EMD Serono, the US biopharmaceutical business of Merck KGaA, Darmstadt, Germany, has begun co-promoting Pfizer's anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib) as part of its global strategic alliance with Pfizer.
The initiation of field-based commercialisation efforts for Xalkori illustrates the company's dedication to oncology, and to bringing important treatment options for challenging cancers to patients.
"The Xalkori co-promotion between EMD Serono and Pfizer marks our first entry into the US oncology market, further delivers on our EMD Serono strategy in specialty care and, most importantly, extends our work to help patients and their families battling serious diseases," said Paris Panayiotopoulos, president and managing director at EMD Serono.
"As our pipeline progresses, we aim to build on this first entry with additional oncology and immuno-oncology therapies."
EMD Serono has extensive expertise in specialty care and is backed by a global organisation with deep oncology experience, which positions the company well to bring oncology treatments to patients in the US. Along those lines, the company is establishing a strong sales force for Xalkori based in US markets with premier cancer centres, deepening EMD Serono's engagement with the clinical oncology community.
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, but has many subtypes and can be difficult to treat. Xalkori is approved in the US for the treatment of patients with metastatic NSCLC whose tumours are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. Xalkori is the first ALK inhibitor approved in the US, Japan and the European Union (EU) and is supported by two positive global randomised trials in the first- and second-line ALK-positive advanced NSCLC treatment settings.
More than 8,000 patients have been treated worldwide with Xalkori, including those who received the treatment in clinical trials.
This co-promotion relationship is part of the larger, global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer to jointly develop and commercialise avelumab, an investigational anti-PD-L1 monoclonal antibody, to accelerate the development of immuno-oncology medicines for patients with cancer. The immuno-oncology alliance will also advance Pfizer's PD-1 antibody.
Outside of the scope of its alliance with Pfizer, EMD Serono has a diversified oncology and immuno-oncology pipeline which includes multiple, high-priority projects currently in development to optimise patient outcomes in challenging cancers that have significant unmet patient need.
Globally, lung cancer is the most common cause of cancer-related deaths in men and the second most common in women, responsible for almost twice as many deaths as both breast and prostate cancer combined. Non-small cell lung cancer is the most common type of lung cancer, accounting for 85 to 90 per cent of all lung cancers. Locally advanced and metastatic disease account for approximately 35 to 40 per cent and 70 per cent of patients, respectively with NSCLC.
Xalkori is a kinase inhibitor indicated in the US for the treatment of patients with metastatic non-small cell lung cancer whose tumours are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The US indication is not limited to any specific line of therapy.
Safety was evaluated in a phase 3 study in patients with ALK-positive metastatic NSCLC randomised to Xalkori (n=172) or chemotherapy (n=171). Serious adverse reactions were reported in 37.2 per cent patients treated with Xalkori.
The most frequent serious adverse reactions reported in patients treated with Xalkori were pneumonia (4.1 per cent ), pulmonary embolism (3.5 per cent ), dyspnea (2.3 per cent ), and ILD (2.9 per cent ). Fatal adverse reactions in Xalkori-treated patients occurred in 9 (5 per cent ) patients, consisting of acute respiratory distress syndrome, arrhythmia, dyspnea, ILD, pneumonia, pneumonitis, pulmonary embolism, respiratory failure, and sepsis.
Common adverse reactions occurring in 25 per cent included vision disorder (diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters), diarrhea, nausea, vomiting, constipation, edema, decreased appetite, fatigue, upper respiratory infection, and dysgeusia.
Grade 3 or 4 events occurring at a higher incidence with Xalkori than with chemotherapy and at greater than 2 per cent incidence were syncope (3 per cent ), QT prolongation (3 per cent ), and pulmonary embolism (5 per cent ). Elevation of ALT of any grade occurred in 76 per cent of patients and grade 3 or 4 in 17 per cent of patients. Neutropenia of any grade occurred in 49 per cent of patients and grade 3 or 4 in 12 per cent of patients. Lymphopenia of any grade occurred in 51 per cent of patients and grade 3 or 4 in 9 per cent of patients. Renal cysts occurred in 4 per cent and neuropathy in 19 per cent of patients treated with Xalkori.