This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
Signed ICF before initiation of any study procedures.
Age ≥ 18 years at signing of ICF.
Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.
Known leptomeningeal involvement
Any systemic anticancer therapy within 4 weeks prior to randomization.
Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
Parallel
Petosemtamab
DrugMCLA-158
Investigator's Choice
DrugCetuximab
Investigator's Choice
DrugMethotrexate
Investigator's Choice
DrugDocetaxel
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review
PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause.
Duration of Response (DOR) as Assessed by Blinded Independent Central Review
For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.
Objective Response Rate (ORR) as Assessed by Investigator Review
ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation.
