Head & Neck Cancers

The oncolytic virus product MVR-T3011 has received FDA fast track designation for recurrent or metastatic head and neck squamous cell cancer.

Quad Shot radiation plus a checkpoint inhibitor significantly improved local control vs Quad Shot alone and was well tolerated as a palliative treatment for patients with advanced head and neck cancer.

TNO155 plus spartalizumab or ribociclib was well tolerated and demonstrated disease control in patients with advanced solid tumors.

A high rate of disease control was seen with the novel MDM2 inhibitor APG-115-alrizomadlin in patients with p53 wild-type salivary gland cancer.

Iopofosine plus EBRT elicited a 64% CR rate and was well tolerated in patients with locoregionally recurrent/metastatic head and neck cancer.

Adding lenvatinib to pembrolizumab improved ORR and PFS, but not OS, vs placebo for patients with head and neck squamous cell carcinoma.

The FDA has granted clearance for an investigational new drug application for a phase 1/2 safety lead-in trial investigating the engineered tumor-infiltrating lymphocyte KSQ-001EX in patients with melanoma, head and neck squamous cell carcinoma, and non–small cell lung cancer.

Nabil F. Saba, MD, FACP, and Shravan Kandula, MD, highlight the significance of the approval of toripalimab for nasopharyngeal carcinoma; key data from JUPITER-02 and POLARIS-02 trials; and how the addition of this agent to the treatment armamentarium heightens the importance of multidisciplinary collaboration.

TerSera Therapeutics LLC announced that The National Comprehensive Cancer Network Head and Neck Cancers Panel recommended the GnRH agonist goserelin for patients with recurrent, unresectable, or metastatic salivary gland tumors who were not eligible for surgery or radiation therapy.

The combination of PDS0101, PDS0301 (formerly M-9241), and bintrafusp alfa, an investigational immune checkpoint inhibitor extended survival in patients with advanced human papillomavirus 16–positive cancers, according to final data from a phase 2 trial (NCT04287868) led by the National Cancer Institute.

Julien Hadoux, MD, PhD, discusses the efficacy of selpercatinib in advanced, kinase inhibitor-naïve, RET-mutant medullary thyroid cancer as seen in the phase 3 LIBRETTO-531 trial.

The FDA has approved toripalimab-tpzi (Loqtorzi) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma, and as monotherapy for the treatment of adult patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma with disease progression on or after platinum-containing chemotherapy.

Selpercatinib resulted in a statistically significant improvement in progression-free survival and overall response rate compared with cabozantinib or vandetanib in patients with advanced, multikinase inhibitor–naïve, RET-mutant medullary thyroid cancer, according to interim findings from the phase 3 LIBRETTO-531 trial.

Sacituzumab govitecan-hziy led to modest but durable antitumor activity with predominant gastrointestinal toxicities in patients with metastatic or locally recurrent head and neck squamous cell carcinoma who received between 1 and 3 prior lines of therapy.

David Sher, MD, discusses efficacy outcomes with daily adaptive radiotherapy with 1-mm planning target volume margins in patients with head and neck squamous cell carcinoma.

Treatment with the first-in-class radioenhancer NBTXR3 proved tolerable and effective in older patients with advanced head and neck squamous cell carcinoma and a comorbidity index.

Daily adaptive radiotherapy with 1-mm planning target volume margins is feasible in patients with head and neck squamous cell carcinoma and was associated with improved dosimetric parameters compared with standard radiotherapy.

Second-line treatment with NT219 alone and in combination with cetuximab demonstrated safety and tolerability, and the combination produced confirmed partial responses in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

The addition of PDS0101 to pembrolizumab resulted in a 2-year overall survival rate of 74% in patients with unresectable, recurrent, or metastatic, HPV16-positive head and neck squamous cell carcinoma who were naïve to an immune checkpoint inhibitor.

Bernard Doger de Spéville, MD, PhD, discusses the investigation of eftilagimod alpha plus pembrolizumab in the TACTI-002 trial, including prior evidence supporting this approach, the trial’s design and primary objective, and the combination’s efficacy and safety in both the head and neck squamous cell carcinoma and non–small cell lung cancer cohorts.

The FDA has granted fast track designation to ALE.C04 for use as a potential therapeutic option in patients with recurrent or metastatic, Claudin-1–positive head and neck squamous cell carcinomas.

The combination of pembrolizumab and lenvatinib demonstrated a statistically significant improvement in progression-free survival and objective response rate but failed to improve overall survival compared with pembrolizumab plus placebo as frontline therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma.

Selpercatinib demonstrated a statistically significant improvement in progression-free survival vs physician’s choice of cabozantinib or vandetanib in patients with advanced or metastatic RET-mutant medullary thyroid cancer, meeting the primary end point of the phase 3 LIBRETTO-531 trial.

The FDA has issued a complete response letter to the new drug application seeking the approval of avasopasem manganese as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment.

Treatment with the combination of ENB-003 and pembrolizumab was well tolerated and produced preliminary signs of clinical activity in patients with platinum-refractory or -resistant, microsatellite stable ovarian cancer, and those with other advanced refractory solid tumors.

The combination of the NOX1/4 inhibitor setanaxib and pembrolizumab produced progression-free survival benefits compared with placebo plus pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma.

Treatment with ASP-1929 in combination with pembrolizumab led to responses and was well tolerated in patients with recurrent or metastatic head and neck squamous cell carcinoma.

The US indication for pralsetinib in the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy has been voluntarily withdrawn by Genentech.

A panel of head and neck cancer experts discussed the nuances of managing relapsed or refractory DTC with lenvatinib or sorafenib, as well as sequencing considerations with targeted therapies in the second-line setting and beyond for patients with relapsed or refractory disease.

Nabil F. Saba, MD, FACP, discusses key findings from the phase 3 CONTINUUM trial of sintilimab plus chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.