TY - JOUR
T1 - Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma
T2 - Extended follow-up of outcomes and quality of life analysis
AU - Rischin, Danny
AU - Khushalani, Nikhil I.
AU - Schmults, Chrysalyne D.
AU - Guminski, Alexander
AU - Chang, Anne Lynn S.
AU - Lewis, Karl D.
AU - Lim, Annette M.
AU - Hernandez-Aya, Leonel
AU - Hughes, Brett G.M.
AU - Schadendorf, DIrk
AU - Hauschild, Axel
AU - Thai, Alesha A.
AU - Stankevich, Elizabeth
AU - Booth, Jocelyn
AU - Yoo, Suk Young
AU - Li, Siyu
AU - Chen, Zhen
AU - Okoye, Emmanuel
AU - Chen, Chieh I.
AU - Mastey, Vera
AU - Sasane, Medha
AU - Lowy, Israel
AU - Fury, Matthew G.
AU - Migden, Michael R.
N1 - Funding Information:
Contributors DR, CDS, AG, AH, ES, JB, S-YY, SL, ZC, EO, C-IC, VM, MS, IL, MGF, and MRM conceived and designed the study. DR, NIK, CDS, AG, ALSC, KDL, AML, LH-A, BGMH, DS, AH, and MRM recruited patients and collected the data. S-YY and SL did the data analysis. EO worked on safety analysis strategy and contributed to safety data analysis. All authors contributed to data interpretation, as well as critical review, revision, and approval of the report. Funding This work was funded by Regeneron Pharmaceuticals and Sanofi.
Funding Information:
Competing interests DR—institutional research grant and funding from
Publisher Copyright:
©
PY - 2021/8/19
Y1 - 2021/8/19
N2 - Background To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL). Methods Patients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks). Results Median duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (p<0.0001). Conclusions This is the largest (n=193) clinical dataset for a programmed cell death-1 inhibitor against advanced CSCC, confirming the sustained substantial clinical activity of cemiplimab in these patients, including new findings of improved CR rates over time, increasing DOR, and durable pain control and GHS/QoL improvement. Trial registration number ClinicalTrials.gov Registry (NCT02760498), https://clinicaltrialsgov/ct2/show/NCT02760498.
AB - Background To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL). Methods Patients received cemiplimab 3 mg/kg every 2 weeks (group 1, metastatic CSCC [mCSCC], n=59; group 2, locally advanced CSCC, n=78) or cemiplimab 350 mg every 3 weeks (group 3, mCSCC, n=56). Primary endpoint was objective response rate (ORR) per independent central review (ICR). QoL was repeatedly measured at day 1 of each treatment cycle (groups 1 and 2: 8 weeks; group 3: 9 weeks). Results Median duration of follow-up was 15.7 months. Overall, ORR per ICR was 46.1% (95% CI: 38.9% to 53.4%). Complete response (CR) rates were 20.3%, 12.8%, and 16.1% for groups 1, 2, and 3, respectively. Median time to CR was 11.2 months. Among patients with partial response or CR, the estimated proportion of patients with ongoing response at 12 months from the first objective response was 87.8% (95% CI: 78.5% to 93.3%), with median DOR not reached. Kaplan-Meier estimated probability of overall survival (OS) was 73.3% (95% CI: 66.1% to 79.2%) at 24 months, with median OS not reached. Global Health Status (GHS)/QoL improvements were observed as early as cycle 2 and were significantly improved and durable until last assessment. Kaplan-Meier estimate of median time to first clinically meaningful improvement for pain was 2.1 (95% CI: 2.0 to 3.7) months and was significantly improved in responders versus non-responders (p<0.0001). Conclusions This is the largest (n=193) clinical dataset for a programmed cell death-1 inhibitor against advanced CSCC, confirming the sustained substantial clinical activity of cemiplimab in these patients, including new findings of improved CR rates over time, increasing DOR, and durable pain control and GHS/QoL improvement. Trial registration number ClinicalTrials.gov Registry (NCT02760498), https://clinicaltrialsgov/ct2/show/NCT02760498.
KW - clinical trials
KW - immunotherapy
KW - phase II as topic
KW - programmed cell death 1 receptor
KW - skin neoplasms
UR - http://www.scopus.com/inward/record.url?scp=85113671095&partnerID=8YFLogxK
U2 - 10.1136/jitc-2021-002757
DO - 10.1136/jitc-2021-002757
M3 - Article
C2 - 34413166
AN - SCOPUS:85113671095
SN - 2051-1426
VL - 9
JO - Journal for ImmunoTherapy of Cancer
JF - Journal for ImmunoTherapy of Cancer
IS - 8
M1 - e002757
ER -