Belgian pharmaceutical company Janssen, a subsidiary of Johnson & Johnson, has reported findings from the Phase III MARIPOSA-2 clinical trial of Rybrevant (amivantamab-vmjw) regimens in locally advanced or metastatic non-small cell lung cancer (NSCLC) patients.
The open-label, randomised trial assessed the safety and efficacy of two treatment regimens of Rybrevant and chemotherapy, which were given with and without lazertinib.
It enrolled NSCLC patients with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution and progressed on or after treatment with osimertinib.
According to the findings, Rybrevant (amivantamab-vmjw) plus chemotherapy, given with or without lazertinib, was found to reduce disease progression or mortality risk by 56% and 52%, respectively, compared with chemotherapy alone.
In addition, two regimens of Rybrevant led to a substantial improvement in objective response rate (ORR), duration of response (DOR) and intracranial progression-free survival (PFS) against chemotherapy alone.
Serious adverse events were reported in 52% of patients given Rybrevant plus chemotherapy with lazertinib, against 32% of those given Rybrevant plus chemotherapy and 20% of those who only received chemotherapy.
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Janssen Research & Development late development and global medical affairs vice-president Craig Tendler said: “Rybrevant plus chemotherapy, given with and without lazertinib, showed consistent disease control across all pre-specified patient subgroups in the MARIPOSA-2 study.
“These encouraging results reinforce the distinct profile of Rybrevant-based regimens as potential practice-changing treatment options and mark another important key milestone in our pursuit to transform the treatment of EGFR-mutated NSCLC.”
Rybrevant is a bispecific antibody that acts on EGFR and MET with immune cell-directing activity.
In 2021, the US Food and Drug Administration (FDA) granted accelerated approval for the antibody.
Since the FDA’s approval, Rybrevant has been indicated for treating locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in adult patients who have progressed on or after platinum-based chemotherapy.