Pfizer’s Lorbrena has come out on top in a head-to-head trial against its older ALK inhibitor Xalkori in previously untreated non-small cell lung cancer (NSCLC) with this specific genetic mutation.
Lorbrena (lorlatinib) reduced the risk of disease progression or death by 72% in ALK-positive NSCLC patients compared to Xalkori (crizotinib) in the phase 3 CROWN trial, presented over the weekend at the 2020 European Society for Medical Oncology (ESMO) virtual congress.
In the same trial, the progression-free survival rate was not yet estimable for Lorbrena, compared to 9.3 months for Xalkori. The intracranial objective response rate was 82% in patients with measurable brain metastases, with a complete response rate of 71% associated with Lorbrena treatment.
Despite the NSCLC market being largely dominated by Merck & Co/MSD’s Keytruda (pembrolizumab), the ALK-positive patient group is an important subset, with this type of tumour mutation occurring in around 3-5% of all cases.
Follow-up ALK inhibitors are particularly crucial in this treatment setting, given that many patients experience tumour progression after initial treatment and often require a second- or third-line option. It is also important to note that central nervous system progression often occurs in this type of cancer, wherein the cancer spreads to the brain.
“These results of the CROWN study support the use of Lorbrena as a highly effective first-line therapy for patients with advanced ALK-positive non–small cell lung cancer,” said lead study author Ben Solomon, a medical oncologist in the Lung Service and the Head and Neck service.
The company added that it also intends to share the results from the study with the US Food and Drug Administration (FDA) and other health regulators across the globe to support its approval ambitions.
Currently, Lorbrena is approved only in the second-line setting, for patients who have already been treated with one or more therapies, including Xalkori and treatments from other competitors.