Shots:

• The P-III (TOPAZ-1) trial evaluates Imfinzi + CT vs PBO + CT in 685 patients with unresectable advanced or metastatic BTC at 105 centers across 17 countries including in the US, EU, South America & multiple countries in Asia
• In a predefined interim analysis, 20% reduction in risk of death; m-OS (12.8mos. vs 11.5mos.); patients were alive (25% vs 10%) @2yrs. The results also showed a 25% reduction in risk of disease progression or death, m-PFS (7.2mos. vs 5.7mos.); ORR (26.7% vs 18.7%) & will be presented at ASCO GI'22
• Combination arm only had 8.9% AE related discontinuation vs 11.4% CT. The therapy has received ODD from the US FDA for BTC in Dec'20

Ref: Businesswire | Image: Business Standard