Table 1.

Clinical activity with avelumab monotherapy across different malignancies.

Disease site – ClinicaTrial.gov ID	Study design/patient population	Subgroup analysis	ORR	Median DoRa	Median TTR	Median PFSb	Median OS	≥Grade 3 TRAE
Merkel cell carcinoma JAVELIN Merkel 200 – NCT02155647 Kaufman HL et al. Lancet Oncol 2016	Metastatic, chemotherapy-refractory Merkel cell carcinoma (n = 88) Open-label phase II PD-L1 and MCPyV status unselected	Total population PD-L1 (+) (TC ≥1%) MCPyV (+)	31.8% 34.5% 26.1%	92% (at 6 mo) not reached Not reached Not reached	6 weeks	2.7 mo 40% (at 6 mo)	11.3 mo 69% (at 6 mo)	5%
Urothelial carcinoma JAVELIN phase Ib – NCT01772004 Patel MR et al. Lancet Oncol 2017	Metastatic urothelial carcinoma with platinum-refractory disease after ≥1 prior therapy (n = 161) Pooled analysis of open-label phase Ib dose-expansion cohorts PD-L1 status unselected	Total population PD-L1 (+) (TC ≥5%) PD-L1 (−) (TC <5%)	17% 24% 13%	96% (at 6 mo) not reached	11.4 weeks	6.3 mo 23% (at 6 mo) 11.9 mo 37% (at 6 mo) 6.1 mo 16% (at 6 mo)	6.5 mo 53% (at 6 mo) 8.2 mo 59% (at 6 mo) 6.2 mo 51% (at 6 mo)	8%
Non-small cell Lung cancer JAVELIN phase Ib – NCT01772004 Gulley JL et al. Lancet Oncol 2017	Stage IIIB/IV progressive or platinum-refractory NSCLC (n = 184) Open-label phase Ib dose-expansion cohort PD-L1, EGFR, KRAS, ALK status unselected	Total population 9% PD-L1 (+) (TC ≥1%)	12% 14%	83% (at 6 mo) not reached	6–	12 weeksc 3.0 mo 21% (at 12 mo)	2.9 mo 26% (at 6 mo) 18% (at 12 mo) 8.9 mo 39% (at 12 mo)	8.4 mo 36% (at 12 mo)
PD-L1 (−) (TC <1%)	10%	1.5 mo	4.6 mo 36% (at 12 mo)
Breast cancer JAVELIN phase Ib – NCT01772004 Dirix LY et al. Breast Cancer Res Treat 2017	Histologically confirmed LABC/metastatic breast cancer with refractory or progressive disease on SOC (n = 168, 58 with TNBC) PD-L1 status unselected	Total population PD-L1 (+) (IC ≥10%) PD-L1 (−) (IC <10%)	3% [5.2% TNBC] 16.7% [22.2% TNBC] 1.6% [2.6% TNBC]	Not reached	11.4 weeks	1.5 mo 10.1% (at 6 mo) 1.5 mo 25% (at 6 mo) 1.5 mo 7% (at 6 mo)	8.1 mo 40.3% (at 12 mo) 11.3 mo 33.3% (at 12 mo) 6.8 mo 37.4% (at 12 mo)	13.7%
Ovarian cancer JAVELIN phase Ib – NCT01772004 Disis ML et al. ASCO 2016. J Clin Oncol 34, 2016 (suppl; Abstract 5533)	Recurrent/refractory stage III/IV ovarian cancer with PD within 6 mo of platinum or after subsequent therapy for relapse (n = 124) open-label phase Ib dose-expansion cohort PD-L1 status unselected	Total population PD-L1 (+) (TC ≥1%) PD-L1 (−) (TC <1%)	9.7% 12.3% 5.9%		6 weeksd	2.8 mo	10.8mo	6.5%
Gastric and GEJ cancer JAVELIN phase Ib – NCT01772004 Chung HC et al. ASCO 2016. J Clin Oncol 34, 2016 (suppl; Abstract 4009)	Advanced gastric or GEJ cancer as first-line maintenance or second-line therapy (n = 151) Phase Ib expansion; subgroups: switch maintenance [M, n = 89] or as second-line [2L, n = 62] PD-L1 status unselected	Total population PD-L1 (+) (TC ≥1%) PD-L1 (−) (TC <1%)	9.0% [M] 9.7% [2L] 10.0% [M] 18.2% [2L] 3.1% [M] 9.1% [2L]			3.0 mo [M] 1.5 mo [2L] 4.4 mo [M] 1.6 mo [2L] 2.9 mo [M] 2.6 mo [2L]		9.9%
Gastric and GEJ cancer JAVELIN JPN – NCT01943461 Nishina T et al. ASCO 2016. J Clin Oncol 34, 2016 (no. 4_suppl; Abstract 168)	Recurrent/refractory stage IV gastric or GEJ adenocarcinoma with PD after 1–2 chemotherapy regimens with fluoropyrimidines and platinum. Phase Ib dose expansion JAVELIN in Japanese patients (n = 20) PD-L1 status unselected	Total population PD-L1 (+) (TC ≥1%) PD-L1 (−) (TC <1%)	15% 40% 7.1%			3.1 mo 60% (at 3 mo) 2.8 mo 32.1% (at 3 mo)		5%
Non-small cell Lung cancer (1L) JAVELIN phase Ib – NCT01772004 Verschraegen CF et al. ASCO 2016. J Clin Oncol 34, 2016 (suppl; Abstract 9036)	1L avelumab for metastatic/recurrent NSCLC, systemic chemotherapy-naïve for metastatic disease (n = 75 with ≥3 mo FUP) EGFR-wildtype, ALK rearrangement-negative PD-L1 status unselected	Total population PD-L1 (+) (TC ≥1%) PD-L1 (−) (TC <1%)	18.7% 20% 0%			2.9 mo		9%
Merkel cell carcinoma (1L) JAVELIN Merkel 200 – NCT02155647 D’Angelo SP et al. JAMA Oncol. 2018	1L avelumab for chemotherapy-naïve metastatic Merkel cell carcinoma (n = 39) Open-label phase II, pre-planned interim analysis PD-L1 and MCPyV status unselected	Total population	62.1%	77.8% not reached				20.5%

^aamong responders, proportion of patients with durable response defined as response ≥6 s.

^bmedian PFS reported as weeks in primary source are displayed as s for consistency.

^cmedian time to response (TTR) not reported, 39% of responders had responded by 6 weeks and 73% of responders had responded by 12 weeks.

^dmedian time to response (TTR) not reported, 50% of responders (n = 6) had responded by 6 weeks and 83.3% of responders has responded by 10 weeks.

1L: first-line; 2L: second-line; AE,DoR: duration of response; FUP: follow-up; GEJ: gastroesophageal junction; IC: tumor-associated immune cells; LABC: locally advanced breast cancer; M: maintenance therapy; MCPyV: Merkel cell polyoma virus; mo: months: NSCLC: non-small cell lung cancer; ORR: objective response rate; OS: overall survival; PD: progression of disease; PFS: progression-free survival; SOC: standard-of-care; TC: tumor cell; TNBC: triple-negative breast cancer; TRAE: treatment-related adverse event; TTR: time to response.