J&J's Rybrevant combo bests AstraZeneca's established Tagrisso in key lung cancer study

A highly anticipated head-to-head matchup between a Johnson & Johnson combination and AstraZeneca’s star Tagrisso as a first-line treatment in a subset of non-small cell lung cancer (NSCLC) has yielded a winner.

In the MARIPOSA trial, J&J’s Rybrevant—combined with its Yuhan-partnered lazertinib—helped patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC survive longer without disease progression compared with Tagrisso.

An interim analysis showed a “trend” favoring the combo over Tagrisso in life extension, J&J said in a Thursday press release. Investigators will continue to follow study patients for more overall survival data.

The positive results “reinforce the potential of the Rybrevant and lazertinib combination in frontline EGFR-mutated non-small cell lung cancer as a future standard of care," Janssen R&D’s oncology head, Peter Lebowitz, M.D., Ph.D., said in a statement.

J&J plans to present the study data at the upcoming European Society for Medical Oncology (ESMO) congress.

In an August note to clients, Leerink analysts pointed out that the peak sales potential for the combo will depend on the “magnitude of progression-free survival superiority” and overall survival results. The team noted that “the bar for MARIPOSA is high” because of Tagrisso’s “compelling” first-line commercial profile.

AZ recently reaffirmed its belief that Tagrisso can keep its standard-of-care designation in the first-line setting after a positive showing in a new chemotherapy combo at this year’s World Conference on Lung Cancer (WCLC) in Singapore.

That data in newly diagnosed EGFR-mutated NSCLC showcased the drug as a “valuable regimen for patients with higher tumor burden,” AZ’s oncology R&D chief Susan Galbraith, Ph.D. said in the company’s second-quarter earnings call.

Rybrevant’s 2021 accelerated approval made it the first treatment to target NSCLC with EGFR exon 20 insertion mutations before Takeda’s Exkivity came along as a challenger. The two rivals split the U.S. market roughly 50-50 in the second-line setting, according to Takeda.