FOR IMMEDIATE RELEASE
July 27, 2015
Bristol-Myers Squibb’s nivolumab first immuno-oncology agent approved by European Commission for lung cancer
The European Commission’s recent approval of nivolumab as a treatment for patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) following prior chemotherapy is the first for patients in Europe with squamous NSCLC in over a decade.
In Europe, lung cancer currently accounts for 20% of all cancer-related deaths. NSCLC is one of the most common types of the disease and accounts for approximately 85% of lung cancer cases, and squamous NSCLC accounts for approximately 25% to 30% of all lung cancers. For patients with NSCLC, whose disease reoccurs or progresses despite chemotherapy, treatment options are limited and the prognosis is poor, with a five-year survival rate of approximately 2%, globally.
“[The approval of nivolumab] strengthens our armamentarium to fight cancer in patients with advanced or metastatic squamous NSCLC to an unprecedented extent,” explained SITC member Heinz Zwierzina, MD (Innsbruck University, Austria). “The toxicity profile of the drug is comparably low and patients are expected to live a longer life with a gain in quality of life.”
What the Approval Means for the Field
First approved in July 2014 for the treatment of unresectable melanoma in Japan, nivolumab has since demonstrated clinical benefit leading to approvals in several countries across the globe.
In the United States, nivolumab received FDA approval in December 2014 for the treatment of unresectable or metastatic melanoma following treatment with ipilimumab or a BRAF inhibitor. And, in March 2015, the FDA granted approval for nivolumab as a treatment for patients with metastatic squamous NSCLC following a platinum-based chemotherapy.
The approval of nivolumab for squamous NSCLC marks the second approval in all 28 Member States of the European Union, following an approval for the treatment of advanced melanoma—regardless of BRAF mutation status—just last month.
“The approval of nivolumab for the treatment of lung cancer in Europe is a major step forward for immunotherapy,” stated SITC President Howard L. Kaufman, MD, FACS (Rutgers Cancer Institute of New Jersey). “Not only does the approval bring an important new option for patients with lung cancer, but it also supports the increasing role of immunotherapy as a viable option for the treatment of all cancers worldwide.”
What this Means for Patients
The European Commission approval is based on the results of phase III trial, CheckMate-017, and phase II trial, CheckMate-063, which involved patients who had previously been treated with chemotherapy for advanced or metastatic squamous NSCLC. CheckMate-017 revealed improved overall survival (OS) by 3.2 months versus comparator chemotherapy drug, docetaxel. In the single-arm phase II CheckMate-063 study, nivolumab demonstrated a 1-year OS rate of 41%.
For patients with advanced or metastatic squamous NSCLC, this approval is life changing. A second-line, non-chemotherapy option, nivolumab is a well-tolerated treatment. Patients who undergo this therapy experience fewer and less severe side effects and are able to lead more normal lives.
“One major challenge of ongoing research is to learn [for whom immunotherapy does not work],” explained Professor Zwierzina. “The way ahead will involve defining subgroups of patients who would benefit better from other immunomodulatory agents or combinations with ‘standard’ therapies, such as chemotherapy, signal transduction inhibitors or radiotherapy.” Further, “the definition of biomarkers will be key not only for treatment selection but also for pharmacoeconomic reasons.”