e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2021

Health-related quality of life (HRQoL) in patients (pts) with locally advanced basal cell carcinoma (laBCC) treated with cemiplimab: analysis of a phase II, open-label clinical trial   (#323)

Alexander J Stratigos 1 , Chieh-I Chen 2 , Cristina Ivanescu 3 , Karl D Lewis 4 , Ketty Peris 5 , Oliver Bechter 6 , James Harnett 2 , Vera Mastey 2 , Matthew Reaney 3 , Christina Daskalopoulou 3 , Patrick R LaFontaine 7 , Gerasimos Konidaris 7 , Denise Bury 7 , Suk-Young Yoo 2 , Kosalai Mohan 2 , Ebony Coates 2 , Timothy Bowler 2 , Matthew G Fury 2 , Aleksandar Sekulic 8
  1. University of Athens, A. Sygros Hospital, Athens, Greece
  2. Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA
  3. IQVIA, Durham, North Carolina, USA
  4. University of Colorado Cancer Center, Aurora, Colorado, USA
  5. Catholic University Fondazione Policlinico Universitario, Rome, Italy
  6. UZ Leuven, Leuven, Belgium
  7. Sanofi, Cambridge, Massachusetts, USA
  8. Mayo Clinic, Scottsdale, Arizona, USA

Aim: Cemiplimab-rwlc is the first immunotherapy to receive approval in US, fully for pts with laBCC and accelerated for metastatic BCC, post hedgehog inhibitors (HHI) or for whom HHIs are not appropriate. Cemiplimab resulted in clinically meaningful anti-tumor activity in laBCC pts who progressed on or were intolerant to HHIs (NCT03132636). This analysis evaluated HRQoL in these pts.

Methods: Adults with laBCC (n=84) received cemiplimab 350 mg Q3W for up to 9 treatment cycles. At BL and day 1 of each cycle (C), pts completed HRQoL questionnaires (EORTC QLQ-C30 and SKINDEX-16). MMRM models were used to estimate LS mean (SE) change from BL during treatment. For pts with non-missing data from BL, responder analyses determined proportions with clinically meaningful improvement, deterioration, or stability on QLQ-C30 and SKINDEX-16 at C2 and C9. For all QoL assessments, 10-point change was considered clinically meaningful.

Results: BL scores showed moderate-to-high levels of functioning and low symptom burden. In MMRM models, overall changes from BL on QLQ-C30 indicated stability for Global Health Status (GHS)/QoL and all scales, except for clinically meaningful worsening of fatigue (∆LS mean [SE] 12.5 [3.9]; P<0.05). In responder analysis, majority of pts reported clinically meaningful improvement or stability on QLQ-C30 functioning scales and pain, but not fatigue (Table). On SKINDEX-16, MMRM models showed clinically meaningful improvement on emotional subscale (∆LS mean [SE] –13.2 [3.9]; P<0.05) and stability on symptom and functional subscales. Responder analysis showed clinically meaningful improvements or stability across SKINDEX-16 subscales in ~80% of pts at C2, and 70-80% of pts at C9.

Conclusions: In laBCC pts treated with cemiplimab, the majority reported clinically meaningful improvement or stability in GHS/QoL and functional status while maintaining low symptom burden, except for fatigue. 

Table

                                                                                                                                                               

Pts with clinically meaningful improvement or stability/clinically meaningful deterioration, N (%)

 

C2

C9

GHS/QoL

63 (87.5)/9 (12.5)

10 (58.8)/7 (41.2)

Physical functioning

58 (77.3)/17 (22.7)

14 (77.8)/4 (22.2)

Role functioning

52 (69.3)/23 (30.7)

11 (61.1)/7 (38.9)

Emotional functioning

60 (81.1)/14 (18.9)

12 (66.7)/6 (33.3)

Cognitive functioning

56 (75.7)/18 (24.3)

13 (72.2)/5 (27.8)

Social functioning

60 (81.1)/14 (18.9)

11 (61.1)/7 (38.9)

Pain

56 (74.7)/19 (25.3)

14 (77.8)/4 (22.2)

Fatigue

46 (61.3)/29 (38.7)

8 (44.4)/10 (55.6)

 © 2021 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2021 ASCO Annual Meeting. All rights reserved.