Safety and Efficacy of Nivolumab, an Anti-PD1 Immunotherapy, in Patients with Advanced Basal Cell Carcinoma, after failure or intolerance to Sonic HedgeHog inhibitors: UNICANCER AcSé NIVOLUMAB Trial
Mené sur 32 patients atteints d'un carcinome basocellulaire de stade avancé, cet essai "panier" de phase II évalue l'efficacité, du point de vue du taux de réponse, et la toxicité du nivolumab après l'échec d'inhibiteurs de la voie de signalisation Sonic Hedgehog
Background : Basal cell carcinoma (BCC) is the most common human malignancy. In most cases, BCC has slow progression and can be definitively cured by surgery or radiotherapy. However, in rare cases, it can become locally advanced or, even more rarely, metastatic. The alternative recommended treatments are Sonic Hedgehog (SHH) pathway inhibitors; however, the response is often short-lived. Methods : This was a phase 2 basket study (NCT03012581) evaluating the efficacy and safety of nivolumab in a cohort of 32 advanced BCC patients, enrolled after failure of SHH inhibitors, including 29 laBCC (91%) and 3 mBCC (9%). Results : Compared to previously published studies, our population consisted of severe patients with a poor prognosis because they had already received multiple lines of treatment: all patients received previous SHH inhibitors, 53% of patients already had chemotherapy and 75% radiotherapy. At 12 weeks, we reported 3.1% of complete responses (CR), 18.8% of partial responses (PR), and 43.8% of stable diseases (SD). The best response rate to nivolumab reached 12.5% of CR (4 patients), 18.8% of PR (3 patients), and 43.8% of SD (14 patients). Adverse events (AE) were mostly grade 2 or 3, slightly different to the AE observed in the treatment of metastatic melanoma (higher rate of diabetes, no thyroid dysfunction). Conclusion : Nivolumab is a relevant therapeutic option for patients with advanced relapsing/refractory BCC.