Top Stories
Updated results from the Chinese HARMONi-2 trial bolster the case for Summit and Akeso's PD-1/VEGF bispecific.
The failure of the SERENA-4 trial follows Roche's similar setback with giredestrant earlier this year.
Issues at a manufacturing facility led the FDA to issue a complete response letter last year.
The Dresden, Germany facility employs about 640 workers.
The oral, selective PI3Kδ inhibitor is approved for children aged 4 to 11 with activated phosphoinositide 3-kinase delta syndrome (APDS), adding to an earlier clearance for individuals aged 12 and older.
Conference News
HARMONi-2 may be a China-only study, but the bispecific has delivered compelling OS data against a high bar.
Phase 3 EVOKE-03/KEYNOTE-D46 reports numerically longer progression-free survival and higher response rates, but no statistically significant PFS or OS benefitSEOUL, Republic of Korea, Sept. 13, 2026 ...
Phase 2 DeLLphi-309 study suggests every-three-week and every-four-week regimens may offer patients greater treatment flexibility.(SEOUL, Republic of Korea — Saturday, September 12th, 6:15 p.m. Korea ...
Phase III LONESTAR trial finds adding radiation or surgery after nivolumab plus ipilimumab did not improve overall or progression-free survival.(SEOUL, Republic of Korea — Saturday, September 12th, 6:...
Phase 1b DeLLphi-308 study evaluates an investigational subcutaneous formulation of the bispecific T-cell engager.(SEOUL, Republic of Korea — Saturday, September 12th, 6:15 p.m. Korea Standard Time) -...
