Dr Hauschild on Ongoing Research With Adjuvant Immunotherapy in CSCC

Axel Hauschild, MD, PhD, head, Skin Cancer Trial Center, University Hospital Schleswig-Holstein, discusses ongoing research that may further define the use of adjuvant immunotherapy for patients with cutaneous squamous cell carcinoma (CSCC), as well as current indications for immunotherapy in patients with basal cell carcinoma.

Several global treatment guidelines do not currently include recommendations for adjuvant therapy in CSCC, Hauschild says. Since chemotherapy is not a feasible treatment option for these patients, 2 clinical trials are exploring the use of adjuvant immunotherapy in this population, Hauschild explains. The phase 3 C-POST trial (NCT03969004) is evaluating adjuvant cemiplimab-rwlc (Libtayo) vs placebo in patients with high-risk CSCC who have received surgery and radiation therapy. The phase 3 KEYNOTE-630 trial (NCT03833167) is investigating adjuvant pembrolizumab (Keytruda) compared with placebo in patients with high-risk, locally advanced disease. In the context of these trials, “high risk” refers to patients with CSCC at high risk for relapse after surgery, Hauschild notes. Although findings from these trials have yet to be reported, by the end of 2024, these data will be mature enough to potentially impact guideline changes for the adjuvant treatment of patients with CSCC, Hauschild emphasizes.

In the United States and Europe, cemiplimab is indicated for the second-line treatment of patients with locally advanced or metastatic basal cell carcinoma who have exhibited best responses of stable disease or progressive disease on a hedgehog inhibitor (HHIs), including sonidegib (Odomzo) or vismodegib (Erivedge). Patients may also receive second-line cemiplimab if they are intolerant to or ineligible for HHIs, which is a common occurrence, according to Hauschild.

Notably, the overall response rate (ORR) with second-line cemiplimab in patients with basal cell carcinoma is approximately 32%, which is much lower than the approximate ORR of 50% observed with this agent in the frontline treatment of patients with other cutaneous malignancies, Hauschild says. This disparity between ORRs is expected, as pretreated patients tend to respond less favorably to second-line therapy vs patients who receive the same agent in the first line, Hauschild explains. Further research is needed to determine the efficacy of frontline cemiplimab in patients with basal cell carcinoma, Hauschild concludes.