45 patients with Non–Small-Cell Lung Cancer (NSCLC) who received the 600-mg dose, 36% had a partial response, the median progression-free survival (PFS) was 8.3 months, estimated 12-month overall survival was 59% 21 patients with metastatic pancreatic ductal adenocarcinoma 24% had a response, the median PFS was 3.0 months and the median overall survival was 10.3 months.
At 2 years, estimated event-free survival was 74.7% in the enfortumab vedotin–pembrolizumab group and 39.4% in the control group (hazard ratio) HR 0.4 estimated overall survival was 79.7% and 63.1% HR 0.50. Perioperative enfortumab vedotin plus pembrolizumab new standard of care for cisplatin ineligible patients who are candidates for surgery.
Study compared CAPOX vs radiation with capecitabine. Locoregional recurrence free survival (LRRFS) was the primary end point. 3-year LRRFS was 97.4% in the nCRT group and 96.3% in the nCT group, DFS 89.2% v 87.9% 3-year overall survival (OS) 95.0% v 94.1% were similar. The nCT group showed a lower incidence of grade 2 to 4 long-term AEs 16.0% v 26.3% and proctitis 33.6% v 41.7% compared with nCRT group, nCT offers comparable DFS and OS while mitigating the burden of toxicity as compared to nCRT.
Gedatolisib potently targets all four class I PI3K isoforms and mTORC1 and mTORC2 to comprehensively block the PI3K/AKT/mTOR pathway. PFS was 9.3 m in the gedatolisib-triplet group vs 2.0 m in the fulvestrant group (hazard ratio) HR 0.24, and 7.4 m in the gedatolisib-doublet group HR 0.33 v fulvestrant.
Combination improved progression-free survival (PFS) 6.2 months vs 2.8 months, hazard ratio (HR) 0.64 but not overall survival (OS) (15 months for combination vs 17.9 months for pembro), no safety concerns. Overall, although the combination demonstrated a clinically meaningful PFS advantage, the absence of an OS benefit limits its impact on standard first-line treatment, where survival remains the key endpoint.