Breaking News Briefs

• Pembrolizumab (Keytruda) received FDA approval for use in combination with pemetrexed and carboplatin for the first-line treatment of patients with metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. This approval was based on randomized phase II data from KEYNOTE-021, Cohort G1, in 123 previously untreated patients with metastatic nonsquamous NSCLC and no evidence of EGFR or ALK genomic tumor aberrations , which showed an improvement in overall response rate and in progression-free survival for patients receiving pembrolizumab plus pemetrexed and carboplatin compared to chemotherapy alone. (5/10/17)

• Brigotinib (Alunbrig) received FDA accelerated approval for use in patients with ALK-positive non-small-cell lung cancer (NSCLC) whose disease has progressed on or who are intolerant to crizotinib. Approval was based on a non-comparative, two-arm, open-label, multicenter clinical trial demonstrating a clinically meaningful and durable overall response rate (ORR) in crizotinibexposed patients with locally advanced or metastatic ALK-positive NSCLC (the ALTA Trial; NCT02094573). (4/28/17)

• Lorlatinib was granted breakthrough therapy designation from the FDA for use in patients with ALK-positive metastatic NSCLC who had previously received one or more ALK inhibitors. Results were submitted to the FDA from the ongoing phase I/II study NCT01970865 (N = 54) presented at the 17th World Conference on Lung Cancer in 2016. Patients with ALK- or ROS1-positive NSCLC can develop resistance to TKI therapy, with the CNS as a common site of relapse. Lorlatinib is a selective brain-penetrant ALK/ROS1 TKI active against most known resistance mutations. (4/27/17)

• Pembrolizumab (Keytruda) received its second Med safe registration in New Zealand for PD-L1—positive patients with advanced NSCLC). Lung cancer is the leading cause of deaths due to cancer in New Zealand. In September 2016, funding of pembrolizumab was approved in New Zealand for treatment of advanced melanoma. (4/22/17)