March 29th 2023
Adding avelumab to VEGFR inhibitor axitinib may prolong survival and improve outcomes among patients with recurrent/metastatic adenoid cystic carcinoma.
FDA Issues Complete Response Letter to Toripalimab BLA in Metastatic Nasopharyngeal CarcinomaJanuary 3rd 2023
The biologic license application for toripalimab plus chemotherapy for the treatment of recurrent or metastatic nasopharyngeal carcinoma is expected to be resubmitted by mid-summer 2023.
FDA Receives New Drug Application for Avasopasem to Treat Radiotherapy-Induced Severe Oral Mucositis in Head and Neck CancerDecember 15th 2022
The new drug application for avasopasem for radiotherapy-induced severe oral mucositis in patients with head and neck cancer is supported by findings from the phase 3 ROMAN trial and phase 2b GT-201 trial.
Adjuvant Capecitabine Plus Concurrent CRT Yields FFS Benefit in Locoregionally Advanced LA-NPCNovember 20th 2022
Adjuvant capecitabine following concurrent chemoradiotherapy yielded higher failure-free survival rates compared with chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma.
Lobaplatin Combination Regimen May Minimize Toxicity in HNSCCOctober 28th 2022
Induction chemotherapy combined with concurrent lobaplatin chemoradiotherapy improved safety outcomes without sacrificing efficacy vs a cisplatin-based regimen in patients with head and neck squamous cell carcinoma.
Durvalumab Plus Chemotherapy Did Not Improve PFS Vs Cetuximab in Locoregionally Advanced Head and Neck CancerOctober 25th 2022
Results from the phase 2 NRG-HN004 trial found durvalumab plus radiotherapy did not show improved progression-free survival vs cetuximab in patients with locoregionally advanced head and neck cancer who had a contraindication to cisplatin.
Data Support the Use of First-/Second-Line Immune Checkpoint Inhibitors in HNSCCOctober 24th 2022
Findings from a retrospective cohort study found that immune checkpoint inhibitors induced promising responses in the first- and second-line treatment of head and neck squamous cell carcinoma.
Pembrolizumab Plus Chemotherapy Demonstrates Continued Benefit in Recurrent/Metastatic HNSCCOctober 21st 2022
Findings from the phase 3 KEYNOTE-048 study indicated that long-lasting improved survival benefit can be achieved with pembrolizumab plus chemotherapy compared with cetuximab and chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma.
FDA Grants Fast Track Designation to CUE-101 ± Pembrolizumab for HPV16+ Advanced HNSCCOctober 4th 2022
CUE-101 alone or in combination with pembrolizumab was granted fast track designation by the FDA for patients with human papillomavirus 16–positive recurrent/metastatic head and neck squamous cell carcinoma.
Triplet Induction Chemotherapy Improves FFS in Nasopharyngeal Carcinoma Vs Doublet RegimenSeptember 15th 2022
Patients with stage IVA to IVB nasopharyngeal carcinoma experienced an improvement in failure-free survival following treatment with paclitaxel, cisplatin, and capecitabine for 2 cycles vs 2 cycles of cisplatin and fluorouracil.
Continued Benefit Demonstrated With Xevinapant Plus Standard CRT for Locally Advanced HNSCCSeptember 11th 2022
At the 5-year mark, overall survival was improved with xevinapant plus standard chemoradiotherapy vs matched placebo in locally advanced head and neck squamous cell carcinoma.
Multiprofessional Assessment and Information Day Associated With Shortened Hospital Stay Following Complex Oncologic Head and Neck SurgerySeptember 4th 2022
Patients undergoing complex oncologic surgery for head and neck cancer appeared to have shorter hospital stays when using a multiprofessional assessment and information day compared with those who did not.
10-Year Follow-Up Findings of Leukocyte Interleukin Injection Demonstrate Promise in Locally Advanced Primary SCCHNAugust 22nd 2022
A long-term data readout from the phase 3 IT-MATTERS trial highlighted the potential of leukocyte interleukin injection as a treatment for patients with locally advanced primary squamous cell carcinoma of the head and neck, oral cavity, and soft palate.
Phase 3 INTERLINK-1 Trial of Monalizumab Plus Cetuximab in Recurrent or Metastatic HNSCC DiscontinuedAugust 3rd 2022
Findings from the planned futility interim analysis of the phase 3 INTERLINK-1 trial has led to the study’s termination after monalizumab and cetuximab did not meet efficacy end points in recurrent or metastatic squamous cell carcinoma in the head and neck.
Radiotherapy Induced Taste Dysfunction During and 3 Months After Treatment in Head and Neck CancerAugust 1st 2022
Treatment with radiotherapy for head and neck cancer resulted in taste dysfunction during treatment and 3 months thereafter, although reduction in oral cavity intensity-modulated radiotherapy dose may result in early taste function recovery.
Pembrolizumab, CRT Combo Misses EFS End Point in Unresected Locally Advanced HNSCCJuly 22nd 2022
The phase 3 KEYNOTE-412 trial assessing pembrolizumab and consolidation chemoradiotherapy plus maintenance pembrolizumab in unresected locally advanced head and neck squamous cell carcinoma missed its primary end point of event-free survival improvement vs matched placebo.
Intensity-Modulated Radiotherapy Plus 2 Cycles of Concurrent Cisplatin Improved Low-Risk LA-NPC OutcomesJuly 11th 2022
Patients with low-risk locoregionally advanced nasopharyngeal carcinoma who received 2 cycles of concurrent cisplatin plus intensity-modulated radiotherapy compared with 3 cycles had better survival and manageable toxicities.
Toripalimab BLA Resubmission Accepted by FDA for the Treatment of Advanced Nasopharyngeal CarcinomaJuly 8th 2022
After receipt of a complete response letter in May 2022, a biologics license application for toripalimab monotherapy in the second line or later following platinum chemotherapy or in combination with chemotherapy in the first-line setting for advanced recurrent or metastatic nasopharyngeal carcinoma was resubmitted to and accepted by the FDA.
FDA Grants Fast Track Designation to PDS0101 Plus Pembrolizumab in Advanced Head and Neck CancerJune 29th 2022
Fast track designation was granted to PDS0101 plus pembrolizumab, which is currently being assessed in the phase 2 VERSATILE study in patients with recurrent or metastatic human papillomavirus 16–positive head and neck cancer.
Primary Transoral Surgery Yields Good Swallowing Outcomes Despite Increased Risk of Death in HPV-related OPSCCJune 28th 2022
Despite an increased risk of grade 5 toxicities, patients with human papillomavirus–related oropharyngeal squamous cell carcinoma who received primary transoral surgery and neck dissection vs radiotherapy experienced good swallowing outcomes at 1 year.
Lifting the Stigma: The Importance of HPV Vaccination Education in Head and Neck CancerJune 14th 2022
Tom Thomas, MD, highlights how the stigma surrounding human papillomavirus–associated head and neck cancer is being unraveled through education and the importance of vaccination as a prevention strategy.
Tislelizumab Approved By China NMPA for Recurrent or Metastatic Nasopharyngeal CancerJune 14th 2022
Based on results of the phase 3 RATIONALE-309 trial, the China National Medical Products Administration has approved tislelizumab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal cancer.
Severe Oral Mucositis Reduction Noted With Avasopasem During Chemoradiotherapy in Advanced Head and Neck CancerJune 4th 2022
Findings from the phase 3 ROMAN trial showed a significant reduction in severe oral mucositis with receipt of avasopasem manganese during chemoradiotherapy for patients with locally advanced, nonmetastatic head and neck cancer.
Weekly Chemoradiotherapy and Cisplatin Non-Inferior to Cisplatin Every 3 Weeks in LA-SCCHNJune 1st 2022
Chemoradiotherapy plus cisplatin administered weekly was found to be non-inferior to cisplatin once every 3 weeks for patients with high-risk locally advanced squamous cell carcinoma of the head and neck.
FDA Issues Complete Response Letter to Toripalimab for Advanced Nasopharyngeal CarcinomaMay 3rd 2022
Plans to resubmit a biologics license application for toripalimab as treatment of advanced recurrent or metastatic nasopharyngeal carcinoma have been made for midsummer 2022 following receipt of a complete response letter from the FDA.
Upper-Neck Irradiation and Whole-Neck Irradiation Yielded Similar Regional Control in Nasopharyngeal CarcinomaMay 2nd 2022
Patients with N0 to N1 nasopharyngeal carcinoma who received upper-neck radiation vs whole-neck radiation saw similar regional control with less radiation toxicity.