Avelumab (MSB0010718C; anti-PD-L1) in patients with advanced gastric or gastroesophageal junction cancer from JAVELIN solid tumor phase Ib trial: Analysis of safety and clinical activity.
2016; Lippincott Williams & Wilkins; Volume: 34; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2016.34.15_suppl.4009
ISSN1527-7755
AutoresHyun Cheol Chung, Hendrik‐Tobias Arkenau, Lucjan Wyrwicz, Do‐Youn Oh, Keun-Wook Lee, Jeffrey R. Infante, Sung Sook Lee, Jeeyun Lee, Ulrich Keilholz, Alain C. Mita, Elizabeth Ruth Plummer, Margaret Kemeny, Bohuslav Melichar, Denis Smith, Kevin M. Chin, Anja von Heydebreck, Jean-Marie Cuillerot, Yoon‐Koo Kang, Howard Safran,
Tópico(s)Cholangiocarcinoma and Gallbladder Cancer Studies
Resumo4009 Background: Avelumab (proposed INN) is a fully human anti-PD-L1 IgG1 antibody under clinical investigation in multiple cancers. We report safety and clinical activity of avelumab as a first-line maintenance (Mn) or second-line (2L) therapy in patients (pts) with advanced gastric or gastroesophageal junction cancer (GC/GEJ; NCT01772004), including activity associated with PD-L1 expression. Methods: Pts with GC/GEJ received avelumab at 10 mg/kg IV Q2W until progression, unacceptable toxicity, or withdrawal. Response was assessed every 6 wks (RECIST 1.1). Best overall response and progression-free survival (PFS) were evaluated. Adverse events (AEs) were graded by NCI CTCAE v4.0. PD-L1 expression was assessed by IHC. Results: As of Oct 23 2015, 151 pts were treated with avelumab (62 pts, 2L; 89 pts, Mn) and followed for median of 49 wks (range 9-84). Treatment-related adverse events (TRAEs) of any grade occurred in 89 pts (58.9%); most common ( > 10%) were infusion-related reaction (19 [12.6%]) and fatigue (16 [10.6%]). Grade ≥ 3 TRAEs were reported in 15 pts (9.9%); fatigue, asthenia, increased GGT, thrombocytopenia, and anemia occurred in > 1 pt (2 each; 1.3%). There was 1 treatment-related death (hepatic failure/autoimmune hepatitis). Fourteen pts had an unconfirmed response: 2L 6/62 (9.7%), all PRs; Mn 8/89 (9.0%), 2 CRs, 6 PRs. In 2L and Mn pts, disease control rate was 29.0% and 57.3%, and median PFS was 6.0 wks (95% CI: 5.7, 6.4) and 12.0 wks (95% CI: 9.9, 17.6), respectively. PD-L1 expression was evaluable in 74 pts (22/62 2L, 52/89 Mn). Activity based on a ≥ 1% cutoff for tumor cell staining is shown in the table. Conclusions: Single-agent avelumab had an acceptable safety profile and promising clinical activity in unselected pts with GC/GEJ treated in Mn and 2L settings. These data represent the largest study of anti-PD-(L)1 agents in GC/GEJ. Two randomized phase III trials of avelumab in GC are open. Clinical trial information: NCT01772004. 2L (n = 22) Mn (n = 52) PD-L1+ (n = 11) PD-L1− (n = 11) PD-L1+ (n = 20) PD-L1− (n = 32) ORR, % (95% CI) 18.2 (2.3, 51.8) 9.1 (0.2, 41.3) 10.0 (1.2, 31.7) 3.1 (0.1, 16.2) Median PFS, wks (95% CI) 6.3 (5.4, 18.0) 10.4 (4.1, 21.9) 17.6 (6.0, 24.1) 11.6 (5.7, 14.1)
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