February 20th 2023
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.
February 4th 2023
December 22nd 2022
Phase 1 Study Shows Signals of Response With Vaccine for HPV16+ PremalignanciesDecember 1st 2022
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.
KEYNOTE B10 Evaluates New Triplet Regimen for Patients With HNSCCNovember 1st 2022
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.
Pembrolizumab +/- Chemotherapy Continues to Show OS Benefit in HNSCCOctober 18th 2022
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.
Only Numerical Improvement in Survival Seen in Locally Advanced HNSCC With Pembrolizumab Plus ChemoradiationSeptember 11th 2022
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.
Xevinapant Plus CRT in Locally Advanced HNSCC Shows Continued BenefitSeptember 11th 2022
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.
Study of Monalizumab and Cetuximab in Recurrent/Metastatic SCCHN DiscontinuedAugust 1st 2022
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.
Phase 2 INSPIRE Trial of IRX-2 Misses EFS End Point in Head and Neck CancerJuly 28th 2022
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.
KEYNOTE-412 Fails to Show EFS Advantage in Unresected Locally Advanced HNSCCJuly 20th 2022
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.
Frontline Tislelizumab Plus Chemo Improves PFS in Recurrent/Metastatic Nasopharyngeal CancerJune 9th 2022
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.
HPV16+ HNSCC Response to PDS0101 Plus Pembrolizumab in VERSATILE-002June 8th 2022
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.
Avasopasem Treatment Lead to Fewer Severe Oral Mucositis in Patients Receiving Chemoradiotherapy for Advanced Head and Neck CancerJune 4th 2022
Reductions in severe oral mucositis across all intensity-modulated radiotherapy landmarks was observed with avasopasem treatment in patients with locally advanced, nonmetastatic head and neck cancer.
FDA Grants Fast Track Status to PDS0101 Plus Pembrolizumab for Recurrent/Metastatic HPV16+ HNSCCJune 2nd 2022
A fast track designation has been granted by the FDA to the combination of PDS0101 and pembrolizumab, an investigational regimen for the treatment of patients with recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma.
FDA Does Not Approve Frontline Toripalimab +/- Chemo for Advanced/Metastatic Nasopharyngeal CarcinomaMay 2nd 2022
A complete response letter from the FDA has been issued regarding the biologics license application for toripalimab with or without chemotherapy for the treatment of advanced recurrent or metastatic nasopharyngeal carcinoma.
Head and Neck Cancer Treatment Evolution Leads the Way for Future DevelopmentsApril 29th 2022
For Head and Neck Cancer Awareness Month, Robert L. Ferris, MD, PhD, FACS, elaborated on the significant progress in the head and neck cancer space, as well as potentially practice-changing results that will come with emerging agents In an interview with Targeted Oncology™.
FDA Grants Fast Tracks SQZ-PBMC-HPV for HPV16+ Advanced/Metastatic Solid TumorsApril 28th 2022
The FDA has granted fast track designation to SQZ-PBMC-HPV for the treatment of patient with HPV16-positive advanced or metastatic solids tumors, according to an announcement by SQZ Biotechnologies.
Pepinemab/Pembrolizumab May Be Active in Recurrent/Metastatic Head and Neck CancerApril 22nd 2022
According to results from the phase 1b portion of the study KEYNOTE-B84 study, pepinemab plus pembrolizumab achieved complete responses in 2 of the first 3 patients with head and neck cancers enrolled.
Tislelizumab Holds PFS Benefit After 15 Months in Recurrent/Metastatic Nasopharyngeal CarcinomaApril 20th 2022
Updated results from the RATIONALE-309 study show that tislelizumab continues to prolong PFS extend PFS after the next line of therapy in patients with recurrent or metastatic nasopharyngeal carcinoma.
High Predictive Value Is Observed for Circulating Tumor Tissue in Oropharyngeal CancerApril 15th 2022
Results from a study evaluating circulating tumor tissue–modified viral (TTMV)–human papillomavirus (HPV) DNA among patients treated for HPV-driven oropharyngeal squamous cell carcinoma is of interest.
Addition of Toripalimab to SOC Extends Survival, Boosts Responses in Advanced Nasopharyngeal CarcinomaApril 14th 2022
Adding toripalimab to the chemotherapy combination of gemcitabine and cisplatin may lead to better efficacy outcomes in patients with advanced nasopharyngeal carcinoma, compared with chemotherapy alone.
DART Demonstrates Noninferiority to Historical Controls in HPV-Related OPSCCFebruary 28th 2022
Findings from the MC1273 and MC1675 trials show that de-escalated adjuvant radiation therapy met criteria for efficacy in human papillomavirus–related oropharyngeal squamous cell carcinoma.