Data from the Phase I CHRYSALIS trial also support an expanded access program that will allow some patients to be eligible for amivantamab treatment while the FDA reviews the submission.
Janssen Pharmaceutical Companies of Johnson & Johnson announced the filing of a Biologics License Application (BLA) to obtain FDA approval of amivantamab for the treatment of metastatic non-small cell lung cancer (NSCLC) with exon of the epidermal growth factor receptor (EGFR ) 20 insertion mutations are requested with progression of the disease during or after treatment with platinum-based chemotherapy. 1
Amivantamab, a bispecific antibody against EGFR and mesenchymal epithelial transition factor (MET) with immune cell directing activity, targets tumors with activating and resistant EGFR and MET mutations and amplifications. The investigational drug was recognized by the FDA in March for a breakthrough therapy for the specified patient population. This BLA filing is the first regulatory filing for the treatment of NSCLC with EGFR exon 20 insertion mutations.
EGFR mutations are among the most common in NSCLC, and EGFR exon 20 insertion mutations are the third most common EGFR primary mutation. They often go undetected, but wider application of next generation sequencing could help identify more patients with EGFR exon 20 insertion mutations.
« This filing is an important step forward in our quest to further develop the treatment landscape for patients with NSCLC who have EGFR exon 20 insertion mutations and for whom there are no FDA-approved targeted treatment options, » said Dr. Peter Lebowitz ;; Global Therapist Leader, Oncology, Janssen Research & Development, LLC; said in a statement. “We are committed to developing therapies like amivantamab that advance precision medicine and target specific pathways, and provide access through advanced access programs. ”
Filing for approval is based on early results in the monotherapy arm of the Phase I CHRYSALIS trial (NCT02609776), a multicenter, open-label, cross-cohort study of the safety and efficacy of amivantamab in advanced NSCLC patients monotherapy and in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI).
The data, presented as a poster in the American Society of Clinical Oncology (ASCO) virtual science program in May, found that patients in the monotherapy cohort had an overall response rate of 36% and patients who were previously platinum A response rate was found for chemotherapy based on 41%. 2
Data from the Phase I trial also support the establishment of an expanded access program (NCT04599712) that will allow some patients to be eligible for amivantamab treatment prior to approval while the FDA reviews the BLA.
« Lung cancer is still the leading cause of cancer death worldwide. Given this significant unmet need, at Johnson & Johnson, we are committed to improving outcomes for patients diagnosed with this complex, deadly disease. With today’s submission of amivantamab, we have come one step closer to this goal, ”Dr. med. Mathai Mammen; Janssen Research & Development, Johnson & Johnson said. “We are steadfastly focused on developing novel therapeutics and drugs that will change the course of some of the most challenging and deadly diseases of our time, including lung cancer. ”
1. Janssen submits application to U.. S.. . FDA applies for approval of amivantamab for the treatment of metastatic non-small cell lung cancer patients with EGFR exon 20 insertion mutations. Press release. Janssen Pharmaceutical Companies by Johnson & Johnson; 3. December 2020. Accessed on 4. December 2020. https: // www. janssen. com / janssen-submits-the-application-us-FDA-for-approval-an-amivantamab-treatment-patient-metastatic-not
2. Janssen announces phase 1 results for the bispecific antibody amivantamab in the treatment of patients with advanced non-small cell lung cancer that contains exon 20 insertion mutations. Press release. Janssen Pharmaceutical Companies by Johnson & Johnson; 18th. May 2020. Accessed on 4. December 2020. https: // www. janssen. com / janssen-announces-phase-1-results-bispecific-antibodies-amivantamab-treatment-patient-advanced-not
Non-Small Cell Lung Cancer, Epidermal Growth Factor Receptor, Johnson & Johnson, Food and Drug Administration, Lung, Osimertinib, Janssen Pharmaceutica, Mutation, AstraZeneca, Tyrosine Kinase Inhibitor
World news – AU – Janssen applies for FDA approval of amivantamab for metastatic NSCLC with EGFR exon 20 insertion mutations
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