A decision was made to discontinue all trials evaluating bempegaldesleukin in combination with nivolumab.
Bempegaldesleukin is an investigational immunostimulatory interleukin 2 (IL-2) cytokine prodrug. The decision to discontinue development was based on data from pre-planned analyses of the randomized phase 3 PIVOT-09 study (ClinicalTrials.gov Identifier: NCT03729245) and the single-arm phase 2 PIVOT-10 study (ClinicalTrials.gov Identifier: NCT03785925).
The PIVOT-09 study compared bempegaldesleukin plus nivolumab with an investigator’s choice of tyrosine kinase inhibitor (TKI) therapy (either sunitinib or cabozantinib monotherapy) in patients with previously untreated advanced RCC in the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) all-risk and the IMDC intermediate/poor-risk categories. The coprimary endpoints were the objective response rate (ORR) and overall survival (OS).
Following a final ORR analysis, results showed that bempegaldesleukin plus nivolumab did not meet the prespecified boundary for statistical significance in the IMDC all-risk or intermediate/poor-risk populations compared with the TKI control arm. Moreover, an interim OS analysis showed that bempegaldesleukin plus nivolumab did not meet the prespecified boundary for statistical significance in either IMDC population.
The PIVOT-10 study evaluated the antitumor activity of bempegaldesleukin plus nivolumab in patients with cisplatin-ineligible, locally advanced or metastatic urothelial carcinoma. According to a final analysis of ORR (primary endpoint), bempegaldesleukin plus nivolumab did not reach an efficacy threshold to support continuing the program.
The Companies plan to share results from both studies with the scientific community after reviewing the data.
Additionally, all other studies investigating bempegaldesleukin plus nivolumab will be discontinued, including a pivotal study in muscle-invasive bladder cancer (ClinicalTrials.gov Identifier: NCT04209114), a phase 1/2 study in patients with previously untreated kidney cancer that has advanced or has spread (ClinicalTrials.gov Identifier: NCT04540705), and a phase 1/2 study in recurrent and/or refractory pediatric tumors (ClinicalTrials.gov Identifier: NCT04730349).
Nektar and Bristol Myers Squibb announce update on clinical development program for bempegaldesleukin (BEMPEG) in combination with Opdivo (nivolumab). News release. Nektar Therapeutics and Bristol Myers Squibb. Accessed April 18, 2022. https://news.bms.com/news/corporate-financial/2022/Nektar-and-Bristol-Myers-Squibb-Announce-Update-on-Clinical-Development-Program-for-Bempegaldesleukin-BEMPEG-in-Combination-with-Opdivo-nivolumab/default.aspx