Preliminary Avelumab Trial Suggests ‘Durable Activity’ Against Advanced Mesothelioma

Phase Ib results indicate that patients with unresectable mesothelioma may derive a benefit from the PD-L1 inhibitor avelumab

medwireNews: Preliminary results from the JAVELIN Solid Tumor trial show “durable antitumor activity and disease control” with avelumab in patients with metastatic mesothelioma. 

After a median follow-up of 24.8 months, the RECIST objective response rate (ORR) among the 53 patients given avelumab 10 mg/kg every 2 weeks was 9.4%, with one complete response and four partial responses, say Raffit Hassan, from the National Cancer Institute in Bethesda, Maryland, USA, and co-authors. 

Including the 49% of patients who had a best response of at least stable disease, the disease control rate was 58%, and disease responses lasted a median of 15.2 months, they report in JAMA Oncology

Responses occurred in both patients with programmed cell death ligand 1 (PD-L1)-positive and -negative disease, with corresponding ORRs of 19% and 7% when using a PD-L1 cutoff of 5% or above, the team reports. The ORR was 6% for the patients who had received one prior line of treatment, 13% for those with two prior lines and 10% for those with three previous regimens.  

Median progression-free survival was 4.1 months, with a 1-year rate of 17.4%. For overall survival (OS), the median value was 10.7 months and the 1-year rate was 43.8%.  

And an exploratory landmark analysis of 46 patients according to the best response achieved after 3 months of avelumab indicated that OS was significantly longer among those who achieved a complete or partial response than those who did not. 

Raffit Hassan et al add that avelumab had an “acceptable safety profile that compares favorably with chemotherapy”, citing a “low” grade 3 or more severe treatment-related adverse event rate of 9% and an absence of deaths attributed to treatment. 

“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 OS, and the safety profile suggest that avelumab could be a potential new therapeutic option for patients with mesothelioma”, the team concludes. 

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



Hassan R, Thomas A, Nemunaitis JJ, et al. Efficacy and safety of avelumab treatment in patients with advanced unresectable mesothelioma. Phase 1b results from the JAVELIN Solid Tumor Trial . JAMA Oncol; Advance online publication 3 January 2019. doi:10.1001/jamaoncol.2018.5428  

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