Best of The Week: Oral HPV's Role in SCCHN and More

This week's most popular content includes the FDA putting a full clinical hold on pacritnib due to patient deaths, a link drawn between oral HPV and risk of head and neck cancer, as well as the opinion of Robert Ferris, MD, PhD, on nivolumab in head and neck cancer.

Link Drawn Between Oral HPV and Risk of Head and Neck Cancers

Patients with a certain type of oral human papilloma virus (HPV) have an increased risk of developing head and neck squamous cell carcinoma (HNSCC), as well as oropharyngeal cancer (OPC), according to a new study.

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FDA Requests ODAC Meeting for Rociletinib Following Updated Data

The study, led by Ilir Agalliu, MD, ScD, and whose data were published in JAMA Oncology, showed that patients with detectable HPV 16 in their mouthwash samples were 22 times more likely to develop OPC than those without the type of virus.

The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) advisory hearing for April 12, 2016, to review the new drug application for rociletinib (CO-1686). Rociletnib is currently employed as a treatment for metastatic EGFR T790M­­-mutated non—small cell lung cancer (NSCLC), according to the drug's developer, Clovis Oncology.

Rolling submission was completed for rociletinib in July 2015. The drug was subsequently granted a priority review by the FDA, though at a preplanned 90-day review meeting, changes in response rates from two pivotal ongoing single-arm trials prompted the FDA to request additional data. This set off the chain of events leading to the scheduling of the ODAC hearing.

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Full Clinical Hold Announced by FDA for Pacritnib

The FDA has announced a full clinical hold for trials exploring pacritinib following reports of patient deaths. These deaths stemmed from intracranial hemorrhage, cardiac failure, and cardiac arrest in the phase III PERSIST-2 trial, according to a statement from CTI BioPharma, the developer of the JAK2/FLT3 inhibitor.

The FDA recommended that CTI BioPharma conduct additional dose exploration studies for pacritinib in myelofibrosis. The FDA also asked CTI BioPharma to amend existing protocols, revise consent forms and investigator brochures, and submit final data from the PERSIST-2 trial and earlier phase III PERSIST-1 study for further review.

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Nivolumab Could Change Head and Neck Cancer Treatment Paradigm

With the phase III CheckMate-141 trial being stopped early due to the anti—PD-1 agent nivolumab having met its primary endpoint of overall survival improvement in head and neck cancer, Robert Ferris, MD, PhD, couldn't be more elated.

"This is what I've devoted my career to, and it is gratifying to see that really come to pass," said Ferris, professor and chief, Division of Head and Neck Surgery, vice chair for Clinical Operations, associate director for Translational Research, and coleader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, in an exclusive interview with Targeted Oncology.

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Immunotherapies Gaining Traction in Head and Neck Cancers

An explosion of immunotherapies is on the horizon for patients with metastatic head and neck cancer, specifically as phase III trials begin to report findings for PD-1 inhibitors. This upcoming wave of new therapies places importance on understanding optimal treatment settings and adverse events associated with these therapies.

In late January, the phase III CheckMate-141 trial investigating the anti—PD-1 agent nivolumab was stopped early, due to a substantial improvement in the primary endpoint of overall survival (OS). The drug was put up against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel following progression on a platinum-based therapy.

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