First Immunotherapy for Advanced Lung Cancer Patients, Nivolumab BMS Launched in the UK

Bristol-Myers Squibb (BMS) has announced the UK launch of Nivolumab BMSq* (nivolumab), indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adult patients. The approval of nivolumab represents an important development in treatment for this group of patients because it offers significant superiority in survival rates compared with the current standard of care chemotherapy, docetaxel — one year overall survival of 42% (n=135, 95% confidence interval [CI] = 34-50) vs. 24% (n=137, 95% CI = 17-31) — as well as a marked improvement in safety profile.

Nivolumab has an innovative mode of action that works by harnessing the ability of the immune system to find and fight cancer. Nivolumab is the first in a new class of medicines — PD-1 (programmed death-1) immune checkpoint inhibitors — to be approved for lung cancer, with over 44,000 new diagnoses in the UK in 2012 and killed more people than breast and bowel cancer combined over this period.

Commenting on the UK launch, Dr Sanjay Popat, Consultant Thoracic Medical Oncologist at The Royal Marsden said: “This group of patients with relapsed squamous-type lung cancer represents a considerable unmet medical need in the UK, as chemotherapy has been their main option until now. Many patients at advanced stages of this disease are unable to tolerate the side effects of chemotherapy and some patients will choose to discontinue treatment. The launch of nivolumab is a milestone that changes the treatment landscape from one where existing treatment options have offered modest improvements in survival, to one where lung cancer patients have an additional option which can significantly extend survival.”   

             

Data supporting the approval of nivolumab in this indication includes results from the pivotal Phase III, CheckMate -017 study. This assessed the efficacy and safety of nivolumab in adult patients with advanced squamous-cell NSCLC whose disease had progressed during or after one prior platinum containing chemotherapy regimen. In this study (n=272), patients were randomly assigned to receive either nivolumab (3 mg/kg every 2 weeks, n=135) or docetaxel (75 mg/m2 of body-surface area every 3 weeks, n=137). Patients were treated until disease progression or discontinuation of treatment owing to toxic effects or for other reasons. The results showed that treatment with nivolumab in patients with previously-treated advanced, squamous-cell NSCLC achieved a one-year overall survival rate of 42% vs. 24% for docetaxel. Median overall survival observed was 9.2 months (95% CI, 7.3-13.3) versus 6.0 months (95% CI, 5.1-7.3) for nivolumab and docetaxel respectively.

The safety profile of nivolumab in CheckMate -017 was favourable versus docetaxel. Treatment-related adverse events occurred less frequently with nivolumab (n=131, grade 3–4, 7%) than docetaxel (n=129, grade 3–4, 55%). The majority of adverse reactions were mild to moderate (Grade 1 or 2). Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab.

Commenting on the announcement, Johanna Mercier, General Manager, BMS UK & Ireland said: “BMS is pioneering the field of immuno-oncology and we are delighted that nivolumab has been approved for the treatment of advanced squamous lung cancer second line. The next step will be to ensure that eligible patients in the UK are able to benefit from nivolumab as soon as possible and we are totally committed to continued collaboration with the reimbursement authorities to achieve this.”