Non-Melanoma Skin Cancers Coverage from Every Angle

ESMO 2021: Final Results of Phase II Trial of First-Line Nivolumab in Squamous Cell Carcinoma

By: Vanessa A. Carter, BS
Posted: Tuesday, September 21, 2021

Rodrigo Ramella Munhoz, MD, of Hospital Sirio Libanes, Complexo Hospitalar Bela Vista, São Paulo, Brazil, and colleagues presented the final results from their phase II CA209-9JC study of first-line nivolumab in patients with squamous cell carcinoma during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 1064P). The investigators concluded that nivolumab was well tolerated, demonstrating durable responses and “pronounced” antitumor activity, and suggested anti–PD-1 agents may prove to be useful as a standard treatment option for this disease.

A total of 24 patients with systemic therapy–naive, advanced cutaneous squamous cell carcinoma were enrolled in this study. Participants were not eligible for complete resection or radiation therapy. Nivolumab was administered at 3 mg/kg every 2 weeks until unacceptable toxicity, disease progression, or 12 months of treatment.

The median patient age was 74 years, and primary lesions were found most often on the head or neck (41.7%) and trunk (29.2%). Prior radiotherapy was received by 41.7% of patients, and the most common presentation was locoregional disease (n = 16), followed by metastatic (n = 4) and locally advanced (n = 4) disease. Although 37.4% of patients experienced disease progression, more than half (54.2%) of participants completed the full 12-month treatment and entered surveillance.

With all 24 patients evaluable for response, the best objective response rate was 58.3%, but 20.8% of individuals had progressive disease as the best response. Although the median duration of response has not yet been reached, the median overall survival and progression-free survival were 20.7 and 12.7 months, respectively. Prior exposure to radiotherapy appeared to worsen outcomes, according to univariate analysis (P = .035).

Treatment-related adverse events affected 21 patients, with the most common being fatigue, arthralgias, hypothyroidism, lymphopenia, and pruritus. Additionally, six patients experienced grade 3 or higher adverse events, and one individual discontinued therapy due to toxicity.

Disclosure: For full disclosures of the study authors, visit

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