Immuno-oncology
The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.
With positive data versus radiation therapy in KEYNOTE-689, Merck & Co. files for approval in perioperative head and neck cancer, adding to additional claim in that cancer type.
Akeso explains the circumstances behind the release of preliminary overall survival data from a head-to-head Phase III trial with ivonescimab in lung cancer, which some investors viewed as disappointing.
Sales of the company’s approved cancer therapies were weaker or down, but Trodelvy is likely to see a label expansion and cell therapies are making progress.
Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.
Results from the Phase III HARMONi-6 trial showed the PD-1/VEGF bispecific antibody beating out BeiGene’s Tevimbra in NSCLC.
Arbele has emerged as a global leader in the Cadherin 17 area, not only in clinical progress but also for its “secret recipe” for application in T-cell engagers, its CEO tells Scrip.
The company reported positive topline results for ASCENT-04, which also bode well for the ASCENT-03 trial in patients with low PD-L1 expression.
BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.
The Oxford group has linked up with the NHS Cancer Vaccine Launch Pad.
Bristol Myers Squibb notched two approvals in one week for its immuno-oncology combination, pitting the regimen head-to-head with Keytruda in a subset of CRC and with two combos in HCC.
BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.
Merck expects Keytruda to come under Medicare price controls in 2028, but an analyst said the subcutaneous version could shield revenues for the franchise.
J&J is confident that its bispecific antibody/kinase inhibitor combo’s overall survival win over AstraZeneca’s single-agent pill will shift the standard of care.
Increasingly focused on maximizing and accelerating the progress of its PD-L1 x VEGF inhibitor BNT357, the company expects new partnerships to be announced this year.
Sun is acquiring Checkpoint Therapeutics, opening up opportunities to build out its strategy in the onco-derm segment with the US firm’s FDA-approved anti-PD-L1 mAb.
The MATTERHORN study could set Imfinzi up for another new perioperative use, even though the gastric cancer trial has yet to demonstrate an overall survival benefit.
Summit and Akeso have established a big lead in lung cancer with ivonescimab, but BioNTech aims to make its rival, BNT327, the leader in other tumor types.
The company sees a potential billion-dollar market opportunity in its approved indications and is launching the drug in what an exec called “a very targeted fashion” at a recent conference.
The companies will work together to combine Summit’s PD-1/VEGF bispecific antibody ivonescimab, with Pfizer’s antibody drug conjugates, but have not signed any licensing deals as yet.