Johnson & Johnson (J&J) has secured the US Food and Drug Administration (FDA) approval for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) to treat a type of lung cancer.
Rybrevant is a fully human bispecific antibody targeting epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET) with immune cell-directing activity, already approved in the US, Europe, and other markets worldwide.
Lazcluze is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR.
The combination is approved as the first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The mutations include exon 19 deletions or exon 21 L858R substitution, as determined by the FDA-approved test.
In 2018, J&J’s subsidiary Janssen Biotech signed a license and collaboration agreement with Yuhan for the development of Lazcluze, marketed as LACLAZA in Korea.
The US-based pharmaceutical company said that Rybrevant plus Lazcluze becomes the first and only multitargeted combination regimen to show superiority over Osimertinib.
Johnson & Johnson innovative medicine worldwide chairman executive vice president Jennifer Taubert said: “Building on more than three decades of oncology innovation, we are uniquely positioned to build best-in-class treatments where survival rates have remained stagnant for years.
“Rybrevant plus Lazcluze establishes a new benchmark in the advanced first-line setting, and we look forward to bringing this new chemotherapy-free treatment regimen to patients.”
Johnson & Johnson R&D innovative medicine executive vice president John Reed said: “Johnson & Johnson is deeply committed to setting new standards of care for people living with some of the most devastating and complex diseases of our time.”
The FDA approval is based on positive results from the Phase 3 MARIPOSA study, which evaluated Rybrevant plus Lazcluze in 1,074 NSCLC patients with EGFR mutations.
In the Phase 3 study, first-line treatment using the regimen reduced the risk of disease progression or death by 30%, compared to Osimertinib.
The Rybrevant plus Lazcluze combination showed a safety profile that was consistent with the profiles of the individual treatments.
The combination caused Venous thromboembolic events (VTE) in participants, and Adverse event (AE) rates in the study were consistent compared to other Rybrevant regimens.
Virginia Cancer Specialists Research Institute director and study investigator Alexander Spira said: “The unique combination of Rybrevant and Lazcluze demonstrated superior efficacy in the first-line treatment of certain patients with EGFR-mutated advanced NSCLC as shown with the MARIPOSA study.
“Patients will now have the option of a potential new first-line standard of care with significant clinical benefits over osimertinib.
“This first-line therapy uses a targeted approach aiming to achieve the best possible patient outcomes while reserving chemotherapy for later stages of treatment when resistance becomes more complex.”
