Immunotherapy for Head and Neck SCC
Table 1. Key clinical immunotherapy recommenda ons for
treatment of pa ents with HNC
Subject Summary Recommenda ons
Level of
Evidence*
Evalua on
Indica ons • Do NOT automa cally disqualify pa ent for an -PD-1
immunotherapy based on: age, lung metastases, co-
morbidi es, auto-immune disease.
• Pa ents who have controlled diseases such as Hepa s
C or who are HIV+ with normal CD4+ T cell counts and
who are on an retroviral therapy are generally suitable
for ICI treatment.
Consensus
Biomarkers • The subcommi ee recommends against standard MSI
tes ng.
• The best use of biomarker tes ng when trea ng
pa ents with HNSCC with immunotherapy is by
combined posi ve score (CPS).
Positivity for PD-L1 is ≥1% TPS or ≥1 CPS by IHC staining.
Consensus
HPV status HPV status (based on p16 overexpression) should be
included in treatment planning but should not influence
the decision to treat pa ents with R/M HNSCC with
standard of care (SOC) immunotherapy.
Consensus
Treatment
Combina on
systemic
therapy
Since no combina on strategies are currently approved
in this disease se ng, the subcommi ee recommends
enrolling a pa ent with R/M HNSCC into a clinical trial
assessing a combina on immunotherapeu c approach.
Consensus was reached between all clinical members of the
subcommittee to recommend combination therapy (notably
chemotherapy + IO, once FDA-approved) for rapidly growing
disease due to the need for an enhanced response rate.
Consensus
Integra ng
PD-1
inhibitors
First-line:
• Pembrolizumab is indicated for treatment-naïve R/M
HNSCC.
▶ ▶ Pembrolizumab monotherapy may be used to treat
patients with treatment naïve R/M HNSCC and PD-L1
CPS ≥1.
▶ ▶ Pembrolizumab + chemotherapy (platinum and
fluorouracil (FU)) may be used to treat all patients
with treatment naïve, biomarker-unspecified R/M
HNSCC patients.
Positivity for PD-L1 is ≥1 CPS by IHC staining.
Second-line:
• Pembrolizumab or nivolumab monotherapy should
be used to treat pa ents with R/M HNSCC who are
pla num-refractory, including those that progressed
within six months of pla num-based chemotherapy.
Alternatively, if a clinical trial is available, this is the preferred
option, especially if biomarker-based, hypothesis-driven.
1
