相关临床试验
2045
1923 进行中
药物批准
333
批准总数
监管机构
4
监管机构数
成立时间
N/A
尚未招募
6
0.3%
No Longer Available
1
0.1%
终止
4
0.2%
招募中
34
1.7%
撤回
2
0.1%
进行中（未招募）
1917
93.7%
Unknown
1
0.1%
已完成
80
3.9%
• The European Commission has approved amivantamab plus lazertinib for first-line treatment of EGFR-mutated non-small cell lung cancer (NSCLC). • The approval is based on the Phase 3 MARIPOSA trial, which showed superior progression-free survival compared to osimertinib. • The combination therapy reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy. • Common adverse events were manageable and primarily Grade 1 or 2, supporting the combination's safety profile.
- The CHMP has recommended subcutaneous amivantamab with lazertinib for first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. - Subcutaneous amivantamab monotherapy is recommended for NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure. - PALOMA-3 study results support the recommendation, showing non-inferior pharmacokinetics and a five-fold reduction in infusion-related reactions compared to IV administration. - The subcutaneous formulation reduces administration time to approximately five minutes, offering improved convenience and safety for patients.
- Updated results from the Phase 3 MARIPOSA-2 study show RYBREVANT plus chemotherapy demonstrates a favorable trend toward improved overall survival. - At 18 months, 50% of patients treated with the combination were alive, compared to 40% receiving chemotherapy alone. - The combination significantly improved treatment discontinuation rates and prolonged time to subsequent therapy. - The safety profile of RYBREVANT plus chemotherapy was consistent with established profiles of individual treatments.
