October 8th 2024
The KEYNOTE-689 study evaluating pembrolizumab in this patient population met its primary end point of event-free survival.
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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Head and Neck Cancer Trial Expands to Include Patients Who Failed Checkpoint Inhibitors
June 4th 2021The phase 2 VERSATILE-002 trial of PDS0101 in combination with pembrolizumab for patients with advanced head and neck cancer has expanded to include those who have progressed on prior treatment with checkpoint inhibitors.
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Tislelizumab Prolongs PFS in Recurrent or Metastatic Nasopharyngeal Cancer
May 21st 2021Tislelizumab, an anti-PD-1 antibody combined with gemcitabine and cisplatin demonstrated improvement in progression-free survival (PFS) compared with chemotherapy as first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial, according to a press release by BeiGene, Ltd.
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Further Research Needed to Support Use of Checkpoint Inhibitors in Locally Advanced HNSCC
May 6th 2021Avelumab was explored in a clinical trial for the treatment of locally advanced head and neck squamous cell carcinoma, but more research is needed to position the agent and other checkpoint inhibitors in the treatment landscape, experts say.
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Tipifarnib Elicits Encouraging Responses in Patients With Recurrent or Metastatic HNSCC
April 27th 2021Results from the phase 2 study of farnesyltransferase inhibitor tipifarnib showed significant responses in patients with recurrent and/or metastatic head and neck squamous cell carcinoma and demonstrated that variant alle frequency could be a potential biomarker in this patient population.
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Roundtable Discussion: Treating Radioiodine-Refractory Differentiated Thyroid Cancer
April 26th 2021During a virtual Targeted Oncology Case-Based Roundtable event, Lori Wirth, MD, discussed the treatment patients with radioiodine-refractory differentiated thyroid cancer with a group of peers.
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GlaxoSmithKline Discontinues Feladilimab in Clinical Trials for Metastatic HNSCC
April 16th 2021GlaxoSmithKline plc has announced that they will stop enrolling patients in the phase 2 INDUCE-3 and INDUCE-4 trials while simultaneously ending the use of feladilimab, originally GSK3359609, for the treatment of PD-L1-positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma after the recommendation of the Independent Data Monitoring Committee.
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FDA Grants Fast Track Designation to 1L Eftilagimod Alpha for Recurrent or Metastatic HNSCC
April 8th 2021A Fast Track designation was granted by the FDA to the soluble LAG-3 protein, eftilagimod alpha for the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.
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Cabozantinib Lands Breakthrough Therapy Designation in RAI-Refractory Differentiated Thyroid Cancer
February 26th 2021The FDA has granted Breakthrough Therapy Designation to cabozantinib for the potential treatment of patients with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory if eligible for radioactive iodine.
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FDA Grants Breakthrough Therapy Designation to Tipifarnib in HRAS+ HNSCC
February 25th 2021The FDA has granted a Breakthrough Therapy Designation to tipifarnib for the treatment of patients with recurrent or metastatic HRAS-mutant head and neck squamous cell carcinoma with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy.
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KESTREL Study Misses Primary and Secondary End Points in Advanced HNSCC
February 5th 2021Treatment with single-agent durvalumab did not improve overall survival when compared with the standard-of-care frontline combination of chemotherapy plus cetuximab as treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma whose tumors highly expressed PD-L1.
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Second-Line Tislelizumab Demonstrates OS Benefit in Advanced Esophageal Squamous Cell Carcinoma
January 28th 2021Tislelizumab improved overall survival compared with investigator’s choice of chemotherapy in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma who have received prior systemic therapy.
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