OHC Plays Key Role in Approval of Nivolumab – First Immunotherapy for Lung Cancer
We have tremendous news to share with you on a breakthrough cancer treatment.
The FDA has approved the anti–PD-1 agent nivolumab (Opdivo) for the treatment of patients with advanced squamous non–small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. The approval comes 3 months ahead of the FDA’s scheduled decision date.
Non-small-cell lung carcinomas are any type of epithelial lung cancer other than small cell lung carcinoma (SCLC). As a class, NSCLCs are relatively insensitive to chemotherapy, compared to small cell carcinoma.
Approval was based on data from the phase III CheckMate-017 clinical trial in which nivolumab improved overall survival (OS) by 3.2 months versus docetaxel in previously treated patients with advanced or metastatic squamous cell NSCLC. This new treatment modality has demonstrated unprecedented results, with the potential to replace chemotherapy for these patients. It is the first immunotherapy for lung cancer.
Dr. David M. Waterhouse, chair of the OHC Research Department, expressed his unabashed excitement over the news in his correspondence to his OHC research colleagues and team:
“I can’t tell you how exciting it is to see this announcement. I saw the data from this trial (along with other trials) two weeks ago when I went to Dallas to represent OHC. We were one of the largest enrollers to this trial and will be authors on a paper just submitted to The New England Journal of Medicine. There will certainly be more to come as we move forward with immune checkpoint inhibition. Thanks to everyone who saw yet another PD-1 patient, entered the data, managed the regulatory, or covered their partner so they could be free to do the work. All of you are making a difference in the lives of our patients and many others who will benefit from your work! I’m so proud of our team.”
Also excited about the news was Sarah Canon Research Institute’s David Spigel who said, “This pivotal phase III trial (LUN 226) was a global study and OHC and SCRI played central roles in getting this trial enrolled quickly – helping to bring immunotherapy into lung cancer treatment today. This represents a substantial step forward in lung cancer care.”
This breakthrough cancer treatment is making news everywhere, so a quick Google search will give you more information. But here’s a head start on the specifics of the study.