HEAD & NECK CANCERS

The FDA has granted a fast-track designation for RRx-001 and accepted the investigational new drug application for a phase 2b trial of severe oral mucositis in chemotherapy- and radiation-treated patients with head & neck cancer.

Based on findings from the phase 2b GT-201 and phase 3 ROMAN trials, 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.

In an interview with Targeted Oncology, Everett E. Vokes, MD, discussed precision oncology for head and neck cancer and how the molecular biology of head and neck cancers is an opportunity for new investigations and treatment development.

The FDA has not made a decision on the approval application for toripalimab plus chemotherapy or toripalimab monotherapy for the treatment of advanced recurrent or metastatic nasopharyngeal carcinoma.

In an interview with Targeted Oncology, Jimmy Caudell, MD, PhD, discussed the biggest challenges being faced in the head and neck cancer space.

In an interview with Targeted Oncology, Allan Pickens, MD, discussed research on racial disparities in surgery for esophageal cancer.

Jimmy Caudell, MD, PhD, discusses the overall incidence of human papillomavirus-positive and negative oropharyngeal cancers in the United States.

In an interview with Targeted Oncology, Glenn J. Hanna, MD, discussed the phase 2 study evaluating treatment with nivolumab in patients with high-risk oral proliferative leukoplakia.

In a phase 1 study, a peptide conjugated vaccine showed potent immunogenicity and was able to induce functional T-cell responses in almost all vaccinated patients with HPV16-positive premalignancies.

Treatment with CUE-101 continued to show promise for patients with head and neck squamous cell carcinoma when combined with pembrolizumab or used as a monotherapy.

In an interview with Targeted Oncology, Marcin Dzienis, MD, further discussed the phase 4 trial of pembrolizumab plus carboplatin and paclitaxel in patients with recurrent/metastatic head and neck squamous cell carcinoma.

Long-term follow-up of KEYNOTE-048 shows improvements in overall survival with pembrolizumab monotherapy and in combination for patients with recurrent or metastatic head and neck squamous cell carcinoma.

Jean Bourhis, MD, discusses results from the phase 2 study of xevinapant plus chemoradiation vs placebo and chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck.

Building on data showing its preclinical anti-tumor activity, CUE-101 will be examined in a phase 1b study and has been granted FDA fast track designation.

Patients with locally advanced head and neck squamous cell carcinoma did not show statistically significant improvement in event-free survival with pembrolizumab plus chemoradiation vs chemoradiation alone.

Improvement in overall survival for patients with locally advanced head and neck squamous cell carcinoma was demonstrated with xevinapant plus standard chemoradiotherapy vs matched placebo at the 5-year mark.

Erasca has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company to evaluate the anti-EGFR antibody cetuximab.

The phase 3 INTERLINK-1 study of monalizumab and cetuximab as treatment of recurrent or metastatic squamous cell carcinoma of the head and neck has been discontinued. The study did not meet its efficacy goal.

IRX-2 did not demonstrate a statistically significant improvement in event-free survival as neoadjuvant therapy vs standard of care in patients with newly diagnosed, stage II, III, or IVA squamous cell carcinoma of the oral cavity, according to data from the phase 2 INSPIRE trial.

Patients with unresected locally advanced head and neck squamous cell carcinoma did not show a significant improvement in event-free survival when treated with pembrolizumab and concurrent chemoradiation followed by pembrolizumab maintenance in the phase 3 KEYNOTE-412 study.

Hispanic and Black men are showing higher cancer-specific mortality rates from HPV-associated throat cancer, and most new cases are being diagnosed in White men at a late-stage.

A biologics license application resubmission for toripalimab in combination with gemcitabine and cisplatin and for toripalimab monotherapy has been accepted by the FDA.

Benefit across a range of survival end points, including progression-free survival, shown with tislelizumab and chemotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma.

In CPI-naïve, HPV16-positive, CPS-positive patients, PDS0101 plus pembrolizumab exhibits preliminary evidence of clinical benefit in a majority of patients with an acceptable safety profile and allows continued dosing of pembrolizumab.

Rivoceranib showed promising responses in regard to objective response rate and disease control rate when used in patients with recurrent or metastatic adenoid cystic carcinoma.