October 21, 2023
Libtayo Neoadjuvant Treatment Shows Promising Event-Free Survival in Resectable Cutaneous Squamous Cell Carcinoma (CSCC).
Regeneron presented critical secondary endpoints from an experimental treatment featuring PD-1 inhibitor Libtayo (cemiplimab) in a neoadjuvant monotherapy role for stage II to IV resectable cutaneous squamous cell carcinoma (CSCC). These findings indicate encouraging results in patients who received Libtayo before surgery, particularly in event-free survival.
In a Phase 2 clinical trial comprising two parts, the first part involved 79 patients who received Libtayo at 350 mg every three weeks for up to four doses before undergoing curative-intent surgery. The primary analysis revealed an impressive combined pathologic response rate of 63.3% in these patients. Among this group, 50.6% achieved a pathologic complete response (pCR), characterized by the absence of viable tumour cells, while 12.7% achieved a major pathologic response (MPR), signifying less than or equal to 10% residual tumour cells.
In the second part of the trial, patients who completed curative intent surgery (n=70) could receive Libtayo, radiation, or undergo observation as determined by the investigator.
The latest presentation at the ESMO Conference 2023 unveiled secondary survival endpoints for all 79 patients involved in the trial. The data, assessed over a median follow-up duration of 19 months (ranging from 1 to 30 months), illustrated the following encouraging results at one year:
An 89% event-free survival rate, with the median not yet reached.
Patients who attained a pCR (n=40) experienced no disease recurrence, and among those achieving an MPR, 9 out of 10 remained disease-free at one year.
A 92% overall survival rate at one year, with the median not reached.
Among all patients, adverse events (AE) of any grade were observed in 89% of cases, with 19% being of ≥grade 3. Notably, one death, possibly related to treatment, was attributed to worsening congestive heart failure.