AstraZeneca

Platinum-based therapies are mainstay for endometrial and ovarian cancers but often recur. Antibody drug conjugates (ADCs) like Elahere and datopotamab deruxtecan (Dato-DXd) show promise, with Dato-DXd demonstrating improved outcomes in recurrent EC and OC at ESMO 2024. Dato-DXd's efficacy and safety profile, along with a convenient dosing schedule, position it as a potential preferred treatment over competitors like Merck's sacituzumab govitecan (Sac-TMT), which also shows comparable efficacy in heavily pretreated patients. Both TROP2-directed ADCs offer hope for challenging gynecological cancers.

HIMALAYA Phase III trial showed Imfinzi plus Imjudo significantly improved 5-year survival in advanced liver cancer, with 19.6% of patients alive vs. 9.4% on sorafenib.

Imfinzi showed no new safety signals in neoadjuvant and adjuvant settings, with 69% of patients experiencing Grade 3 and 4 adverse events. Imfinzi is being tested in various bladder cancer treatments, including the NIAGARA trial, which evaluates its use before and after radical cystectomy. Imfinzi is also approved for multiple cancer treatments, including lung, biliary tract, and endometrial cancers.

Recent Delaware Chancery Court and Third Circuit decisions impact life sciences licensing and M&A transactions, with rulings on commercially reasonable efforts in acquisitions and post-patent expiration royalty obligations.

AstraZeneca's NIAGARA Phase III trial showed IMFINZI (durvalumab) plus chemotherapy improved event-free survival (EFS) and overall survival (OS) over neoadjuvant chemotherapy alone. The IMFINZI regimen reduced disease progression risk by 32% and death risk by 25%.

TORL-1-23, a CLDN6-targeted ADC, showed responses in heavily pretreated, CLDN6-positive advanced solid tumors, including platinum-resistant ovarian cancer, with a well-tolerated safety profile. The ORR was 26% at doses <2.4 mg/kg, 42% at 2.4 mg/kg, and 31% at 3.0 mg/kg, with a complete response rate of 4% at the highest dose. Neutropenia risk was mitigated by prophylactic pegfilgrastim, and the MTD was not yet reached.

AstraZeneca's Imfinzi in bladder cancer reduced death risk by 25%; Merck and Eisai's combo in liver cancer cut progression or death risk by a third; Bristol's lung cancer approach faced criticism for 'cherry-picking' subgroups.

Early switch to atezolizumab after vemurafenib plus cobimetinib in BRAF V600-positive melanoma showed improved OS at 4 and 5 years in the ImmunoCobiVem trial, but not statistically significant. Rapid progression after switch to immune checkpoint inhibition was observed in some patients.

NIAGARA Phase III trial results show AstraZeneca's IMFINZI (durvalumab) in combination with chemotherapy significantly improves event-free survival (EFS) and overall survival (OS) in muscle-invasive bladder cancer (MIBC) patients, compared to neoadjuvant chemotherapy alone.