Avelumab (MSB0010718C; anti-PD-L1) in patients with recurrent/refractory ovarian cancer from the JAVELIN Solid Tumor phase Ib trial: Safety and clinical activity.
2016; Lippincott Williams & Wilkins; Volume: 34; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2016.34.15_suppl.5533
ISSN1527-7755
AutoresMary L. Disis, Manish R. Patel, Shubham Pant, Erika Hamilton, A. Craig Lockhart, Karen Kelly, J. Thaddeus Beck, Michael S. Gordon, Glen J. Weiss, Matthew H. Taylor, Jorge Chaves, Alain C. Mita, Kevin M. Chin, Anja von Heydebreck, Jean-Marie Cuillerot, James L. Gulley,
Tópico(s)Ovarian cancer diagnosis and treatment
Resumo5533 Background: Avelumab* is a fully human anti-PD-L1 IgG1 antibody under clinical investigation in multiple cancers. We report safety and clinical activity of avelumab in patients (pts) with recurrent/refractory ovarian cancer (OC; NCT01772004). Methods: Pts with advanced OC unselected for PD-L1 expression received avelumab 10 mg/kg IV Q2W until progression, unacceptable toxicity, or withdrawal. Tumors were assessed every 6 wks (RECIST 1.1). Unconfirmed objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were evaluated. Adverse events (AEs) were graded by NCI-CTCAE v4.0. PD-L1 expression was assessed by immunohistochemistry. Results: As of Oct 23, 2015, 124 pts were treated with avelumab (median 12 wks [range 2-54]) and followed for a median of 54 wks (range 11-101). Median age was 62 y (range 27-84), ECOG PS was 0 (47.6%) or 1 (52.4%), and median number of prior therapies was 4 (range 1-13). Treatment-related (TR) AEs occurred in 82 pts (66.1%); most common (≥10%) were fatigue (13.7%), infusion-related reaction (12.1%), and diarrhea (11.3%), all of grade 1/2. Grade 3/4 TRAEs were reported in 8 pts (6.5%); of these, only increased lipase occurred in > 1 pt (n = 2). There were no treatment-related deaths. ORR was 9.7% (95% CI: 5.1-16.3) based on 12 partial responses; 6 were ongoing. Stable disease was observed in 55 pts (44.4%); disease control rate was 54.0%. PD-L1 expression was evaluable in 74 pts (59.7%). Using a ≥1% cutoff for tumor cell staining, 57/74 (77.0%) were PD-L1+ and ORR was 12.3% in PD-L1+ (7/57; 95% CI: 5.1, 23.7) vs 5.9% in PD-L1− pts (1/17; 95% CI: 0.1, 28.7). Overall, median PFS was 11.3 wks (95% CI: 6.1, 12.0) and median OS was 10.8 mos (95% CI: 7.0, 16.1). Conclusions: Single-agent avelumabshowed an acceptable safety profile and clinical activity in heavily pretreated pts with OC. These data represent the largest study of anti-PD(L)1 agents in pts with OC to date. The potential relationship between biomarkers, such as germline BRCA mutational status, and the probability of response is being investigated. Randomized phase 3 trials of avelumab in OC are underway. *Proposed INN. Clinical trial information: NCT01772004.
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