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Phase I Clinical Trial Shows Promising Long-Term Disease Control in Mesothelioma Patients

An immune checkpoint inhibitor known as Bavencio (avelumab) has shown promising long-term disease control in heavily pretreated malignant mesothelioma patients. According to a recent Phase 1 clinical trial, the treatment, jointly developed by Merck KGaA (operating as EMD Serono in the U.S. and Canada) and Pfizer, controlled the disease in a remarkable 58% of patients, with a noteworthy 17% living without the disease worsening for one year or longer.

According to JAMA Oncology (publisher of the study), “avelumab is a human IgG1 monoclonal antibody that targets PD-L1.21 Unlike other available PD-1/PD-L1 antibodies, avelumab retains a wild-type Fc region that, in preclinical models, can induce antitumor activity via adaptive and innate effector cells, including against mesothelioma cells.” The drug “has been approved in various countries for the treatment of metastatic Merkel cell carcinoma and in North America for locally advanced or metastatic urothelial carcinoma that progressed during or after platinum-containing chemotherapy.”

The study “Efficacy and Safety of Avelumab Treatment in Patients With Advanced Unresectable Mesothelioma,” consisted of 53 patients with unresectable mesothelioma and previous platinum and pemetrexed treatment. Participants received avelumab, 10 mg/kg, every two weeks until disease progression, unacceptable toxic effects, or withdrawal from the study.

Of the 53 patients treated with avelumab, the median age was 67 (range, 32-84) years. Thirty-two patients (60%) were male. As of December 31, 2016, median follow-up was 24.8 (range, 16.8-27.8) months. In addition to disease control in 58% of patients and 17% living without disease progression for one year or longer, there were no treatment-related deaths.

Mesothelioma is a disease with a very poor prognosis, with patients living only for a median of 12.1 months after their initial treatment. With such promising results, avelumab could change this.

The study concluded that avelumab “showed clinically meaningful antitumor activity in a heavily pretreated population of patients with pleural or peritoneal mesothelioma. Although the study and its findings should be interpreted in context as a small phase 1b cohort, the level of long-term disease control, the duration of overall survival (OS), and the safety profile suggest that avelumab could be a potential new therapeutic option for patients with mesothelioma.”

“Further studies of avelumab or other anti–PD-1 or anti–PD-L1 antibodies in this disease, including combinations with other agents, are warranted.”

If you have been diagnosed with mesothelioma, talk to your doctor about participating in a clinical trial for innovative treatments such as avelumab. A newer or experimental treatment could be effective in treating your specific type of mesothelioma. Talk to your doctor today.

 

Sources

EMD Serono. Merck KGaA, Darmstadt, Germany, 2019. Web. 30 Mar. 2019.

Hassan, Raffit, Anish T, and John N, et al. “Efficacy and Safety of Avelumab Treatment in Patients With Advanced Unresectable Mesothelioma.” JAMA Oncology. American Medical Association, 03 Jan. 2019. Web. 30 Mar. 2019.

Martins, Ines. “Bavencio Shows Promise in Phase 1 Trial of Heavily Treated Malignant Mesothelioma Patients.” Immuno-Oncology News. BioNews Services, LLC., 12 Feb. 2019. Web. 30 Mar. 2019.

Pfizer.com. Pfizer, Inc., 2002-2018. Web. 30 Mar. 2019.