Abstract 1109P
Background
At the 3-y follow-up of KEYNOTE-151 (NCT02821000), second-line pembro showed manageable safety and clinically meaningful antitumor activity in Chinese pts with advanced melanoma. Results from more than 5 y of follow-up are presented.
Methods
Adults who had histologically confirmed locally advanced or metastatic melanoma, who were of Chinese descent, and whose disease progressed with first-line therapy received pembro 2 mg/kg IV Q3W for ≤35 cycles (∼2 y) or until disease progression or unacceptable toxicity. Pts with SD or better who discontinued pembro could receive a second course of pembro (≤17 cycles) upon disease progression. Primary end points were safety and tolerability and ORR per RECIST v1.1 by blinded independent central review (BICR). Secondary end points were DOR and PFS per RECIST v1.1 and irRECIST by BICR, ORR per irRECIST by BICR, and OS. Safety and OS were analyzed in pts who received ≥1 dose of pembro. Other efficacy end points were assessed in pts who received ≥1 dose of pembro and had measurable disease per RECIST v1.1 at baseline.
Results
One hundred three pts received pembro (102 with measurable disease at baseline). Median age was 52 y, 57.3% of the pts were female, 51.5% had PD-L1 positive disease, and 14.6% had mucosal melanoma. Median follow-up at data cutoff (Nov 30, 2022) was 73.2 mo (IQR, 67.6-74.8). No new safety signals were reported. Grade 3-5 treatment-related AEs occurred in 12.6% of pts; no pts died of treatment-related AEs. ORR per RECIST v1.1 was 17.6% (95% CI, 10.8-26.4; 1 CR, 17 PR); DCR was 38.2% (95% CI, 28.8-48.4). Median DOR per RECIST v1.1 was 13.8 mo (range, 2.7-69.4+); an estimated 37.7% of pts had DOR ≥60 mo. Median PFS was 2.8 mo (95% CI, 2.7-3.5); 60-mo PFS was 5.0%. One additional pt had PR per irRECIST (ORR, 18.6%; 95% CI, 11.6-27.6). Median OS was 13.2 mo (95% CI, 10.4-16.5); 60-mo OS was 13.4%. One pt with PR as the best overall response per RECIST v1.1 received second-course pembro.
Conclusions
After more than 5 y of follow-up, second-line pembro continued to show manageable safety and clinically meaningful antitumor activity in Chinese pts with advanced melanoma. These results support the continued use of pembro in this population.
Clinical trial identification
NCT02821000.
Editorial acknowledgement
Medical writing and/or editorial assistance was provided by Jemimah Walker, PhD, and Rob Steger, PhD, of ApotheCom (Yardley, PA, USA).
Legal entity responsible for the study
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Funding
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Disclosure
L. Si: Financial Interests, Personal, Invited Speaker: MSD, Novartis, Oriengene, Roche, Shanghai Junshi Biosciences; Financial Interests, Personal, Advisory Board: MSD, Novartis, Shanghai Junshi Biosciences. S. Diede: Financial Interests, Personal, Full or part-time Employment: Merck. S.S. Chen, H. Hu: Financial Interests, Personal, Full or part-time Employment: MSD. J. Guo: Financial Interests, Personal, Advisory Board: MSD, Roche, Pfizer, Bayer, Novartis, Simcere, Shanghai Junshi Biosciences, Oriengene. All other authors have declared no conflicts of interest.
Resources from the same session
1140P - Cemiplimab versus historical systemic treatments for locally advanced (la) or metastatic (m) cutaneous squamous cell carcinomas (CSCC): Results from the French study TOSCA
Presenter: Emilie Gerard
Session: Poster session 13
1141P - Early discontinuation of cemiplimab in patients with advanced cutaneous squamous cell carcinoma
Presenter: Elena Croce
Session: Poster session 13
1142P - Personalized decision making in cutaneous squamous cell carcinoma: Integrating a clinico-pathological model for absolute metastatic risk into the staging systems
Presenter: Marlies Wakkee
Session: Poster session 13
1143P - Changes in peripheral and local tumor immunity after cemiplimab treatment early describe clinical outcomes in patients with cutaneous squamous cell carcinoma
Presenter: Daniela Esposito
Session: Poster session 13
1144P - High-plex spatial profiling of cutaneous squamous cell carcinoma to identify biomarkers associated with clinical outcomes: The cMIC study
Presenter: Rahul Ladwa
Session: Poster session 13
1145P - Clinical characteristics and survival of patients with advanced Merkel cell carcinoma (MCC) treated with avelumab: Analysis of a prospective German MCC registry (MCC TRIM)
Presenter: Juergen Becker
Session: Poster session 13
1146P - Updated results from POD1UM-201: A phase II study of retifanlimab in patients with advanced or metastatic Merkel cell carcinoma (MCC)
Presenter: Giovanni Grignani
Session: Poster session 13
1148P - Avelumab as second-line or later (2L+) treatment (tx) in patients (pts) with metastatic Merkel cell carcinoma (mMCC): Real-world tx patterns in France
Presenter: Astrid Blom Fily
Session: Poster session 13
1149P - Prognosis for patients with metastatic Merkel cell carcinoma with a complete response on avelumab treatment
Presenter: Lisanne Zijlker
Session: Poster session 13