Johnson & Johnson (J&J) has announced positive results from its Phase 3 MARIPOSA trial, revealing that the combination of Rybrevant (amivantamab) and lazertinib significantly improved progression-free survival compared to AstraZeneca's Tagrisso (osimertinib) in patients with EGFR-mutated non-small cell lung cancer (NSCLC). This outcome marks a potential shift in the treatment landscape for this specific patient population.
The MARIPOSA study enrolled over 1,000 previously untreated patients with EGFR-mutated NSCLC. The trial's primary endpoint was progression-free survival, with secondary endpoints including overall survival and response rates. While J&J has not yet released detailed data, the company stated that the combination therapy demonstrated a "clinically meaningful" benefit over Tagrisso. This is particularly significant as it represents the first chemotherapy-free option to achieve such an outcome in a pivotal trial.
Rybrevant, a bispecific antibody approved in the U.S. in 2021, targets both EGFR and MET. Lazertinib is a small molecule EGFR inhibitor. The combination aims to provide a more comprehensive blockade of EGFR signaling pathways, potentially overcoming resistance mechanisms that can develop with single-agent EGFR inhibitors like Tagrisso.
Tagrisso has become a standard-of-care treatment for EGFR-mutated NSCLC, generating approximately $5.4 billion in sales for AstraZeneca last year. It is also approved as an adjuvant therapy after surgery. However, the emergence of resistance and the need for more effective first-line treatments remain significant challenges.
J&J's MARIPOSA-2 study previously demonstrated a progression-free survival benefit for Rybrevant plus chemotherapy, with or without lazertinib, compared to chemotherapy alone in lung cancer patients. The MARIPOSA trial extends these findings by showing the benefit of Rybrevant and lazertinib without chemotherapy, offering a potentially less toxic treatment option.
Although the overall survival data from the MARIPOSA trial showed a trend favoring the J&J combination, the difference has not yet reached statistical significance. The study is ongoing to further assess long-term survival outcomes. Detailed results from the MARIPOSA trial are expected to be presented at an upcoming medical conference.
