Opdivo and Yervoy Combination Misses Primary Endpoint in Phase III Trial for NSCLC
Blockbuster cancer therapies failed to improve progression-free survival as combination.
In an update on the Phase III CheckMate -73L trial, Bristol Myers Squibb announced it did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). The study evaluated Opdivo (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy (ipilimumab) versus CCRT followed by AstraZeneca’s Imfinzi (durvalumab) in patients with unresectable stage III NSCLC.1
The Phase III study (NCT04026412) is a randomized, open label trial. A total of 925 patients were administered either Opdivo and CCRT, followed by Opdivo and Yervoy combination therapy (arm A), Opdivo monotherapy (arm B) or CCRT followed by Imfinzi (arm C).
“Unfortunately, adding immunotherapy concurrently with definitive chemoradiation did not improve PFS outcomes in this setting,” Joseph Fiore, vice president, global program lead, thoracic cancers, Bristol Myers Squibb said in a press release. “There remains a critical need to improve long-term outcomes for these patients and we believe these results will help inform future drug development efforts in this setting. We want to thank the patients, families, and investigators for their contributions to this important research.”
Earlier in January 2024, BMS shared positive results from the open-label, randomized Phase III CheckMate -8HW trial (NCT04008030), which evaluated the Opdivo plus Yervoy combination in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). The combination produced a 79% reduction in the risk of disease progression or death compared to chemotherapy.2
Opdivo plus Yervoy was the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy as first line treatment in MSI-H/dMMR mCRC.
Looking forward for research of the combination in NSCLC patients, BMS plans on completing a full evaluation of the data and working with investigators to share the results.
References
1. Bristol Myers Squibb Provides Update on Phase 3 CheckMate -73L Trial. News release. May 10, 2024. Accessed May 13, 2024. https://news.bms.com/news/corporate-financial/2024/Bristol-Myers-Squibb-Provides-Update-on-Phase-3-CheckMate--73L-Trial/default.aspx
2. Opdivo (nivolumab) Plus Yervoy (ipilimumab) Reduced the Risk of Disease Progression or Death by 79% Versus Chemotherapy in Patients with Microsatellite Instability-High or Mismatch Repair Deficient Metastatic Colorectal Cancer in CheckMate -8HW Trial. News release. January 20, 2024. Accessed May 13, 2024. https://news.bms.com/news/corporate-financial/2024/Opdivo-nivolumab-Plus-Yervoy-ipilimumab-Reduced-the-Risk-of-Disease-Progression-or-Death-by-79-Versus-Chemotherapy-in-Patients-with-Microsatellite-Instability-High-or-Mismatch-Repair-Deficient-Metastatic-Colorectal-Cancer-in-CheckMate--8HW-Trial/default.aspx
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
