First Patient Dosed in Head and Neck Cancer Trial of Petosemtamab

The first patient in a phase 3 trial for head and neck cancer has received petosemtamab.

The first patient has been dosed in a phase 3 clinical trial evaluating the novel drug, petosemtamab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

According to a press release from the drug’s manufacturer, Merus, the drug phase 3 LiGeR-HN2 trial will compare the safety and efficacy of petosemtamab compared with either single-agent chemotherapy of investigator’s choice or Erbitux (cetuximab). Of note, in 2021, the Food and Drug Administration (FDA) approved Erbitux for KRAS wildtype, EGFR-expressing squamous cell carcinoma of the head and neck.

Eligibility for the LiGeR-HN2 Trial

Researchers in cancer centers throughout the United States, Australia and Israel are recruiting adult patients with head and neck cancer to participate in the trial. To be eligible, individuals must have:

• Histologically previously confirmed head and neck squamous cell carcinoma that is metastatic (spread to other parts of the body) or locally advanced (spread nearby to the original cancer site) that is not eligible for standard therapy of curative intent
• Disease that progressed on or after an anti-PD-1 and platinum-containing therapy
• Tumors in the oropharynx, oral cavity, hypopharynx and/or larynx
• The ability to perform their daily tasks with minimal — if any — assistance
• Life expectancy of 12 weeks or longer, as determined by the investigator
• Adequate organ function

According to the trial’s listing on ClinicalTrials.gov, the researchers plan on enrolling approximately 500 patients in the study.

The FDA informed Merus that a petosemtamab dose of 1500 milligrams every two weeks either alone or in combination with Keytruda (pembrolizumab) is acceptable for further development. However, the LiGeR-HN2 study’s listing on ClinicalTrials.gov did not mention combining the drug with Keytruda in this setting.

“With petosemtamab’s strong clinical data in [head and neck squamous cell carcinoma] and alignment with the FDA on dose, we are excited to have treated our first patient in the [second- or third-line] phase 3 trial,” said Dr. Fabian Zohren, chief medical officer of Merus said in the press release.

READ MORE: FDA Expedites Review of Petosemtamab in Head and Neck Cancer

Primary, Secondary Endpoints of the Trial

The main goal of the LiGeR-HN2 trial is to determine the objective response rate (percentage of patients whose disease responds partially or completely to therapy) up to approximately two years, as well as overall survival (time from treatment until death of any cause) up to three years. Other outcomes include progression-free survival (time from treatment until death or disease worsening), duration of response (time from complete or partial response until progression or death), rate of side effects and rate of those who stopped therapy due to side effects and more.

“We believe petosemtamab has the potential to become the new standard of care across [relapsed or metastatic head and neck squamous cell carcinoma].”

The estimated study completion date, according to the listing on ClinicalTrials.gov, is March 2029.

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