Tuesday, July 16, 2024

Lung Cancer Treatment Advances as Johnson & Johnson Submits BLA for SC Amivantamab to FDA

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Johnson & Johnson has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for a fixed SC combination of amivantamab and recombinant human hyaluronidase for all approved or submitted IV RYBREVANT® indications in non-small cell lung cancer (NSCLC) patients. This submission is based on Phase 3 PALOMA-3 study results showing a five-fold reduction in infusion-related reactions and significantly shorter administration times with SC amivantamab. Moreover, SC amivantamab demonstrated longer overall survival, progression-free survival, and duration of response compared to the IV formulation. Data from the Phase 3 PALOMA-3 study were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

The study included 418 patients and showed that SC amivantamab had comparable overall response rates to IV administration in non-small cell lung cancer patients with EGFR exon 19 deletion or L858R mutations. Importantly, SC amivantamab demonstrated a five-fold reduction in infusion-related reactions, alongside improved overall survival, progression-free survival, and duration of response. These significant findings underline the potential of SC amivantamab to enhance patient convenience and treatment outcomes.

PALOMA-3 also evaluated the pharmacokinetics (PK) of SC amivantamab, revealing trough concentrations and area under the curve comparable to the IV formulation. The primary endpoints included objective response rate and progression-free survival, with overall survival as a predefined exploratory endpoint. These results were complemented by data from the Phase 2 PALOMA-2 study, which further supports the efficacy and safety of SC amivantamab in various treatment settings.

A Five-Minute Administration Transforming Lung Cancer Treatment

Kiran Patel, M.D., Vice President of Clinical Development, Solid Tumors at Johnson & Johnson, highlighted the transformative potential of SC amivantamab, noting that it can be administered in approximately five minutes. This advancement could significantly improve the treatment experience for patients, oncologists, and nursing staff. The BLA submission follows recent milestones for the IV formulation of RYBREVANT®, including its approval in combination with chemotherapy for first-line treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations.

RYBREVANT® (amivantamab-vmjw) is a fully human bispecific antibody targeting EGFR and MET, with immune cell-directing activity. It is approved for treating adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. The subcutaneous formulation, co-formulated with recombinant human hyaluronidase PH20, offers a more convenient administration route without compromising efficacy.

The PALOMA-2 study is an open-label Phase 2 trial evaluating SC amivantamab combined with lazertinib and/or chemotherapy in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer. This study involved 126 patients across two cohorts and aimed to determine the objective response rate, which was the primary endpoint. Prophylactic anticoagulation was recommended for the first four months of treatment, ensuring patient safety during the trial.

Lung Cancer

Promising Clinical Trials Highlight Advancements in Lung Cancer Treatment

RYBREVANT® has shown promise in multiple clinical trials, including the Phase 3 MARIPOSA and PAPILLON studies, which assess its efficacy in various combinations and settings for NSCLC. These studies have contributed to the comprehensive understanding of RYBREVANT®’s role in treating EGFR-mutated non-small cell lung cancer, highlighting its potential to improve patient outcomes significantly.

The NCCN Clinical Practice Guidelines for NSCLC prefer next-generation sequencing-based strategies for detecting EGFR exon 20 insertion variants, with RYBREVANT® being a preferred first-line therapy in combination with chemotherapy for patients with newly diagnosed advanced or metastatic EGFR exon 20 insertion mutation-positive non-small cell lung cancer. The Phase 3 PALOMA-3 study results support the transition to subcutaneous administration, offering a more patient-friendly treatment option.

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Johnson & Johnson’s commitment to advancing cancer care is evident in their extensive clinical trials and research. The PALOMA-3 and PALOMA-2 studies underscore the potential of SC amivantamab to improve the quality of life for patients with EGFR-mutated NSCLC. The company’s ongoing efforts aim to enhance treatment efficacy while minimizing side effects, contributing to the broader goal of transforming cancer care.

RYBREVANT®’s safety profile is well-documented, with the most common adverse reactions being rash, infusion-related reactions, and paronychia. These reactions are manageable and do not significantly impact the overall efficacy of the treatment. The transition to subcutaneous administration aims to reduce infusion-related reactions further, making the treatment more accessible and less burdensome for patients. The approval and use of RYBREVANT® in combination with other therapies highlight its versatility and efficacy in treating non-small cell lung cancer. The ongoing research and development efforts continue to explore new combinations and administration methods to enhance patient outcomes and treatment experiences.

 

Resource: Johnson & Johnson, June 17, 2024

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