The latest data from Johnson and Johnson’s Rybrevant and Lazcluze lung cancer combo was better than standard of care Tagrisso on overall survival. But analysts say the next step is getting a subcutaneous formula approved.
A combo regimen of Johnson & Johnson’s Rybrevant and Lazcluze significantly prolonged overall survival in non-small cell lung cancer patients, beating AstraZeneca’s Tagrisso in a late-stage trial.
“We view today’s update as an incremental positive for JNJ,” analysts at Guggenheim Partners wrote in a note on Wednesday evening, adding that the findings are “in line” with a September 2024 readout. At the time, J&J reported a 23% overall survival benefit in patients on Rybrevant plus Lazcluze. Though data were still immature for statistical analysis, the pharma had called the OS trend “strong and improving.”
J&J updated these results in the latest release from the Phase III MARIPOSA study on Wednesday. At a median follow-up of 37.8 months, Rybrevant plus Lazcluze lowered the risk of death from any cause by 25% as compared with Tagrisso. This effect was highly statistically significant, according to J&J. MARIPOSA tested the Rybrevant regimen as a first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring specific EGFR mutations.
At the time of the readout, median OS had not yet been reached in patients treated with Rybrevant and Lazcluze, “indicating that survival benefits continue to extend beyond the measured follow-up period,” according to J&J. Median OS in Tagrisso comparators was 36.7 months.
J&J also conducted survival projections for study participants treated with the drug combo and found that Rybrevant plus Lazcluze could likely extend median OS by at least 12 months versus Tagrisso.
MARIPOSA also met multiple secondary endpoints, demonstrating that the Rybrevant combo was superior to Tagrisso in terms of intracranial progression-free survival, intracranial duration of response and intracranial overall response rate. J&J’s regimen also significantly delayed symptom progression.
The combo of Rybrevant and Lazcluze has been approved since August 2024, when the FDA hgave the green light for the regimen to be used as a first-line option in a subgroup of patients with EGFR mutations and with locally advanced or metastatic disease. Tagrisso is currently a common treatment option in this indication.
J&J on Wednesday said that it plans on sharing the updated OS data from MARIPOSA with health regulators worldwide.
According to the Guggenheim analysts, however, “the next key step” for the Rybrevant-Lazcluze combo “would be obtaining FDA approval” for a subcutaneous formulation of Rybrevant. In December 2024, the regulator rebuffed J&J’s first attempt at this, citing concerns with a manufacturer. The regulator did not identify problems with the drug formulation or with its data package.
If approved, subcutaneous Rybrevant could “offer patients a more tolerable option as the company works towards its goal of >$5bn in annual peak sales for the franchise,” according to the Guggenheim analysts.
