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Authors J.J. Grob R. Gonzalez Mendoza N. Basset-Seguin O. Vornicova J. Schachter A. Joshi N. Meyer F. Grange J.M. Piulats J. Bauman P. Zhang B. Gumuscu R.F. Swaby B.G.M. Hughes
Title Pembrolizumab for recurrent/metastatic cutaneous squamous cell carcinoma (cSCC): Efficacy and safety results from the phase II KEYNOTE-629 study
Journal Annals of Oncology
Vol 30
Issue Suppl 5
Abstract Text Background: The global, single-arm, phase II KEYNOTE-629 trial (NCT03284424) studied the safety and efficacy of pembrolizumab in patients with recurrent/metastatic (R/M) cSCC. Methods: Patients with R/M cSCC received pembrolizumab 200 mg Q3W for up to 35 infusions (Grob JJ et al. J Clin Oncol. 2019;37(suppl; abstr TPS9598)). The primary end point was ORR by blinded independent central review per RECIST v1.1. Secondary end points were DOR, DCR, PFS, OS, and safety. DOR, PFS, and OS were estimated using the Kaplan-Meier method. Results of an interim analysis are presented. Results: Of 105 patients, 76.2% were male, median age was 72 years, 86.7% had previously received ≥1 line of systemic therapy, and 74.3% had previously undergone radiation. At data cutoff (April 8, 2019), median duration of follow-up was 9.5 months (range, 0.4-16.3 months). ORR was 34.3% (95% CI, 25.3%-44.2%); 4 patients (3.8%) achieved CR (95% CI, 1.0%-9.5%), and 32 patients (30.5%) achieved PR (95% CI, 21.9%-40.2%). Median DOR was not reached (range, 2.7-13.1+ months). Of the 36 responders, 31 patients and 7 patients had a minimum follow-up of 6 months and 12 months, respectively, after achieving response; 25 (79.5%) and 1 (65.6%) were estimated to have ongoing responses at > 6 months and >12 months, respectively. DCR (CR + PR + stable disease ≥12 weeks) was 52.4% (95% CI, 42.4%-62.2%). Median PFS was 6.9 months (95% CI, 3.1-8.5 months); 12-month PFS rate was 32.4%. Median OS was not reached (95% CI, 10.7 months-not reached); 12-month OS rate of 60.3%. Treatment-related adverse events (TRAEs) occurred in 70 patients (66.7%), and 6 patients (5.7%) had grade 3-5 TRAEs; 1 patient died of treatment-related cranial nerve neuropathy. The most common TRAEs were pruritus (14.3%), asthenia (13.3%), and fatigue (12.4%). Conclusions: Pembrolizumab demonstrated a clinically meaningful ORR (34.3%), durable responses, and remarkable PFS and OS in patients with R/M cSCC, most of whom were heavily pretreated. Treatment was well tolerated, and the safety profile was generally consistent with that of other pembrolizumab monotherapy studies; no new safety signals were identified. These data support pembrolizumab for the treatment of R/M cSCC. Clinical trial identification: NCT03284424, October 26, 2017.


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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown skin squamous cell carcinoma not applicable Pembrolizumab FDA approved Actionable In a Phase II trial (KEYNOTE-629) that supported FDA approval, Keytruda (pembrolizumab) treatment resulted in an objective response rate of 34.3% (36/105, 4 complete responses, 32 partial responses) and a disease control rate of 52.4% (55/105) in patients with recurrent or metastatic cutaneous squamous cell carcinoma, with median duration of response not reached and a median progression-free survival of 6.9 months (Ann Oncol (Oct 2019) 30 (Suppl_5): V908; NCT03284424). detail... detail...