It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.
In trials name-checking some of the world’s highest peaks, longest rivers and most famous seas, Astrazeneca plc has long sought the best use of its CTLA4 inhibitor tremelimumab. Now, after a disappointing cruise along the first-line bladder cancer trial Danube and travails in non-small-cell lung cancer with the trials Mystic, Neptune and Arctic, a trek to the endpoint of its phase III trial Himalaya has yielded top-line success. A single, high priming dose of tremelimumab added to the company's immune checkpoint inhibitor, Imfinzi (durvalumab), led to a statistically significant overall survival (OS) benefit vs. Nexavar (sorafenib, Bayer AG and Amgen Inc.) in the first-line treatment for patients with unresectable hepatocellular carcinoma.
Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.
In a setback for Astrazeneca plc's plans to tackle previously untreated cases of advanced bladder cancer, neither its immune checkpoint inhibitor, Imfinzi (durvalumab), nor a pairing of it with the investigational drug tremelimumab beat standard-of-care (SOC) chemotherapy in improving overall survival (OS) during a phase III trial evaluating the treatments as first-line (1L) care for patients with advanced disease.
DUBLIN – Neotx Therapeutics Ltd. raised $45 million in a series C round to continue clinical development of an immuno-oncology agent that already has a long clinical history behind it. Its lead molecule, naptumomab estafenatox, is a fusion protein comprising an antibody fragment that recognizes the oncofetal antigen 5T4 and a bacterial “super-antigen” comprising a modified version of the Staphylococcal enterotoxin A.