October 8th 2024
The KEYNOTE-689 study evaluating pembrolizumab in this patient population met its primary end point of event-free survival.
Ficlatuzumab With Cetuximab Achieves PFS Benefit in Recurrent/Metastatic HNSCC
April 5th 2023HGF and c-MET inhibition with ficlatuzumab and cetuximab showed progression-free survival benefit in patients with pan-refractory recurrent or metastatic head and neck squamous cell carcinoma, according to phase 2 study data.
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FDA Green Lights FTD of RRx-001 to Mitigate Severe Oral Mucositis in Head and Neck Cancers
March 30th 2023The 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.
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FDA Grants Priority Review to NDA of Avasopasem for RT-Induced Severe Oral Mucositis
February 20th 2023Based 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.
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Precision Oncology Inches into Head and Neck Cancer Paradigm
February 4th 2023In 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.
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Phase 1 Study Shows Signals of Response With Vaccine for HPV16+ Premalignancies
December 1st 2022In 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.
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KEYNOTE B10 Evaluates New Triplet Regimen for Patients With HNSCC
November 1st 2022In 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.
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Xevinapant Plus CRT in Locally Advanced HNSCC Shows Continued Benefit
September 11th 2022Improvement 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.
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Study of Monalizumab and Cetuximab in Recurrent/Metastatic SCCHN Discontinued
August 1st 2022The 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.
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Phase 2 INSPIRE Trial of IRX-2 Misses EFS End Point in Head and Neck Cancer
July 28th 2022IRX-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.
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KEYNOTE-412 Fails to Show EFS Advantage in Unresected Locally Advanced HNSCC
July 20th 2022Patients 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.
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Frontline Tislelizumab Plus Chemo Improves PFS in Recurrent/Metastatic Nasopharyngeal Cancer
June 9th 2022Benefit across a range of survival end points, including progression-free survival, shown with tislelizumab and chemotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma.
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HPV16+ HNSCC Response to PDS0101 Plus Pembrolizumab in VERSATILE-002
June 8th 2022In 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.
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FDA Grants Fast Track Status to PDS0101 Plus Pembrolizumab for Recurrent/Metastatic HPV16+ HNSCC
June 2nd 2022A 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.
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