Citing a high rate of patients leaving the study, Merck & Co. Inc. has discontinued the anti-TIGIT antibody vibostolimab and the anti-PD-1 Keytruda (pembrolizumab) portion of it phase III Keyvibe-10 trial as an adjuvant treatment for those with resected high-risk melanoma.
There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
Amid intensifying competition in the PD-1/PD-L1 checkpoint space, Samsung Bioepis Co. Ltd. kicked off a phase I study of SB-27, a biosimilar of Merck & Co Inc.’s blockbuster immunotherapy, Keytruda (pembrolizumab), for lung cancer. Posted on clinicaltrials.gov on Feb. 20, the randomized, double-blind, three-arm, parallel group and multicenter phase I study will examine the pharmacokinetics, efficacy and safety of SB-27 against an EU-sourced and U.S.-sourced Keytruda in 135 patients with non-small-cell lung cancer.
MSD had a banner year at the ESMO Asia Congress earlier this month, presenting 14 abstracts on eight different types of cancers, including gastric, esophageal, colorectal, biliary tract, kidney, urothelial, breast and gynecological cancers. Ten of these studies were focused on Asian-related data. Roche AG, meanwhile, presented Asia-specific results from the phase III Alina study in patients with ALK-positive early stage non-small-cell lung cancer.
MSD had a banner year at the ESMO Asia Congress earlier this month, presenting 14 abstracts on eight different types of cancers, including gastric, esophageal, colorectal, biliary tract, kidney, urothelial, breast and gynecological cancers. Ten of these studies were focused on Asian-related data. Roche AG, meanwhile, presented Asia-specific results from the phase III Alina study in patients with ALK-positive early stage non-small-cell lung cancer.
Three giants have produced new phase III study data for their already approved, big name therapies. Two were positive and the third was stopped for futility.
Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news.
Korean bioventure GI Innovation Inc. inched closer to achieving its goal of “five tech transfer deals in five years” with another licensing deal for its allergy drug, GI-301, with Japan-based Maruho Co. Ltd. for ₩298 billion (US$220.7 million), although share prices still dropped on the news.
Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form the basis of global approval bids, as Astrazeneca plc with Daiichi Sankyo Co. Ltd. unveiled interim results from a study called Tropion-Breast01. Targeting trophoblast cell surface antigen 2, datopotamab deruxtecan (dato) hit the mark in progression-free survival for patients with hormone receptor-positive, HER2-low or negative breast cancer in the study called Tropion-Breast01.
