FDA to Review Subcutaneous Rybrevant for NSCLC Treatment

The FDA is pushing for subcutaneous administration of Rybrevant for certain patients with non-small cell lung cancer.

A Biologics License Application has been filed with the Food and Drug Administration (FDA) for subcutaneous treatment with the bispecific monoclonal antibody Rybrevant (amivantamab-vmjw) and the enzyme recombinant human hyaluronidase for all currently approved or submitted indications for intravenous (IV) Rybrevant among some patients with non-small cell lung cancer (NSCLC).

Subcutaneous drugs are administered via an injection under the skin, and sometimes given with hyaluronidase, which helps with the dispersion and absorption of the medication.

“Rybrevant administered intravenously is a foundational treatment for patients with EGFR-mutated NSCLC,” said Dr. Kiran Patel, vice president, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine, in a news release from the manufacturer. “This subcutaneous option, administered in approximately five minutes, is a clinically important advancement that could transform the treatment experience for patients, oncologists and nursing staff.”

Rybrevant, according to the National Cancer Institute, binds to receptors for the EGFR and MET proteins found on some cancer cells. In doing so, it prevents more cancer cells from growing.

Rybrevant was approved by the FDA in 2021 for the treatment of adults with NSCLC with EGFR exon 20 insertion mutations, making it the first targeted treatment option approved for that patient population. Earlier this year, the agency approved Rybrevant plus carboplatin and pemetrexed as frontline treatment for patients with locally advanced (cancer that has spread to nearby tissue or lymph nodes) or metastatic (cancer that has spread to other parts of the body) NSCLC with EGFR exon 20 insertion mutations, as well as for adults with the disease who experienced disease progression on or following treatment with platinum-based chemotherapy.

The Biologics License Application was based on findings of the phase 3 PALOMA-3 study, which were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and were also published in the Journal of Clinical Oncology.

In the study, 418 patients with NSCLC whose disease progressed after treatment with Tagrisso (osimertinib) and platinum-based chemotherapy received either subcutaneous (206 patients) or intravenous (212 patients) Rybrevant with Leclaza (lazertinib).

Learn more: Rybrevant Plus Leclaza May Be New Standard for EGFR-Mutant Lung Cancer

Notably, the median administration time for the first infusion was 4.8 minutes in the subcutaneous group and five hours in the intravenous group. At the start of treatment, 85% and 52% of patients in the subcutaneous and infusion groups, respectively, found treatment to be convenient. Those numbers at the end of treatment were steady at 85% among the subcutaneous group and had fallen to 35% among patients in the intravenous group.

Among the subcutaneous and intravenous groups, the objective response rates (the percentage of patients whose disease responded partially or completely to treatment) were 30% and 33%, respectively, while the median progression-free survival (the time that a patient lives without their disease spreading or worsening) times were 6.1 and 4.3 months. The 12-month overall survival (the time that a patient is alive, regardless of disease status) rates were 65% and 51%, respectively.

Thirteen percent of patients in the subcutaneous group experienced infusion-related reactions, compared to 66% of the intravenous group, and rates of venous thromboembolism (blood clots in the veins) were 9% and 14%, respectively.

The application, according to the news release, also included data from the phase 2 PALOMA-2 study. This trial evaluated subcutaneous Rybrevant in scenarios where intravenous Rybrevant has already been submitted for approval with the intention of supporting dosing schedules of every two and three weeks.

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