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
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Phase II ALPACA Trial Shows Lepodisiran Produces Significant, Sustained Lipoprotein(a) Reductions
March 31st 2025Eli Lilly’s lepodisiran, an investigational siRNA therapy, achieved significant and durable reductions in lipoprotein(a) levels, a major genetic risk factor for cardiovascular disease.
