Rybrevant (amivantamab-vmjw) improved progression-free survival when given with or without lazertinib to patients with locally advanced or metastatic EGFR exon 19 (ex19del) or L8588R substitution non-small cell lung cancer that has previously progressed on Tagrisso (Osimertinib), according to findings from the phase 3 MARIPOSA-2 study announced in a press release by Janssen.
Overall, the study met the primary endpoint of improved progression-free survival (time from treatment until death or disease worsening) with both Rybrevant groups compared with chemotherapy. Janssen plans on revealing the study’s results at an upcoming event, which will also include results of overall survival (time from treatment until death of any cause), objective response rate (percentage of patients whose disease shrinks or disappears from treatment), duration of response and intracranial progression-free survival.
“MARIPOSA-2 provides the first phase 3 study data of Rybrevant-based regimens in the broader EGFR-mutated non-small cell lung cancer population. The study builds on the significant innovation of Rybrevant, a first-in-class bispecific antibody targeting two major oncogenic driver pathways, with clinically meaningful results that may change the treatment paradigm,” explained Dr. Peter Lebowitz, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC, said in a press release.
Rybrevant was approved by the FDA in 2020 for the treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutationsas detected within an FDA-approved test, the press release established. Further approval will be based on clinical benefit within future trials.
The phase 3 MARIPOSA-2study measured the efficiency and safety of Rybrevant, with or without lazertinib and chemotherapy. Patients who had been taking Tagrisso and experienced disease progression were randomly assigned to receive Rybrevant with chemotherapy; Rybrevant plus chemotherapy and Lazertinib; or chemotherapy alone. All participants within the study underwent brain imagining to determine if Rybrevant activity was prominent within the central nervous system, be it with or without lazertinib.
Treating brain metastases in patients with lung cancer remains a high unmet need, as it can result in poor outcomes for patients.
Within the phase 3 MARIPOSA study, a Rybrevant and lazertinib study is still being measured in patients with EGFR-mutated NSCLC. Rybrevant with lazertinib is also being studied versus Tagrisso on its own. Alongside this, a third arm of lazertinib is being investigated, according to the press release.
Rybrevant is currently being studied in nine other trials, investigating its overall efficiency and safety within patients.
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