Janssen's Rybrevant (Amivantamab) Receives Conditional EU Approval as First Targeted Therapy for EGFR Exon 20 Insertion-Mutated NSCLC
Dec 13, 2021 01:02
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01:02
Johnson & Johnson
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European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
December 12, 2021 /BioValleyBIOON/ -- Johnson & Johnson (JNJ) subsidiary Janssen Pharmaceuticals recently announced that the European Commission (EC) hasConditional Approval of EGFR-MET Bispecific Antibody Rybrevant(amivantamab-vmjw), for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) who have failed platinum-based therapy and carry activating EGFR exon 20 insertion mutations. Notably, Rybrevant is the first drug approved in the EU for the treatment of NSCLC with EGFR exon 20 insertion mutations.
Rybrevant is the first targeted therapy approved by regulatory authorities for the treatment of NSCLC with EGFR exon 20 insertion mutations.In May 2021, Rybrevant was first approved in the United States.FDAApproval: For the treatment of adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed after failing platinum-based chemotherapy and are positive for EGFR exon 20 insertion mutations (EGFRex20ins+). In the United States, Rybrevant was approved through the priority review process and had previously received Breakthrough Therapy Designation (BTD).
Lung cancer is the most common type of cancer globally and the leading cause of cancer-related deaths. Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancer cases.Approximately 2%-3% of NSCLC patients carry EGFR exon 20 insertion mutations., this is a group of mutations on EGFR that can lead to rapid cell growth and help cancer spread.EGFR Exon 20 Insertion Mutation is the Third Most Common Type of EGFR Mutation。
The active pharmaceutical ingredient in Rybrevant is amivantamab, a fully human EGFR-MET bispecific antibody with immune cell-directed activity, targeting activating and resistance EGFR and MET mutations and amplifications.TumorThe production and development of amivantamab follow the license agreement between Janssen Biotech, Inc. and Genmab for the use of the DuoBody technology platform.
Mechanism of Action of Amivantamab (Image source: literature — doi:10.1158/2159-8290.CD-20-0116)
This conditional approval by the EU was based on results from the Phase 1 CHRYSALIS study. This is a multicenter, open-label clinical study conducted in adult patients with NSCLC who have failed platinum-based therapy and harbor EGFR exon 20 insertion mutations, evaluating the efficacy and safety of Rybrevant as a monotherapy. The results showed that Rybrevant demonstrated efficacy and a generally well-tolerated safety profile.
The specific data are as follows: Median follow-up of 12.5 months, among the 114 evaluable patients treated with Rybrevant, the investigator-assessedThe overall response rate (ORR) was 37%, with a median duration of response (DOR) of 12.5 months.。In patients whose condition has improved,64% had a duration of response ≥6 months. These results are consistent with the findings from the blinded independent central review assessment report (81 evaluable patients, median follow-up of 9.7 months), which showed an ORR of 43%, a median DOR of 10.8 months, and among patients with a response, 55% had a duration of response ≥6 months.
The analysis also shows,Median progression-free survival (PFS) was 8.3 months (95% CI: 6.5-10.9), and median overall survival (OS) was 22.8 months (95% CI: 14.6-not reached).In the study, the most common adverse events (AEs) of all grades included rash (76%), infusion-related reactions (67%), and nail toxicity (47%), primarily grade 1-2. Treatment discontinuation due to AEs occurred in 3% of patients. Infusion-related reactions took place during the first infusion in 99% of cases and rarely affected the ability to continue subsequent treatments (1.1% led to treatment interruption). (Bioon.com)