Dive Brief:
- A cancer drug combination developed by Johnson & Johnson succeeded in an important late-stage trial testing the new regimen against a widely used medicine from AstraZeneca.
- According to J&J, treatment with its approved drug Rybrevant and an experimental therapy called lazertinib kept a common type of metastatic lung tumor at bay for longer than AstraZeneca’s Tagrisso alone. The results were from an interim analysis of the study, which is continuing to study patient survival.
- J&J’s trial, called Mariposa, has been followed closely by analysts as it could offer J&J a chance to compete with AstraZeneca in a large cancer drug market. J&J didn’t share any specific data in its statement Thursday, but said it plans to submit the study results for presentation at an upcoming medical conference.
Dive Insight:
The Mariposa study is a key part of J&J’s plans to compete with AstraZeneca in lung cancer, and its results have been anticipated for months.
According to J&J, its drug combination is the first chemotherapy-free option to show a “clinically meaningful” benefit over Tagrisso in a pivotal study. The positive results follow the success of another Phase 3 study, dubbed Mariposa-2, which showed a progression-free survival benefit over chemo for lung cancer patients who received Rybrevant plus chemo with or without lazertinib.
The two studies focused on people whose non-small cell lung cancer was driven to growth by mutations in a gene called EGFR that helps control cell division. The mutations are found in anywhere from 10% to 15% of European and North American patients with non-small cell lung cancer, and an even higher proportion among people in Asia.
Tagrisso has become a go-to treatment for these lung tumors. Last year, AstraZeneca earned about $5.4 billion from sales of the drug, which is also approved in the U.S. as an “adjuvant” therapy after surgery for people with EGFR-mutated non-small cell lung cancer.
Earlier this year, analysts were predicting that a four- to six-month progression-free survival benefit over Tagrisso would be enough to support the use of Rybrevant and lazertinib. But an AstraZeneca study recently showed that combining Tagrisso with chemotherapy extended median progression-free survival by nearly nine months over Tagrisso alone, potentially raising the bar for J&J.
More than 1,000 patients with EGFR-mutated non-small cell lung cancer who had not previously been treated participated in J&J’s study. The main objective was to show a progression-free survival benefit over Tagrisso, but investigators are also tracking response and survival rates. J&J said the data showed a survival “trend” favoring its combination compared to Tagrisso, but the difference was not yet statistically significant.
Rybrevant, which was approved in the U.S. in 2021, is a bispecific antibody, meaning it binds to two targets at once — in this case EGFR and another cancer drug target called MET. Lazertinib is a small molecule drug that’s aimed at certain types of EGFR.