Drug Development
Sac-TMT significantly extended overall and progression-free survival for patients with advanced or recurrent endometrial cancer by 6.9 months over chemotherapy in a Phase 3 trial—becoming the first TROP2-directed ADC to do so in this setting, Merck told BioSpace.
FEATURED STORIES
At the European Society for Medical Oncology meeting this weekend, Merck will showcase three late-stage trials of its Kelun-Biotech–partnered TROP2-directed antibody sac-TMT that VP of Chemistry Alan Northrup says gets the payload release “just right.”
Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession.
BioSpace is launching an IPO dashboard to help the industry keep tabs on U.S. biotechs that have taken the public plunge in 2026.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
CROs cite faster startup timelines, regulatory predictability and tax incentives as reasons for growing interest in Australia. State investments in manufacturing, translational research and advanced therapies aim to expand that advantage into a broader biotech ecosystem. The question remains whether Australia can support drug development at broader scale.
The disclosure—which came ahead of a presentation of data from the Phase 1 Breakfree-2 study at the ACTRIMS-ECTRIMS meeting—follows Bristol Myers Squibb’s late summer revelation that it had paused certain trials of zolacabtagene autoleucel.
RNAi specialist Alnylam Pharmaceuticals will advance the Huntington’s disease drug brezosiran into a placebo-controlled study in 2027 once regulatory alignment is achieved.
A combination of Tango Therapeutics’ vopimetostat and Revolution Medicines’ recently approved Rasonque led to a response rate of 82% in an ongoing Phase 1/2 trial—a drop from 92% that was reported in June in fewer patients.
Following the withdrawal of billions of dollars in investments from Boehringer Ingelheim and Eli Lilly, German lawmakers have proposed a clause to the country’s healthcare reforms set to take effect Jan. 1.
Invikafusp alfa, a first-in-class dual T cell agonist, showed an objective response in various types of cancer, particularly among patients who did not respond to previous checkpoint inhibitor therapy.
A combination of the personalized cancer vaccine intismeran autogene and Merck’s Keytruda just barely cleared analysts’ expectations for recurrence-free survival, leaving questions as to its applicability to tumor types beyond melanoma.
AbbVie is eyeing regulatory filings in 2027 for the skin disease drug lutikizumab after clearing multiple endpoints in a late-stage trial, but the results have disappointed some analysts, raising questions about its commercial prospects.
Troriluzole, in development for spinocerebellar ataxia, was rejected nearly a year ago when the FDA took issue with the design of Biohaven’s registrational study. The agency has now agreed to review a new application and render a decision in the first quarter of 2027.
The sector’s IPO tally has surpassed each of the past four years, with four October debuts adding momentum—but activity still remains well below the COVID-19 boom that saw nearly 100 public debuts in 2021.