Lung cancer
Ivonescimab notched its third approval in China last week, but the label update has tempered expectations for the Summit Therapeutics/Akeso drug, showing that progression-free survival declines over time.
AstraZeneca will push through with its other Phase 3 studies for volrustomig, including in cervical cancer and mesothelioma.
Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February.
With Enhertu and Datroway hitting their peak revenue and rivals flowing into the antibody-drug conjugate space, Jefferies cuts expectations for Daiichi Sankyo.
Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval?
Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer assets in late-stage development.
Summit Therapeutics and Akeso are answering questions raised about ivonescimab’s ability to translate to Western populations, though the partners have yet to share if the new findings are statistically significant.
The Phase 3 results are the first direct proof-of-concept for an ADC replacing platinum-based chemo in a first-line standard-of-care regimen for non-small cell lung cancer, according to Leerink Partners. The readout also represents the second late-stage win for the Merck and Kelun-Biotech asset, called sac-TMT.
Just weeks after Pfizer’s Seagen-acquired antibody-drug conjugate sigvotatug vedotin failed a Phase 3 non-small cell lung cancer study, the big pharma has quietly culled another program being developed by the ADC specialist.
Dizal Pharmaceutical’s Zegfrovy is approved in the U.S. for locally advanced or metastatic non-small cell lung cancer. For $600 million upfront, AstraZeneca will gain global rights to advance and commercialize the asset.
PRESS RELEASES