Long-Term Survival Update From JAVELIN Merkel 200 With Avelumab in Metastatic Disease
Posted: Monday, December 6, 2021
The PD-1 inhibitor avelumab appears to be an effective therapy in patients with metastatic Merkel cell carcinoma who exhibited disease progression following chemotherapy. Paul T. Nghiem, MD, PhD, of the University of Washington Medical Center at South Like Union, Seattle, and colleagues found that patients treated with avelumab had “meaningful” long-term overall survival, which was longer than that shown in previous studies of second-line or later chemotherapy. Their 5-year follow-up findings, which were published in the journal ESMO Open Cancer Horizons, “further support the role of avelumab as a standard of care for patients with metastatic Merkel cell carcinoma.”
This single-arm, open-label, phase II JAVELIN Merkel 200 trial followed 88 patients who exhibited disease progression following one or more previous lines of chemotherapy for stage IV metastatic Merkel cell carcinoma. Patients received 10 mg/kg of avelumab intravenously every 2 weeks until disease progression, unacceptable toxicity, or study withdrawal.
The median follow-up was 65.1 months, at which point one patient remained on treatment and one additional patient reinitiated treatment after previous discontinuation. Results showed an overall survival of 12.6 months, with overall survival rates at 3, 4, and 5 years of 32%, 30%, and 26%, respectively. Of note, median overall survival in patients with PD-L1–positive (n = 57) or PD-L1–negative (n = 16) tumors was 12.9 months and 7.3 months, respectively.
Of the patients who discontinued treatment, the researchers followed up with 19 as of data cutoff. At the 5+ years of follow-up, 71.6% of patients had died. Disease progression was the most common cause of death at 55.7%. There were no treatment-related adverse events that led to death. Study limitations included the small cohort size of patients as well as the single-arm design of the study.
Disclosure: The study authors’ full disclosures can be found at esmoopen.com.