Currently Viewing:
Newsroom
Currently Reading
Opdivo Fails to Meet Primary Endpoint in Phase 3 SCLC Trial
October 17, 2018 – Samantha DiGrande
ACOs Had No Significant Impact on Spending for Patients With Cancer
October 14, 2018 – Laura Joszt
Know the Risk: 5 Breast Cancer Risk Factors
October 12, 2018 – Samantha DiGrande
The US Oncology Network Announces Highly Positive MIPS Results for 2017
October 12, 2018 – Laura Joszt
Tisagenlecleucel's High Price Aligns With Its Benefit in Pediatric B-ALL, Study Finds
October 11, 2018 – Laura Joszt
NCCN Releases Patient Guidelines for Neuroendocrine Tumors
October 10, 2018 – Samantha DiGrande
FDA Approves Libtayo to Treat Second Most Common Skin Cancer
October 09, 2018 – Samantha DiGrande
Some Metro Areas Facing Shortages of Oncologists in Coming Years, Report Says
October 09, 2018 – Allison Inserro
Does Transcriptional Loss of HLA Cause Immunotherapy Resistance?
October 08, 2018 – David Bai

Opdivo Fails to Meet Primary Endpoint in Phase 3 SCLC Trial

Samantha DiGrande
Last week, Bristol-Myers Squibb announced results from the phase 3 CheckMate -331 trial that investigated nivolumab (Opdivo) versus the current standard of care, chemotherapy, in the treatment of patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The trial found that nivolumab did not significantly increase overall survival compared with chemotherapy.
 
Last week, Bristol-Myers Squibb announced results from the phase 3 CheckMate -331 trial that investigated nivolumab (Opdivo) versus the current standard of care, chemotherapy, in the treatment of patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The trial found that nivolumab did not significantly increase overall survival compared with chemotherapy.

Lung cancer is the leading cause of cancer deaths globally, accounting for approximately 1.8 million deaths each year, according to the World Health Organization. SCLC makes up about 10% to 15% of all lung cancer cases. Although chemotherapy remains the standard of care in the front-line setting, many patients experience relapse within 1 year. 

The primary endpoint of overall survival with nivolumab, a PD-1 immune checkpoint inhibitor, versus chemotherapy was notably not met in the end-stage trial. CheckMate-331 is an open-label, randomized phase 3 study in which patients were randomized into 2 treatment arms: 1 evaluating nivolumab; and an active comparator arm evaluating topotecan or amrubicin, investigators choice. Though the drug did not meet the primary endpoint in the study, the safety profile remained consistent with that observed in previously reported monotherapy studies. 

This finding is significant however, as it comes nearly 2 months after the FDA approved the drug to treat patients whose SCLC had progressed despite undergoing 2 previous therapies. 

“Small cell lung cancer is a highly aggressive disease in which significant unmet needs remains. We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer,” said Sabine Maier, MD, development lead for thoracic cancers at Bristol-Myers Squibb.

Nivolumab competes with pembrolizumab, sold as Keytruda. In the second quarter of 2018, nivolumab generated sales of $1.63 billion, while pembrolizumab earned $1.67 billion. Nivolumab is already approved for numerous indications across various disease states including melanoma, renal cell carcinoma, and classical Hodgkin lymphoma, among others. 

Related Articles

Opdivo Plus Chemo Boosts Progression-Free Survival 26% Over Chemo Alone in Late-Stage NSCLC
Immunotherapy-Based Combination Improves Survival in SCLC for First Time in Phase 3 Study
Opdivo, Yervoy Combination Approved for Certain Colorectal Cancers
 
Copyright AJMC 2006-2019 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up