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.
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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Head and Neck Cancer Treatment Evolution Leads the Way for Future Developments
April 29th 2022For 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™.
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FDA Grants Fast Tracks SQZ-PBMC-HPV for HPV16+ Advanced/Metastatic Solid Tumors
April 28th 2022The 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.
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Pepinemab/Pembrolizumab May Be Active in Recurrent/Metastatic Head and Neck Cancer
April 22nd 2022According 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.
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Tislelizumab Holds PFS Benefit After 15 Months in Recurrent/Metastatic Nasopharyngeal Carcinoma
April 20th 2022Updated 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.
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High Predictive Value Is Observed for Circulating Tumor Tissue in Oropharyngeal Cancer
April 15th 2022Results 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.
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