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
Summit Therapeutics expands ivonescimab development with SMT112-216 trial
Summit Therapeutics opens a global Phase 2 kidney cancer trial testing ivonescimab combinations against established immunotherapy. What comes next?
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
Summit Therapeutics has $690.7m, but one November FDA decision now towers over everything
Summit Therapeutics ends Q2 with $690.7m as ivonescimab approaches an FDA decision and pivotal HARMONi-3 data in late 2026.