Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors Journal Article
| Authors: | Lewis, K. D.; Peris, K.; Sekulic, A.; Stratigos, A. J.; Dunn, L.; Eroglu, Z.; Chang, A. L. S.; Migden, M. R.; Yoo, S. Y.; Mohan, K.; Coates, E.; Okoye, E.; Bowler, T.; Baurain, J. F.; Bechter, O.; Hauschild, A.; Butler, M. O.; Hernandez-Aya, L.; Licitra, L.; Neves, R. I.; Ruiz, E. S.; Seebach, F.; Lowy, I.; Goncalves, P.; Fury, M. G. |
| Article Title: | Final analysis of phase II results with cemiplimab in metastatic basal cell carcinoma after hedgehog pathway inhibitors |
| Abstract: | Background: Metastatic basal cell carcinoma (mBCC) is a rare condition with no effective second-line treatment options. Cemiplimab is an immune checkpoint inhibitor that blocks the binding of programmed cell death-1 (PD-1) to its ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). Here, we present the final analysis of cemiplimab in patients with mBCC after first-line hedgehog pathway inhibitor (HHI) treatment (NCT03132636). Patients and methods: In this open-label, single-arm, phase II study, adults with mBCC and Eastern Cooperative Oncology Group performance status ≤1, post-HHI treatment, received cemiplimab 350 mg intravenously every 3 weeks for ≤93 weeks or until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by independent central review (ICR). Duration of response (DOR) was a key secondary endpoint. Other secondary endpoints were ORR per investigator assessment, progression-free survival (PFS), overall survival (OS), complete response rate, safety, and tolerability. Results: Fifty-four patients were enrolled: 70% were male and the median age of patients was 64 [interquartile range (IQR) 57.0-73.0] years. The median duration of follow-up was 8 months (IQR 4-21 months). The ORR per ICR was 22% [95% confidence interval (CI) 12% to 36%], with 2 complete responses and 10 partial responses. Among responders, the median time to response per ICR was 3 months (IQR 2-7 months). The estimated median DOR per ICR was not reached [95% CI 10 months–not evaluable (NE)]. The disease control rate was 63% (95% CI 49% to 76%) per ICR and 70% (95% CI 56% to 82%) per investigator assessment. The median PFS per ICR was 10 months (95% CI 4-16 months); the median OS was 50 months (95% CI 28 months-NE). The most common treatment-emergent adverse events were fatigue [23 (43%)] and diarrhoea [20 (37%)]. There were no treatment-related deaths. Conclusions: Cemiplimab demonstrated clinically meaningful antitumour activity, including durable responses, and an acceptable safety profile in patients with mBCC who had disease progression on or intolerance to HHI therapy. © 2023 The Author(s) |
| Keywords: | adult; cancer survival; treatment outcome; treatment response; aged; major clinical study; overall survival; constipation; drug tolerability; fatigue; cancer growth; diarrhea; drug safety; hypertension; side effect; bone metastasis; follow up; lymph node metastasis; progression free survival; multiple cycle treatment; pain; phase 2 clinical trial; anemia; actinic keratosis; basal cell carcinoma; nausea; vomiting; myalgia; creatinine blood level; antineoplastic activity; hematuria; abdominal pain; alanine aminotransferase blood level; arthralgia; asthenia; backache; coughing; dizziness; dyspnea; fever; hyperglycemia; pruritus; rash; alanine aminotransferase; hypokalemia; maculopapular rash; liver metastasis; lung metastasis; immunotherapy; multicenter study; urinary tract infection; peripheral edema; xerostomia; anxiety disorder; colitis; open study; creatine kinase; sex difference; headache; age distribution; hyperthyroidism; hypothyroidism; cancer control; muscle spasm; dry skin; atrial fibrillation; upper respiratory tract infection; creatine kinase blood level; pd-1; soft tissue metastasis; neck pain; decreased appetite; vismodegib; body weight loss; response evaluation criteria in solid tumors; infusion related reaction; eczema; human; male; female; article; hedgehog inhibitor; sonidegib; body weight gain; cemiplimab; treatment response time; metastatic basal cell carcinoma |
| Journal Title: | Annals of Oncology |
| Volume: | 35 |
| Issue: | 2 |
| ISSN: | 0923-7534 |
| Publisher: | Oxford University Press |
| Date Published: | 2024-02-01 |
| Start Page: | 221 |
| End Page: | 228 |
| Language: | English |
| DOI: | 10.1016/j.annonc.2023.10.123 |
| PUBMED: | 38072158 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
