Un-avel-able.

Top Line: Does the addition of concurrent and maintenance avelumab improve progression free survival in patients receiving concurrent chemoradiation (CRT) for head and neck cancer? 

The Study: Cisplatin-based chemotherapy concurrent with radiation reigns supreme as the standard treatment for locally advanced head and neck cancer. And while efforts to de-escalate therapy for lower risk, HPV-mediated oropharyngeal cancer are ongoing, there remains room for improvement in treatment outcomes for other types of locally advanced HNSCC. In the phase 3 JAVELIN Head and Neck 100 trial, 697 patients receiving definitive chemoradiation for locally advanced head and neck cancer (except the nasopharynx) were randomly assigned to receive concurrent and adjuvant avelumab. Avelumab was given as a lead-in dose (10 mg/kg) 7 days prior to CRT, every 2 weeks concurrent with CRT, and then every 2 weeks in maintenance for up to 12 months total. The VENTANA PD-L1 assay was used to assess PD-L1 expression from tumor samples, but PD-L1 expression was not required for enrollment. Oropharyngeal primaries were the most frequent (47%), and over a third of patients were HPV-positive. The trial was stopped when interim analysis showed no improvement in median PFS with the addition of avelumab. In fact, PFS favored placebo in almost every subgroup. The exception was the subset (20%) of patients with high PD-L1 expression (≥ 25%) in whom there was a suggestion of better PFS with avelumab. Avelumab was not associated with any significant increase in toxicity.

TBL: JAVELIN Head and Neck 100, the first phase 3 trial to evaluate concurrent and maintenance immunotherapy for locally advanced HNSCC, found no significant improvement in progression free survival when avelumab was added to standard CRT. | Lee, Lancet Oncol 2021

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