By. Neil Gross, MD
Date. October 26, 2023
In a discussion detailing the primary outcomes of the Phase 2 trial for Libtayo as a neoadjuvant therapy for Cutaneous Squamous Cell Carcinoma (CSCC), Dr. Neil Gross presented critical aspects related to the study. The trial, incorporating the use of Libtayo, a PD-1 inhibitor developed by Regeneron Pharmaceuticals, Inc., aimed to assess its effectiveness as a neoadjuvant monotherapy in stage II to IV resectable CSCC. This trial marked a significant milestone in oncology and was showcased at the European Society for Medical Oncology (ESMO) Congress 2023 and concurrently published in The Lancet Oncology.
Dr. Gross emphasized key findings from the Phase 2 trial, noting an estimated 89% event-free survival at one year among patients with stage II to IV resectable CSCC who received Libtayo as a neoadjuvant treatment. He discussed the absence of disease recurrence among 51% of patients who achieved a pathologic complete response (pCR) in the primary analysis, highlighting the potential of this treatment approach.
The interview further explored how Libtayo compared to existing treatment options, focusing on response rates and safety profiles. Dr. Gross highlighted the encouraging one-year results and the significance of the 92% overall survival rate, emphasizing its implications for enhancing patient care.
Additionally, the interview addressed the query about the trial's long-term effectiveness, discussing the absence of two-year outcome data and the necessity for continued research. Dr. Gross also examined notable adverse events linked with Libtayo and their impact on patient outcomes.
In considering patient selection and characteristics, Dr. Gross pondered specific groups that might benefit more from Libtayo as a neoadjuvant treatment, stressing the importance of personalized medicine in cancer care.
The interview offered insights into an ongoing global Phase 3 trial investigating Libtayo in the adjuvant CSCC setting for high-risk patients and deliberated on the current regulatory status for Libtayo in this specific indication, emphasizing the need for further evaluation of its safety and efficacy. It was clarified that the use of Libtayo as a neoadjuvant treatment remains investigational, underlining that its full regulatory approval is yet to be determined.