Lung cancer
ArriVent BioPharma’s Phase 3 lung cancer trial was clouded by stronger-than-expected data for patients receiving chemotherapy, prompting analysts to pivot focus to a late-stage test of the tyrosine kinase inhibitor in a different type of lung cancer and to the biotech’s antibody-drug conjugate pipeline.
Merck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Capital Markets.
Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year.
BioNTech, Summit Therapeutics, GSK and Roche have made a splash at the ongoing World Conference on Lung Cancer taking place in South Korea. These companies and their partners have all shared new findings for their closely watched programs, highlighting overall survival benefits in various types of lung cancer.
The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.
New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.
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.
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