review of Amgen's supplemental New Drug Application (sNDA) for full approval of LUMAKRAS on December 26, 2023, resulting in a complete response letter. However, the FDA concluded that the dose comparison postmarketing requirement (PMR) was fulfilled, with 960 mg once daily being the indicated dose. A new PMR was issued for an additional confirmatory study to be completed by February 2028.

About Metastatic Colorectal Cancer and the KRAS G12C Mutation

Colorectal cancer is the second leading cause of cancer deaths globally, with KRAS mutations being common genetic alterations in these cancers. The KRAS G12C mutation occurs in approximately 3-5% of colorectal cancers.

About Advanced Non-Small Cell Lung Cancer and the KRAS G12C Mutation

Lung cancer is the leading cause of cancer-related deaths worldwide. The KRAS G12C mutation is the most common KRAS mutation in NSCLC, found in about 13% of patients with non-squamous NSCLC.

About CodeBreaK

The CodeBreaK clinical development program for sotorasib aims to address the unmet medical need for cancers with the KRAS G12C mutation. It includes multiple Phase 1b studies investigating sotorasib monotherapy and combination therapy across various advanced solid tumors and ongoing Phase 2 and Phase 3 studies.

Amgen's commitment to innovation and leadership in oncology continues to drive the development of cutting-edge therapies for difficult-to-treat cancers, offering hope to patients worldwide.

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