Kedar Kirtane, MD from Moffitt Cancer Center discusses an ASCO 2020 abstract entitled Concurrent cetuximab (CTX) and nivolumab (NIVO) in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): Results of phase II study
Although there is efficacy of anti-programmed death-1 (anti-PD-1) inhibitors, only some patients (pts) with R / M HNSCC gain substantial clinical benefits. In patients who had progressed to at least one previous treatment for their R / M HNSCC, the research was designed to evaluate the 1-year overall survival (OS) rate of concurrent CTX and NIVO.
Pts were handled as lead-in with CTX 500 mg / m2 IV on day (D) -14 followed by CTX 500 mg / m2 IV and NIVO 240 mg / m2 IV on day (D) and day (D15) every 28-D period. Pts with CTX infusion reaction, or who for some reason did not obtain C1D1, were not useful and were substituted. Reduction of the NIVO dose was not authorized but was withheld / discontinued depending on the nature of the adverse event (AE).
47 pts are enrolled in total. 2 pts are inestimable. It analyzes 45 assessable pts. The median age is 64 years (24-77 years). At baseline, the ECOG output status is 0 (9, 20%), 1 (33, 73%), and 2 (3, 7%). Main sites include oral cavity 10 (22%), oropharynx 24 (53%), hypopharynx 3 (7%), larynx 6 (13%), and total unknown 2 (4%). At 33 (73 percent), p16 status is accessible. Prior treatments before registration for the study are: chemotherapy (CT) 42 (93%), no CT 3 (7%), radiotherapy (RT) 38 (84%), no RT 7 (16%), checkpoint inhibitors (CPI) 23 (51%) and no CPI 22 (49%). PD-L1 combined positive scores (CPS) of 30 (67 percent) are available. The total survival (OS) median follow-up period is 12.6 months. Fatigue 6 (13 percent) and rash-acneiform 2 (4.4 percent) are the most common grade 3 treatment-related AE (TRAE) ⁇ 2. CTX infusion reaction at 1 (2.2 percent) is the only grade 4 TRAE. Fatigue 3 (6.7 percent) is the most common grade 3 immune-related AE (IRAE) ⁇ 2. No grade 4 is observed in IRAE. Table summarizes the median progression-free survival (PFS) and mean OS. Pts without previous CPI exposure have favorable PFS and OS compared to previous CPI pts (PFS: HR 0.49, 95 percent CI 0.25-0.97, p=0.04 and OS: HR 0.5, 95 percent CI 0.22-1.14, p=0.09).
Our data indicate that the combination of CTX and NIVO is successful in pts with no prior exposure to CPI and well tolerated in all pts overall. These preliminary findings help further study of the CPI Naïve Pts combination. Details about the clinical trials: NCT03370276.