Johnson & Johnson scored a label expansion for Rybrevant in combination with the newly-approved Lazcluze to treat certain first-line lung cancer patients, putting it in direct competition with AstraZeneca and its blockbuster Tagrisso.
The approval, announced Tuesday, is based on Phase 3 data from J&J’s MARIPOSA study, which showed that the Rybrevant-Lazcluze combo reduced the risk of disease progression or death by 30% compared to Tagrisso in non-small cell lung cancer patients with the two most common EGFR mutations. The median duration of response for Rybrevant (amivantamab) and Lazcluze (lazertinib) was nine months longer than the Tagrisso arm, according to J&J.
Biljana NaumovicAnalysts have said that overall survival data could be a key differentiator for Rybrevant and Lazcluze. Biljana Naumovic, J&J’s president of US oncology in solid tumors, told Endpoints News that it expects to share another cut of overall survival data from the MARIPOSA trial next month at the World Conference on Lung Cancer in San Diego. A final overall survival readout will come later, she said.
Last year at ESMO, J&J said that overall survival data were trending in favor of the Rybrevant combo, though those results were not statistically significant. J&J has expressed confidence that a later prespecified analysis will show statistical significance.
Naumovic stressed that many patients with EGFR-mutated non-small cell lung cancer in the US never make it to second-line treatment because of disease progression or limited options.
“That means for the physicians, they need to use the best therapy option first,” Naumovic said. “This is a very compelling argument for the physicians to use Rybrevant and Lazcluze.”
AstraZeneca’s Tagrisso has been approved in the same lung cancer population since 2018. Tagrisso recently won a label expansion as part of a chemotherapy combination regimen in that indication. The drug generated $5.8 billion in sales in 2023.