Persistence has paid off for Incyte’s Zynyz in anal cancer with a Phase III win that should make up for a previous disappointment at the FDA and give a boost to the firm’s pipeline prospects for a post-Jakafi era.
Incyte Corporation is going to have a second go at getting its PD1 inhibitor Zynyz (retifanlimab) approved as the first anti PD-1/PD-L1 inhibitor for squamous cell anal carcinoma (SCAC) following a hit in the Phase III POD1UM-303/InterAACT 2 trial presented at the European Society for Medical Oncology meeting in Barcelona, Spain, on 14 September.
A successful filing at the US Food and Drug Administration for first-line use, due by the end of the year,...
Attendees at this year's European Society for Medical Oncology meeting in Barcelona can look forward to a range of interesting datasets, from Phase III trials of established products in new settings to preliminary studies of novel products coming through the pipeline.
J&J acquired Taris in 2019 to gain access to TAR-200 and its drug delivery platform. Now, early clinical data suggest the product could delay or remove the need for cystectomy in several bladder cancer settings and the US healthcare giant is eyeing multi-blockbuster sales.
The Barcelona meeting saw early data from two candidates from Incyte and Pfizer which suggest some progress for a new drug mechanism that has so far underwhelmed.
New Phase II data for the bispecific antibody show promise in colorectal cancer as the company seeks to spread the bispecific antibody’s wings. Phase III trials are on the horizon, where it will need to go up against standard of care.
AstraZeneca’s NIAGARA trial of perioperative Imfinzi in bladder cancer was positively received at the ESMO meeting but its design did not distinguish the contributions of each treatment portion to the overall effect – something that the US FDA is likely to have a view on.
Persistence has paid off for Incyte’s Zynyz in anal cancer with a Phase III win that should make up for a previous disappointment at the FDA and give a boost to the firm’s pipeline prospects for a post-Jakafi era.
Sutro Biopharma CEO Bill Newell spoke with Scrip about the company’s novel platform, its goal of improving folate receptor alpha-driven ovarian cancer and its business development strategy.
