Lung cancer, diagnosed in more than two million people in 2018, continues to be the most common type of cancer worldwide. At diagnosis, approximately 75 percent of all of them are already in advanced stages of the disease. In addition, about 85 percent of all lung cancers belong to the non-small cell typology, and of these, between 3 percent and 5 percent of cases have the ALK translocation.
Precisely for these patients the European Commission has approved lorlatinib, on a conditional basis, in monotherapy as a treatment for adult patients with advanced non-small cell lung cancer ALK positive, whose disease has progressed after treatment with alectinib or ceritinib as the first ALK inhibition therapy , or crizotinib and at least one more ALK inhibitor.
This decision is supported by the results of a non-randomized Phase 1 and 2 clinical study B7461001, with dose escalation and activity estimation, from multiple and multicentre cohorts, which showed the results of the administration of lorlatinib in a total of 139 patients with ALK-positive NSCLC previously treated with at least one second generation ALK inhibitor.
Specifically, the overall response rate was 42.9 percent in those previously treated with an ALK inhibitor, and 39.6 percent in those previously treated with two or more inhibitors. Sixty-seven percent of the patients had brain metastases.
In the words of Cecilia Guzmán, medical director of the Oncology Unit of Pfizer Spain, “we are excited about this approval because it is the second Pfizer drug for non-small cell lung cancer approved in less than two months and the third with biomarkers for this pathology. “
The approval of lorlatinib represents an advance in the treatment of ALK + NSCLC, although it should be noted that it has a conditional nature, since, despite the fact that the data obtained in its development phase are less numerous than what is required in the general approval processes, this medicine covers an urgent need in the approach of the disease in which the balance between benefit and risk is positive and the immediate availability of the drug is highly positive.
That is why, in this approval framework, Pfizer is committed to provide additional data from post-authorization clinical trials, including phase 3 CROWN, which is underway and evaluates lorlatinib versus crizotinib in the first-line treatment of patients with CPNM ALK +.