Date: 2016-10-09
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2016 Congress
Company: BMS (USA - NY) Ono Pharmaceutical (Japan)
Product: Opdivo® (nivolumab)
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. Opdivo® (nivolumab) is an investigational human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. Opdivo® is approved: - as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma - as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma - in combination with Yervoy® (ipilimumab), for the treatment of patients with unresectable or metastatic melanoma - for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo® - for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. - for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post- transplantation brentuximab vedotin. In 2011, through a collaboration agreement with Ono Pharmaceutical, BMS expanded its territorial rights to develop and commercialize Opdivo® globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, BMS and Ono further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
Disease: stage IV or recurrent non-small cell lung cancer
Therapeutic area: Cancer - Oncology
Country: Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Japan, Republic of Korea, Mexico, The Netherlands, Poland, Romania, Spain, Sweden, Switzerland, Taiwan, Turkey, UK, USA
Trial
details: CheckMate -026 is a Phase 3, open-label, randomized study of Opdivo as monotherapy versus investigator’s choice chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). Patients enrolled in the trial had received no prior systemic treatment for advanced disease and tested positive for PD-L1 expression. The trial randomized 541 patients to receive either Opdivo 3 mg/kg intravenously every two weeks or investigator’s choice chemotherapy in squamous patients (gemcitabine with cisplatin/gemcitabine with carboplatin/paclitaxel with carboplatin) and non-squamous patients (pemetrexed with cisplatin/pemetrexed with carboplatin) until disease progression, unacceptable toxicity, or completion of 6 cycles. The primary endpoint is progression-free survival, as assessed by the Independent Radiology Review Committee, in patients with ? 5% PD-L1 tumor expression. (NCT02041533)
Latest
news: * On October 9, 2016, BMS announced the final primary analysis of CheckMate -026, a trial investigating the use of Opdivo® (nivolumab) monotherapy as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 ?1%. The study was powered to assess progression-free survival (PFS) for patients with ?5% PD-L1 expression. The topline results from this study were previously disclosed and showed CheckMate -026 did not meet the primary endpoint of superior PFS compared to chemotherapy. In patients with ?5% PD-L1 expression, the median PFS was 4.2 months with Opdivo® and 5.9 months with platinum-based doublet chemotherapy (stratified hazard ratio [HR]=1.15 [95% CI: 0.91, 1.45, p=0.25]). Overall survival was 14.4 months for Opdivo® versus 13.2 months for chemotherapy (HR=1.02 [95% CI: 0.80, 1.30]), and 60% of patients on the chemotherapy arm received subsequent Opdivo® use after progression either through crossover or commercial access. The safety of Opdivo® was consistent with the known safety profile of the drug in previous studies. Among all-treated patients, treatment-related adverse events (AE) of any grade and Grade 3/4 occurred in 71% and 18% of Opdivo®-treated patients and 92% and 51% of chemotherapy-treated patients, respectively. “Opdivo has replaced the standard of care in previously treated metastatic NSCLC patients regardless of PD-L1 expression, and this study aimed to answer an important clinical question of whether this PD-1 inhibitor could provide superior benefit over chemotherapy in a broad patient population in the first-line setting,” said Mark Socinski, M.D., executive medical director, Florida Hospital Cancer Institute, Orlando, and lead author of the study. “These findings provide additional understanding of the role of PD-1 monotherapy in treatment-naïve patients and confirm there is still a significant opportunity for improving outcomes for the majority of these patients.” These data have been presented at the 2016 European Society for Medical Oncology (ESMO ) Congress from 5:35 – 5:50 p.m. CEST (Abstract #LBA7_PR). * On August 5, 2016, BMS announced that CheckMate -026, a trial investigating the use of Opdivo® (nivolumab) as monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at ? 5%. The company will complete a full evaluation of the CheckMate -026 data and work with investigators on the future presentation of the results.
