J&J Wins Full FDA Approval for Rybrevant, Chemo Combo in NSCLC
04 Mar 2024
Clinical ResultPhase 3Drug ApprovalAccelerated Approval
Pictured: J&J building in Madrid, Spain/iStock, BrasilNut1
The FDA on Friday approved Johnson & Johnson’s bispecific antibody Rybrevant (amivantamab-vmjw) for the first-line treatment of locally advanced non-small cell lung cancer in combination with carboplatin and pemetrexed.
Friday’s regulatory victory, which also converts Rybrevant’s accelerated approval into a traditional approval, allows the use of the Rybrevant-based combination regimen in patients with confirmed exon 20 insertion mutations in the EGFR gene, as determined by an FDA-approved test.
The approval also makes Rybrevant, when used with a chemotherapy regimen, the “first targeted approach approved for the first-line treatment” of this specific patient population, Kiran Patel, vice president of clinical development, solid tumors at J&J Innovative Medicines, said in a statement.
The FDA’s decision was backed by data from the randomized, open-label Phase III PAPILLON trial, which demonstrated that the Rybrevant-based regimen cut the risk of disease progression or death by 60% versus chemotherapy alone. The objective response rate was also significantly improved following treatment with the Rybrevant combo, according to an October 2023 readout.
At the time, overall survival also showed a positive trend in favor of the Rybrevant combo, though this result did not reach statistical significance.
Administered via an intravenous infusion, Rybrevant is a bispecific antibody that targets both the EGF sand MET receptors. This mechanism of action allows Rybrevant to block the EGF and MET signaling cascades, preventing the cancer cells’ uncontrolled division and proliferation while also tagging these receptors for degradation, according to the website of J&J subsidiary Janssen.
Rybrevant also marks the tumor cells for destruction by immune cells, such as macrophages and natural killer cells.
The FDA granted Rybrevant accelerated approval in May 2021 for the treatment of metastatic or locally advanced non-small cell lung cancer patients with EGFR exon 20 insertion mutations and who had progressed on or after platinum-based chemotherapy. PAPILLON was J&J’s confirmatory trial for Rybrevant.
The company is also evaluating Rybrevant in combination with lazertinib, an oral EGFR tyrosine kinase inhibitor that targets the T790M mutation, among other activating EGFR mutations. In September 2023, J&J released topline data from the Phase III MARIPOSA study demonstrating that the treatment combo met its primary endpoint, significantly boosting progression-free survival versus AstraZeneca’s Tagrisso (osimertinib).
The same month, J&J posted data from another Phase III trial—dubbed MARIPOSA-2—showing that Rybrevant, with or without lazertinib, significantly improved progression-free survival in patients who had progressed after Tagrisso treatment.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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