Abstract
e14556 Background: All clinical trials studying ipi+nivo have involved treatment-naive pts. Knowledge about the safety and efficacy of ipi+nivo is limited for pts previously treated with PD1. Methods: Nine pts were retrospectively evaluated and treated with ipi (3 mg/kg) and nivo (1 mg/kg) q3wk for 4 doses followed by maintenance nivo q2wk after progression on PD1 from 10/2014 to 11/2016. Data regarding clinical history, treatment response, and toxicity were collected. Results: Six pts had advanced melanoma, 2 pts had metastatic HNSCC (mHNSCC), and 1 pt had recurrent parotid myoepithelial carcinoma. Age ranged from 44 to 86. Eight pts had ECOG PS 0-1; 1 pt had ECOG PS 2. Three melanoma pts were BRAF+; 1 was BRAF WT and 2 were NRAS+. Both mHNSCC pts were p16+. Pts received a median of 3 prior lines of treatment including chemotherapy and immune treatments encompassing ipi, PD1, 4-1BB agonist, autologous TILs, high-dose IL2, IFN, T-VEC, and TLR8 agonist. All 9 pts received pembro prior to ipi+nivo; 1 pt received both pembro and nivo separately. Median number of PD1 doses prior to ipi+nivo was 10 (range 3-13). All 9 pts received all 4 doses of ipi+nivo without delay. Seven pts received nivo maintenance for median number of 11 cycles (range 1-22). Two pts were unable to receive nivo maintenance due to progressive disease (PD) and instead were treated with ipi+T-VEC and BRAF/MEK inhibition. Objective responses were seen in 6/9 pts (67%) with 2 radiological CRs and 4 radiological PRs. PD was seen in 3/9 pts (33%) including in the 1 pt with ECOG PS 2; all 3 pts died from clinical deterioration unrelated to ipi+nivo treatment. CRs were observed in 1 BRAF+ and 1 NRAS+. 7/9 pts (78%) had ≥1 clinically significant irAE and 3 of these pts required systemic steroids. Five pts are still receiving maintenance nivo with clinical benefit. One pt with CR was taken off nivo maintenance, remains disease-free, and is now on surveillance. Conclusions: Ipi+nivo demonstrated significant anti-tumor activity in pts previously treated with PD1. The toxicity profile is consistent with known irAEs. While this is a small series, these data support the use of ipi+nivo after PD1 failure.
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