J&J's (JNJ) Rybrevant Combo Meets Primary Goal in NSCLC Study
Johnson & Johnson JNJ announced positive top-line data from a late-stage study evaluating a chemotherapy-free regimen of its drug, Rybrevant (amivantamab-vmjw), for treating EGFR-mutated first-line non-small cell lung cancer (NSCLC).
The phase III MARIPOSA study evaluated Rybrevant in combination with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor (TKI), versus AstraZeneca’s AZN Tagrisso (osimertinib) as a first-line treatment in EGFR-mutated NSCLC. Tagrisso is AZN’s third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC.
AstraZeneca received the FDA approval for Tagrisso in March 2017 for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, whose disease has progressed on or after EGFR TKI therapy.
JNJ’s Rybrevant is currently approved for the treatment of adult patients with locally advanced or metastatic NSCLC, whose disease has progressed on or after platinum-based chemotherapy.
The MARIPOSA study met its primary endpoint of progression-free survival (PFS) in patients receiving Rybrevant plus lazertinib compared with AZN’s Tagrisso, demonstrating statistical significance and clinically meaningful improvement.
Furthermore, an interim analysis of the overall survival (OS), one of the secondary endpoints of the study, also favored the treatment arm receiving the combination therapy of Rybrevant and lazertinib compared with Tagrisso. However, the statistical and clinical significance of OS data has not been determined yet.
Other secondary endpoints in the MARIPOSA study include objective response rate, duration of response, intracranial PFS, PFS after first subsequent therapy and time to symptomatic progression.
The safety profile of the Rybrevant/lazertinib combo was also consistent with that observed in previously reported data of the combo drug.
Management claims that the current standard-of-care EFGR TKIs in the first-line treatment of EGFR-mutated NSCLC often lead to resistance and disease progression when used as monotherapy, representing a serious unmet medical need. The combination therapy of Rybrevant and lazertinib, subject to successful development, has the potential to advance treatment beyond TKI monotherapy in this indication.
The data readout from the MARIPOSA study marks the third late-stage study on Rybrevant to be announced in 2023, following results from the PAPILLON and MARIPOSA-2 studies.
JNJ plans to present results from MARIPOSA, PAPILLON and MARIPOSA-2 studies at an upcoming medical conference, which will include additional details on select secondary endpoints.
Johnson and Johnson is also currently evaluating Rybrevant in multiple other studies in NSCLC indication.
Currently, the standard of care in the frontline treatment of metastatic NSCLC is Merck’s MRK Keytruda. Notably, Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and approved for several types of cancer, accounting alone for around 40% of Merck’s pharmaceutical sales.
Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
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