Amgen, a renowned biotech company, has announced the presentation of pivotal new data from its evolving oncology portfolio at the upcoming American Society of Clinical Oncology (ASCO) 2024 Annual Meeting in Chicago. The event is set to take place from May 31 to June 4, and the company will share findings from 17 abstracts derived from Amgen-led and partner-led studies, underscoring its dedication to improving outcomes for patients with challenging cancers.
Highlighting Amgen’s commitment, Jay Bradner, M.D., Executive Vice President of Research & Development and Chief Scientific Officer at Amgen, expressed excitement about presenting robust clinical data at ASCO. He emphasized the company’s focus on targeting critical molecular pathways in cancer progression through innovative combination therapies, aiming to significantly enhance patient outcomes. Dr. Bradner noted advancements in T-cell Engager therapies for both hematologic and solid tumors, and the potential of LUMAKRAS combined with Vectibix in treating metastatic colorectal cancer (mCRC).
Key studies sponsored by Amgen include:
1. A Subgroup Analysis from the Phase 2 DeLLphi-301 Study: This study demonstrated sustained anticancer activity in relapsed or refractory small cell lung cancer (SCLC) patients, irrespective of treated, stable brain metastases. Detailed intracranial activity results will be shared.
2. Phase 1b DeLLpro-300 Study: This research highlighted IMDELLTRA's safety profile with promising anti-tumor activity in DLL3-expressing neuroendocrine prostate cancer (NEPC), whether de novo or treatment-emergent.
3. Global Phase 3 CodeBreaK 300 Study: The study evaluates the combination of LUMAKRAS with Vectibix in KRAS G12C-mutated mCRC. Accepted as a late-breaking abstract, it will report on overall survival (OS) outcomes.
4. Updated Analysis from the Phase 1b CodeBreaK 101 Study: This analysis showed that LUMAKRAS combined with chemotherapy offers a favorable benefit-risk balance, with durable responses and long-term disease control in patients with advanced non-small cell lung cancer (NSCLC) who had or had not received prior KRAS G12C-targeted treatments.
Details of these presentations include:
- LUMAKRAS (sotorasib) plus panitumumab (Vectibix) demonstrating overall survival benefits in KRAS G12C-mutated mCRC.
- IMDELLTRATM (tarlatamab-dlle) showing efficacy and safety in SCLC with brain metastasis.
- Tarlatamab’s performance in de novo or treatment-emergent NEPC.
- Sotorasib combined with carboplatin-pemetrexed in advanced KRAS G12C-mutant NSCLC, indicating positive outcomes.
Additionally, Amgen's partner-led studies include significant findings:
- Patterns of acquired gene alterations and survival post-progression in mCRC from the PARADIGM study.
- Efficacy analyses of panitumumab maintenance therapy in RAS wild-type mCRC.
- Comparative studies of MRD in pediatric B-ALL using BLINCYTO.
About IMDELLTRA (tarlatamab-dlle):
IMDELLTRA, approved by the FDA, is designed to connect DLL3 on tumor cells with CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. DLL3 is found on about 85-96% of SCLC cells but is minimally present on healthy cells, making it an ideal target.
About SCLC:
SCLC is an aggressive form of lung cancer with a median survival of around 12 months post-initial therapy. Despite initial responses to platinum-based chemotherapy, most patients relapse quickly, necessitating new treatment options. IMDELLTRA is currently approved for patients with extensive-stage SCLC who have progressed after platinum-based chemotherapy.
About LUMAKRAS (sotorasib):
LUMAKRAS targets KRAS G12C mutations and has shown efficacy in treating advanced NSCLC. The FDA has acknowledged the need for further confirmatory studies to secure full approval, with a new PMR requiring completion by February 2028.
About Vectibix (panitumumab):
Vectibix, a fully human monoclonal antibody against EGFR, is approved for treating mCRC with wild-type RAS. It is indicated for first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior chemotherapies.
Amgen’s presentations at ASCO 2024 will provide critical insights into these therapies, potentially shaping future cancer treatment paradigms.
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