Background:
In the NCT04362722 clinical trial, treatment with intralesional injections of Bifikafusp alfa plus Onfekafusp alfa was initiated in a patient with nasal sclerodermiform basal cell carcinoma BCC. These fully-human antibody-cytokine fusions (L19-IL2 and L19-TNF) consist of the L19 antibody fragment (specific to an EDB domain of fibronectin) fused to IL-2 or to TNF, respectively. The L19 antibody moiety allows to anchor the corresponding pro-inflammatory cytokines in the tumor extracellular matrix rich in EDB fibronectin. Bifikafusp alfa plus Onfekafusp alfa were intralesionally injected, once a week for four weeks.
Observation:
Two months after the first injection, the tumor had become necrotic and had disappeared, with a decent cosmetic outcome which was constantly improving. Mapping biopsies revealed fibrosis without residual BCC tissue. In order to determine the duration of the response, patient continues to be monitored. The treatment was well tolerated. The patient experienced mild to moderate episodes of chills and elevated temperature up to 38.5 °C persisting for up to 36 hours following the injections. Locally, the patient experienced a temporary facial edema persisting for three to four days following the injections.
Conclusion:
We report a first patient with difficult-to-treat sclerodermiform nasal BCC treated with two proinflammatory fusion proteins Bifikafusp alfa and Onfekafusp alfa. The patient experienced a rapid full clinical and histologic remission. We continue exploring the potential of Bifikafusp alfa plus Onfekafusp alfa in BCC and in other cutaneous neoplasms. Currently we and others are investigating these study drugs in clinical trials for epithelial skin cancers and melanoma.

Complete Remission of Basal Cell Carcinoma Following Intralesional Injections of two Antibody-Cytokine Fusion Proteins

Growing Momentum in Dermatology
The SSDV congress brings together Dermatologists from all over Switzerland. The program of the 105th edition of the SSDV Annual Congress offers an attractive scientific program covering a broad spectrum of our field, with topics relevant for your practice and hot topics.