European Commission Approves Nivolumab BMS for Previously-Treated Patients With Advanced Squamous Non-Small Cell Lung Cancer

European Commission Approves Nivolumab BMS for Previously-Treated Patients With Advanced Squamous Non-Small Cell Lung Cancer

Bristol-Myers Squibb, a global pharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases, has recently announced that the European Commission (EC) approved Nivolumab BMS for advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) patients following previous chemotherapy.

The EC approval is the first treatment advance within the European Union (EU) for NSCLC in more than a decade, allowing the marketing of Nivolumab BMS in all 28 EU Member States.

Nivolumab is the first and the only PD-1 immune checkpoint inhibitor able to improve overall survival (OS) in metastatic previously treated SQ NSCLC patients. It acts as an immunomodulator by blocking ligand activation of the programmed cell death 1 (PD-1) receptor on activated T cells.

“With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care,” said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. “Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal.”

The European Commission’s approval was established following data from two clinical trials: Phase III CheckMate -017 and Phase II CheckMate -063. Both clinical studies examined nivolumab efficacy over a dose that had been established across the Phase III clinical development program of nivolumab for various tumors (3 mg/kg every two weeks).

Results from CheckMate -017, a Phase III open-label, randomized clinical trial showed that the drug had superior clinical benefit across all endpoints in comparison to docetaxel, the standard treatment, regardless of PD-L1 (programmed death ligand-1) expression status. The results showed a risk of death reduction of 41%, and also a superior rate of OS of 42% versus 24% for docetaxel at one-year and superior durable antitumor activity.

In the CheckMate -063, a Phase II single-arm, open-label trial that included patients with metastatic SQ NSCLC who had progressed after two or more lines of therapy, nivolumab demonstrated an estimated 41% one-year survival rate and a median OS of 8.2 months.

Nivolumab’s safety profile was found to be consistent with data from previous clinical trials, and in the Checkmate -017 trial the safety profile was also found to be favourable in comparison to docetaxel.

“Today’s approval of nivolumab for squamous non-small cell lung cancer is truly a major advance for patients fighting this devastating disease, and the providers that treat them,” said Rolf Stahel, M.D., president of the European Society of Medical Oncology and Professor at University Hospital Zurich. “Nivolumab has shown statistically significant and clinically meaningful improvement in efficacy versus standard of care in this patient population. This approval reinforces the science behind Immuno-Oncology including our understanding of the role of PD-L1 expression.”

The rates of lung cancer incidence and mortality in Europe are increasing and account for 20% of all deaths caused by cancer. NSCLC and SQ NSCLC account for about 85% and 25% of all lung cancer cases.

For those NSCLC patients with disease reoccurrence or disease progression despite chemotherapy, treatment options are reduced. The clinical prognosis for NSCLC is poor, with a five-year survival rate of about 2%, worldwide.

Results from CheckMate -017 are published in The New England Journal of Medicine and were recently presented in May during an oral abstract session at the 2015 Annual Meeting of the American Society of Clinical Oncology.

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