Head & Neck Cancers

Toripalimab plus gemcitabine and cisplatin demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone as frontline therapy in patients with recurrent or metastatic nasopharyngeal carcinoma.

The FDA has granted priority review to the new drug application for avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.

Radiation plus docetaxel improved disease-free survival and overall survival vs radiation alone in patients with head and neck squamous cell carcinoma unsuitable for cisplatin-based chemoradiation, regardless of patients’ prespecified prognostic groups, according to findings from a phase 2/3 trial.

HPV status has broad applicability across head and neck cancers, whereas the clinical utility of PD-L1 expression remains a more nuanced question.

The FDA has not sent an action letter regarding the biologics license application for toripalimab in combination with chemotherapy as treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.

Treatment with PDS0101 plus the tumor-targeting IL-12 fusion protein M9241 and bintrafusp alfa elicited encouraging overall survival data in patients with checkpoint inhibitor–naïve and –refractory advanced human papillomavirus–positive anal, cervical, head and neck, vaginal, and vulvar cancer.

Ranee Mehra, MD, discusses the significance of 5-year follow-up data and the subgroup analysis from KEYNOTE-048, the benefits and limitations of IO therapy in head and neck squamous cell carcinoma, and research aiming to expand the role of IO combination regimens in this space.

Galera Therapeutics, Inc. has submitted a new drug application to the FDA that is seeking the approval ofavasopasem manganese for radiotherapy-induced severe oral mucositis in patients with head and neck cancer who are undergoing standard treatment.

Aarti Bhatia, MD, discusses the rationale for investigating berzosertib in this patient population, key updates from the phase 1 trial, and how these findings support the need for continued research of novel regimens in HNSCC.

The combination of cabozantinib and atezolizumab generated rapid and durable responses in patients with advanced head and neck squamous cell carcinoma who received prior treatment with platinum-based chemotherapy.

Alan L. Ho, MD, PhD, discusses targeted therapies such as TKIs that have demonstrated promising efficacy in multiple patient populations as well as the agents lenvatinib and pembrolizumab.

Nabil F. Saba, MD, FACP, expanded on efficacy data from a phase 2 trial investigating pembrolizumab plus cabozantinib in patients with recurrent metastatic head and neck squamous cell carcinoma and current challenges and safety concerns in selecting patients for evaluation.

A doublet regimen comprised of pembrolizumab and cabozantinib elicited encouraging responses in patients with recurrent metastatic head and neck squamous cell carcinoma, meeting the primary end point of a phase 2 trial.

Jean Bourhis, MD, PhD, discusses the overall survival benefit of xevinapant plus chemoradiotherapy in head and neck squamous cell carcinoma.

The 4-drug combination of irinotecan, temozolomide, dinutuximab, and granulocyte-macrophage colony-stimulating factor elicited objective responses in almost half of patients with high-risk neuroblastoma.

Treatment with adjuvant capecitabine following concurrent chemoradiotherapy resulted in superior failure-free survival compared with observation and CRT for patients with locally advanced nasopharyngeal carcinoma carrying at least 2 high risk factors.

Single-agent cemiplimab demonstrated safety and efficacy in patients with locally advanced or metastatic cutaneous squamous cell carcinoma who comprised group 6 of the phase 2 EMPOWER-CSCC-1 trial that was in line with what was previously reported in groups 1, 2, and 3 of the study.

Xevinapant plus chemoradiotherapy more than halved the risk of death vs placebo plus chemoradiotherapy without increasing toxicity in patients with unresectable, locally advanced head and neck squamous cell carcinoma.

Lutetium-177-FAP-2286 produced preliminary evidence of antitumor activity with a manageable safety profile in patients with advanced or metastatic solid tumors, according to data from the phase 1/2 LuMIERE trial.

Pembrolizumab, alone and in combination with chemotherapy, maintained an overall survival benefit compared with cetuximab plus chemotherapy for patients with recurrent or metastatic head and neck squamous cell carcinoma at 4 years.

Nabil Saba, MD, FACP, discusses the disparities seen in clinical trials in head and neck cancer.

The FDA has granted a fast track designation to CUE-101 for use as a monotherapy and in combination with pembrolizumab in patients with human papillomavirus recurrent or metastatic head and neck squamous cell carcinoma.

The FDA has agreed on key elements of the clinical program to support the biologic license application for the combination of PDS0101 and pembrolizumab for the treatment of unresectable, recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma.

The FDA has granted a fast track designation to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma.

The combination of lenvatinib and pembrolizumab was found to induce high response rates, including long-lasting remissions, and have acceptable safety in patients with metastasized anaplastic thyroid carcinoma and poorly differentiated thyroid carcinoma.