Time To Clinically Meaningful Changes In Pain In Patients With Advanced Cutaneous Squamous Cell Carcinoma Treated With Cemiplimab In A Phase Ii Clinical Trial

Cemiplimab, a PD-1 inhibitor, is indicated for treatment of cutaneous squamous cell carcinoma (CSCC) in patients (pts) with metastatic (mCSCC) or locally advanced (laCSCC) disease not eligible for curative surgery/radiation. Cemiplimab resulted in RECIST objective response rate (tumour response; complete+partial) of 44.0%, with median times to tumour response of 2.0 months and progression-free survival (PFS) of 18.4 months; the safety profile was consistent with other anti–PD-1 inhibitors. Cemiplimab-treated pts achieved clinically meaningful (CM) reductions in pain measured using the patient-reported EORTC QLQ-C30 pain domain. Interpretation of change in pain was further characterised by the relationship between time to a CM change in pain and tumour response. Adults (N=193) with confirmed diagnosis of invasive CSCC received IV cemiplimab 3 mg/kg Q2W (mCSCC n=59; laCSCC n=78) or 350 mg Q3W (mCSCC n=56). The QLQ-C30 was administered at baseline (BL) and day 1 of each treatment cycle. Kaplan–Meier (KM) survival analysis (with censoring at drop-out) was used to estimate time to 1st CM (≥10-point) reduction (improvement) or increase (worsening) in QLQ-C30 pain scores. Pain medication use was captured over the treatment period. Compared to non-responders, pts with tumour response reported a CM reduction in pain from BL at 1st tumour response (cycle 2) (P<0.0001) (Table); pain reduction was maintained at least through cycle 5 and was independent of opioid pain medication use. KM analysis showed median time to 1st CM pain improvement and 1st CM pain worsening (Table) approximated median times to tumour response and PFS, respectively. In cemiplimab-treated CSCC pts, early pain reduction tracked with 1st tumour response, and pain worsening with PFS. These results suggest that changes in pain may correlate with tumour response.Table: 1087PClinical responders (complete+partial)Clinical non-responders (stable+progressive)AllBaseline pain score, mean ± SD (n)26.1 ± 28.4 (81)33.7 ± 31.6 (87)29.8 ± 30.4 (152)Change from baseline in pain score at 1st tumour response, n8171–Least squares mean change ± SE–13.8 ± 1.7–3.3 ± 2.1–Least squares mean (95% CI) difference vs non-responders–10.5 (–15.6, –5.3)––Median time to tumour response, months (n)2.0 (85)––Median progression-free survival, months (n)––18.4 (193)Median time to 1st clinically meaningful pain improvement, months (n)2.1 (51)–2.1 (100)Median time to 1st clinically meaningful pain worsening, months (n)14.8 (77)–12.9 (142) Open table in a new tab