March 30th 2023
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.
Less Toxicity Observed With Radiotherapy De-Escalation in p16+ Oropharyngeal Squamous Cell Carcinoma
February 25th 2022New data show that de-escalated radiotherapy dose to 54 Gy vs 70 Gy may achieve better measures of toxicity in patients with p16-positive oropharyngeal squamous cell carcinoma.
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Evorpacept Pairs Well With Anticancer Regimens Plus Chemotherapy to Elicit Responses in Solid Tumors
November 10th 2021The novel checkpoint inhibitor, evorpacept induced responses in patients with head and neck squamous cell carcinoma and gastric cancer when used in combination with anticancer therapy and chemotherapy in a phase 1b study.
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FDA Grants Priority Review to Toripalimab +/- Chemotherapy in Advanced NPC
November 1st 2021The biologics license application for toripalimab will undergo a speedy review by the FDA for consideration as a frontline treatment option for patients with advanced recurrent or metastatic nasopharyngeal carcinoma in combination with gemcitabine and cisplatin, and as a single-agent for the second-line or above treatment of recurrent or metastatic disease after platinum-containing chemotherapy.
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NBTXR3 With or Without I/O Shows Survival Benefit in Locally Advanced HNSCC
October 28th 2021NBTXR3, which is activated by radiotherapy, was found to be safe and tolerable in frail patients with head and neck squamous cell carcinoma. The agent can be used on its own or in combination with other immunotherapy agents.
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Avasopasem Does Not Significantly Reduce Severe Oral Mucositis in Head and Neck Cancer
October 20th 2021The primary end point of the ROMAN trial was not reached after avasopasem was found to not significantly reduce the incidence of severe oral mucositis. A full analysis of the results is ongoing.
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Early-Phase Targeted Agents Are Poised to Expand Armamentarium in HNSCC
September 23rd 2021The emergence of early-phase immune-oncology agents and their respective novel mechanisms of action in head and neck squamous cell carcinoma suggests a new standard of care in the metastatic first-line setting within the next 2 years.
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Enrollment is Complete for Trial of PDS0101 in HPV16-Associated Head and Neck Cancer
September 13th 2021Enrollment has been completed in the VERSATILE-002 trial, a phase 2 study of PDS0101 for the treatment of advanced human papillomavirus-associated head and neck cancer that has returned or spread.
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Buparlisib Treatment Begins in Combination With AN0025 and Atezolizumab for Advanced Solid Tumors
September 9th 2021The first patient with a locally advanced or metastatic solid tumor has been dosed with buparlisib in combination with A0025 with or without atezolizumab in a phase 1a clinical trial.
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A biologics license application has been submitted to the FDA seeking approval for toripalimab in combination with 2 chemotherapy agents to treat metastatic nasopharyngeal carcinoma in the front-line setting and single-agent toripalimab to treat patients in the second-line setting.
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FDA Grants Breakthrough Therapy Designation to Toripalimab Combination in Nasopharyngeal Carcinoma
August 12th 2021The FDA has granted breakthrough therapy designation to toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma.
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FDA Approval Decision Pending on Cabozantinib as a New Treatment Option for RR-DTC
August 11th 2021Progression-free survival was significantly prolonged with cabozantinib as treatment of patients with radioiodine-refractory differentiated thyroid cancer in the phase 3 COSMIC-311 clinical trial, showing potential as a new treatment option and leading to the filing of a application for FDA approval.
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Survival in Advanced ESCC Improved With Frontline Nivolumab Plus Ipilimumab or Chemotherapy
July 22nd 2021Improved survival outcomes were reported with the addition of nivolumab to either ipilimumab or chemo-therapy vs chemotherapy alone in the frontline treatment of patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.
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JAVELIN HEAD AND NECK 100 Informs Future Trials in HNSCC
June 26th 2021The potential benefit of avelumab in the subgroup of patients with high PD-L1 expression in JAVELIN HEAD AND NECK 100 provides a basis for further investigation and suggests a potential role for immune checkpoint inhibitors for locally advanced HNSCC.
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