European regulator endorses approving Leclaza combo therapy to treat NSCLC

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the combination therapy of Leclaza (lazertinib), which is known in Europe as Lazcluze, and Rybrevant (amivantamab) for the first-line treatment of non-small cell lung cancer (NSCLC), bringing the drug closer to entering the European market.

Last Thursday (local time), the CHMP released the results of its November meeting, which took place from Monday to Thursday, and gave a positive opinion for the combination of lazertinib and amivantamab as a first-line treatment for advanced NSCLC with EGFR mutations.

Leclaza is a third-generation EGFR TKI developed by Yuhan Corp. and licensed globally to Johnson & Johnson, excluding Korea. In December 2023, J&J filed for approval of the combination of lazertinib and amivantamab with the U.S. Food and Drug Administration (FDA) and EMA for the first-line treatment of EGFR-mutant NSCLC.

In August, it received approval from the FDA for the first-line treatment of patients with EGFR-mutation-positive metastatic NSCLC.

The CHMP's recommendation is the final step toward final approval by the EMA, which typically issues its decision within a few months. Final approval by the EMA is expected in late 2024 or early 2025. If approved by the EMA, lazertinib will be available for commercialization in the European market, further strengthening its position in the global lung cancer treatment market, according to Yuhan.

Market watchers are looking to see if this combination therapy can become the new standard of care across Europe.

Last Wednesday, the American Society of Clinical Oncology (ASCO) also updated its guidelines for treating advanced NSCLC with EGFR mutations.

The update strongly recommends Tagrisso (osimertinib) monotherapy as the first-line treatment option for patients with EGFR-mutant NSCLC. It suggests that the combination of osimertinib with platinum-based chemotherapy or lazertinib and amivantamab may be additionally considered.

This recommendation is based on the results of the FLAURA 2 and MARIPOSA studies. In particular, the MARIPOSA study showed that progression-free survival (PFS) in the lazertinib plus amivantamab arm was significantly longer than osimertinib alone (23.7 months vs. 16.6 months, hazard ratio [HR] 0.70, P<0.001).

However, the amivantamab plus lazertinib combination had a higher incidence of grade 3 or higher treatment-related adverse events (75 percent) than osimertinib monotherapy (43 percent), highlighting the importance of toxicity management.