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  • Subcutaneous amivantamab BLA submitted to FDA for ...

Subcutaneous amivantamab BLA submitted to FDA for patients with EGFR-mutated non-small cell lung cancer

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Published:18th Jun 2024

Johnson & Johnson announced the submission of a Biologics License Application (BLA) to the FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) for all currently approved or submitted indications of intravenous (IV) Rybrevant (amivantamab-vmjw) in certain patients with non-small cell lung cancer (NSCLC)

Data from the Phase III PALOMA-3 study (NCT05388669)  presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology showed SC amivantamab had comparable overall response rates to IV administration in patients with NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations. SC amivantamab also demonstrated significantly shorter administration time and a five-fold reduction in infusion-related reactions, alongside longer overall survival, progression-free survival and duration of response. Efficacy results like these have not been seen before in a study assessing IV and SC comparability. The BLA submission includes data from the Phase II PALOMA-2 (NCT05498428) study evaluating SC amivantamab in settings where IV amivantamab has been previously submitted for approval and is intended to support dosing schedules of every two and every three weeks.

“Rybrevant administered intravenously is a foundational treatment for patients with EGFR-mutated NSCLC,” said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Johnson & Johnson Innovative Medicine. “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. We look forward to working with the FDA and global regulators in the review of these applications.”

PALOMA-3 (NCT05388669), which enrolled 418 patients, is a randomized, open-label Phase III study evaluating the pharmacokinetics (PK), efficacy and safety of subcutaneous amivantamab (administered via manual injection) combined with lazertinib compared to IV amivantamab and lazertinib in patients with EGFR-mutated advanced or metastatic NSCLC after progression on osimertinib and chemotherapy. The co-primary PK endpoints of the study were trough concentration (Ctrough on Cycle [C] 2 Day [D] 1 or C4D1) and C2 area under the curve (AUCD1-D15). Key secondary endpoints were objective response rate and progression-free survival. Overall survival was a predefined exploratory endpoint. Prophylactic anticoagulation was recommended for the first four months of treatment.

About the PALOMA-2 Study: PALOMA-2 (NCT05498428) is an open-label Phase II study evaluating the efficacy, safety, and PK of first-line SC amivantamab (administered via manual injection) combined with lazertinib and/or chemotherapy in patients with EGFR-mutated advanced or metastatic NSCLC. Sixty-eight and 58 patients were enrolled in Cohorts 1 and 6, respectively. Prophylactic anticoagulation for the first four months of treatment was recommended in Cohort 1 and mandatory in Cohort 6. The primary endpoint was objective response rate (ORR) as assessed by the investigator per RECIST v1.

See- "Subcutaneous versus Intravenous Amivantamab, both in Combination with Lazertinib, in Refractory EGFR-mutated NSCLC: Primary Results from the Phase III PALOMA-3 Study" Authors: Natasha B. Leigh, MD , Hiroaki Akamatsu, MD, PhD , Sun Min Lim, MD, PhD , Ying Cheng, MD , Anna R. Minchom, MD, Melina E. Marmarelis, MD , Rachel E. Sanborn, MD for the PALOMA-3 .publication: Journal of Clinical Oncolog

Condition: NSCLC / EGFR
Type: drug

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