Relevant statistics show that about 2 to 3% of people with non-small cell lung cancer (NSCLC) have an EGFR exon 20 insertion mutation. This mutant form is the third most common EGFR mutation, which can lead to rapid proliferation and migration of tumor cells. Proliferation and migration. The new anti-cancer drug Rybrevant is the world's first bispecific antibody for the treatment of NSCLC. Its approval allows NSCLC patients with EGFR exon 20 insertion mutations to obtain brand-new targeted treatment options.
The first phase of the CHRYSALIS study is a first-time human, open-label, multicenter study evaluating the safety, pharmacokinetics and effectiveness of Rybrevant as a monotherapy and in combination with the novel third-generation EGFR tyrosine kinase inhibitor (TKI) lazertinibi, 50 patients with NSCLC with EGFR exon 20 insertion mutationThe patient received the recommended phase 2 dose (RP2D) of Rybrevant. Of these 50 patients, 39 could evaluate the response and 13 different EGFR exon 20 insertion mutations were identified.
Data showed that the observed overall response rate (ORR) for Rybrevant was 36% (95% CI: 21-53) in all evaluable patients, and 41% (95% CI: 24-61) in patients who had previously received platinum-based chemotherapy. Furthermore, the median duration of response (DoR) was 10 months in all 14 responding patients, and 7 months in patients who had previously received platinum-based chemotherapy.
In all patients treated with Rybrevant, the median progression-free survival (PFS) was 8.3 months (95% CI: 3.0–14.8); in patients who had previously received platinum-based chemotherapy, the median PFS was 8.6 months (95% CI: 3.7–14.8). The clinical benefit rate (≥ partial response [PR] or disease stability ≥ 11 weeks) was 67% (95% CI: 50–81) in all patients; and 72% (95% CI: 53–87) in patients who had previously received platinum-based chemotherapy. Responses were observed in both previously treated and previously platinum-based chemotherapy patients. Tumor response was most commonly observed during the first disease assessment after treatment initiation.
The most common side effects of Rybrevant include rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling of the lower legs, hands, or face, mouth ulcers, cough, constipation, vomiting, and changes in certain blood tests. Rybrevant should be discontinued if a patient has symptoms of interstitial lung disease, and permanently discontinued in patients with a confirmed diagnosis. Patients taking Rybrevant should limit sun exposure during treatment and for two months after treatment. Rybrevant may cause vision problems and should not be used in pregnant women.
Rybrevant drug Introduction
Drug name: Amivantamab
Product name: Rybrevant
Manufacturer: Janssen Pharmaceutical (Janssen)
Rybrevant is a humanized bispecific antibody targeting EGFR and MET. This antibody exhibits immune cell-directed activity, including antibody-dependent cytotoxicity, and has demonstrated clinical activity in patients with both primary and acquired EGFR resistance mutations. Rybrevant has previously received Breakthrough Therapy Designation from the U.S. FDA for the treatment of previously treated NSCLC patients with EGFR exon 20 insertions.
Reminder: The bispecific antibody Rybrevant has immune cell-directed activity. Its approval allows NSCLC patients with EGFR exon 20 insertion mutations to have targeted treatment options for the first time.
