UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for a new indication for its PD-L1 inhibitor Imfinzi (durvalumab). The approval allows Imfinzi to be used in combination with chemotherapy for adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC), specifically for patients without EGFR or ALK mutations.
Treatment Regimen
The approved treatment sequence involves administering Imfinzi plus chemotherapy prior to surgery (in the neoadjuvant setting), followed by Imfinzi monotherapy post-surgery (as an adjuvant therapy). This regimen marks a significant advancement in the treatment of early-stage NSCLC, offering a comprehensive approach to reduce cancer recurrence and improve patient outcomes.
Clinical Trial Basis
The NMPA’s approval, Imfinzi’s fourth indication in China, is based on results from the pivotal Phase III AEGEAN study, published in the New England Journal of Medicine in October 2023. The study demonstrated a 32% reduction in the risk of cancer recurrence, progression events, or death compared with neoadjuvant chemotherapy alone (CI 0.53-0.88; p=0.003902). Additionally, the combination therapy showed a significant improvement in pathologic complete response (pCR), with a rate of 17.2% versus 4.3% for neoadjuvant chemotherapy alone.
Previous Approvals
Imfinzi’s first three indication approvals in China include:
- Treatment of unresectable, stage III NSCLC patients who have not experienced disease progression after platinum-based chemotherapy and concurrent radiotherapy.
- Combination with etoposide and carboplatin or cisplatin for first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
- Combination with chemotherapy as first-line treatment for locally advanced or metastatic biliary tract cancer (BTC).-Fineline Info & Tech
Leave a Reply