KEYNOTE 048 RESULTS TRIAL

Many patients are diagnosed with locally advanced disease but recurrence occurs within 1 year for 30–45% of patients. Ī minority of patients with HNSCC (< 20%) are initially diagnosed with metastatic HNSCC disease.

In 2018, 3357 Argentinians were diagnosed with HNSCC, 9.88 cases per 100,000 men and 2.43 cases per 100,000 women. HNSCCs are relatively common and more often found in men in whom the incidence is two to four times higher than among women. Head and neck squamous cell carcinoma (HNSCC) refers to tumors arising from the mucosa of the upper aerodigestive tract and accounts for roughly 90% of tumors occurring in the region of the head and neck. Pembrolizumab either as monotherapy or in combination with chemotherapy offers substantial survival gains for patients with R/M HNSCC at small additional costs, making it a cost-effective treatment versus cetuximab + platinum + 5-FU in Argentina.

Considering a threshold of AR $1,676,122/QALY gained, pembrolizumab monotherapy and combination therapy had an 88.0% and a 77.1% probability of being cost-effective, respectively. Additional life-years and QALYs gained with pembrolizumab combination therapy versus cetuximab + platinum + 5-fluorouracil were 1.3296 and 1.0536, respectively (ICERs of AR $680,143/life-year and AR $858,306/QALY). With pembrolizumab monotherapy, patients accrued 1.1040 additional life-years and 0.8768 additional quality-adjusted life-years (QALYs), for incremental cost-effectiveness ratios (ICERs) of AR $135,801/life-year and AR $170,985/QALY gained over cetuximab + platinum + 5-fluorouracil. Utilities were derived using an Argentina-specific algorithm. Time-on-treatment and EuroQol five-dimension scores were taken from KEYNOTE-048. Costs for initial and subsequent treatments, disease and adverse events management, and terminal care were included (AR $74.00 = 1 USD). Health state occupancy was modeled using KEYNOTE-048 Kaplan–Meier curves until the final analysis data cutoff, followed by parametric extrapolations guided by statistical criteria. MethodsĪ partitioned survival model projected costs and outcomes over 20 years with 3% annual discounting. We evaluated the cost-effectiveness of pembrolizumab as monotherapy in the CPS ≥ 1 population or combined with platinum + 5-fluorouracil in the total population versus cetuximab + platinum + 5-fluorouracil from the social security perspective in Argentina.

KEYNOTE 048 RESULTS TRIAL

The phase III KEYNOTE-048 trial showed that the programmed death receptor 1 (PD-1) inhibitor pembrolizumab, in the combined positive score (CPS) ≥ 1 population and combined with platinum + 5-fluorouracil in the total population, improves survival over cetuximab + platinum + 5-fluorouracil in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Keynote 048 results