JnJ wins USFDA approval for subcutaneous Rybrevant Faspro for EGFR-Mutated NSCLC

Compared to intravenous (IV) delivery, RYBREVANT FASPRO offers significantly higher patient convenience and lower burden on healthcare resources.

• Reducing administration time from several hours to five minutes (significantly less administration time than chemotherapy-based regimens, which could take up to an hour);
• Demonstrating an approximately fivefold reduction in administration-related reactions (ARRs) (13 percent in SC vs 66 percent in IV arm); and
• Reducing venous thromboembolism (VTE) incidence (11 percent in SC vs 18 percent in IV arm).

Based on the results from the Phase 3 PALOMA-3 study (NCT05388669), RYBREVANT FASPRO delivered consistent results to RYBREVANT, meeting both co-primary pharmacokinetic (PK) endpoints as measured by amivantamab levels in the blood [C_trough on Cycle (C) 2 Day (D) 1 or C4D1 and C2 area under the curve (AUC_D1-D15)]. Results from PALOMA-3 were first presented as a late-breaking oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology.

Data presented at ASCO in 2024 and published in the Journal of Clinical Oncology also found that the SC arm showed longer duration of response (DoR), improved progression-free survival (PFS), and longer overall survival (OS) compared to the IV arm. Median OS was notably higher for patients treated with the SC arm in combination with LAZCLUZE (HR 0.62; 95 percent CI, 0.42–0.92; nominal P=0.02). At 12 months, 65 percent of patients receiving SC were alive, compared with 51 percent treated with IV.

“Patients now have a simple, chemotherapy-free frontline option that not only targets the disease more precisely but also significantly improves survival,” said Joelle Fathi, D.N.P., Chief Healthcare Delivery Officer, GO2 for Lung Cancer.^* “With the introduction of RYBREVANT FASPRO, care becomes faster, less invasive, and more aligned with what matters most to patients: time, comfort, and dignity. This therapy reduces the physical and emotional burden of lengthy infusions, giving patients and their families the opportunity to reclaim precious moments and focus on living, rather than treatment.”

This builds upon the statistically significant and clinically meaningful OS data demonstrated with RYBREVANT plus LAZCLUZE for patients with untreated (first-line) locally advanced or metastatic NSCLC with EGFR exon 19 deletions (ex19del) or L858R substitution mutations in the Phase 3 MARIPOSA study. At a median follow-up of 37.8 months, RYBREVANT plus LAZCLUZE showed a statistically significant reduction in the risk of death compared to osimertinib (hazard ratio [HR], 0.75; 95 percent confidence interval [CI], 0.61-0.92, P=0.0048). Median OS was not yet reached with the combination (95 percent CI, 42.9-not estimable) and the OS benefit is projected to exceed four years, which is at least one year beyond the median of three years observed with osimertinib (36.7 months; 95 percent CI, 33.4-41.0).

“The combination of RYBREVANT plus LAZCLUZE changes the biology of the disease by preventing resistance and delivers unmatched overall survival in the first-line setting, while omitting chemotherapy from treatment,” said Danny Nguyen, M.D., Assistant Clinical Professor, Department of Medical Oncology & Therapeutics Research, City of Hope, and principal investigator for the PALOMA-3 and MARIPOSA studies. “Now, with the approval of RYBREVANT FASPRO, we have an entirely new subcutaneous therapy that offers consistent results compared to intravenous delivery, while providing a more patient-centered experience.”

“The approval of RYBREVANT FASPRO is a pivotal step forward, as EGFR+ NSCLC patients have previously faced limited treatment options,” explains Biljana Naumovic, President, Solid Tumor, Johnson & Johnson Innovative Medicine. “Now, patients are gaining greater access to this transformative treatment, as well as the tools needed to proactively manage common dermatological effects.”

Lower rates of ARRs (13 percent vs. 66 percent) were observed with RYBREVANT FASPRO compared to IV administration. The incidence of ARRs leading to interruption of any study treatment was also substantially lower in the RYBREVANT FASPRO and LAZCLUZE arm (1.0 percent). When treated with RYBREVANT FASPRO plus LAZCLUZE and prophylactic anticoagulant use (n=164), a VTE rate of 7 percent was observed, representing a return to baseline risk for patients with advanced NSCLC. Rates of VTE were lower (11 percent vs. 18 percent) in all patients treated with RYBREVANT FASPRO plus with LAZCLUZE, compared to patients treated with IV administration.Overall, the safety profile of RYBREVANT FASPRO was largely consistent with the known profile of IV administration, and in combination with LAZCLUZE.