2022年ESMO年会上公布的研究结果中,tremelimumab+度伐利尤单抗+化疗联合治疗与单独化疗相比显著改善了OS(14.0个月 vs. 11.7个月;HR 0.75;95%CI:0.63~0.88;双侧P=0.00304)。这意味着死亡风险降低了25%。联合治疗组的3年OS约为25%,单独化疗组为13.6%[7]。 2022年11月,基于该试验,FDA批准tremelimumab/durvalumab/...
2022年ESMO年会上公布的研究结果中,tremelimumab+度伐利尤单抗+化疗联合治疗与单独化疗相比显著改善了OS(14.0个月 vs. 11.7个月;HR 0.75;95%CI:0.63~0.88;双侧P=0.00304)。这意味着死亡风险降低了25%。联合治疗组的3年OS约为25%,单独化疗...
2.Abou-Alfa GK, Chan SL, Kudo M, et al. Phase 3 randomized, open-label, multicenter study of tremelimumab (T) and durvalumab (D) as first-line therapy in patients (pts) with unresectable hepatocellular carcinoma (uHCC): HIMALAYA. J Clin Oncol. 2022;40(suppl 4):379. doi:10.1200/JCO....
HIMALAYA was a randomized, open-label, multicenter, global trial, in which anti–CTLA-4 antibody, tremelimumab, was administered in combination, a PD-L1 blocking antibody. The trial evaluated 1324 patients from across 16 different countries. The key end point was overall survival, and sec...
On October 21, 2022, the FDA approved the combination for adult patients with unresectable HCC based on an earlier analysis of HIMALAYA which showed improved OS, progression-free survival (PFS), and objective response rate (ORR) with the combination.2 The randomized, open-label, ...
Later in 2016, nivolumab was approved by the FDA for r/m HNSCC. Nivolumab is another humanized IgG4 anti-PD-1 monoclonal antibody, which had previously demonstrated efficacy in multiple tumor types. In the landmark open-label, Phase III Checkmate 141 trial, patients with platinum-refractory r...
PD-L1 expression on formalin-fixed paraffin-embedded pretreatment biopsies was assessed with chromogenic immunohistochemistry (IHC) using the VENTANA PD-L1 (SP263) Assay performed according to the Federal Drug Administration (FDA) label. PD-L1 positivity was determined by consensus review of 2 patholog...
This Phase 1 open-label, multicentre trial (NCT02088112) was conducted in 56 patients with NSCLC. Dose expansion permitted TKI-naive patients, primarily with activating L858R or Ex19del EGFRm. Arms 1 + 1a received concurrent therapy; Arm 2 received 4 weeks of gefitinib induction followed ...
Clinical researchPhase IAsiaEurope Daiichi Sankyo MORE ON THIS TOPIC Gene therapy Bluebird’s Gene Therapy Skysona Under FDA Safety Probe for Hematologic Malignancies December 2, 2024 · 2 min read · Tristan Manalac Canc...
Bridgeport, CT; Yale Cancer Center, New Haven, CT Background: Atezolizumab plus bevacizumab (A+B) is approved by the Food and Drug Ad- ministration (FDA) for treatment of advanced stage hepatocellular carcinoma (HCC) as first line systemic therapy following results of the IMBRAVE150 trial. ...