NEW YORK – Johnson & Johnson CEO Joaquin Duato believes that Rybrevant (amivantamab) plus Lazcluze (lazertinib) will become the new standard of care in first-line EGFR-mutated advanced non-small cell lung cancer after the combination extended overall survival by more than a year, compared to AstraZeneca's Tagrisso (osimertinib) in a clinical trial.
Duato and other J&J executives discussed the future of Rybrevant-Lazcluze during a call on the firm's financial performance during the first quarter of 2025, a period during which J&J reported worldwide sales of $21.89 billion, a 2.4 percent increase over $21.38 billion in Q1 2024 and slightly above analysts' consensus revenue estimate of $21.65 billion.
In results from the Phase III MARIPOSA trial presented this year at the European Lung Cancer Congress, advanced NSCLC patients with EGFR exon 19 deletions or L858R substitution mutations on Rybrevant-Lazcluze had not reached median overall survival after a median follow-up of 37.8 months, compared to patients on Tagrisso, who had a median overall survival of 36.7 months. Patients on Rybrevant-Lazcluze also had a 56 percent rate of progression-free survival after 3.5 years compared to 44 percent of patients on Tagrisso, the current standard of care in this setting. J&J estimated that Rybrevant-Lazcluze could extend overall survival by at least 12 months compared to Tagrisso.
Lee Brown, healthcare sector global team leader at the investment research firm Third Bridge, noted in an interview that Lazcluze and Tagrisso are comparable in that they are both third-generation tyrosine kinase inhibitors, but when Rybrevant, a bispecific-antibody targeting EGFR and MET, is added to Lazcluze, the combo appears to have an edge over Tagrisso. "This is a chemo-free combination therapy, and it's the first and only regimen to beat AstraZeneca's Tagrisso," Brown said, adding that the trial results make a "strong argument" for doctors to choose Rybrevant-Lazcluze over Tagrisso. And while, in theory, Rybrevant plus Tagrisso might have similar benefits, Brown pointed out that "there's not a study that shows that."
John Reed, J&J executive VP of Innovative Medicine, called the MARIPOSA data "a truly practice-changing achievement" during the investor call. He noted that NSCLC is the most prevalent form of lung cancer, comprising about 85 percent of lung cancer diagnoses. "Sadly, less than 20 percent of people diagnosed with this form of the disease are alive after five years," he said. "And only a fraction live long enough to try a second treatment. That's why it's so important to use the best treatment first."
The drugmaker also recently netted an approval of a subcutaneous formulation of Rybrevant in Europe in indications where the intravenous formulation of the drug is already approved. "This was an important milestone for patients, as subcutaneous Rybrevant reduces administration time from hours to minutes," Duato said.
J&J reported $141 million in sales of Rybrevant-Lazcluze in the first quarter of 2025, a threefold increase from the $47 million it recorded in Q1 2024. Over the same period, sales of J&J's BCMA-directed CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) more than doubled to $369 million from $157 million in Q1 2024. In its oncology segment overall, J&J reported a nearly 18 percent increase in worldwide sales to $5.68 billion in Q1 2025 from $4.81 billion during the same period last year.
J&J CFO Joseph Wolk said during the call that the company expects tariff costs of about $400 million this year, "based on the programs that have been announced and the timing that correlates with those programs." He added that that's inclusive of Mexican and Canadian import tariffs and, "to a very small degree," some of the steel and aluminum tariffs and Chinese tariffs, both import and retaliatory. The firm's medtech business will primarily be impacted, Wolk said.
In Q1 2025, J&J recorded net earnings of $11.0 billion, or $4.54 per share, compared to net earnings of $3.26 billion, or $1.34 per share, in Q1 2024. On an adjusted basis, J&J reported Q1 EPS of $2.77. On average, analysts had expected $2.59 per share.
J&J increased its full-year 2025 sales guidance from a range of $89.2 billion to $90.0 billion in January to between $91.0 billion and $91.8 billion as of April 2025. It maintained EPS expectations in the range of $10.50 and $10.70.