Adjuvant nivolumab for 1-year versus placebo showed improved DFS 0.70 (95% CI 0.54-0.89; median follow-up of 20.9 months). There were also positive results in the 26% of patients who were PD-L1-positive [DFS 0.53 (95% CI 0.34-0.84)]. OS (a secondary endpoint) has not yet been presented.65 17.9% grade 3 or more treatment-related adverse events occurred in the nivolumab arm. These results are promising, especially in the biomarker-positive population. Due to the inconsistency across trials and uncertainty of the relationship between DFS and OS with immunotherapy, OS results are awaited before this treatment can be recommended

Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%....The EC’s decision is based on results from the Phase 3 CheckMate -816 trial, in which three cycles of Opdivo with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone when administered before surgery.

...NCCN-FACT FKSI-19 (Version 2)`To monitor immunogenicity of nivolumab and nivolumab/ipilimumab "boosts" with regard to prediction of response as well as immune related adverse events, including: frequency, differentiation and activation of blood-circulating CD4+ and CD8+ T cells (CD27, CD28, CD45RA, CD45RO, CD57, CD95, CD69, CD25, IFN-γ, TNF- α, IL-4, IL 17, IL-10, CD107a) frequency of blood-circulating dendritic cells (HLA-DR, slan, CD1c, CD11c, CD123, CD141, CD303), myeloid-derived suppressor cells (HLA-DR, CD11b, CD14, CD15, CD33), and regulatory T cells (FoxP3, CD25, CD45RA, CD127) expression of molecules involved in immune checkpoint modulation (ICOS, PD-1, PD-L1, CTLA-4) on blood-circulating dendritic cells and T cells To determine the presence of autoantibodies in the serum of RCC patients To explore the expression of PD-L1 and PD-L2 in tumor tissues of mRCC patients and correlation with efficacy parameters...

...Investigator-assessed Objective Response Rate (ORR)`Investigator-assessed Duration of Objective Response`Investigator-assessed Time to Objective Response`Investigator-assessed Time of Progression-free Survival (PFS)`Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level`Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events`Percentage of Participants With Disease-related Symptom Progression (DRSP)`Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests`Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units...

...Maximum response rate of distant non-irradiated disease`Progression-free survival`Correlation between tumor PD-L1 expression and clinical outcomes`Patient quality of life`Neurocognitive function, as measured by the HVLT-R`Neurocognitive function, as measured by TMT`Neurocognitive function, as measured by COWA`Acute and late toxicity of SRS + Nivolumab`Imaging indicators of response...

Eligible patients with treatment-naive ccRCC received nivolumab until progressive disease (PD), toxicity, or completing 96 treatment weeks (part A). Patients with PD before or stable disease at 48 weeks could receive salvage nivolumab/ipilimumab (part B)....The ORR was 26.9%, 50.0%, and 75.0% for patients with the tumor PD-L1 expression of 0, 1-20, or > 20%, respectively (trend test P value = .002). The median duration of response was 27.6 (19.3 to not reached) months, with 26 of 42 responders including 17 of 20 with favorable-risk disease remaining progression-free.

Progression-free survival was significantly longer in patients with a low sPD-L1 level (not reached vs. 2.3 months, p = 0.03). Overall survival was not significantly different regardless of the sPD-L1 level (both not reached, p = 0.33). The objective response rate in patients with high and low levels were 0.0% and 27.2%, respectively...sPD-L1 might be a strong predictive factor of the efficacy of nivolumab monotherapy.

Cell proliferation has value in predicting response to nivolumab in clear cell mRCC patients, especially when combined with PD-L1 expression.