Merck and Pfizer's Bavencio Fails Head and Neck Cancer Trial
核心洞察
Merck KGaA and Pfizer's PD-L1 (搜索) inhibitor Bavencio failed a phase 3 trial in previously untreated locally advanced squamous cell carcinoma of the head and neck (搜索).
The JAVELIN Head and Neck 100 study was abandoned after it became unlikely to show a significant improvement in time to disease progression or death versus control.
The partners continue to study Bavencio combinations in SCCHN, including the phase 3 REACH trial pairing it with Erbitux in locally advanced tumours.
Merck KGaA and Pfizer's checkpoint inhibitor Bavencio (avelumab) has failed a phase 3 trial in head and neck cancer, ending for now their hopes of extending the drug into first-line use. The JAVELIN Head and Neck 100 study compared Bavencio with placebo on top of chemoradiotherapy in previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (搜索) (SCCHN). The trial was abandoned after it became clear it was unlikely to show a significant improvement in time to disease progression or death compared with control.
Head and neck cancer is the sixth most common cancer worldwide, and almost two-thirds of patients are diagnosed with locally advanced disease, a group with few treatment advances over the past decade, according to the two companies. Approval in first-line SCCHN would have opened a sizeable patient population, with around 150,000 new cases diagnosed annually in the US, Japan and Europe. JAVELIN Head and Neck 100 is the first late-stage trial to report data for a checkpoint inhibitor combined with chemoradiotherapy in locally advanced SCCHN.
Bavencio is already approved for Merkel cell carcinoma (搜索), as second-line therapy for urothelial carcinoma (搜索), and with Pfizer's Inlyta (axitinib) for previously untreated advanced renal cell carcinoma (搜索). The partners are continuing to evaluate Bavencio combinations in SCCHN, including the phase 3 REACH trial pairing the PD-L1 (搜索) inhibitor with Merck's Erbitux (cetuximab) in locally advanced tumours. Other checkpoint inhibitors approved in SCCHN are so far limited to metastatic disease; Merck & Co/MSD's Keytruda (pembrolizumab) became the first PD-1/PD-L1 agent cleared by the FDA as first-line monotherapy for metastatic or unresectable PD-L1-positive SCCHN and with chemotherapy for all-comer patients, based on KEYNOTE-048. Bavencio has also missed endpoints in late-stage trials in non-small cell lung cancer (搜索), ovarian cancer (搜索) and stomach cancer (搜索).
Source: pharmaphorum