Ovarian cancer
In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, including two that would expand the labels of blockbuster drugs.
Corcept’s overall survival data “look competitive” with AbbVie’s Elahere and Merck’s blockbuster Keytruda, Truist Securities said Thursday.
Analysts at Truist Securities called the mid-stage data a “mixed bag,” also flagging gastrointestinal adverse events. However, the readout is unlikely to be “incremental” to Corcept’s overall stock narrative.
First approved in 2021, Jemperli has now become a cornerstone of GSK’s cancer business, earning more than $160 million in the third quarter.
Amgen has quietly discontinued the development of its Phase I bispecific T-cell engager AMG 794, which the company had been studying for several malignant solid tumors.
Following two deaths due to presumed sepsis, the FDA has placed a partial clinical hold on three trials for Zentalis’ azenosertib including a Phase I in solid tumors, Phase II in platinum-resistant ovarian cancer and Phase II in uterine serous carcinoma.
AbbVie’s antibody-drug conjugate Elahere, developed by ImmunoGen, elicited a nearly 52% objective response rate in heavily pretreated patients with folate receptor-alpha-positive, platinum-sensitive ovarian cancer.
Bristol Myers Squibb-backed TORL BioTherapeutics announced Wednesday it will use proceeds from the Series B-2 financing round to advance its pipeline of antibody-drug conjugate therapies.
Genmab announced Wednesday it is buying ProfoundBio and its pipeline of next-generation antibody-drug conjugates being developed for gynecologic cancers and other solid tumors.
With second-generation antibody-drug conjugates, Eli Lilly, Daiichi Sankyo and others look to reduce toxicity and improve the magnitude and duration of response.
PRESS RELEASES