NEW YORK – The European Commission on Friday granted marketing authorization to Pfizer's lorlatinib (Lorviqua in the EU; Lorbrena in the US) as a first-line treatment for advanced ALK-positive non-small cell lung cancer patients who have not received prior ALK inhibitor treatment.
Regulators reviewed results from the Phase III CROWN trial, in which nearly 300 ALK-positive NSCLC patients received either lorlatinib or Pfizer's ALK inhibitor crizotinib (Xalkori). The response rate was 76 percent in the lorlatinib arm compared to 58 percent in the crizotinib arm. Lorlatinib also improved outcomes for patients with brain metastases, with 82 percent of patients in the lorlatinib arm seeing an intracranial response versus 23 percent in the crizotinib arm. Additionally, 80 percent of lorlatinib-treated patients were alive without disease progression at 12 months compared to 35 percent of crizotinib-treated patients.
Lorlatinib in 2019 was approved in the European Union as a second- or third-line treatment for advanced ALK-positive NSCLC after patients progressed on other ALK inhibitors. The US Food and Drug Administration approved the drug for the same indication in 2018 and then expanded the drug's use in 2021 into the first-line ALK-positive metastatic NSCLC setting.
"The expanded approval for Lorviqua in Europe is a considerable advancement — especially for the close to 40 percent of patients with ALK-positive metastatic NSCLC who are faced with brain metastases at diagnosis," Benjamin Solomon, investigator for the CROWN trial and a professor in the department of medical oncology at the Peter MacCallum Cancer Center in Australia, said in a statement. "It is exciting to see the significant data generated from the CROWN trial continuing to support expanded use around the world and providing physicians in Europe with a highly effective option from the onset of their patients' treatment journey."
Other drugs on the market in Europe for ALK-positive NSCLC patients include crizotinib, Takeda's brigatinib (Alunbrig), Genentech's alectinib (Alecensa), and Novartis' ceritinib (Zykadia).