#None #Head and Neck Cancer #JNJ #Amivantamab

Promising Results for Subcutaneous Amivantamab in Treating Metastatic Head and Neck Cancer

Johnson & Johnson recently revealed encouraging findings from the Phase 1b/2 OrigAMI-4 study, showcasing the efficacy and safety of a new subcutaneous (SC) formulation of amivantamab for patients suffering from recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This investigational therapy has demonstrated an impressive overall response rate of 45%, with a median response duration of 7.2 months in patients who previously underwent treatment involving checkpoint inhibitors and platinum-based chemotherapy. These results were announced during a mini-oral session at the European Society for Medical Oncology (ESMO) Congress, shining a light on a potential breakthrough in treatment options for this underserved patient population.

Background on Head and Neck Cancer

Head and neck squamous cell carcinoma is a prevalent form of cancer, accounting for nearly 90% of head and neck malignancies. Traditionally, patients diagnosed with R/M HNSCC face a grim prognosis, particularly following the failure of standard treatments such as PD-1 or PD-L1 inhibitors and platinum-based chemotherapy. With only 10-24% response rates in available therapies, the need for innovative treatment options is evident. The ramifications of this disease extend beyond survival statistics, substantially impacting patients’ quality of life due to symptoms like difficulty swallowing, jaw pain, and speech impairment.

Key Findings from the OrigAMI-4 Study

In the OrigAMI-4 study, 38 patients with HPV-unrelated R/M HNSCC, who had experienced disease progression after undergoing previous treatments, were administered SC amivantamab. The study’s results display promising efficacy, with rapid responses noted—most patients exhibited a response within approximately 6.4 weeks of treatment. An impressive 82% of treated patients showed tumor shrinkage in targeted lesions after an average follow-up of around 8.3 months. Furthermore, the median progression-free survival was recorded at 6.8 months, while the median overall survival figure had yet to be determined, reinforcing the durable nature of amivantamab's effects.

Professor Kevin Harrington, a leading investigator on the study from The Institute of Cancer Research, emphasized the substantial quality of life implications these findings could entail for patients dealing with this challenging cancer type. He noted that the observed response rates were among the most promising reported, providing hope for extended intervals without disease progression for affected individuals.

Safety Profile of SC Amivantamab

The safety profile of the SC formulation of amivantamab appeared consistent with previous studies involving other doses and administration methods. Among the 86 patients who received at least one dose, treatment-emergent adverse events were primarily mild to moderate, including fatigue, hypoalbuminemia, and stomatitis. Notably, administration-related reactions were observed in about 7% of patients, but were classified as mild to moderate. Importantly, only a small fraction (2%) of patients discontinued treatment due to adverse effects.

Broader Implications and Next Steps

Given these successful outcomes, Johnson & Johnson is set to initiate the Phase 3 OrigAMI-5 study, further exploring the viability of SC amivantamab in combination with pembrolizumab and carboplatin. This study aims to evaluate its effectiveness against 5-fluorouracil plus pembrolizumab and platinum-based chemotherapy in patients with HPV-unrelated R/M HNSCC. The initiative showcases Johnson & Johnson's commitment to expanding treatment options for patients with substantial unmet medical needs in oncology.

Overall, the investigation of SC amivantamab holds the potential to transform treatment landscapes for head and neck cancer and possibly various other solid tumors where EGFR and MET pathways are activated, reinforcing its promise as a cornerstone in modern oncology therapies.