Ivonescimab clears half of lung tumours before surgery, but can Akeso prove lasting benefit?
Akeso's ivonescimab delivered 70.1% major pathological response in resectable lung cancer. The Phase 2 trial reveals promise and limitations.
Pharma & Biotech
Pharma & Biotech
Summit Therapeutics has $2bn from AstraZeneca and stronger cancer survival data, but will the FDA approve ivonescimab?
Summit Therapeutics has secured a $2 billion strategic equity investment from AstraZeneca while expanding the global development programme for ivonescimab. However, the November 14 FDA decision remains uncertain because the original HARMONi overall-survival analysis did not achieve statistical significance, despite favourable results from subsequent analyses and separate Chinese trials.
Pharma & Biotech
Summit Therapeutics partners with Lunit to study AI tumor biomarkers for ivonescimab
Summit Therapeutics and Lunit will study AI-derived tumor biomarkers for ivonescimab, while clinical validation and patient-selection benefits remain unproven.
Pharma & Biotech
Cadonilimab delivered 84.6% complete responses in an earlier study. Can Akeso prove lasting benefit?
Akeso starts Phase III cadonilimab testing in colon cancer, with 386 patients planned and recurrence outcomes central to its clinical strategy.
Pharma & Biotech
Why the PD-L1-high subgroup could be crucial for Summit Therapeutics’ global strategy
Summit shares rise after ivonescimab delivers 30.8-month survival versus 22.6 months for pembrolizumab in China’s HARMONi-2 trial.
Pharma & Biotech
Lancet Oncology publishes Summit’s global ivonescimab Phase 3 with PFS at 6.8 months versus 4.4
Global HARMONi data show ivonescimab plus chemotherapy reduced progression or death risk by 48% after third-generation EGFR-TKI failure, while overall survival had not reached statistical significance at the primary analysis.
Pharma & Biotech
Akeso adds B7-H3 to its ADC strategy, but AK157D1 enters a field where a rival is already under FDA review
China has cleared Akeso’s AK157D1 for Phase 1 testing in advanced solid tumors, adding a DXd-class B7-H3 programme to a target already attracting late-stage ADC competition.
Pharma & Biotech
Akeso is betting a dual-target ADC can break through breast cancer’s increasingly crowded treatment field
Akeso starts Phase II testing of AK146D1 plus ivonescimab in advanced breast cancer. See what the dual-target ADC strategy must prove.
Pharma & Biotech
What Akeso’s AK138D1 and ivonescimab combination must prove in advanced NSCLC
Akeso has started a Phase Ib/II lung cancer trial of HER3 ADC AK138D1 with ivonescimab. See what the combination must prove.
Pharma & Biotech
Why Akeso’s gumokimab approval could sharpen China’s psoriasis biologics race
Find out how Akeso’s gumokimab approval could reshape China’s psoriasis biologics market and IL-17 competition.