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Avelumab conferred longer durable responses among patients with advanced chemotherapy-refractory Merkel cell carcinoma, according to updated results from a prospective study presented at the American Association for Cancer Research Annual Meeting.
“Avelumab monotherapy showed durable antitumor activity and fairly good activity overall,” Howard L. Kaufman, MD, FACS, surgical oncologist at Rutgers Cancer Institute of New Jersey, said during a press conference. “It is now approved by the FDA as a therapeutic option and includes patients 12 years and older for first-line and second-line therapy.”
Howard L. Kaufman
Kaufman and colleagues conducted a multicenter phase 2 study of 88 patients (median age, 72.5 years) with stage IV Merkel cell carcinoma from 35 hospitals and cancer centers in North America, Europe, Asia and Australia. All patients had failed at least one round of prior chemotherapy.
Patients received 10 mg/kg avelumab (Bavencio, Pfizer) via IV every 2 weeks until disease progression, toxicity or other cause for withdrawal.
During 6 months of follow-up, the researchers observed durable responses to treatment.
Kaufman presented updated efficacy data with more than 1 year follow-up from the same cohort of patients.
As of Sept. 3, 2016, median follow-up was 16.4 months (range, 12-25.3), and 19 patients (22%) were still receiving treatment.
Causes for treatment discontinuation included disease progression (50%), mortality (8%), adverse events (8%) or withdrawal (5%).
From 6 months to 1 year, researchers observed increases in the overall response rate (31.8% to 33%) and complete response rate (9.1% to 11.4%). Partial responses occurred in 19 patients (21.6%) at 1 year follow-up. These data reflected one new complete response and one improvement from partial to complete response since 6-month follow-up.
The 6-month durable response rate was 30.6% (95% CI, 20.9-40.3). The median duration of response had not yet been reached (range, 2.8-23.3+ months; 95% CI, 18-unestimatable) because 21 responses were ongoing at the time of analysis, Kaufman said.
“While 92% of patients were in response at 6 months or more, 74% of this population remained in response at 1 year after treatment,” he said.
Patients who had one prior therapy yielded a better response rate compared with patients who received two or more prior therapies (44% vs. 22%). In addition, the higher the disease burden, the more likely a patient was to have a poor response to treatment, Kaufman said.
The estimated 1-year PFS rate was 30% (95% CI, 21-41) and 1-year OS was 52% (95% CI, 41-62), which “is quite remarkable for this disease,” Kaufman said.
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The treatment was fairly well tolerated; the most common adverse events were fatigue and infusion-related reactions.
“Among these patients, the majority of responses were durable beyond 1 year and two new complete responses were reported,” Kaufman said. “It is great to watch some of these patients doing so well for so long now.” – by Melinda Stevens
Reference:
Kaufman HL, et al. Abstract CT079. Presented at: AACR Annual Meeting; April 1-5, 2017; Washington, D.C.
Disclosures:The study was funded by EMD Serono Inc. Kaufman reports advisory roles with Amgen, Celldex, Compass Therapeutics, EMB Serono Inc., Merck, Prometheus and Turnstone Biologics.
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