European Commission Approves Amivantamab for NSCLC Treatment
European Commission Approves Amivantamab for Treatment of Advanced NSCLC
Patients with EGFR ex19del or EGFR L858R mutations, the most common mutations in non-small cell lung cancer (NSCLC), have until now faced a poor prognosis and limited treatment options after disease progression on a previous therapy.
Amivantamab, in combination with chemotherapy, is the first regimen to show significant improvement in progression-free survival compared to chemotherapy alone in this patient population.
Janssen-Cilag International NV, part of Johnson & Johnson, has announced that the European Commission (EC) has granted a Type II extension of indication for RYBREVANT (amivantamab) in combination with chemotherapy (carboplatin and pemetrexed) for the treatment of adults with advanced NSCLC harboring epidermal growth factor receptor (EGFR) Exon 19 deletions (ex19del) or L858R substitutions, following the failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
Antonio Passaro, M.D., Ph.D., a medical oncologist from the European Institute of Oncology, noted the progress being made in lung cancer treatment over recent years. He emphasized that resistance to existing therapies continues to pose a significant challenge for patients with advanced NSCLC harboring EGFR mutations, which highlights the critical need for ongoing innovation in this arena.
He further stated that the addition of the bispecific antibody amivantamab to chemotherapy provides a vital new treatment option for patients who have progressed on or after osimertinib. In this context, this combination set a new landmark for overall response rate and significantly reduced the risk of disease progression or death by more than half compared to standard chemotherapy treatment. Moreover, it demonstrated notable improvements in intracranial progression-free survival, which is critical given the tendency of NSCLC to metastasize to the brain.
Dr. Henar Hevia, Senior Director and EMEA Therapeutic Area Lead in Oncology at Johnson & Johnson, remarked that the approval addresses a significant unmet need for patients whose disease has progressed following earlier treatment with an EGFR TKI and who have limited treatment options available.
The expanded indication for amivantamab is derived from findings from the Phase 3 MARIPOSA-2 study, which aimed to evaluate the efficacy and safety profile of amivantamab and chemotherapy in patients with locally advanced or metastatic EGFR ex19del or L858R substitution NSCLC who experienced disease progression after treatment with osimertinib. The study found that the combination therapy significantly reduced the risk of disease progression or death by 52 percent compared to chemotherapy alone, with a median progression-free survival of 6.3 months versus 4.2 months.
Furthermore, the study demonstrated an objective response rate of 64 percent for the amivantamab plus chemotherapy arm, compared to 36 percent with chemotherapy alone. The data showed that this combination also possessed intracranial activity, which is of particular importance as nearly 30 percent of patients with advanced NSCLC develop brain metastases.
Amivantamab combined with chemotherapy was found to reduce the risk of intracranial progression or death by 45 percent, with a median intracranial progression-free survival of 12.5 months compared to 8.3 months for chemotherapy alone.
The safety profile of amivantamab combined with chemotherapy was consistent with that of the individual components. Adverse events of Grade 3 or higher were reported in 72 percent of patients treated with the combination, while 48 percent of those receiving chemotherapy alone experienced similar adverse events. Notably, the most common Grade 3 or higher adverse events included neutropenia, thrombocytopenia, anaemia, and leukopenia.
The treatment-related adverse events leading to death were infrequent across all treatment groups, occurring in only 2 percent of patients receiving the combination therapy and in 1 percent of those receiving chemotherapy alone.
Dr. Kiran Patel, Vice President of Clinical Development for Solid Tumours at Johnson & Johnson, commented on the approval as a pivotal step towards transforming the treatment landscape for those living with lung cancer. He reiterated the company's commitment to advancing a robust lung cancer portfolio, especially through the use of precision medicine approaches which redefine standards of care.
Significance of the MARIPOSA-2 Study
Results from the MARIPOSA-2 study were presented during a Presidential Symposium at a recent congress and have been published simultaneously in a significant oncology journal. The study, which enrolled 657 patients, is a randomized, open-label Phase 3 trial evaluating the efficacy and safety of two combination regimens of amivantamab (with and without another investigational therapy) and chemotherapy.
All participants underwent serial brain imaging to allow for the comprehensive assessment of intracranial endpoints, further demonstrating the study’s focus on a critical area of high unmet need.
Overview of Amivantamab
Amivantamab is a fully-human bispecific antibody targeting both EGFR and MET alterations. It is designed to harness the immune system in targeting tumours exhibiting these mutations, which are prevalent in various cancers.
The European Commission has granted marketing authorization for amivantamab in multiple indications, including its use in combination therapies for the treatment of adults with advanced NSCLC characterized by specific activating mutations. The drug demonstrates a significant capability in improving treatment outcomes in this challenging patient population.
Future Directions
Several regulatory applications are underway to expand the indication of amivantamab further. The company continues to explore innovative solutions to address the evolving landscape of cancer treatment.
Frequently Asked Questions
What is Amivantamab?
Amivantamab is a bispecific antibody targeting EGFR and MET mutations, offering a new treatment option for patients with advanced NSCLC.
How does Amivantamab work?
It works by targeting tumors that exhibit specific mutations, leveraging the immune system to enhance cancer treatment efficacy.
What is the significance of the MARIPOSA-2 study?
The study demonstrated that the combination of Amivantamab with chemotherapy significantly improves progression-free survival and overall response rates in patients with advanced NSCLC.
What are the common side effects of Amivantamab?
Common side effects include hematologic toxicities such as neutropenia, anemia, and thrombocytopenia, but serious adverse events remain low.
Is Amivantamab approved for other treatments?
Yes, it has received marketing authorization for multiple indications regarding patients with advanced NSCLC with specific mutations.
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