Abstract LB004: Nivolumab (NIVO) and ipilimumab (IPI) treatment in prostate cancer with an immunogenic signature: cohort 1 of the NEPTUNES multi-centre, two-stage biomarker-selected Phase II trial
Background: Responses to checkpoint inhibitor (CPI) monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) have been limited. This is likely due to a “cold” tumour immune microenvironment. We hypothesised that patients with mCRPC will be more likely to respond if they h...
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Veröffentlicht in: | Cancer research (Chicago, Ill.) Ill.), 2021-07, Vol.81 (13_Supplement), p.LB004-LB004 |
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Sprache: | eng |
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Zusammenfassung: | Background: Responses to checkpoint inhibitor (CPI) monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC) have been limited. This is likely due to a “cold” tumour immune microenvironment. We hypothesised that patients with mCRPC will be more likely to respond if they have a positive immunogenic signature (ImS+). We report the response/safety for NIVO + IPI in pts with ImS+ mCRPC from cohort 1 of the NEPTUNES study.
Methods: Pts with mCRPC who progressed following ≥1 line of therapy and ImS+ were eligible. ImS+ was defined by ≥1 of the following: 1) mismatch repair deficient (MMRD) by immunohistochemistry (IHC); 2) DNA damage repair deficient (DDRD) excluding MMRD, detected by the UW-OncoPlex targeted exome sequencing assay and; 3) high tumour infiltrating lymphocytes (TILs) on multiplexed immunohistochemistry (CD4, CD8 or FoxP3+ >20% nucleated cells). Treatment was NIVO 1 mg/kg + IPI 3 mg/kg Q3W for 4 doses, then NIVO 480 mg every 4 weeks. Primary endpoint was composite response rate (CRR) defined by ≥1 of the following: 1) radiological response by RECIST 1.1; 2) PSA response ≥50%; 3) conversion of circulating tumour cells (CTC) at week 9. Treatment would be deemed ineffective if the CRR was |
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ISSN: | 0008-5472 1538-7445 |
DOI: | 10.1158/1538-7445.AM2021-LB004 |